SABRESOURCE DRAPE

K041846 · Minrad, Inc. · KKX · Aug 26, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041846
• Device Name: SABRESOURCE DRAPE
• Applicant: Minrad, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.

Device Story

Sterile plastic bag designed to cover SabreSource™ targeting system; features optically clear, hemispherical window (30 cm radius) for undistorted laser beam transmission. Used in operating rooms or surgical environments; protects equipment from patient fluids/liquids during procedures involving x-ray machine-mounted targeting systems. Prevents device contamination; maintains sterile field.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile plastic bag; optically clear hemispherical window (30 cm radius) for laser transmission. Designed for equipment protection.

Indications for Use

Indicated for use in an operating room environment to cover the SabreSource™ device when mounted on an x-ray machine to protect the device from contamination with patient fluids or liquids.

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

• Microtek Medical, Inc. - Large C-Arm Drape Product Number 4982
• Contour Fabricators Number CFI-600, equipment drape
• MINRAD INC. - DRTSTM Drape

Submission Summary (Full Text)

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UG 2 6 2004

# K041846 510(k) SUMMARY MINRAD INC. SabreSource™ Drape

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

## Contact Person

John McNeirney MINRAD INC. 847 Main Street Buffalo, NY 14203 Phone: [phone] Facsimile: [phone] Date Prepared December 19, 2003

# Name of Device and Name/Address of Sponsor

## SabreSource™ Drape

MINRAD INC. 847 Main Street Buffalo, NY 14203

#### Device Name

| Trade Name: | SabreSource™ Drape |
|----------------------|-----------------------------------------------------------------------------------------|
| Common Names: | Equipment Cover, Equipment Drape |
| Classification Name: | Light Beam Patient Position Indicator Accessory<br>Surgical Drape and Drape Accessories |

## Predicate Devices

1) Microtek Medical, Inc. - Large C-Arm Drape Product Number 4982 2) Contour Fabricators Number CFI-600, equipment drape 3) MINRAD INC. - DRTSTM Drape

## Intended Use

The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments.

## Technological Characteristics and Substantial Equivalence

The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient. Any dimensional or design differences between the SabreSource™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with three stylized lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 6 2004

Mr. John McNeirney Vice President and CTO MINRAD, Inc. 847 Main Street BUFFALO NY 14203

Re: K041846 Trade/Device Name: SabreSource™ Drape Model 301900 Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories

Regulatory Class: II Product Code: 79 KKX Dated: July 28, 2004 Received: July 30, 2004

Dear Mr. McNeirney:

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 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.

1f 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 requirements as set forth 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter watification. The FDA finding of substantial equivalence of your device to a legally promaticated 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), please 11 you deem office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Other or other world to premarket notification" (21CFR Part 807.97) you may obtain. 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,

Nancy C. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SabreSource™ Drape Indications for Use Statement

# K041846

## 510(k) Number (if known):

This is an initial submission; no 510(k) number has been issued.

## Device Name:

SabreSource™ Drape

#### Indications for Use:

The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use _ (Per 21 C.F.R. 801.109)

(Division Sign-Off

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)