MENTOR SKIN PROTECTION PAD

K980050 · Mentor Corp. · GCJ · Feb 27, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980050
• Device Name: MENTOR SKIN PROTECTION PAD
• Applicant: Mentor Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Skin protection pad designed for surgical use; adheres to patient skin around incision site. Protects against abrasion and frictional heat. Composed of rayon/polypropylene substrate, polyethylene lining, and pressure-sensitive adhesive. Sterile, single-use device. Used by surgical staff in clinical settings.

Clinical Evidence

No clinical data. Bench testing included biocompatibility studies: guinea pig sensitization (closed patch method), rabbit skin irritation, and ISO agarose overlay cytotoxicity test (L-929 mouse fibroblast cell line). Results showed no sensitization, no irritation, and no toxicity greater than USP grade 2.

Technological Characteristics

Materials: rayon and polypropylene substrate, polyethylene lining, double-coated pressure-sensitive adhesive. Form factor: rectangular or semicircular pads. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients undergoing surgical procedures to protect skin from abrasion, frictional heat, or minor damage at the incision site.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Guyuron Endoscopic Access Device

Submission Summary (Full Text)

{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: | [phone] |
|------------|----------------|
| FAX: | [phone] |

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 < 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.

{3}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

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)

OR

Over-The Counter Use

(Optional Format 1-2-96)