(163 days)
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 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.
The Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure to infectious bodily fluids, and the transfer of microorganisms and particulate material. The device is sterile, disposable, and for single-use only.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Barrier Performance (Gown - Critical Zone Level 4 Protection) | |
| ASTM F1671 testing - BVB & Sleeve Seam | Passes requirements for PB70 Level 4 protection |
| Barrier Performance (Gown - Non-Critical Zone) | |
| AATCC Test Method 42 Per AAMI/ANSI PB70 | Passes AATCC Test Method 42 (< 4.5g) |
| Barrier Performance (Hood - Exempt) | |
| All materials and seams | Non-protective (meets acceptance criteria as intended) |
| Physical Performance | |
| Flammability per 16 CFR Part 1610 (Class 1) | Class 1 requirements met |
| Water Spray Impact per AATCC 42 (Water Penetration ≤ 4.5 g) | Water Penetration ≤ 4.5 g |
| Synthetic Blood per ASTM F1862 (No visible penetration) | No visible penetration |
| Fabric Viral Penetration per ASTM F1671 (no detectable (< 1 PFU/mL)) | No detectable (< 1 PFU/mL) |
| Particulate Filtration Efficiency per ASTM F2299 (≥ 95%) | ≥ 95% |
| Bacterial Filtration Efficiency per ASTM F2101 (≥ 95%) | ≥ 95% |
| Particle Release per ISO 9073-10 (Lint Count ≤ 4.0 (Log10, Upper Quartile)) | Lint Count ≤ 4.0 (Log10, Upper Quartile) |
| Air Permeability per ASTM D737 | Better or equivalent to predicate product |
| Tear Strength per ASTM D5587 (≥ 2.3 lbf) | ≥ 2.3 lbf |
| Tensile Strength per ASTM D5034 (≥ 7.0 lbf) | ≥ 7.0 lbf |
| Seam Strength per ASTM D1683 (≥ 7.0 lbf) | ≥ 7.0 lbf (Predicate was ≥ 6.0 lbf, so this is an improvement or meets threshold) |
| Evaporative Resistance per ASTM F1868 | Better or equivalent to predicate product |
| Light Transmittance and Haze per ASTM D1003 | Better or equivalent to predicate product |
| Perforation Tear Strength Testing (Stryker Internal Testing) (0.15 lbf < Tear Force ≤ 1.5 lbf) | 0.15 lbf < Tear Force ≤ 1.5 lbf |
| Biocompatibility | |
| Human Factors and Usability | Product is found to be safe and effective for the intended users, uses and use environment |
| Noise and Speech Interference Levels | Better or equivalent to predicate product |
| Carbon Dioxide (CO2) Testing (Inhale CO2 ≤ 5000ppm per OSHA Exposure Limits) | Inhale CO2 ≤ 5000ppm |
| ISO 10993-1, -5, -10, -23, -11 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity) | Cytotoxicity – MEM Grade ≤ 2; Sensitization – Sensitization response ≤ 0; Irritation – Intracutaneous Reactivity ≤ 1.0; Acute Systemic Toxicity – No signs of toxicity, no weight loss in excess of 10% (Note: Cytotoxic response in one test article was mitigated by in vivo testing and chemical characterization) |
| ISO 10993-17 (Toxicological risk assessment) | Assessment performed |
| ISO 10993-18 (Chemical characterization of medical device materials) | Characterization performed |
| Sterilization | |
| Finished (Terminal) Product Sterilization Method (SAL 10-6 Terminally sterilized via Ethylene Oxide (EO)) | SAL 10-6 Terminally sterilized via Ethylene Oxide (EO) in accordance with ISO 11135, Half cycle overkill method |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each test mentioned (e.g., number of hoods or togas tested for flammability, water resistance, etc.). The tests are described as "Performance Data (Non-Clinical Tests)," indicating that they were conducted in a laboratory setting on product samples. The data provenance is not specified beyond being generated by Stryker Instruments as part of their 510(k) submission. Given the nature of performance testing for surgical apparel standards, these tests are typically conducted on representative samples of the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The acceptance criteria for the Stryker Steri-Shield 8 Surgical Hoods and Togas are based on recognized industry standards (e.g., ASTM, AATCC, ISO, 16 CFR) for material properties and device performance, not on expert interpretations of outcomes.
4. Adjudication method for the test set:
This information is not applicable as the acceptance criteria are based on objective, quantifiable measurements from recognized standards, not subjective assessments requiring adjudication.
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:
This information is not applicable. The device is a surgical hood and toga, not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical product (surgical apparel), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on established, quantifiable metrics and pass/fail criteria defined by recognized national and international standards for medical textiles, barrier materials, and biological safety. Examples include:
- Physical properties (e.g., tear strength, tensile strength, air permeability).
- Barrier effectiveness against fluids, synthetic blood, viruses, and particulates.
- Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
- Flammability.
- CO2 levels within the hood.
These "ground truths" are objective measurements against defined thresholds in the standards.
8. The sample size for the training set:
This is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device is a physical product and not an AI/ML algorithm.
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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"
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(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).
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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
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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 Instruments1941 Stryker WayPortage, 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 ProductCodes and Names | FYA- Gown, SurgicalFXY- 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 | ProductCode | Manufacturer | |
|---|---|---|---|---|
| Predicate | Stryker T7 Surgical Hoodsand 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 SurgicalHoods and Togas | Predicate Device:Stryker T7 Surgical Hoods andTogas (K200493) | EquivalenceAssessment |
|---|---|---|---|
| ProprietaryName | Stryker Steri-Shield 8 SurgicalHoods and Togas | Stryker T7 Surgical Hoods andTogas | Brandingname, lineextension |
| ProductClassification/Regulation | Class II21 CFR 878.4040Surgical Apparel | Class II21 CFR 878.4040Surgical Apparel | Identical |
| FDA ProductCodes | FXY, FYA | FXY, FYA | Identical |
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| Indications forUse Statement | The Stryker Steri-Shield 8disposables, including all hoodand toga models, arecomponents of the StrykerSteri-Shield 8 PersonalProtection System and areintended to protect the patient,healthcare personnel, andoperating room personnelagainst contamination,exposure of infectious bodilyfluids, and the transfer ofmicroorganism and particulatematerial. The Stryker Steri-Shield 8 disposables are sterile,disposable, single-use onlydevices. | The Stryker T7 SurgicalPersonal Protective EquipmentHoods and Togas arecomponents of Stryker T7Personal Protective Equipment(PPE). These surgical devicesare intended to protect thepatient, health care personneland operating room personnelagainst contamination,exposure of infectious bodilyfluids, and the transfer ofmicroorganism and particulatematerial. The Stryker T7Surgical Personal ProtectiveEquipment Hoods and Togasare sterile, single use onlydevices. | Identical(except forbranding) |
|---|---|---|---|
| Primary UserPopulation | Healthcare Professionaloperating within anenvironment requiringbarrier protection. | Healthcare Professionaloperating within anenvironment requiringbarrier protection. | Identical |
| Hood and TogaModels | Hood, Pullover Toga,Zippered Toga, Tie BackToga | Hood, Pullover Toga,Zippered Toga | Similar |
| Characteristic | Subject Device:Stryker Steri-Shield 8 SurgicalHoods and Togas | Predicate Device:Stryker T7 Surgical Hoods andTogas (K200493) | EquivalenceAssessment |
| Shelf Life | 1.5 years | 3 years | Different |
| Available Sizes | Hood Single Size OnlyToga: Large, X Large, 2XLarge, 3X Large | Hood Single Size OnlyToga: Large, X Large, 2XLarge, 3X Large | Identical |
| Conditions forUse | Single Use Only | Single Use Only | Identical |
| Raw Materials | |||
| Face ShieldStandard | Clear PC | Clear PC | Identical |
| Face Shield PeelAway | Clear PET Laminate | Clear PET Laminate | Identical |
| Face ShieldAnti-Reflective | Clear PET with Anti-ReflectiveCoating | Clear PET with Anti-ReflectiveCoating | Identical |
| Hood Side/Back | MB20:Electrostatically chargedmelt blown polypropylenewith spunbond scrim onboth sides | MB20:Electrostatically chargedmelt blown polypropylenewith spunbond scrim onboth sides | Identical |
| Filter Material | Polypropylene and Acrylic;TS030Plus | Polypropylene and Acrylic;TS050Plus | Similar |
| Hood Front | BVB - trilaminate withpolyethylene and polyesterouter layers with monolithicfilm in the middle | BVB - trilaminate withpolyethylene and polyesterouter layers with monolithicfilm in the middle | Identical |
| Toga BodiceBack Panel | SMS: Tri-laminatepolypropylene nonwoven fabricwith layers of spunbond,meltblown and spunbond | SMS: Tri-laminatepolypropylene nonwoven fabricwith layers of spunbond,meltblown and spunbond | Identical |
| Toga Front | BVB - trilaminate withpolyethylene and polyesterouter layers with monolithicfilm in the middle | BVB - trilaminate withpolyethylene and polyesterouter layers with monolithicfilm in the middle | Identical |
| Toga Sleeves | BVB - trilaminate withpolyethylene and polyesterouter layers with monolithicfilm in the middle | BVB - trilaminate withpolyethylene and polyesterouter layers with monolithicfilm in the middle | Identical |
| Toga SleeveCuffs | 100% Type 310Polyester | 100% Type 310Polyester | Identical |
| Thread | Polyester | Polyester | Identical |
| Characteristic | Subject Device:Stryker Steri-Shield 8 SurgicalHoods and Togas | Predicate Device:Stryker T7 Surgical Hoods andTogas (K200493) | EquivalenceAssessment |
| Weave andThread Count | All materials are non-woven | All materials are non-woven | Identical |
| Barrier Performance | |||
| Critical ZoneBarrierPerformance:Gown | ASTM F1671 testing - BVB &Sleeve Seam: passesrequirements for PB70 Level 4protection | ASTM F1671 testing - BVB &Sleeve Seam: passesrequirements for PB70 Level 4protection | Both meetacceptancecriteria |
| Non-CriticalBarrierPerformance:Gown | All materials and seams ofTogas pass AATCC TestMethod 42 Per AAMI/ANSIPB70 (<4.5g) | All materials and seams ofTogas pass AATCC TestMethod 42 Per AAMI/ANSIPB70 (<4.5g) | Both meetacceptancecriteria |
| Exempt BarrierPerformance:Hood | All materials and seams arenon-protective | All materials and seams arenon-protective | Both meetacceptancecriteria |
| Physical Performance | |||
| Flammabilityper 16 CFR Part1610 | Class 1 | Class 1 | Both meetacceptancecriteria |
| Water SprayImpact perAATCC42 | AATCC Test Method 42:Water Penetration ≤ 4.5 g | AATCC Test Method 42:Water Penetration ≤ 4.5 g | Both meetacceptancecriteria |
| Synthetic Bloodper ASTMF1862 | No visible penetration | No visible penetration | Both meetacceptancecriteria |
| Fabric ViralPenetration perASTM F1671 | ASTM F1671, Procedure B:no detectable (< 1 PFU/mL) | ASTM F1671, Procedure B:no detectable (< 1 PFU/mL) | Both meetacceptancecriteria |
| ParticulateFiltrationEfficiency perASTM F2299 | ≥ 95% | ≥ 95% | Both meetacceptancecriteria |
| BacterialFiltration | ≥ 95% | ≥ 95% | Both meetacceptancecriteria |
| Characteristic | Subject Device:Stryker Steri-Shield 8 SurgicalHoods and Togas | Predicate Device:Stryker T7 Surgical Hoods andTogas (K200493) | EquivalenceAssessment |
| Efficiency perASTM F2101 | |||
| Particle Releaseper ISO 9073-10 | Lint Count ≤ 4.0 (Log10, UpperQuartile) | Lint Count ≤ 4.0 (Log10, UpperQuartile) | Both meetacceptancecriteria |
| Air Permeabilityper ASTM D737 | Better or equivalent topredicate product | Better or equivalent topredicate product | Both meetacceptancecriteria |
| Tear Strengthper ASTMD5587 | ≥ 2.3lbf | ≥ 2.3lbf | Both meetacceptancecriteria |
| TensileStrength perASTM D5034 | ≥ 7.0lbf | ≥ 7.0lbf | Both meetacceptancecriteria |
| Seam Strengthper ASTMD1683 | ≥ 7.0lbf | ≥ 6.0lbf | Both meetacceptancecriteria |
| EvaporativeResistance perASTM F1868 | Better or equivalent topredicate product | Better or equivalent topredicate product | Both meetacceptancecriteria |
| LightTransmittanceand Haze perASTM D1003 | Better or equivalent topredicate product | Better or equivalent topredicate product | Both meetacceptancecriteria |
| Finished(Terminal)ProductSterilizationMethod | SAL 10-6 Terminally sterilizedvia Ethylene Oxide (EO) inaccordance with ISO 11135,Half cycle overkill method | SAL 10-6 Terminally sterilizedvia Ethylene Oxide (EO) inaccordance with ISO 11135,Half cycle overkill method | Identical |
| PackagingConfiguration | Individually packaged in aPoly-Tyvek pouch | Individually packaged in aPoly-Tyvek pouch | Identical |
| Labeling | Adhesive backed labelplaced on carton andpouch label printeddirectly onto the Tyvek.Label specifies partdescription, quantity,sterilization method, lot | Adhesive backed labelplaced on carton andpouch label printeddirectly onto the Tyvek.Label specifies partdescription, quantity,sterilization method, lot | Identical |
| Characteristic | Subject Device:Stryker Steri-Shield 8 SurgicalHoods and Togas | Predicate Device:Stryker T7 Surgical Hoods andTogas (K200493) | EquivalenceAssessment |
| number, expiration date,and contact information. | number, expiration date,and contact information. |
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Performance Data (Non-Clinical Tests)
The following table provides an overview of the standards and testing 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 to aid in determination of the subject devices as safe and effective for use and to support a determination of substantial equivalence.
| Testing Standard with Year | Acceptance Criteria | TestResults |
|---|---|---|
| Standard for the Flammability of ClothingTextiles (16 CFR Part 1610:2023) | Meets Class 1 requirements | Pass |
| Water Resistance: Impact Penetration Test(AATCC 42-2017) | Water Penetration ≤ 4.5 grams | Pass |
| Standard Test Method for Resistance ofMedical Face Masks to Penetration bySynthetic Blood (Horizontal Projection of FixedVolume at a Known Velocity) (ASTMF1862/F1862M-2017) | No visible penetration | Pass |
| Standard Test Method for Resistance ofMaterials Used in Protective Clothing toPenetration by Blood-Borne Pathogens UsingPhi-X174 Bacteriophage Penetration as a TestSystem (ASTM F1671-2022) | < 1 PFU/mL | Pass |
| Standard Test Method for Determining theInitial Efficiency of Materials to Penetration byParticulates Using Latex Spheres (ASTM F2299-2017) | ≥ 95% | Pass |
| Standard Test Method for Evaluating theBacterial Filtration Efficiency (BFE) of MedicalFace Mask Materials (ASTM F2101-2022) | ≥ 95% | Pass |
| Textiles. Test methods for nonwovens-Lint andother particles generation in the dry state (ISO9073-10:2004) | Lint Count ≤ 4.0 ( $Log$ 10, Upper Quartile) | Pass |
| Standard Test Method for Air Permeability ofTextile Fabrics (ASTM D737-2018) | Better or equivalent to predicate product | Pass |
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| Standard Test Method for Tearing Strength ofFabrics by Trapezoid Procedure (ASTM D5587-2019) | $\ge 2.3lbf$ | Pass |
|---|---|---|
| Standard Test Method for Breaking Strengthand Elongation of Textile Fabrics (Grab Test)(ASTM D5034-2021) | $\ge 7.0lbf$ | Pass |
| Standard Test Method for Failure in SewnSeams of Woven Fabrics (ASTMD1683/D1683M-17(2018)) | $\ge 7.0lbf$ | Pass |
| Standard Test Method for Thermal Resistance,Evaporative Resistance, and Total Heat LossMeasurements of Clothing Materials Using aSweating Hot Plate (ASTM F1868-2017) | Better or equivalent to predicate product | Pass |
| Standard Test Method for Haze and LuminousTransmittance of Transparent Plastics (ASTMD1003-2021) | Better or equivalent to predicate product | Pass |
| Perforation Tear Strength Testing (StrykerInternal Testing) | $0.15lbf < Tear Force \le 1.5lbf$ | Pass |
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| Human Factors and Usability | Product is found to be safe and effective for the intended users, uses and use environment while following Agency "Human Factors and Usability Engineering to Medical Devices" guidance. | Pass |
|---|---|---|
| Noise and Speech Interference Levels | Better or equivalent to predicate product | Pass |
| Carbon Dioxide (CO2) Testing | Inhale CO2 $\le$ 5000ppm per OSHA Exposure Limits | Pass |
| Biological Evaluation of Medical Devices – Part1: Evaluation and testing within a riskmanagement process (ISO 10993-1:2018)Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity (ISO 10993-5:2009) Biological evaluation of medical devices – Part 10: Tests for skin sensitization (ISO 10993-10:2021) Biological evaluation of medical devices – Part 23: Test for irritation (ISO 10993-23:2021) Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2017) | Cytotoxicity – MEM Grade $\le$ 2 Sensitization – Sensitization response $\le$ 0 Irritation – Intracutaneous Reactivity $\le$ 1.0 Acute Systemic Toxicity – No signs of toxicity, no weight loss in excess of 10% | Pass* |
| Biological evaluation of medical devise - Part17: Toxicological risk assessment of medicaldevice constituents (ISO 10993-17:2023) | Assessment performed | Comply |
| Biological evaluation of medical devices – Part18: Chemical characterization of medicaldevice materials within a risk managementprocess (ISO 10993-18: 2020) | Characterization performed | Comply |
*Test article Zippered Toga with Peel-Away Face Shield showed a cytotoxic response under the test. However, in vivo testing and chemical characterization (extractables and simulated use extractables) were completed and serve to mitigate the in vitro cytotoxicity result observed in the MEM elution assay to support the biocompatibility of the subject article.
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Summary of Clinical Testing
No clinical testing was performed for the subject device.
Conclusion/ Substantial Equivalence Rationale
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Stryker Steri-Shield 8 Surgical Hoods and Togas, is as safe, as effective, and performs as well as or better than the legally marketed predicate device under K200493.
§ 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.