(172 days)
Not Found
No
The device description and performance studies focus on material properties and barrier protection standards, with no mention of AI or ML.
No.
The device is intended for protection against contamination and transfer of microorganisms, not for therapeutic purposes.
No
The device is described as components of a personal protection system intended to protect against contamination and transfer of microorganisms, not for diagnosing any medical conditions.
No
The device description clearly outlines physical components like hoods, togas, lenses, and non-woven material, and the performance studies focus on physical barrier properties and material testing standards (AAMI, ASTM, AATCC). There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Stryker T6 Hoods and Togas are components of a personal protection system. Their intended use is to protect individuals (patient, healthcare personnel, operating room personnel) from contamination, exposure to bodily fluids, and the transfer of microorganisms and particulate material.
- Mechanism of Action: The device works by providing a physical barrier, not by analyzing biological samples.
- Performance Studies: The performance studies mentioned focus on barrier protection standards (AAMI, ASTM, AATCC) and resistance to penetration, which are relevant to protective apparel, not diagnostic testing.
The device is a form of personal protective equipment (PPE), specifically surgical gowns and hoods, designed to prevent the spread of infection through physical barriers. This is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FYA, FXY
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.
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 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.
Stryker T6 Toga, Pullover
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.
Stryker T6 Toga, Zippered and Stryker T6 Toga with Peel-away Lens, Zippered.
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.
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
health care personnel and operating room personnel
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Instruments |
4100 East Milham Avenue | |
Kalamazoo, 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 Hytrel |
K023167-Allegiance Breathable Surgical Gown | |
Device Description: | Device History |
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. | |
Summary of Stryker T6 Hoods and Togas | |
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. |
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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 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.
Stryker T6 Toga, Pullover
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.
Stryker T6 Toga, Zippered and Stryker T6 Toga with Peel-away Lens, Zippered.
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
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K063005 s 30 3
| | will be available in a variety of sizes ranging from Small/Medium
thru 3X-Large sizes. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | 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. |
| Substantial Equivalence
(SE) Rational: | The Stryker T6 Hoods and Togas are substantially equivalent to
devices in commercial distribution.
Stryker T6 Hoods and Togas have an equivalent intended use,
patient contact materials, operating principles and physical
specifications as compared to predicate devices. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker
T6 Hoods and Togas are substantially equivalent to legally
marketed devices. The Stryker T6 Hoods and Togas do not raise
any new safety or efficacy concerns. |
| Submitted by: | Paulette D. Johnson
Regulatory Affairs Analyst
Stryker 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
5
Indications for Use
510(k) Number (if known): K063005
Device Name: Stryker T6 Hoods and Togas
Indications for Use:
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.
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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