DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR

K972130 · Fairmontmedical · IZJ · Oct 9, 1997 · Radiology

Device Facts

• Record ID: K972130
• Device Name: DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
• Applicant: Fairmontmedical
• Product Code: IZJ · Radiology
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1620
• Device Class: Class 2

Intended Use

The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation. This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.

Device Story

Disposable sterile drape for operative X-ray machines; provides physical barrier between non-sterile X-ray equipment and sterile surgical field. Prevents transmission of contaminants from machine to patient and bodily fluids from patient to machine. Used in surgical settings; operated by surgeons or surgical staff. Single-patient use; gamma-sterilized. Facilitates equipment adjustment during surgery without compromising sterility.

Clinical Evidence

Clinical testing for viral penetration demonstrated that the Disposable X-Ray Cover allows no penetration of virus and provides effective protection against viral penetration.

Technological Characteristics

Sterile, disposable drape; gamma radiation sterilization; physical barrier material; dimensions 150 cm x 104 cm (model 8015).

Indications for Use

Indicated for use as a sterile barrier/drape for operative X-ray machines during surgical procedures requiring a sterile environment to prevent cross-contamination between the patient and the equipment.

Regulatory Classification

Identification

A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for Fairmont Medical and the date OCT-9 1997. The logo consists of a stylized cross symbol on the left and the words "FAIRMONT MEDICAL" on the right. The date is printed below the words "FAIRMONT MEDICAL". The image is in black and white.

## 510(k) SUMMARY

510(k): K 972130

Fairmont Medical Products, Pty., Ltd. Factory 4, 21 Malvern Street Bayswater, Victoria 3153 Australia

Telephone: [phone] 9720-8860 Facsimile:

JoAnne McBain Contact:

9 September 1997 Date:

Disposable Universal X-Ray Cover Trade Name: DXC 8015 Code Number: Trade Name: Disposable Mini X-Ray Cover Code Number: DXC 8025

510(k) Number: K 972130

The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machines utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field.

As with most major surgical equipment, X-ray machines cannot be sterilised. It would damage them, rendering them useless. The Disposable X-Ray Cover provides a sterile barrier between the patient and the X-ray machine. Contaminants from operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the The DXC is disposable and single patient use only, so there is no cross machine. contamination between patients. It is sterilised via gamma radiation.

Clinical testing for viral penetration has demonstrated that the Disposable X-Ray Cover allows no penetration of virus and provides effective protection against viral penetration.

This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.

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Image /page/1/Figure/3 description: The image shows a product label for a "Universal X-Ray Cover" by Fairmont Medical. The label includes the company's name and address, as well as contact information. The label also states that the product is sterile and disposable, and includes a diagram with dimensions of 150 cm and 104 cm. The catalog number is 8015, and it indicates that the product is for single-patient use and should only be used if the packaging is unopened and undamaged.

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51064) 491250

f11/9/97 Fair Changes Cover_18/9/97_9:23 AM Page 1

Image /page/2/Picture/2 description: The image shows a product package for Fairmont Medical Mini X-Ray Covers. The package indicates that the product is sterile and disposable. The address is 4/21 Malvern Street, Bayswater, Victoria 3153, and the phone number is [phone]. The catalog number is 8025.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line. The text is black against a white background.

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending upwards from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. JoAnne McBain Quality Assurance Fairmont Medical 4/21 Malvern Street Bayswater, Victoria Australia

OCT - 9 1997

Re : K972130 Disposable Universal X-Ray Covers Trade Name: Regulatory Class: II Product Code: IZJ Dated: September 18, 1997 September 24, 1997 Received:

Dear Ms. McBain:

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 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 requlations 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 the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Ms. McBain

through 542 of the Act for devices under the Electronic enroagle Siz or on 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 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 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 "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo A 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): K972月30

Device Name: Disposable X Ray Cover

Indications For Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field.

The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation.

This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON 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 | K972130 |
| Prescription Use | OR |
| (Per 21 CFR 801.109) | Over-The-Counter Use X |

(Optional Format 1-2-96)