THE SURGICAL GOWN/TOGA IS INTENDED TO BE WORN Room BOTH THE SURG PROCEDURES TO PROTE RODM PERSONAL TRANSFER OF MICROORGANIST ARTICULATE MATER MATERIAL

Device Description

The Microtek gown/toga consists of a non-woven material and woven cuff material manufactured to protect the wearer and patient from contamination during various procedures throughout the clinical setting. This gown/toga is similar to other gowns/togas currently being marketed for the same intended use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a surgical gown/toga. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies as might be required for a novel device. Therefore, the information provided does not fully align with all the questions typically asked about acceptance criteria and detailed study designs for AI/ML devices.

However, based on the available text, here's an attempt to answer the questions within the given context:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Measured Performance Standard)	Reported Device Performance (Reference to Standard)
Viral Penetration Resistance (ASTM Method F 1671)	Conforms to ASTM Method F 1671 (Material tested alone and together)
Flammability	Conforms to Flammability testing (Material tested alone and together)
Overall Product Performance Standard	Conforms to ANSI/AAMI PB-70:2003 (Final finished product)
Biocompatibility (ISO 10993-1)	Conforms to ISO 10993-1 (Materials tested alone and together)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the testing of the materials or the final product. It only states that the "materials have been tested alone and together" and the "final finished product conforms" to the standards. The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

This information is not applicable and not provided in the document. The performance evaluation relies on standardized laboratory testing (e.g., ASTM, ISO, ANSI/AAMI) for physical properties and barrier effectiveness, rather than expert judgment on a dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. The testing involves objective measurements against established standards, not subjective adjudication of cases.

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, an MRMC comparative effectiveness study was not done. This device is a surgical gown, not an AI/ML-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The device is a physical product (surgical gown) and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., ASTM F1671 for viral penetration, ISO 10993-1 for biocompatibility, ANSI/AAMI PB-70:2003 for general product performance). These standards dictate the methodologies and acceptable limits for various physical and biological properties.

8. The sample size for the training set

This question is not applicable. There is no "training set" for a physical medical device like a surgical gown.

9. How the ground truth for the training set was established

This question is not applicable. There is no "training set" for this device.

Summary

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Premarket (510k) Summary

Submitter Information

Microtek Medical, Inc. 512 Lehmberg Road Columbus, Mississippi 39702 662-327-1863 Contact person: Thomas Bonner Date prepared: August 8, 2006

JAN 2 5 2007

Device Name

Proprietary name: Microtek Medical, Inc., Gown/Toga Common name: Surgical Apparel. CDRH Product Regulation: Surgical Apparel (21 CFR, 878.4040)

Owner/Operator Number: 9009921

Establishment Registration Number: 1043582 (Microtek Medical, Inc.)

Classification: II

Statement of Substantial Equivalence

Microtek Medical, Inc. Gown/Toga is equivalent to:

1. DePuy Orthopedics gown/toga
1. Stryker gown/toga

Description of Device

Intended Use

The intended use of this device is to protect the health care professional and the patient from contamination during a variety of procedures throughout the clinical setting.

Materials

The component materials used in the manufacture of these products are Ahlstrom nonwoven material (that maintains a premarket notification for the material by itself) that is cut/sewn and configured to specification. The gown also contains a woven gown cuff.

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Performance

. . . . . . . . . .

100 come of the comments of

These materials have been lested alone and together to ISO 10993-1, ASTM Method F 1671 for Viral Fenetration and flammability. The final finished product conforms to PB-70:2003.

. . . . .

. . . . . .

and the comments of the comments of

. . . .

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

. . . . . .

and the control of the country of the country

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas B. Bonner Vice President Microtek Medical, Incorporated 512 Lehmberg Road Columbus, Mississippi 39702

JAN 2 5 2007

Re: K062899

Trade/Device Name: Microtek Surgical Gowns/TOGA Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: December 18, 2006 Received: December 28, 2006

Dear Mr. Bonner:

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 application (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 such 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. Bonner

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 begin 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 vour 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/industry/support/index.html.

Sincerely yours,

Syrtie H. Michael, M.D.

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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Indications for Use

510(k) Number (if known): K 062899

Device Name: MICROTEK SURGICAL GOON/TOGA

Indications For Use:

THE SURGICAL GOWN/TOGA IS INTENDED TO BE JAEZ WORN Room BOTH THE SURG PROCEDURES TO PROTE RODM PERSONAL TRANSFER OF MICROORGANIST ARTICULATE MATER MATERIAL

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)

Shila A. Mayhew, MD

Ka2994

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Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.