(125 days)
Not Found
Not Found
No
The device description and intended use clearly define the device as a sterile cover for an X-ray machine, acting as a physical barrier. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI or ML.
No.
Explanation: This device is described as a sterile cover or drape for X-ray machines, providing a barrier to prevent contamination and cross-contamination. Its primary function is to maintain a sterile field during surgical procedures, not to treat or diagnose a disease or condition. While it has a protective function for the patient and equipment, it does not directly perform therapy.
No
The device, a Disposable X-Ray Cover, provides a sterile barrier and protects against contamination. It does not diagnose any condition or disease.
No
The device is a physical, sterile cover for an X-ray machine, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable X-Ray Cover is a physical barrier designed to maintain a sterile field during surgical procedures involving an X-ray machine. Its function is to prevent contamination between the non-sterile X-ray machine and the sterile surgical environment and patient.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from the patient. It is a physical cover.
- Intended Use: The intended use is to provide a sterile barrier for an X-ray machine during surgery, not to diagnose or provide information about a patient's health status based on biological samples.
Therefore, the Disposable X-Ray Cover falls under the category of a surgical drape or cover, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IZJ
Device Description
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 machine. The DXC is disposable and single patient use only, so there is no cross 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1620 Cine or spot fluorographic x-ray camera.
(a)
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.(b)
Classification. Class II.
0
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: 613 9720-8840 613 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.
1
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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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 (03) 9720 8840. 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page of of i
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)