Definition: To Distend The Uterus With Saline And Maintain Distension Through Closed-loop Recirculation Of Filtered Distension Fluid During Diagnostic And Operative Hysteroscopy. It Is Also Intended For Cutting And Coagulation Of Uterine Tissue.
| Device Type ID | 4082 |
| Device Name | Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar |
| Physical State | Controller That Provides Bipolar Frequency And Fluid Management Through The Use Of Two Peristaltic Pumps. Bipolar Frequency Is Delivered To A Bipolar Electrosurgical Resection Device. Fluid Management Is Provided Via Infusion/aspiration Through Tubin |
| Technical Method | A Closed-loop System With A Preset Volume Of Saline Available For Use During Hysteroscopy. Fluid Is Continuously Recirculated By Pumps From A 3L Saline Bag, Into The Uterus, Through A Tissue Trap And A Filter And Then Back To The Bag. Cutting And Coa |
| Target Area | Uterus |
| Regulation Description | Closed Loop Hysteroscopic Insufflator With Cutter-coagulator. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.1710 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4082 |
| Device | Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar |
| Product Code | PGT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Closed Loop Hysteroscopic Insufflator With Cutter-coagulator. |
| CFR Regulation Number | 884.1710 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORPORATION | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Pressure Sensor | 46 |
Device Inoperable | 33 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Communication Or Transmission Problem | 12 |
Device Packaging Compromised | 4 |
Unsealed Device Packaging | 3 |
Connection Problem | 3 |
Electrical /Electronic Property Problem | 3 |
Seal | 3 |
Contamination During Use | 2 |
Component Or Accessory Incompatibility | 2 |
Leak / Splash | 2 |
Device-Device Incompatibility | 2 |
Controller | 2 |
Fluid Leak | 1 |
Thermal Decomposition Of Device | 1 |
Device Subassembly | 1 |
Material Separation | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Delivered As Unsterile Product | 1 |
| Total Device Problems | 138 |