(163 days)
Not Found
No
The device is described as surgical protective equipment (hoods and togas) and the performance metrics are related to physical and barrier properties, not data processing or analysis. There is no mention of AI, ML, or image processing.
No.
Explanation: The device is intended to protect personnel and patients from contamination and infectious bodily fluids, rather than to treat or diagnose a disease or condition.
No
Explanation: The device is described as surgical protective equipment (hoods and togas) intended to protect against contamination and transfer of microorganisms. It measures physical and barrier performance, not physiological data or diagnostic indicators from a patient.
No
The device description clearly indicates that the device is composed of physical components (hoods and togas) and the performance studies focus on physical and barrier properties, not software functionality.
Based on the provided information, the Stryker Steri-Shield 8 disposables are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to protect patients and healthcare personnel from contamination and exposure to infectious bodily fluids and microorganisms. This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The device is described as surgical protective equipment (hoods and togas) designed to be worn by healthcare personnel. This aligns with personal protective equipment (PPE), not IVD devices.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on the physical and barrier properties of the material (water penetration, blood penetration, viral penetration, etc.), which are relevant to protective equipment, not diagnostic accuracy.
- Key Metrics: The key metrics are related to the protective capabilities of the device (filtration efficiency, strength, CO2 levels, biocompatibility), not diagnostic performance metrics like sensitivity, specificity, PPV, or NPV.
In summary, the Stryker Steri-Shield 8 disposables are designed to provide a physical barrier for protection, which is the function of personal protective equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.
Product codes
FYA, FXY
Device Description
The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.
The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.
The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
User's head, neck, and shoulder region (for hoods); User's head, neck, arms, torso, and upper legs region (for togas).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Professional operating within an environment requiring barrier protection.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted in accordance with FDA Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued August 1993, and applicable recognized and published standards.
Key results:
- Flammability: Meets Class 1 requirements (Pass)
- Water Resistance: Water Penetration Less than or equal to 4.5 grams (Pass)
- Resistance to Penetration by Synthetic Blood: No visible penetration (Pass)
- Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens:
§ 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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October 16, 2024
Stryker Instruments Susanne Galin Chief Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K241272
Trade/Device Name: Stryker Steri-Shield 8 Surgical Hoods and Togas Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA, FXY Dated: May 6, 2024 Received: September 17, 2024
Dear Susanne Galin:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Stryker Steri-Shield 8 Surgical Hoods and Togas
Indications for Use (Describe)
The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This Traditional 510(k) is submitted by:
| Address: | Stryker Instruments
1941 Stryker Way
Portage, MI 49002, USA |
|-------------------|-------------------------------------------------------------------|
| Telephone Number: | 269-389-2300 |
| 510(k) Number: | K241272 |
| Date Prepared: | October 16, 2024 |
Contact Information
| Contact Name: | Susanne Galin |
|---|---|
| Title: | Chief Regulatory Affairs Specialist |
| Email: | Susanne.Galin@stryker.com |
Device Information
| Device Proprietary Name | Stryker Steri-Shield 8 Surgical Hoods and Togas |
|---|---|
| Device Common Names | Gown, Surgical; Hood, Surgical |
| Classification | Class II |
| Classification Product | |
| Codes and Names | FYA- Gown, Surgical |
| FXY- Hood, Surgical | |
| Classification Regulation | CFR 878.4040 |
| Review Panel | General Hospital |
Predicate Device
The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k):
| | Trade Name | 510(k) Number | Product
Code | Manufacturer |
|-----------|----------------------------------------|---------------|-----------------|---------------------|
| Predicate | Stryker T7 Surgical Hoods
and Togas | K200493 | FXY, FYA | Stryker Corporation |
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Device Description
The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.
The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.
The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.
Indications for Use
The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.
Comparison to Predicate Device
| Characteristic | Subject Device:
Stryker Steri-Shield 8 Surgical
Hoods and Togas | Predicate Device:
Stryker T7 Surgical Hoods and
Togas (K200493) | Equivalence
Assessment |
|------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------|
| Proprietary
Name | Stryker Steri-Shield 8 Surgical
Hoods and Togas | Stryker T7 Surgical Hoods and
Togas | Branding
name, line
extension |
| Product
Classification/
Regulation | Class II
21 CFR 878.4040
Surgical Apparel | Class II
21 CFR 878.4040
Surgical Apparel | Identical |
| FDA Product
Codes | FXY, FYA | FXY, FYA | Identical |
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| Indications for
Use Statement | The Stryker Steri-Shield 8
disposables, including all hood
and toga models, are
components of the Stryker
Steri-Shield 8 Personal
Protection System and are
intended to protect the patient,
healthcare personnel, and
operating room personnel
against contamination,
exposure of infectious bodily
fluids, and the transfer of
microorganism and particulate
material. The Stryker Steri-
Shield 8 disposables are sterile,
disposable, single-use only
devices. | The Stryker T7 Surgical
Personal Protective Equipment
Hoods and Togas are
components of Stryker T7
Personal Protective Equipment
(PPE). These surgical devices
are intended to protect the
patient, health care personnel
and operating room personnel
against contamination,
exposure of infectious bodily
fluids, and the transfer of
microorganism and particulate
material. The Stryker T7
Surgical Personal Protective
Equipment Hoods and Togas
are sterile, single use only
devices. | Identical
(except for
branding) |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Primary User
Population | Healthcare Professional
operating within an
environment requiring
barrier protection. | Healthcare Professional
operating within an
environment requiring
barrier protection. | Identical |
| Hood and Toga
Models | Hood, Pullover Toga,
Zippered Toga, Tie Back
Toga | Hood, Pullover Toga,
Zippered Toga | Similar |
| Characteristic | Subject Device:
Stryker Steri-Shield 8 Surgical
Hoods and Togas | Predicate Device:
Stryker T7 Surgical Hoods and
Togas (K200493) | Equivalence
Assessment |
| Shelf Life | 1.5 years | 3 years | Different |
| Available Sizes | Hood Single Size Only
Toga: Large, X Large, 2X
Large, 3X Large | Hood Single Size Only
Toga: Large, X Large, 2X
Large, 3X Large | Identical |
| Conditions for
Use | Single Use Only | Single Use Only | Identical |
| Raw Materials | | | |
| Face Shield
Standard | Clear PC | Clear PC | Identical |
| Face Shield Peel
Away | Clear PET Laminate | Clear PET Laminate | Identical |
| Face Shield
Anti-Reflective | Clear PET with Anti-Reflective
Coating | Clear PET with Anti-Reflective
Coating | Identical |
| Hood Side/Back | MB20:
Electrostatically charged
melt blown polypropylene
with spunbond scrim on
both sides | MB20:
Electrostatically charged
melt blown polypropylene
with spunbond scrim on
both sides | Identical |
| Filter Material | Polypropylene and Acrylic;
TS030Plus | Polypropylene and Acrylic;
TS050Plus | Similar |
| Hood Front | BVB - trilaminate with
polyethylene and polyester
outer layers with monolithic
film in the middle | BVB - trilaminate with
polyethylene and polyester
outer layers with monolithic
film in the middle | Identical |
| Toga Bodice
Back Panel | SMS: Tri-laminate
polypropylene nonwoven fabric
with layers of spunbond,
meltblown and spunbond | SMS: Tri-laminate
polypropylene nonwoven fabric
with layers of spunbond,
meltblown and spunbond | Identical |
| Toga Front | BVB - trilaminate with
polyethylene and polyester
outer layers with monolithic
film in the middle | BVB - trilaminate with
polyethylene and polyester
outer layers with monolithic
film in the middle | Identical |
| Toga Sleeves | BVB - trilaminate with
polyethylene and polyester
outer layers with monolithic
film in the middle | BVB - trilaminate with
polyethylene and polyester
outer layers with monolithic
film in the middle | Identical |
| Toga Sleeve
Cuffs | 100% Type 310
Polyester | 100% Type 310
Polyester | Identical |
| Thread | Polyester | Polyester | Identical |
| Characteristic | Subject Device:
Stryker Steri-Shield 8 Surgical
Hoods and Togas | Predicate Device:
Stryker T7 Surgical Hoods and
Togas (K200493) | Equivalence
Assessment |
| Weave and
Thread Count | All materials are non-
woven | All materials are non-
woven | Identical |
| Barrier Performance | | | |
| Critical Zone
Barrier
Performance:
Gown | ASTM F1671 testing - BVB &
Sleeve Seam: passes
requirements for PB70 Level 4
protection | ASTM F1671 testing - BVB &
Sleeve Seam: passes
requirements for PB70 Level 4
protection | Both meet
acceptance
criteria |
| Non-Critical
Barrier
Performance:
Gown | All materials and seams of
Togas pass AATCC Test
Method 42 Per AAMI/ANSI
PB70 (