(33 days)
Not Found
No
The device is a personal protection system (toga, helmet, etc.) and the summary focuses on barrier protection and material properties, with no mention of AI/ML or related concepts.
No
Explanation: The device is intended to provide a barrier for protection against contamination and exposure to infectious materials, not to treat a disease or condition. It is a component of a personal protective system.
No
The device is described as a component of a personal protection system intended to provide a barrier against contamination and exposure to infectious materials, not to diagnose medical conditions.
No
The device description clearly lists hardware components such as a ventilation helmet, hood, toga, and rechargeable battery.
Based on the provided information, the Stryker T4 Hytrel Zipper Toga is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a component of a personal protection system designed to provide a barrier against contamination and exposure to infectious body fluids and harmful microorganisms in the operating environment. This is a protective function for the user, not a diagnostic test performed on a sample from a patient.
- Device Description: The description confirms it's part of a personal protection system, including a helmet, hood, toga, battery, and accessories. These are all components related to physical protection.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies listed (Viral Penetration, Synthetic Blood Penetration, Water Resistance, Flammability, Tear Resistance) are all related to the barrier and protective properties of the material, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Stryker T4 Hytrel Zipper Toga does not fit this description.
N/A
Intended Use / Indications for Use
The Stryker T4 Hytrel Zipper Toga is a component 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
FYA
Device Description
The Stryker Personal Protection Systems include a self-contained ventilation helmet, a hood, a toga, rechargeable battery, and accessories.
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
members of the surgical team / operating environment
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
The material used on the front and sleeves of the Stryker T4 Hytrel Zipper Toga was shown to be equivalent to or better than the material used on the front and sleeves of the Stryker Steri-Shield Personal Protection System (K944393, K011755), as is detailed in Tab 4. Equivalence was based on the results of the following tests: Viral Penetration, Synthetic Blood Pentration, Water Resistance: Impact Penetration, Water Resistance: Hydrostatic Pressure, Flammability, and Tear Resistance
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.
0
510(k) Summary ______________________________________________________________________________________________________________________________________________________________________________
Ko40764
| Trade Name: | Stryker T4 Hytrel Zipper Toga | |||||
|---|---|---|---|---|---|---|
| Common Name: | Surgical gown and hood | |||||
| Classification Name: | Surgical Apparel (per 21 CFR section 878.4040) | |||||
| Equivalent to: | The Stryker T4 Hytrel Zipper Toga is equivalent to the zipper | |||||
| toga of the Stryker Steri-shield Personal Protection System | ||||||
| (K944393, K011755). The material used on the front and | ||||||
| sleeves of the Stryker T4 Hytrel Zipper Toga was shown to be | ||||||
| equivalent to or better than the material used on the front and | ||||||
| sleeves of the Stryker Steri-Shield Personal Protection System | ||||||
| (K944393, K011755), as is detailed in Tab 4. Equivalence was | ||||||
| based on the results of the following tests: Viral Penetration, | ||||||
| Synthetic Blood Pentration, Water Resistance: Impact | ||||||
| Penetration, Water Resistance: Hydrostatic Pressure, | ||||||
| Flammability, and Tear Resistance | ||||||
| Device Description: | The Stryker Personal Protection Systems include a self-contained | |||||
| ventilation helmet, a hood, a toga, rechargeable battery, and | ||||||
| accessories. | ||||||
| Intended Use: | The Stryker T4 Hytrel Zipper Toga is a component 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. | ||||||
| Technological | Technological characteristics are the same as previously cleared | |||||
| for the Stryker Steri-Shield | ||||||
| Comparison: | Personal Protection System (K944393, K011755). | |||||
| Submitted by: | Jennifer Mars, Regulatory Affairs Representative | |||||
| Stryker Instruments | ||||||
| 4100 E. Milham Avenue | ||||||
| Kalamazoo, MI 49001 | ||||||
| Phone- 269-323-7700 ext. 3808 | ||||||
| Fax- 269-324-5412 | ||||||
| Date Submitted: | March 17, 2004 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes and a stylized body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Stryker Instruments Corporation Ms. Jennifer Mars Regulatory Affairs Representative Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K040764
Trade/Device Name: The Stryker T4 Personal Protection System: Stryker T4 Hytrel Zipper Toga Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 16, 2004 Received: April 19, 2004
Dear Ms. Mars:
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.
2
Page 2 - Ms. Mars
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 vour device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
ChrLs
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
3
Indications for Use Statement
| 510(k) Number | K040764 |
|---|---|
| Device Name | The Stryker T4 Personal Protection System: Stryker T4 Hytrel Zipper Toga |
Indications For Use The Stryker T4 Hytrel Zipper Toga is a component 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.
Prescription Use (Pcr 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Morley
(Division Sign-Off) (Division Sign-On/) ----------------------------------------------------------------------------------------------------------------------------------------------------------Infection Control, Dental Devices
510(k) Number: K040764