(97 days)
MICROTEK MEDICAL EQUIPMENT DRAPES ARE TO BE USED TO COVER A VARIETY OF SURGICAL AND NON-SURGICAL EQUIPMENT IN VARIOUS SETTINGS THE CHOUSE HOUSE THE CUNICAL SETTING. THESE DRAPES ARE USED TO PROFECT THE OQUIPMENT FROM CONTAMINATION DURING VARIOUS PROCEOURES.
The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination, manufactured to protect a variety of surgical and non-surgical equipment from contamination during various procedures throughout the clinical setting. These equipment drapes are similar to other equipment drapes currently being marketed for the same intended use.
The provided text describes a 510(k) premarket notification for "Microtek Medical, Inc., Equipment Drapes." This device is a surgical drape designed to protect equipment from contamination. The information provided heavily focuses on regulatory aspects and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria typically seen for AI/ML-based medical devices or devices with measurable diagnostic/performance outputs.
Based on the provided text, the acceptance criteria and study information are limited and primarily refer to material testing rather than clinical performance with human readers or AI.
Here's an attempt to extract and format the requested information, noting where specific data is not present in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Penetration (ASTM Method F 1671) | "material used in these products has been tested to ASTM Method F 1671 for Viral Penetration." (No specific pass/fail threshold or quantitative result is provided in the text beyond stating it was tested) |
| Biocompatibility (ISO 10993-1) | "...materials have been tested in other applications to ISO 10993-1 standards, however, since these products are non-patient contact..." (Indicates compliance for materials in other applications, but clarifies it's not directly applicable for this specific device's non-patient contact use, hence the focus on viral penetration for this product). |
| Substantial Equivalence to Predicate Devices | Determined to be substantially equivalent by the FDA to predicate devices: - Medline band Bags and Equipment Drapes (K032065) - Custom Medical Products Equipment Drapes (K931417) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the ASTM F 1671 testing.
- Data Provenance: Not specified.
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)
- Experts: Not applicable. The testing described (ASTM F 1671) is a laboratory material testing standard, not a clinical study requiring expert reviews for ground truth.
- Qualifications: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not a clinical study involving adjudication of clinical findings.
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
- MRMC Study: No. The device is a surgical drape, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. The device is a physical product (surgical drape), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For the material testing (ASTM F 1671), the "ground truth" would be established by the standardized methods and controls defined within the ASTM standard itself, which dictates how viral penetration is measured and interpreted. It's a laboratory standard, not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML product developed with training data.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. This device is not an AI/ML product developed with training data.
{0}------------------------------------------------
Premarket (510k) Summary
Submitter Information
Microtek Medical, Inc. 512 Lehmberg Road Columbus, Mississippi 39702 662-327-1863 Contact person: Thomas Bonner Date prepared: January 26, 2005
Device Name
Proprietary name: Microtek Medical, Inc., Equipment Drapes Common name: Equipment Drapes. CDRH Product Regulation: Surgical drape and drape Accessories (21 CFR, 878.4370)
Owner/Operator Number: 9009921
Establishment Registration Number: 1043582 (Microtek Medical, Inc.)
Classification: II
Statement of Substantial Equivalence
Microtek Medical, Inc. Equipment Drapes are equivalent to:
Description of Device
The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination, manufactured to protect a variety of surgical and non-surgical equipment from contamination during various procedures throughout the clinical setting. These equipment drapes are similar to other equipment drapes currently being marketed for the same intended use.
Intended Use
The intended use of this device is to protect equipment from contamination during a variety of procedures throughout the clinical setting.
Materials
Most of the component materials used in the manufacture of these products are polyurethane film that is cut and configured to specification.
{1}------------------------------------------------
Performance
.
These materials have been tested in other applications to ISO 10993-1 standards, however, since these products are non-patient contact, the material used in these products has been tested to ASTM Method F 1671 for Viral Penetration.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas B. Bonner Vice President Regulatory Affairs/Quality Assurance Microtek Medical, Incorporated 512 Lehmberg Road Columbus, Mississippi 39702
Re: K050322
Trade/Device Name: Microter Medical, Inc. Equipment Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 19, 2005 Received: April 22, 2005
Dear Mr. Bonner:
.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to re now a young and have determined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do rood Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it hay of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earl be roundsh further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Mr. Bonner
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 modified in the PDP may made and regulations administered by other Federal agencies. or the Act of all + reathar the Act's requirements, including, but not limited to: registration r out intisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifing (2) - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your even finding of substantial equivalence of your device to a premairer notified.com - 12 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), If you desire specific act 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 may overn bare. gMarwacturers, 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/industry/support/index.html.
Sincerely yours,
Cars
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): Koso322
NICROTEK MEDICAL, INC. EQUIPMENT DRAPES Device Name:
Indications For Use:
MICROTEK MEDICAL EQUIPMENT DRAPES ARE TO BE USED TO COVER A VARIETY OF SURGICAL AND NON-SURGICAL EQUIPMENT IN VARIOUS SETTINGS THE CHOUSE HOUSE THE CUNICAL SETING. THESE DRAPES ARE USED TO PROFECT THE OQUIPMENT FROM CONTAMINATION DURING VARIOUS PROCEOURES.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shala A. Murphy D
of Anesthesiology, General Hospital, Infection Control. Dental
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number.__
§ 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.