(52 days)
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No
The device description and performance studies focus on the physical properties and biocompatibility of a simple skin protection pad, with no mention of AI or ML technologies.
No
The device is described as protecting the skin from abrasion, frictional heat, or minor damage during a surgical procedure, and it does not treat or cure a disease or condition.
No
The device is described as a skin protection pad designed to prevent skin damage during surgery, not to diagnose any condition. Its intended use focuses on physical protection, and the performance studies evaluate biocompatibility, not diagnostic accuracy.
No
The device description clearly outlines physical components (pad substrate, pad lining, adhesive, backing material) and packaging, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the patient's skin during a surgical procedure. This is a physical barrier and protective function applied directly to the patient's body.
- Device Description: The description details a physical pad with adhesive and packaging. There is no mention of reagents, samples of human origin (like blood, urine, or tissue), or any process for analyzing such samples to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition.
- Using reagents or calibrators.
- Performing tests in vitro (outside the body).
The device is clearly intended for in vivo use (on the living body) as a protective barrier during surgery.
N/A
Intended Use / 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. It is intended to adhere to the patient's skin around the incision site.
Product codes
GCJ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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.
1
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. 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.
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).
2
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