(122 days)
The devices are intended 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:
- Stainless Steel Handle (non-ratcheted)
- Stainless Steel Pull Rod attached to a stainless steel jaw
- Insulation material composed of PPSU (PolyPhenylSulfone)
Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist 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.
The provided text describes a 510(k) pre-market notification for Miltex Laparoscopic Instruments, which primarily focuses on establishing substantial equivalence to a predicate device. This type of submission generally does not include extensive performance studies with detailed acceptance criteria as would be expected for novel or high-risk devices requiring clinical trials.
Based on the provided text, here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Explicitly Stated/Implied) | Reported Device Performance |
|---|---|
| Materials commonly used in medical devices with a long history of biocompatibility. | Patient contact materials (stainless steel 420) are compliant with a long history of biocompatibility. |
| Compliance with EN 60601-2-18 for safety of endoscopic equipment. | Subject devices can withstand EN 60601-2-18: Type 2: Particular requirements for the safety of endoscopic equipment. |
| Substantial equivalence to predicate device (CooperSurgical Laparoscopic Instruments - K021237) in indications for use, material (stainless steel jaws), non-sterile sale, and monopolar electrocautery capability. | The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability. The main differences are a change in the material for the handle (stainless steel versus carbon fiber). The submitter concludes that the device is as safe and effective. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This submission is for laparoscopic instruments, and performance is demonstrated through material compliance and comparison to a predicate device, not typically through a test set of data with a specific sample size as would be found in an AI/software device.
- Data Provenance: Not applicable/Not provided. The data provided relates to material specifications and compliance with standards, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment with experts is not relevant for this type of device submission.
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
7. The type of ground truth used:
- Not applicable/Not provided. The "ground truth" in this context is based on engineering specifications, material standards, and functional comparison to a legally marketed predicate device.
8. The sample size for the training set:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
Study Proving Acceptance Criteria:
The "study" or justification for meeting acceptance criteria in this 510(k) submission is based on the following:
- Material Biocompatibility: "The patient contact materials are commonly used in medical materials. The stainless steel 420 is compliant with the long history of biocompatibility." This indicates reliance on established knowledge and historical use of the material.
- Compliance with Safety Standards: "The subject devices can withstand EN 60601-2-18: Type 2: Particular requirements for the safety of endoscopic equipment." This demonstrates the device's adherence to relevant international safety standards for endoscopic equipment.
- Substantial Equivalence to Predicate Device: The core of a 510(k) submission. The applicant states: "The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability." The main difference (handle material) is presented as a minor change that does not affect safety or effectiveness. The conclusion explicitly states that "the subject devices are as safe and effective as the predicate devices."
In summary, for these laparoscopic instruments, the "acceptance criteria" are met by demonstrating that the device uses biocompatible materials, complies with relevant safety standards, and is substantially equivalent in design, function, and intended use to an already legally marketed device (the predicate device). There are no clinical studies or AI performance metrics involved in this type of submission document.
§ 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.