(112 days)
Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures.
The subject instruments include a full line of laparoscopic manual surgical instruments and accessories for various laparoscopic intended uses.
The provided document (K080257) is a 510(k) premarket notification for MicroFrance Laparoscopic Manual Surgical Instruments, various. This type of submission is for medical devices that aim to demonstrate substantial equivalence to previously legally marketed predicate devices, rather than establishing efficacy through clinical trials. As such, direct acceptance criteria and a study proving device performance in the manner typically seen for novel diagnostic or treatment devices (e.g., AI algorithms) are not presented.
Here's an analysis based on the information provided, addressing the questions as best as possible within the context of a 510(k) for manual surgical instruments:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for manual surgical instruments, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices in terms of:
- Intended Use: The proposed device performing the same medical function as the predicate.
- Technological Characteristics: Similar materials, dimensions, operating principles, and sterility.
- Performance: Implied to be equivalent through the commonality of design and materials, and verification/validation testing (e.g., mechanical strength, corrosion resistance) which is usually summarized rather than detailed in the public 510(k) summary.
Acceptance Criteria (Implied by Substantial Equivalence) & Device Performance (as listed in comparison table)
| Aspect | Implied Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (as per K080257) |
|---|---|---|
| Intended Use | Must be equivalent (or within the scope of) predicates. | "Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures." (Same or broader than predicates) |
| Material | Must be equivalent to predicates. | Stainless Steel, Tungsten (Needle Holders), Insulation material (Equivalent to predicates) |
| Diameter & Lengths | Must be within the range of diameters and lengths of predicates. | 3mm to 12mm; Tube, various from 25cm to 60cm (Covers or exceeds predicate ranges) |
| Types of Devices | Must include similar types of instruments as predicates. | Dismantable and Non-dismantable, Insulated and non-insulated, Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knives, Hooks, Knot Guides, Retractors, and Blades (Broadly comparable to predicates) |
| Sterility | Must be distributed in the same sterile/non-sterile state as predicates. | Distributed non-sterile (Matches predicates) |
| Reusable | Must share the same reusability characteristic as predicates. | Yes (Matches predicates) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the 510(k) summary for these manual surgical instruments. 510(k) submissions for non-active, non-diagnostic instruments typically rely on engineering testing, material specifications, and comparison to predicates rather than clinical "test sets" or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth establishment by experts for a test set is relevant for diagnostic devices or those involving interpretation, not for manual surgical instruments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in studies involving expert review of outputs (e.g., images for AI), which is not part of a 510(k) for manual surgical tools.
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
This information is not applicable. This type of study is relevant for AI-powered diagnostic or decision-support tools, not for manual surgical instruments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. Ground truth is not typically established for manual surgical instruments in the same way it is for diagnostic or AI devices. The "ground truth" for these instruments is their ability to perform their mechanical function reliably and safely, which is verified through design verification and validation testing (e.g., mechanical strength, material biocompatibility, cleaning/sterilization validation), rather than clinical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set
This information is not applicable. There is no "training set" for manual surgical instruments.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for manual surgical instruments.
Summary for K080257:
This 510(k) submission successfully demonstrated substantial equivalence of the MicroFrance Laparoscopic Manual Surgical Instruments to multiple predicate devices. The basis for this determination was:
- Identical Intended Use: The proposed instruments are for general laparoscopic and endoscopic procedures, intended to scrape, cut, grasp, hold, remove, or manipulate tissue, which aligns with or expands upon the intended uses of the predicate devices.
- Similar Technological Characteristics: The materials (stainless steel, tungsten, insulation), dimensions (diameter, lengths), types of devices (forceps, scissors, etc.), sterility (distributed non-sterile), and reusability are all comparable to the cited predicate devices.
- Performance: While detailed performance data from specific studies is not included in the public summary, the claim of substantial equivalence implies that the instruments meet established performance standards for such devices (e.g., mechanical strength, biocompatibility, cleaning/sterilization effectiveness) that are consistent with the predicate devices. The FDA's clearance (MAY 22 2008) indicates that Medtronic Xomed, Inc. provided sufficient information to support this claim to the agency.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.