(16 days)
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No
The 510(k) summary describes personal protective equipment (togas) and makes no mention of AI or ML technology.
No
The device is described as a personal protection system intended to provide a barrier against contamination and exposure to infectious body fluids and microorganisms for the surgical team, not to treat a disease or condition.
No
Explanation: The device is described as a personal protection system (toga) intended to provide a barrier against contamination and exposure, not to diagnose a condition.
No
The device description clearly states it is a "Personal Protection System" consisting of "Togas," which are physical garments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a barrier for personal protection against contamination and exposure to infectious body fluids and microorganisms in a surgical environment. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as components of a personal protection system (togas). This aligns with personal protective equipment (PPE), not diagnostic equipment.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Stryker Togas do not fit this description.
N/A
Intended Use / Indications for Use
The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Product codes
LYU
Device Description
The Stryker T4 Personal Protection System: Stryker Hytrel® T4 Togas. The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
members of the surgical team in the operating environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2001
Ms. Suzanne Velasquez Senior Requlatory Affairs Representative Stryker Corporation 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K011755
Stryker T4 Hytrel® Togas Trade/Device Name: Requlation Number: 878.4040 Regulatory Class: II Product Code: LYU Dated: June 6, 2001 Received: June 6, 2001
Dear Ms. Velasquez:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
1
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
K. Olakowski
y A. Ulatowski Timoth Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 1__ of
Indications for Use Statement
| 510(k)
| Number | K011755 |
|---|---|
| Device Name | The Stryker T4 Personal Protection System: Stryker Hytrel® T4 |
| Togas. | |
| Indications | The Stryker Hytrel® Zippered Toga and Pull-over Toga are |
| components of a personal protection system that is intended to | |
| provide a barrier between the operating environment and the | |
| members of the surgical team in order to help protect against | |
| contamination and/or exposure of infectious body fluids and | |
| harmful microorganisms. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number __