(83 days)
Not Found
No
The device is a sterile, disposable magnet cover made of specific materials, intended to provide a physical barrier. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a sterile, disposable magnet cover intended to protect an MRI system from contamination and isolate the sterile field during surgical procedures, not to provide therapy to a patient.
No
The device is a sterile, disposable cover for an MRI magnet, intended to protect the magnet from contamination and maintain sterility during surgical procedures. Its function is protective and barrier-forming, not diagnostic.
No
The device is a physical, disposable cover made of fabric and polyethylene, intended to provide a sterile barrier. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the walls of an MRI magnet from contamination and isolate the sterile field during surgical procedures. This is a physical barrier function, not a diagnostic test performed on biological samples.
- Device Description: The device is a sterile, disposable cover made of a specific material. This aligns with a physical barrier device, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on flammability and resistance to fluid penetration, which are relevant to a barrier device used in a surgical setting, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination.
This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.
Product codes
KKX
Device Description
The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which has been coated with .5 mil of linear low density polyethylene extrusion. The material is blue in color, cut to an overall length and width of 114" x 54", and is 5 mils thick.
Through the use of pressure sensitive adhesive tape, the cover can be attached to a clean, dry surface to establish a barrier.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Flammability:
Material was tested for flammability in accordance with 16 CFR 1610. Because the material is disposable in nature and would not withstand the rigors of washing and dry cleaning specified by the standard, the material was tested in its "as received condition." The average rate of burn for the material was 7.3 seconds, compliant with Class I flammability standards.
Resistance to fluid penetration:
An engineering test was prepared to determine the ability of the material to resist fluid penetration. Material was subjected to fluiddepth-related pressure of .22 psi for 6 hours, visual and tactile inspection revealed no fluid penetration through the material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Grammage (Basis Weight): 69.4 g/m2
Tensile Strength, Dry: MD 3500 g/25mm, CD 2100 g/25mm
Absorbency (Water Drop): 2.5 sec
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a symbol featuring three stylized, curved shapes that resemble abstract human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2004
Mr. Michael Czop Contour Fabricators, Incorporated 4100 E. Baldwin Road Grand Blanc, Michigan 48439
Re: K970185
Trade/Device Name: Sterile Disposable Equipment Magnet Cover Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 27, 1997 Received: March 28, 1997
Dear Mr. Czop:
This letter corrects our substantially equivalent letter of April 10, 1997 regarding the product code.
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 (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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 -- Mr. Czop
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.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
Contour Fabricators, Inc. 4100 East Baldwin Rd. Grand Blanc, MI 48439
(810)695-2910 Phone: (810)695-5336 Fax:
Sterile, Disposable Magnet Cover
Sterile, Disposable Equipment Cover
Michael W. Czop
APR 1 0 1997
caro 185
p //
Contact Person:
Date of Summary:
April 3, 1997
Trade Name:
Classification Name:
Predicate Device:
Bemiss-Jason Corporation (originally Triad Medical Division), E-Z Fit Cover. K831287
Flouroscope and General Equipment Cover. K782155
Contour Fabricators, Inc. Bandbag, Wrap, Sterile, Disposable
Device Description:
The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which has been coated with .5 mil of linear low density polyethylene extrusion. The material is blue in color, cut to an overall length and width of 114" x 54", and is 5 mils thick.
Through the use of pressure sensitive adhesive tape, the cover can be attached to a clean, dry surface to establish a barrier.
Performance Standards: Flammability:
Material was tested for flammability in accordance with 16 CFR 1610. Because the material is disposable in nature and would not withstand the rigors of washing and dry cleaning specified by the standard, the material was tested in its "as received condition." The average rate of burn for the material was 7.3 seconds, compliant with Class I flammability standards.
| Grammage (Basis Weight): g/m2 | 69.4 | |
|---|---|---|
| Tensile Strength, Dry: g/25mm | MD | 3500 |
| CD | 2100 | |
| Absorbency (Water Drop): sec | 2.5 |
3
510(K) SUMMARY (as required by 807.92(c))
Ka70185
PZ:/2
Performance Standards: Resistance to fluid penetration:
(Continued)
An engineering test was prepared to determine the ability of the material to resist fluid penetration. Material was subjected to fluiddepth-related pressure of .22 psi for 6 hours, visual and tactile inspection revealed no fluid penetration through the material.
Intended Use: Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination.
This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.