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.

Device Description

The subject instruments include a full line of laparoscopic manual surgical instruments and accessories for various laparoscopic intended uses.

AI/ML Overview

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.

Summary

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K080257

MAY 22 2008

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR

MicroFrance Laparoscopic Manual Surgical Instruments, various

510(k) Owner	Medtronic Xomed, Inc.
	6743 Southpoint Drive North
	Jacksonville, Florida 32216-0980 USA
	904-296-9600
	904-296-2386 (FAX)
Contact Name	Jayme Wilson
	Senior Regulatory Affairs Specialist
	Medtronic Xomed, Inc.
Date Summary Prepared	January 30, 2008
Proprietary Name	MicroFrance Laparoscopic Instruments, various
Common Name	Laparoscopic Instruments, General and Plastic Surgery
Classification Name	Laparoscope accessories, Endoscopic procedures(21 CFR 876.1500, Product Code GCJ, Class II)Laparoscope accessories, Gynecologic procedures(21 CFR 884.1720, Product Code HET, Class I)

Marketed device claiming equivalence to

MicroFrance Laparoscopic Instruments are equivalent to Geister Medizintechnik GMBH GIMMI ALPHA Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic Accessories - K012660, Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, Scissors - K991928, MicroFrance Electrosurgical Instruments - K993655, and MicroFrance Laparoscopic Manual Surgical Instruments for gynecological use.

Device Description

The subject instruments include a full line of laparoscopic manual surgical instruments and accessories for various laparoscopic intended uses.

Intended Use

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		Comparison to Marketed Devices
	Medtronic Xomed, Inc.MicroFrance Laparoscopic Manual Surgical Instruments, variousPROPOSED	Medtronic Xomed, Inc.MicroFrance Laparoscopic Manual Surgical Instruments for Gynecologic Use(Class I exempt)	MicroFrance Electrosurgical Instruments, VariousK993655	Geister Medizintechnik GMBH GIMMI ALPHA Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic AccessoriesK012660	Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, ScissorsK991928.
Intended Use	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 manual surgical instruments are intended for use in various Gynecological laparoscopic procedures. The instruments enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, or cut internal tissue or organs.	The electrosurgical instruments are intended to remove tissue and control bleeding. The instruments consist of scissors, forceps, and probes available in configurations for laparoscopic/ endoscopic access and open field surgery.	Intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures.	The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, dissecting, coagulating and suturing).
Material	Stainless SteelTungsten (Needle Holders)Insulation material	Stainless SteelInsulation material	Stainless SteelInsulation material	Stainless SteelInsulation material	Stainless SteelInsulation material
DiameterLengths	3mm to 12mmTube, various from 25cm to 60cm	3mm, 5mm, 10mmTube, various from 25cm to 45cm	3mm, 5mm, 10mmTube, various from 25cm to 45cm	5mmTube, various, from 25cm to 38cm	3mm, 5mm, 10mm, 11mmTube various, 32cm to 45cm
Types of Devices	Dismantable and Non-dismantableInsulated and non-insulatedForceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knives, Hooks, Knot Guides, Retractors, and Blades	Dismantable and Non-dismantableInsulated and non-insulatedForceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Hook, Knot Guide, and Blades	Dismantable and Non-dismantable Insulated scissors, forceps, and probes	Dismantable and Non-dismantableInsulated and non-insulatedForceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knife, Hook, Knot Guide, Retractors, Divers and Blades	Modular and Non-Take ApartInsulated and non-insulatedDissectors, Forceps, Graspers, Scissors, Needle Holders, Retractors
Sterility	Distributed non-sterile	Distributed non-sterile	Distributed non-sterile	Distributed non-sterile	Distributed non-sterile
Reusable	Yes	Yes	Yes	Yes	Yes

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2008

Medtronic Xomed, Inc. % Jayme Wilson Senior Regulatory Afairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K080257

Trade/Device Name: MicroFrance Laparoscopic Manual Surgical Instruments, various Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET, GCJ Dated: April 17, 2008 Received: May 6, 2008

Dear Jayme Wilson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Jayme Wilson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Mullison

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K080257/S1

Device Name: MicroFrance Laparoscopic Manual Surgical Instruments, various

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nephrol for man

Division of General, Restorative, and Neurological Devices

510(k) Number K080257

Regulation Number and Section

§ 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.