The Stryker T6 Hood; T6 Hood, Peel-away; T6 Hood, S95; T6 Toga, Pullover; T6 Toga, Zippered; and T6 Toga with Peel-away Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Device Description

The Stryker T6 Hoods and Togas are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

The toga has a hood and gown section. The hood covers the user's head. A lens is attached to the front of the hood. The gown of the toga covers the user's front, back and arms. The Stryker T6 Togas are tested to meet applicable AAMI PB70:2003 standards. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens are exempt from classification under the AAMI PB70:2003 standard.

The Stryker T6 Hood, T6 Hood S95 and T6 Peel Away Hood are intended to be worn over any Stryker T6 Helmet.

The Stryker T6 Hoods with Peel-away Face Shields feature a twolayer protective lens system. When the outer lens becomes soiled, it can be peeled away to reveal another sterile lens surface to reestablish clear vision and make it unnecessary to wipe the lens.

The T6 Hood, S95 consists of higher weight non-woven material than the T6 Hood.

The Stryker T6 Toga, Pullover is intended to be worn over any Stryker T6 Helmet. The Stryker T6 Pullover togas provide Level 4 barrier protection as classified under the AAMI (Association for the Advancement of Medical Instrumentation) guidelines for barrier performance. This garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM F1671:2003 per the AAMI Barrier Classification System and demonstrate a passing result with an AQL of 4% under Procedure A. The Stryker T6 Toga, Pullover will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.

The Stryker T6 Toga Zippered and Stryker T6 Toga with Peelaway Lens, Zippered are intended to be worn over any Stryker T6 Helmet. The Stryker T6 Toga, Zippered and Stryker T6 Toga with Peel-away Lens, Zippered provide protection as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Barrier Classification System. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker T6 Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The Stryker T6 Zipper Toga will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Stryker T6 Hoods and Togas. This submission focuses on establishing substantial equivalence to predicate devices rather than proving novel performance through a clinical study with detailed acceptance criteria and reported performance metrics commonly associated with AI/ML devices. Therefore, the information requested regarding a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance is not directly applicable to this submission.

However, I can extract the relevant acceptance criteria and how the device's performance was compared against standards to demonstrate its intended function and equivalence.

Here's a breakdown of the available information:

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

Since this is a sterile surgical gown and hood, the "acceptance criteria" revolve around barrier protection and resistance to contaminants, tested against established industry standards.

Acceptance Criteria (Standard)	Reported Device Performance	Device(s) Covered
AAMI PB70:2003 standards	Met applicable AAMI PB70:2003 standards	Stryker T6 Togas (general statement)
ASTM F1671:2003 (Procedure A) for bacteriophage Phi-X174 resistance - with AQL of 4%	Passing result	Stryker T6 Toga, Pullover; Stryker T6 Toga, Zippered; Stryker T6 Toga with Peel-away Lens, Zippered
AATCC 42:2000 for liquid penetration - with AQL of 4%	Level 1 zones resist liquid penetration	Stryker T6 Toga, Zippered; Stryker T6 Toga with Peel-away Lens, Zippered
AAMI Barrier Classification System: Level 4 barrier protection (for critical zones)	Provided Level 4 barrier protection (resist liquid and viral penetration)	Stryker T6 Toga, Pullover; Stryker T6 Toga, Zippered; Stryker T6 Toga with Peel-away Lens, Zippered

Note: The AAMI standard does not cover apparel for the head, face, and eyes, meaning the hoods and lens are exempt from classification under AAMI PB70:2003.

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

The text mentions "An AQL of 4%" for the barrier performance tests (ASTM F1671:2003 and AATCC 42:2000). AQL (Acceptable Quality Level) is a statistical sampling term used in quality control to define the maximum percentage of defective items that is acceptable in a lot. While a specific sample size isn't explicitly stated, an AQL of 4% implies a statistical sampling plan was used to test a certain number of units from a production lot. The provenance of the data (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)

Not applicable. The "ground truth" for this device is based on objective measurements against established performance standards (ASTM, AATCC, AAMI) for material properties (liquid and viral penetration), not expert interpretation.

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

Not applicable. This is not a study involving human readers or interpretation.

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

Not applicable. This is a medical device (surgical gown/hood), not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance claims ("resist liquid and viral penetration," "passing result") is the objective outcome of standardized laboratory tests against recognized industry standards (ASTM F1671:2003, AATCC 42:2000, AAMI PB70:2003).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. (See #8)

Summary

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K063005

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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.strykor.com

ﻭ

stryker

Instruments

MAR 23 200
510(k) Summary
Device Sponsor:	Stryker Instruments4100 East Milham AvenueKalamazoo, Michigan 49001(p) 269-323-7700(f) 269-324-5412
Registration No.:	1811755
Trade Name:	Stryker T6 Hoods and Togas
Classification:	Sterile Surgical Gowns
Equivalent to:	K040764-Stryker Steri-shield T4 HytrelK023167-Allegiance Breathable Surgical Gown
Device Description:	Device History
	The Stryker T6 Hoods and Togas are components of a personalprotection system and are intended to protect the patient, healthcare personnel and operating room personnel againstcontamination, exposure of infectious bodily fluids, the transfer ofmicroorganisms and particulate material.
	Summary of Stryker T6 Hoods and Togas
	The toga has a hood and gown section. The hood covers theuser's head. A lens is attached to the front of the hood. The gownof the toga covers the user's front, back and arms. The Stryker T6Togas are tested to meet applicable AAMI PB70:2003 standards.The AAMI standard does not cover apparel for the head, face, andeyes. Therefore, the hoods and lens are exempt from classificationunder the AAMI PB70:2003 standard.

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K063005

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Stryker T6 Hood; Stryker T6 Hood, S95; and Stryker T6 Peel Away Hood

The Stryker T6 Hood, T6 Hood S95 and T6 Peel Away Hood are intended to be worn over any Stryker T6 Helmet.

The T6 Hood, S95 consists of higher weight non-woven material than the T6 Hood.

Stryker T6 Toga, Pullover

Stryker T6 Toga, Zippered and Stryker T6 Toga with Peel-away Lens, Zippered.

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K063005 s 30 3

	will be available in a variety of sizes ranging from Small/Mediumthru 3X-Large sizes.
Indications for Use:	The Stryker T6 Hoods and Togas are components of a personalprotection system and are intended to protect the patient, healthcare personnel and operating room personnel againstcontamination, exposure of infectious bodily fluids, the transfer ofmicroorganisms and particulate material.
Substantial Equivalence(SE) Rational:	The Stryker T6 Hoods and Togas are substantially equivalent todevices in commercial distribution.Stryker T6 Hoods and Togas have an equivalent intended use,patient contact materials, operating principles and physicalspecifications as compared to predicate devices.
Safety and Effectiveness:	Based upon the comparison to the predicate devices, the StrykerT6 Hoods and Togas are substantially equivalent to legallymarketed devices. The Stryker T6 Hoods and Togas do not raiseany new safety or efficacy concerns.
Submitted by:	Paulette D. JohnsonRegulatory Affairs AnalystStryker Instruments
	Signature

Date Submitted:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, representing growth and service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2007

Ms. Paulette D. Johnson Regulatory Affairs Analyst Stryker Instruments Instruments Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K063005

Trade/Device Name: Stryker T6 Hoods and Togas Steri-Shield T6 Hood, Steri-Shield T6 Hood S95, Steri-Shield T6 Peelaway Hood, Steri-Shield T6 Toga, Pullover, Steri-Shield T6 Toga, Zippered, Steri-Shield T6 Toga with Peel-away Lens, Zippered Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA, FXY Dated: February 20, 2007 Received: February 22, 2007

Dear Ms. Johnson:

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 - Ms. Johnson

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 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Clive
Shia-Lian, Ph.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): K063005

Device Name: Stryker T6 Hoods and Togas

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule Murphy, MD
Division of Anesthesiology, General Hospital

Beaon Control, Dental Device

6 - 2018) Number_

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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.