VARIOUS SURGICAL OR PATIENT DRAPES

K980210 · Gel-Lite, LLC · KKX · May 15, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980210
• Device Name: VARIOUS SURGICAL OR PATIENT DRAPES
• Applicant: Gel-Lite, LLC
• Product Code: KKX · General, Plastic Surgery
• Decision Date: May 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination.

Device Story

Device consists of nonwoven fabric or polyethylene film drapes used as protective patient coverings during surgical procedures; drapes isolate operative site from surrounding area to prevent microbial contamination. Features include adhesive tape for temporary attachment to skin and fluid collection pouches for solid/liquid effluents. Used in clinical settings for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty procedures. Sterilized via gamma radiation. Provides physical barrier to fluid transfer; maintains integrity via tensile strength and puncture resistance. Benefits patient by reducing risk of contamination at surgical site.

Clinical Evidence

Bench testing only. Data includes physical property testing (impermeability, tensile strength, puncture resistance) and flammability testing (16 CFR Part 1610). Biocompatibility testing performed in conformance with ISO 10993-10 confirmed materials are non-irritating and non-sensitizing.

Technological Characteristics

Materials: Nonwoven fabrics, polyethylene film, foam laminate, and skin-contacting adhesives. Barrier principle: Impermeable to fluids. Sterilization: Gamma radiation (ISO 11137). Biocompatibility: ISO 10993-10 compliant. Flammability: Class 1 and 2 (16 CFR Part 1610).

Indications for Use

Indicated for patients undergoing Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty surgical procedures requiring a protective barrier to isolate the incision site from contamination.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Invotec International, Inc. Ear Drape (K911039)

Submission Summary (Full Text)

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MAY 1 5 1998

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## 510(k) SUMMARY

| Submitted by: | DEKA Medical, Inc.<br>4820 Executive Park Court, Suite 110<br>Jacksonville, FL 32216 |
|----------------------|--------------------------------------------------------------------------------------|
| Telephone: | [phone]<br>[phone] (FAX) |
| Contact: | Donald G. White |
| Prepared: | 20 January 1998 (Original Submission)<br>28 April 1998 (revised) |
| Proprietary Name: | Patient Drape |
| Common Name: | Surgical Drape or Patient Drape |
| Classification Name: | Drape, Surgical (21 CFR Part 878.4370) |
| Predicate Device: | Invotec International, Inc. Ear Drape<br>(K911039) |

Device Description: DEKA Medical, Inc., will market Surgical Drapes composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluid transfer across them, thus function to isolate the operative site from the surrounding area. Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The DEKA Medical Surgical Drapes will be subjected to a sterilizing dose of gamma radiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6.

Intended Use: The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination. The target population for both the Invotec Ear Drape and the DEKA Medical Surgical Drapes is patients undergoing Otological procedures. In addition the DEKA Medical Surgical

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Drapes are intended for patients undergoing Ophthalmic, Heart & Neurological. Peri/OB. Arthroscopic, and Specialty Procedures. Substantial equivalence is evidenced by the fact that both the Invotec Ear Drape and the DEKA Medical Surgical Drapes are constructed of nonwoven fabric or polyethylene film. Data provided by suppliers of these materials for the DEKA Medical Surgical Drapes indicate they are impermeable to fluids and are compatible for skin contact applications.

The primary difference between the Invotec Ear Drape and the DEKA Medical Surgical Drapes is the method of sterilization. The Invotec Ear Drape is Ethylene Oxide sterilized whereas the DEKA Medical Surgical Drapes are gamma irradiation sterilized. However, sterility is assured by either method and the DEKA Medical Surgical drapes have been found to be biocompatible following gamma irradiation.

Technological Comparison: A comparison of the technological characteristics of the DEKA Medical, Inc., surgical drape and the Invotec ear drape is indicated in the table below:

| Characteristic | Invotec Ear Drape | DEKA Surgical Drapes |
|---------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Otological Procedures | Otological, Ophthalmic,<br>Heart & Neurological,<br>OB/GYN, and<br>Arthroscopic Procedures |
| Target Population | Otological Surgery<br>candidates | Candidates for<br>Otological, Opthalmic,<br>Heart & Neurological,<br>Peri/OB, and<br>Arthroscopic Procedures |
| Design | Isolates ear surgical site<br>from surrounding area<br>through the use of<br>barrier materials | Isolates ear, eye, chest,<br>abdomen, pelvic, or<br>extremities from<br>surrounding area<br>depending on drape<br>through the use of<br>barrier materials.<br>Incorporates fluid<br>collection attachments<br>depending on drape. |
| Materials | Polyethylene film or<br>nonwoven fabrics | Nonwoven fabrics,<br>Polyethylene film, |

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| Characteristic | Invotec Ear Drape | DEKA Surgical Drapes |
|------------------|---------------------|---------------------------------------------------------------|
| | adhesive tapes | adhesive tapes |
| Performance | See adjoining table | See adjoining table |
| Sterility | Per ISO 11135 | Per ISO 11137 |
| Biocompatibility | Skin contact only | None irritating or<br>sensitizing to ISO<br>10993-10 Standard |

## Nonclinical Test Data

Physical properties data was obtained from suppliers of DEKA Medical Surgical Drape nonwoven fabric, polyethylene films, and skin contacting adhesives. These data show the Dexter nonwoven fabric and the various thickness of polyethylene film are impermeable to liquids for the duration of the indicated procedures (see Table below). Tensile strength and puncture resistance data indicate these materials have sufficient tensile strength and puncture resistance to maintain barrier integrity during indicated procedures. The DEKA Medical nonwoven fabric and foam laminate pass the 16 CFR Part 1610 Flammability Classification (Flammability Class 1 and 2). No Classification data is available on DEKA Medical Surqical Drape polyethylene film. However, the flammability of various polyethylene films is comparable and would not be substantially different in flammability from the Invotec Ear Drape polyethylene film. Biocompatibility testing in conformance to ISO 10993-10 of a gamma sterilized Composite Patient Drape shows the drapes to be nonirritating and nonsensitizing.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald G. White ·Director QA/RA Deka™ Medical, Incorporated 4820 Executive Park Court, Suite 110 Jacksonbville, Florida 32216

Re : K980210 Trade Name: Various Surqical or Patient Drapes Requlatory Class: II Product Code: KKX Dated: April 29, 1998 Received: April 30, 1998

Dear Mr. White:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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

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Page 2 - Mr. White

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 regulation entitled, "Misbranding by reference to premarket notification"(21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K980210 Device Name: Various Surgical OR Patrent Drape

## STATEMENT OF INDICATIONS FOR USE

The various surgical or patient drapes manufactured by DEKA Medical, Inc.,
The various surgical controllerister in interested to used as a protective The Vanous surgical or patient urapos naterials intended to be used as a protective
consist of natural or synthetic materials intended to be used of the dra consist of natural or synthelic intenstals intended to to arous of the drapes
patient covering during surgical procedures. The primary purpose of the drapes patient covering during surgical procedures: " The philiasy for ther contamination.
is to isolate a site of surgical incision from microbial or other contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohm S. Lin

(Division Sign-Off) Division of Dental, Info and General Hosp 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)