The Mentor Skin Protection Pad is used to protect the patient's skin from abrasion, frictional heat, or other minor damage that may be encountered during a surgical procedure. It is intended to adhere to the patient's skin around the incision site.

Device Description

The Skin Protection Pad will be available in two shapes: rectangular and semicircular. It will consist of a pad substrate of rayon and polypropylene, a pad lining of polyethylene, a double-coated pressure sensitive adhesive, and a peel-away backing material with a release system. Three pads will be sealed in a TYVEK pouch. Twelve TYVEK pouches will be packaged in a shelf carton. The Skin Protection Pad is sterile and single-use only.

AI/ML Overview

The provided document describes a 510(k) submission for the Mentor Skin Protection Pad. This submission focuses on establishing substantial equivalence to a predicate device and includes biocompatibility testing. It does not involve an AI or software-as-a-medical-device (SaMD) component. Therefore, many of the requested categories related to AI/algorithm performance and ground truth establishment are not applicable.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No evidence of delayed dermal contact sensitization in guinea pigs	No evidence of causing delayed dermal contact sensitization in the guinea pig.
No irritation on rabbit skin	No irritation was observed on the skin of the rabbits.
No cell lysis or toxicity greater than USP grade of 2 (mild reactivity)	Showed no evidence of causing cell lysis or toxicity greater than a USP grade of 2 (mild reactivity).

2. Sample Size Used for the Test Set and Data Provenance

Sensitization Study (Guinea Pig):
- Sample Size: Not specified (refers to "the guinea pig" generally, implying a standard number used for such tests, but not explicitly stated).
- Data Provenance: Prospective (experiments were performed for this submission). Country of origin is not specified, but the submission is to the U.S. FDA.
Skin Irritation Study (Rabbit):
- Sample Size: Not specified (refers to "the rabbits" generally, implying a standard number used, but not explicitly stated).
- Data Provenance: Prospective. Country of origin not specified.
Cytotoxicity Test (L-929 Mouse Fibroblast Cell Line):
- Sample Size: Not specified (refers to "the L-929 mouse fibroblast cell line"). This usually involves multiple plates/wells in a lab setting.
- Data Provenance: Prospective. Country of origin not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This device is a physical product (skin protection pad), and the testing performed is biocompatibility testing (sensitization, irritation, cytotoxicity). Ground truth for these types of tests is established by laboratory protocols and scientific observation, not by expert consensus interpreting images or clinical data. No "experts" in the sense of clinicians establishing ground truth are involved.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, there is no "adjudication" in the context of clinical interpretation. The results of the biocompatibility tests are objective measurements and observations from the laboratory.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is not an AI/SaMD product. No human readers or AI assistance are involved in its primary function or testing as described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is not an AI algorithm.

7. The Type of Ground Truth Used

Experimental Results/Laboratory Observation:
- For sensitization: Observation of dermal reactions in guinea pigs.
- For irritation: Observation of dermal reactions in rabbits.
- For cytotoxicity: Measurement of cell lysis/toxicity level in a cell line.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As per point 8, there is no training set for this device.

Summary

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R480050

FEB & 7 1998

510(k) SUMMARY MENTOR SKIN PROTECTION PAD

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The assigned 510(k) number is: K980050

Submitter/ Donna A. Crawford Contact Person: Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, CA 93111

Telephone:	(805) 681-6000
FAX:	(805) 681-6004

Date Prepared: January 5, 1998

Device Name and Classification

Proprietary Name: Common Name: Classification Name: Classification:

Mentor Skin Protection Pad Skin Protection Pad Unknown Unknown

Manufacturer

Mentor 3000 Longwater Drive Norwell, MA 02061

Substantial Equivalence Claim

The Mentor Skin Protection Pad is substantially equivalent to the Guyuron Endoscopic Access Device manufactured by Applied Medical Technology, Inc.

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Indications For Use

Device Description

Summary of Testing

The Mentor Skin Protection Pad was tested for biocompatibility as follows. A sensitization study in the guinea pig was performed using the closed patch method. Under conditions of this study, the Mentor Skin Protection Pad showed no evidence of causing delayed dermal contact sensitization in the guinea pig. Also, a skin irritation study was performed in the rabbit. No irritation was observed on the skin of the rabbits. Lastly, a cytotoxicity test using the ISO agarose overlay method in the L-929 mouse fibroblast cell line was performed. The Mentor Skin Protection Pad showed no evidence of causing cell lysis or toxicity greater than a USP grade of 2 (mild reactivity).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a bird. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB < 7 1998

Ms. Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Avenue 93111 Santa Barbara, California

K980050 Re: Mentor Skin Protection Pad Trade Name: Regulatory Class: II Product Code: GCJ Dated: January 5, 1998 Received: January 6, 1998

Dear Ms. Crawford:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Crawford

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to che regulation entification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: MENTOR Skin Protection Pad

Indications For Use:

The Mentor Skin Protection Pad is used to protect the patient's skin from abrasion, frictional heat, or other minor damage that may be encountered during a surgical procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K980050

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

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.