(431 days)
The Koh Colpotomizer™ System, comprised of the Koh Cup™ Vaginal Fornices Delineator and Colpo-Pneumo Occluder, are accessories to the RUMI uterine manipulator. K932115. These accessories are designed to attach to the RUMI uterine manipulator device and are intended to be used by the surgeon as an anatomical marker to locate the position of the vaginal fornices as viewed through uterine tissue from within the abdominal cavity (intracorporeal), and also to maintain pneumoperitoneum during laparoscopic surgical procedures in which a colpotomy or culdotomy incision is made. The Koh Colpotomizer™ System is used in conjunction with the RUMI uterine manipulator device.
The Koh Colpotomizer™ System consists of two accessory devices: The Koh Cup™ Vaginal Fornices Delineator, and a Colpo-Pneumo Occluder, each of which are specifically designed to attach to and be used with the RUMI uterine manipulator device. The CooperSurgical RUMI device as described in K932115 is intended to be used as a uterine manipulator during pelvic laparoscopic procedures.
The Koh Cup™ Vaginal Fornices Delineator is a plastic cup-shaped device which fits over the distal end of the RUMI disposable tip and firmly attaches to the tip base. When attached to the RUMI, the Koh Cup™ becomes an extension of the uterine manipulator tip and is thus able to articulate up or down as the uterine manipulator is operated in the normal fashion.
With the RUMI and Koh Cup™ properly positioned inside the patient, the outer rim of the Koh Cup™ will surround the cervix and be located in the vaginal fornices. In this position the rim of the Koh Cup™ will extend or "stretch" the vaginal fornices, thus allowing the surgeon an anatomical marker to conveniently locate the position of the fornix when viewed from an intracorporeal position. The kit will include Koh Cups™ in three outer rim diameter sizes: 3.0 cm, 3.5 cm, and 4.5 cm. The surgeon or nurse will make the selection of the appropriate size Koh Cup™ by visual inspection of the cervix at the time of instrument insertion in the patient.
The Pneumo Occluder consists of a condom-like silicone sleeve whose proximal end is folded back and attached to the main shaft of the sleeve in order to form an inflatable cavity (the "occluding balloon"). Attached to the occluding balloon is an inflation catheter that is available to the surgeon outside the patient's body for inflating the occluding balloon during surgery. The occluding balloon should be inflated until it fully contacts the perimeter wall of the vagina. This creates a pressure barrier which prevents the pneumoperitoneum from leaking out of the patient through the vagina once the colpotomy or culdotomy incision is made. This occluding property allows the surgeon to maintain proper pneumoperitoneum pressure and continue the laparoscopic procedure.
In addition to the Koh Cup™ and Colpo-Pneumo Occluder, a 60 cc syringe is included in the proposed kit to be used for filling the occluding balloon with saline. Typically the occluding balloon will require inflation of approximately 100 cc of saline in order to adequately occlude the vagina.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cooper Surgical Koh Colpotomizer System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Withstand inflation with 250 cc of water. | Passed static burst test: All balloons inflated with 250 cc of water for 12 hours. |
| Maintain inflation for at least 30 minutes. | Passed static burst test: All balloons held 250 cc of water for over 30 minutes (and up to 12 hours) without bursting. (Implied: No loss of water within 30 minutes, as it was maintained for 12 hours). |
| No bursting at specified time intervals. | Passed static burst test: "None of the balloons burst at 10 minutes. 30 minutes or 12 hour time frames." |
| Adequate design margin. | "This is a factor of 2.5 times the inflation generally needed for use in surgery and has been found in practice to be an adequate design margin." (This is a statement of adequacy based on the performance relative to expected use, not a direct performance metric against a specific threshold beyond the 250cc test.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "the balloons" implying more than one, but not a specific number.
- Data Provenance: Not specified. It appears to be an internal laboratory test ("static burst test"). There is no mention of country of origin or whether it was retrospective or prospective in a clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The "ground truth" for this performance test (static burst test) is based on the physical integrity of the device under controlled pressure, not a clinical interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. This was a physical performance test, not a clinical assessment requiring adjudication. The pass/fail criteria were objective (burst vs. no burst, hold volume vs. lose volume).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a benchtop static burst test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a hardware device, not an AI algorithm. The performance test is of the physical device's mechanical integrity.
7. The Type of Ground Truth Used
- Engineered Performance Standard: The "ground truth" for this test is the device's ability to mechanically withstand a specified pressure (250 cc of water equivalent pressure) for a defined duration without failure (bursting or loss of water).
8. The Sample Size for the Training Set
- Not applicable. This is a hardware device, not an AI model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set exists for this type of device.
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.