ULTRASOUND SYSTEMS DRAPE

K970885 · Protek Medical Products, Inc. · MMP · Sep 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970885
• Device Name: ULTRASOUND SYSTEMS DRAPE
• Applicant: Protek Medical Products, Inc.
• Product Code: MMP · General, Plastic Surgery
• Decision Date: Sep 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms.

Device Story

Ultrasound System Drape Kit consists of polyethylene drapes designed to cover ultrasound equipment components; specifically monitors, keyboards, floor pedals, and equipment arms. Used in clinical environments to provide a protective barrier for equipment. Operated by healthcare personnel during ultrasound procedures. Benefits include equipment protection and maintenance of sterile or clean environments during diagnostic imaging.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polyethylene drapes; form factor specific to ultrasound equipment components (monitors, keyboards, floor pedals, equipment arms).

Indications for Use

Indicated for use as protective covers for ultrasound equipment components including monitors, keyboards, floor pedals, and equipment arms in clinical settings.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 22 1997

Mr. Rick L. Pruter
President/CEO
PROTEK Medical Products Incorporated
221 E. Market Street, Suite 291
Iowa City, Iowa 52245

Re: K970885
Trade Name: Ultrasound Systems Drape Kit
Regulatory Class: II
Product Code: MMP
Dated: June 20, 1997
Received: July 23, 1997

Dear Mr. Pruter:

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 of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with

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Page 2 - Mr. Pruter

the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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 the 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" (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 "[e-mail]".

Sincerely yours,

*Patricia Cucente* *for*

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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Document # 9-926-0004 Rev. 3 FDA 510(k) -Ultrasound Systems Drape Kit 510(K)#K970885

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510(k) Number (if known) K970885

Device Name: Ultrasound System Drape Kit

Indication for Use:

Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K970885

Prescription Use
(Per 21 CFR 801.109)

OR

Over The Counter Use ☑

(Optional Format 1-2-96)

PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone [phone] Fax [phone]