(32 days)
The Applied Laparoscopic Monopolar Scissors is indicated for use in gynecologic and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.
The Applied Laparoscopic Monopolar Scissors consists of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilized for monolpolar cautery when attached to standard monopolar cautery cables and their generators. The disposable shaft consists of a stainless steel outer shaft housing an actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, 38cm, and 45cm. The reusable handle is comprised of Polyphenylsulfone male and female handles with various stainless connectors and contacts. The reusable handle will be supplied non-sterile. The handle includes a 360° rotation knob for user convenience. The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and re-sterilized.
The provided text describes a 510(k) premarket notification for a medical device (Laparoscopic Monopolar Scissors), and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on specific performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for the device itself.
Here's why and what information is actually available:
- Acceptance Criteria & Device Performance: The document does not define specific performance acceptance criteria (e.g., maximum force to cut, impedance levels after X uses) for the Laparoscopic Monopolar Scissors, nor does it report the device's performance against such criteria. The entire submission is based on substantial equivalence.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Since a study comparing the device's performance against acceptance criteria is not described, none of this information is present.
What the document does provide is evidence of compliance with regulatory and manufacturing standards, and a comparison to a predicate device:
- Substantial Equivalence: The primary "study" or justification for clearance is the claim of substantial equivalence to the United States Surgical Auto Suture® Endoscopic Scissors (K903206) in intended use, design, use methodology, and similar materials.
- Biocompatibility: The device is stated to be "in compliance with ISO 10993 for Biocompatibility."
- Sterilization Validation (Shaft):
- Method: 100% Ethylene Oxide (EO) sterilization.
- Acceptance Criteria/Performance: Provides a sterility assurance level (SAL) of 10⁻⁶.
- Validation: Uses three half-cycle validation runs with biological indicators (Bacillus atrophaus var. niger with a population of 10⁶) and temperature monitors.
- Residue Levels: Complies with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices (20 mg ethylene oxide and 12 mg ethylene chlorohydrin).
- Sterilization Validation (Handle):
- Method: Steam sterilization by the user.
- Acceptance Criteria/Performance: Provides a sterility assurance level (SAL) of 10⁻⁶.
- Validation: Based on AAMI TIR No. 12 - 1994 and three sterilization cycles at one-half the exposure time using Bacillus stearothermophilus spore strips or inoculum.
- Design Controls: Manufacturer (Applied Medical) followed design control regulations per 21 CFR § 820.30 and conducted a Design Risk Assessment Profile in accordance with internal SOPs, EN 1441, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30. Validation and verification activities addressed the risk profile, including methods, tests, and acceptance criteria (though these specific criteria are not detailed in the document).
In summary, while the document confirms that validation and verification activities included acceptance criteria, it does not detail those criteria or the performance results against them in a format comparable to the request for an AI/diagnostic device study.
Hypothetical Table based on the limited information that resembles acceptance criteria, if it were for a diagnostic device:
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Sterility Assurance Level (EO sterilized shaft) | 10⁻⁶ SAL |
| Sterility Assurance Level (Steam sterilized handle) | 10⁻⁶ SAL |
| Ethylene Oxide Residue (shaft) | ≤ 20 mg (in compliance with ANSI/AAMI/ISO 10993-7:1995) |
| Ethylene Chlorohydrin Residue (shaft) | ≤ 12 mg (in compliance with ANSI/AAMI/ISO 10993-7:1995) |
| Biocompatibility | In compliance with ISO 10993 |
| Design Control Compliance | Follows 21 CFR § 820.30, EN 1441, ISO 9001/ISO 13485, AAMI/ISO TIR 14971 |
| Substantial Equivalence | Equivalent in intended use, design, use methodology, materials to K903206 |
As noted, the remaining points of your request are not applicable as this document details a 510(k) clearance based on substantial equivalence for a physical surgical tool, not an AI or diagnostic device with specific performance metrics defined by a clinical study.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. 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 preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the 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.