(357 days)
The devices are designed to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
These devices represent a family of monopolar laparoscopic instruments that consist of:
- Carbon Fiber Handle (ratcheted and non-ratcheted)
- Stainless Steel Pull Rod attached to a stainless steel jaw
- Insulation material composed of PPSU (PolyPhenylSulfone).
There are various configurations of the jaw (graspers, cutters, and dissectors) to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag that contains the Directions for Use (DFU).
The provided text describes CooperSurgical Laparoscopic Instruments (K021237), which are monopolar laparoscopic instruments. However, it does not include information about a study proving the device meets specific acceptance criteria based on performance data in the way a medical AI/software device would.
The document primarily focuses on demonstrating substantial equivalence to predicate devices. This is a different regulatory pathway than proving performance against specific quantitative acceptance criteria through a clinical or algorithmic study.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set details) are not applicable or cannot be answered from this submission, as they pertain to performance studies not conducted for this type of device submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Biocompatibility of patient contact materials | Patient contact materials are commonly used in medical devices and have a long history of biocompatibility. |
| Corrosion Resistance of stainless steel 420 | Stainless steel 420 is compliant with DIN 17442 standard for Corrosion Resistant Steels for Medical Equipment. |
| Dielectric Constant (withstand voltage) | Devices can withstand 7500 Volts and are compliant with the standard DIN 53483 Dielectric Constant. |
| Overall Substantial Equivalence | "Changes are minor and conclude that the subject devices are as safe and effective as the predicate devices." (This is the primary "performance" claim for this type of submission.) |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for traditional medical instruments, not an AI/software device requiring a test set for performance evaluation. The "performance data" provided relates to material specifications and electrical safety, not a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No experts were used to establish ground truth for a test set in the context of an AI/software device. The "ground truth" for this device relates to established engineering standards (DIN 17442, DIN 53483) and historical biocompatibility of materials.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. An MRMC study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to these surgical instruments.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device. Standalone performance is not applicable.
7. The type of ground truth used
- For the material and electrical properties:
- Established engineering standards: DIN 17442 (for corrosion resistance) and DIN 53483 (for dielectric constant).
- Historical evidence/general knowledge: "long history of biocompatibility" for patient contact materials.
- For the overall device: Substantial equivalence to predicate devices based on technological characteristics and intended use.
8. The sample size for the training set
- Not Applicable. There is no training set as this is not an AI/software device that learns from data.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set.
§ 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.