MEDSURG EQUIPMENT COVERS

K014239 · International Medsurg Connection · MMP · Feb 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014239
• Device Name: MEDSURG EQUIPMENT COVERS
• Applicant: International Medsurg Connection
• Product Code: MMP · General, Plastic Surgery
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

These equipment covers are equipment drapes or drape accessories 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.

Device Story

International Medsurg Connections Equipment Covers are polyethylene drapes or drape accessories; used as protective patient coverings to isolate surgical incision sites from microbial and other contamination. Available in sterile and non-sterile configurations. Used in clinical settings to maintain sterile fields. Healthcare providers apply the covers over equipment to prevent cross-contamination. Benefits include reduced risk of surgical site infection through physical barrier protection.

Clinical Evidence

Bench testing only. Testing included flammability (16 CFR 1610), hydrostatic pressure/fluid penetration (AATCC 127-1989), grab tensile (ASTM D882-91), and tear resistance/strip tensile (ASTM D1424-96).

Technological Characteristics

Polyethylene material construction. Physical properties verified via ASTM D882-91 (grab tensile) and ASTM D1424-96 (tear resistance). Fluid barrier performance verified via AATCC 127-1989. Flammability tested per 16 CFR 1610. Available in sterile and non-sterile versions.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during medical procedures.

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

• Cover-All, Drape-It-All - Pinnacle Products, Inc. (K962288)
• Equipment Covers - United States Surgical (K961699)
• Sterile Equipment Covers - Custom Medical Products, Ltd. (K931417)

Submission Summary (Full Text)

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K01423)

Attachment D

### 510(k) Summary

# FEB 1 9 2002

#### INTERNATIONAL MEDSURG CONNECTIONS EQUIPMENT COVERS

| Manufacturer: | International Medsurg Connections, Inc.<br>1000 E. Woodfield Road, Suite 102<br>Schaumburg, Illinois 60173-5921 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Michele Vovolka<br>P.O. Box 848<br>Grayslake, Illinois 60030 |
| Telephone: | [phone] |
| Date Summary Prepared: | December 17, 2001 |
| Product Trade Name: | International Medsurg Connections Equipment Covers |
| Common Name: | Equipment Covers |
| Classification: | Non-classified |

#### Predicate Devices:

Cover-All, Drape-It-All - Pinnacle Products, Inc. - K962288 Equipment Covers - United States Surgical - K961699 Sterile Equipment Covers - Custom Medical Products, Ltd. - K931417

- The International Medsurg Connections equipment covers are made of Description: polyethylene. The covers are offered sterile and non-sterile.
- Intended Use: These equipment covers are equipment drapes or drape accessories 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.

#### Substantial Equivalence:

The International Medsurg Connections Equipment Covers are substantially equivalent to the Pinnacle Products, United States Surgical, and Custom Medical Product equipment covers in that they provide the following characteristics:

- Intended use is the same
- Size, configuration, color are similar
- Made of polyethylene
- Physical properties are similar

CONFIDENTIAL

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# Attachment D

# 510(k) Summary

## Summary of Testing:

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

.

. The following tests were performed on the finished Medsurg equipment covers:

| Test Method | Standard Used |
|---------------------------------------------------|----------------------------|
| Flammability Testing, Class 1 | 16 CFR 1610 |
| Hyrostatic Pressure Test - Fluid Penetration Test | AATCC Test Method 127-1989 |
| Grab Tensile | ASTM D882-91 |
| Tear Resistance - Strip Tensile | ASTM D1424-96 |

## CONFIDENTIAL

:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular border.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

International MedSurg Connection Regulatory Consultant C/O Ms. Michele H. Vovolka Vantage Consulting International Limited P.O. Box 848 Grayslake, Illinois 60030

Re: K014239

Trade/Device Name: International Medsurg Connections Equipment Covers Regulation Number: 878.4370 Regulation Name: Equipment Covers Regulatory Class: Unclassified and II Product Code: MMP and KXX Dated: December 17, 2001 Received: December 26, 2001

FEB 1 9 2002

Dear Ms. Vovolka:

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 approvisions 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

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#### Page 2 - Ms. Vovolka

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the 100 cm.) - 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 and ifbang (21 er read 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.

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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## Attachment E

510(k) Number (if known):

K014239

International Medsurg Connections Equipment Covers Device Name:

Indications For Use:

These equipment covers are equipment drapes or drapes and of natural or synthetic These equipment covers are equipment of are accessons final of the color control of the colors
materials intended to be used as protective patient covering such as to isolate materials intended to oc and other contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Division Sign-Off)

Division of Dental, Infection Control, And General Hospital Devices

KO14239

510(k) Number

### CONFIDENTIAL

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