(83 days)
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.
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.
This request pertains to the acceptance criteria and study details for a Sterile Disposable Equipment Magnet Cover. However, the provided document is a 510(k) premarket notification summary for this device, and it primarily focuses on detailing the device description, performance standards through internal testing, and its intended use, rather than a clinical study comparing its performance against acceptance criteria in a typical clinical setting or a multi-reader multi-case study.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes for test/training sets, experts, adjudication, MRMC studies, or standalone algorithm performance, is not present within the provided text.
The document describes material performance tests, which can be seen as meeting specific internal "acceptance criteria" for the material properties.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where gaps exist:
1. A table of acceptance criteria and the reported device performance
The document describes performance standards for the material used in the device. These can be considered the acceptance criteria for the material's properties.
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Flammability (16 CFR 1610) | Average rate of burn: 7.3 seconds (Compliant with Class I flammability standards) |
| Grammage (Basis Weight) | 69.4 g/m^2^ |
| Tensile Strength, Dry (MD) | 3500 g/25mm |
| Tensile Strength, Dry (CD) | 2100 g/25mm |
| Absorbency (Water Drop) | 2.5 sec |
| Resistance to fluid penetration | No fluid penetration after 6 hours at 0.22 psi |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for material testing. For example, for flammability, a "material was tested" suggests a sample was used, but the number of samples is not given.
- Data Provenance: Not applicable in the sense of patient data. These are laboratory-based material property tests, presumably conducted by or for Contour Fabricators, Inc. The document does not specify a country of origin for the testing data beyond the company's US location.
- Retrospective or Prospective: Not applicable. These are tests on manufactured material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" here is the measured physical property of the material, not an expert-derived clinical diagnosis or assessment. The tests are based on established standards (e.g., 16 CFR 1610) and engineering methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. These are objective material property measurements, not subjective evaluations requiring adjudication among multiple readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was mentioned or required for this type of device (Sterile Disposable Equipment Magnet Cover). This device is a physical barrier, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance standards described is based on objective physical measurements and adherence to regulatory standards (e.g., flammability standard 16 CFR 1610) or established engineering test methods (fluid penetration test).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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.
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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
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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
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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 |
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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.
§ 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.