SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600

K990253 · Amba Medical , Ltd. · KKX · Sep 24, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990253
• Device Name: SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
• Applicant: Amba Medical , Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Indications for Use

The Securline Operating Room Drape is a drape accessory made of synthetic material 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

Securline Operating Room Camera Drape #3600 is a sterile, synthetic drape accessory; designed to cover surgical cameras or equipment; functions as a physical barrier to isolate surgical incision sites from microbial and other contamination; used in operating room environments by surgical staff; prevents cross-contamination between equipment and patient; maintains sterile field integrity.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Synthetic material; physical barrier drape; non-powered; sterile; single-use; form factor designed for camera/equipment coverage.

Indications for Use

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

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. Mike J. Caudwell Amba Medical Limited Unit 5, Bonville Trading Estate Bonville Road, Brislington, Bristol United Kingdom BS4 5QH

K990253 Re : Securline Operating Room Camera Drape, Model Trade Name: #3600 Requlatory Class: II Product Code: KKX Dated: January 25, 1999 Received: January 27, 1999

Dear Mr. Caudwell:

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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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

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Paqe 2 -Mr. Caudwell

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 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 requlation (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 oriece of compilance and companding 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 "http://www.fda?gov/cdrh/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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## PMN 510(k) number: K990253

## STATEMENT OF INDICATIONS FOR USE

Device name: 'Securline' Operating Room Camera Drape #3600

Classification name: Drape, surgical 79KKX

The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation(ODE)

Chin S. Lin

(Division Sign-Off) Division of Dental, Infection Contr and Ger 510(k) Nu

Prescription Use_ (Per 21 CFR801.109) OR

Over-The-Counter Use

Contact: Mike Caudwell Tel: [phone] Fax: [phone]