(111 days)
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The devices are provided sterile and for single use only.
The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck.
The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens.
The devices are prescription devices, provided sterile and single use only.
This document describes the acceptance criteria and performance data for the Stryker Flyte Hybrid Hoods.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| CO₂ Level Inside the Hood (Internal test) | CO₂ Level < 5000 ppm | Pass |
| Flammability (16 CFR Part 1610) | No burn time or burn time ≥ 3.5 s | Pass |
| Linting (ISO 9073-10) | ≤ 4.0 CL | Pass |
| Tensile Strength (BS EN 29073-3:1992) | ≥ 20 N | Pass |
| Water Spray Impact Penetration (AATCC Test Method 42-2007) | ≤ 4.5 g | Pass |
| Tear Resistance (ASTM D5587-08) | Hood ≥ 2.50 lbfFilter ≥ 2.00 lbf | Pass |
| Evaporative Resistance (ASTM F1868-12 Part B) | Hood ≤ 25.22 Pa·m²/W | Pass |
| Seam Strength Testing (ASTM D1683/D1683M – 11a) | Lens to Hood peel ≥ 2.00 lbfLens to Hood shear ≥ 6.00 lbfAll other seams ≥ 4.00 lbf | Pass |
| Biocompatibility (in vitro cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (primary skin irritation) | Not an irritant | Not an irritant |
| Biocompatibility (skin sensitization) | Not a sensitizer | Not a sensitizer |
| Bacterial Filtration Efficiency (per ASTM F2101-07) | Compliant - Pass | Compliant - Pass |
| Particulate Filtration Efficiency (per ASTM F2299-03) | Compliant - Pass | Compliant - Pass |
| Water Resistance: Impact Penetration (per AATCC 42) Level 1 Critical Zone | Pass AAMI/ANSI PB70 Requirements for Level 1 Protection. | Pass AAMI/ANSI PB70 Requirements for Level 1 Protection. |
| Flammability (16 CFR Part 1610) | No Flame Spread per 16 CFR Part 1610 | No Flame Spread per 16 CFR Part 1610 |
| Finished (Terminal) Product Sterilization Method | SAL 10-6 | SAL 10-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for each performance test. The data provenance is not specified, but the tests were performed by Stryker Instruments, indicating internal testing. The tests are prospective in nature, demonstrating the device's performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests performed are objective physical, chemical, and biological characterizations of the device material, evaluated against established industry and regulatory standards. Expert consensus for test results is not typically required in this context.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements and comparisons to predefined acceptance criteria within established standards.
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:
Not applicable. This is a medical device (surgical apparel) and not an AI-driven diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (surgical apparel) and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests outlined is defined by established industry standards, regulatory guidelines (e.g., 16 CFR Part 1610, AAMI/ANSI PB70), and ISO standards (e.g., ISO 9073-10, ISO 11135-1, ISO 10993-1). These standards provide objective criteria for evaluating the physical, mechanical, and biological properties of the surgical hood material.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 329 7000 f: 269 389 5412
www.stryker.com
510(k) Summary
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-329-7000(f) 269-389-5412 | JUN 2 6 2014 | |||
|---|---|---|---|---|---|
| Contact Person: | Julia L. HelgesonSr. Regulatory Affairs Representative | ||||
| Registration Number: | 1811755 | ||||
| Date Summary Prepared: | June 25, 2014 | ||||
| Trade Name(s): | Stryker Flyte Hybrid Hoods | ||||
| Common Name: | Surgical Apparel | ||||
| Classification Data: | Product Code | Device | RegulationNumber | Class | ReviewPanel |
| FXY | Hood, Surgical | 21 CFR 878.4040 | II | General &PlasticSurgery | |
| Reason for 510(k)Submission: | Special 510(k): Device Modification to Stryker Flyte Hood material | ||||
| Predicate SE Device(s): | K063005, Stryker T6 Hoods and Togas | ||||
| Indications for Use: | The Stryker Flyte Hybrid Hoods are devices within a personal protection system andare intended to protect the patient, healthcare personnel, and operation roompersonnel against contamination, exposure of infectious bodily fluids, and thetransfer of microorganisms and particulate material. The hoods are providedsterile and for single-use only. | ||||
| Device Description: | The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet toprovide protection to the user's face and head region during surgery. Hoods areworn in conjunction with surgical gowns where the hood material extends beyondthe user's upper back and shoulders, while the surgical gown covers the lowerportion of the hood up to the user's neck. | ||||
| The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens.Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens. | |||||
| The devices are prescription devices, provided sterile and single use only. | |||||
| Hood Models: | 0408-801-400 Stryker Flyte Hybrid Hood0408-801-500 Stryker Flyte Hybrid Hood with Peelaway Lens |
.
.
ﺮ
510(k) Summary, Rev. 2
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4100 E. Milham Ave. Kalamazoo, MI 49001 t: 269 329 7000 f: 269 389 5412 www.stryker.com
Image /page/1/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase, except for the "S", which is uppercase. The word is black and the background is white. There is a small circle with an "R" inside of it in the upper right corner of the image.
Device Modification: Stryker submits this Special 510(k): Device Modification to request a modification for our Stryker T6 Hoods. The modification is a change to the material utilized in the hoods. Neither the lens nor the filter material has changed. The modification changes neither the intended use nor the indications for use. Performance Data (Non Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Flyte Hybrid Hoods are sufficient for their Clinical Tests): intended use and support a determination of substantial equivalence.
Summary of Performance Testing
Biocompatibility testing was performed on the subject device in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological Evaluation of Medical Devices-Part 1: Evaluation and AAMI Standards and Recommended Practices, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices. Results of testing validate the subject device is non-cytotoxic, non-sensitizing, and a negligible irritant.
Stryker Flyte Hybrid Hoods will be available only in sterile packaged form. The sterile product will be terminally sterilized using ethylene oxide (EO). The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide. A sterility assurance level of 10 ° has been validated for this product.
| Test Performed | Acceptance Criteria | Conclusion |
|---|---|---|
| CO₂ Level Inside the Hood (Internal test to aid indetermining user comfort) | CO₂ Level < 5000 ppm | Pass |
| Flammability (16 CFR Part 1610) | No burn time or burn time ≥ 3.5 s | Pass |
| Linting (ISO 9073-10) | ≤ 4.0 CL | Pass |
| Tensile Strength (BS EN 29073-3:1992) | ≥ 20 N | Pass |
| Water Spray Impact Penetration (AATCC TestMethod 42-2007) | ≤ 4.5 g | Pass |
| Tear Resistance (ASTM D5587-08) | Hood ≥ 2.50 lbfFilter ≥ 2.00 lbf | Pass |
| Evaporative Resistance (ASTM F1868-12 Part B) | Hood ≤ 25.22 Pa·m²/W | Pass |
| Seam Strength Testing (ASTM D1683/D1683M – 11a) | Lens to Hood peel ≥ 2.00 lbfLens to Hood shear ≥ 6.00 lbfAll other seams ≥ 4.00 lbf | Pass |
Additional Tests Performed as a Result of Material Change
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4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 329 7000 f: 269 389 5412 www.stryker.com
Comparison to Predicate Device(s):
| Description | Stryker T6 Hoods and TogasK063005(Predicate) | Stryker Flyte Hybrid Hoods(Subject) | Explanation of Difference |
|---|---|---|---|
| Classification/Regulation | Class II | Class II | Identical |
| Regulation | 21 CFR 878.4040 SurgicalApparel | 21 CFR 878.4040 SurgicalApparel | Identical |
| Product Code | FXY | FXY | Identical |
| Intended Use | The Stryker T6 Hood; T6Hood, Peel-away; T6 Hood,S95; T6 Toga, Pullover; T6Toga, Zippered; and the T6Toga with Peel-away Lens,Zippered are components ofa personal protection systemand are intended to protectthe patient, health carepersonnel and operatingroom personnel againstcontamination, exposure ofinfectious bodily fluids, thetransfer of microorganismsand particulate materials. | The Stryker Flyte Hybrid Hoodsare devices within a personalprotection system and areintended to protect thepatient, healthcare personnel,and operation room personnelagainst contamination,exposure of infectious bodilyfluids, and the transfer ofmicroorganisms andparticulate material. Thehoods are provided sterile andsingle-use only. | Identical |
| Target Population | Operating room personnel | Operating room personnel | Identical |
| Conditions for Use | Single Use/Disposable | Single Use/Disposable | Identical |
| Materials | |||
| Hood Region | Polypropylene and polyester | Polypropylene | Stryker Flyte HybridHoods utilizes a morebreathable material inthe hood region. |
| Filter | Polypropylene and Acrylic | Polypropylene and Acrylic | Identical |
| Lens: Standard(Non-Peelaway) | Clear Polycarbonate | Clear Polycarbonate | Identical |
| Lens: Peelaway | Clear PET Laminate | Clear PET Laminate | Identical |
| Color | Hood region material: BlueFilter material: White | Hood region material: Light blueFilter material: White | Similar. Stryker FlyteHybrid hood regionmaterial is light blue incolor instead of blue. |
| Physical/Mechanical Specifications | |||
| Lint Level (ISO 9073part 10 ) | Compliant - Pass | Compliant - Pass | Specification met. StrykerFlyte Hybrid Hoods use adifferent hood regionmaterial. The filtermaterial was not testedas part of the predicate510k but was tested forthe subject 510k. |
510(k) Summary, Rev. 2
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4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 329 7000 ff: 269 389 5412
www.stryker.com
Image /page/3/Picture/1 description: The image shows the word "stryker" in bold, black letters. The font is sans-serif and appears to be a custom design. A small circle is present to the right of the letter "r", likely indicating a registered trademark symbol.
| Description | Stryker T6 Hoods and TogasK063005(Predicate) | Stryker Flyte Hybrid Hoods(Subject) | Explanation of Difference |
|---|---|---|---|
| Tensile Strength (BSEN 29073-3) | Compliant - Pass | Compliant - Pass | Specification met. StrykerFlyte Hybrid hood regionmaterial has a lowertensile strength, but itstill meets thespecification. The filtermaterial was not testedas part of the predicate510k but was tested forthe subject 510k. |
| Tear Resistance(Flyte Hybrid: ASTMD 5587-08; Flyte:ASTM D 5733) | Compliant - Pass | Compliant - Pass | Specification met. ASTMD5733 was withdrawn in2008; therefore, differenttest standards werefollowed. The filtermaterial was not testedas part of the predicate510k, but was tested forthe subject 510k. |
| Evaporativeresistance (ASTM F1868 ) | Not Previously Tested | Compliant - Pass | Specifications met.Evaporative Resistancewas not previously testedas part of the predicate510k. |
| Bacterial FiltrationEfficiencyper ASTM F2101-07 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Particulate FiltrationEfficiencyper ASTM F2299-03 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Barrier Performance | |||
| Water Resistance:Impact Penetration(per AATCC 42)Level 1 Critical Zoneas defined inAAMI/ANSI PB70 | Hood Material:Pass AAMI/ANSI PB70Requirements for Level 4Protection. | Hood Material:Pass AAMI/ANSI PB70Requirements for Level 1Protection. | Specification met. StrykerFlyte Hybrid Hoodmaterial offers a lowerlevel of protection whencompared to thepredicate Hood material. |
| General Safety and Performance | |||
| Biocompatibility | |||
| in vitro cytotoxicity | Under the conditions of thestudy, non-cytotoxic | Under the conditions of thestudy, non-cytotoxic | Identical |
| primary skinirritation | Under the conditions of thestudy, not an irritant | Under the conditions of thestudy, not an irritant | Identical |
| skin sensitization | Under the conditions of thestudy, not a sensitizer | Under the conditions of thestudy, not a sensitizer | Identical |
.
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4100 E. Milham Ave. Kalamazoo, MI 49001 t: 269 329 7000 f: 269 389 5412 www.stryker.com
Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the "S", which is uppercase. There is a registered trademark symbol to the right of the "r" at the end of the word. The word is in black and the background is white.
| Description | Stryker T6 Hoods and TogasK063005(Predicate) | Stryker Flyte Hybrid Hoods(Subject) | Explanation of Difference |
|---|---|---|---|
| Flammability | No Flame Spread per 16 CFRPart 1610 | No Flame Spread per 16 CFRPart 1610 | Identical |
| Shelf Life | 3 years | 1 year | Similar – the intent is toextend the shelf life forthe subject device uponsuccessful completion ofaging studies |
| Finished (Terminal)Product SterilizationMethod | SAL 10-6Terminally sterilized viaEthylene Oxide in accordancewith ISO 11135-1 | SAL 10-6Terminally sterilized viaEthylene Oxide in accordancewith ISO 11135-1 | Identical |
| Packaging | Individually packaged in aPoly-Tyvek pouch | Individually packaged in a Poly-Tyvek pouch | Identical |
| Labeling | Adhesive backed label placedon carton and pouch labelprinted directly onto theTyvek.Label specified partdescription, quantity,sterilization method, lotnumber, expiration date, andcontact information.No known contraindications. | Adhesive backed label placedon carton and pouch labelprinted directly onto the Tyvek.Label specified partdescription, quantity,sterilization method, lotnumber, expiration date, andcontact information.No known contraindications. | Identical |
Conclusion/ Substantial Equivalence (SE) Rationale:
The Stryker Flyte Hybrid Hoods are substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker T6 Hoods. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker Flyte Hybrid Hoods are substantially equivalent to the existing predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract human figure embracing a globe or sphere. The logo is black and white.
Public Health Service
Food and Drug Administration t 0903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-000
June 26, 2014
Stryker Instruments Ms. Julia L. Helgeson Senior Regulatory Representative 4100 E. Milham Ave Kalamazoo, MI 49001
Re: K140588
Trade/Device Name: Stryker Flyte Hybrid Hoods Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXY Dated: May 15, 2014 Received: May 27, 2014
Dear Ms. Helgeson,
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. 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.
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Page 2 - Ms. Helgeson
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
... .. ... Tejashri Purohit-Sheth, M.D. Tejashri Purofit-Sheth, M.D. Clinies Deputy Director S - DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140588
Device Name Stryker Flyte Hybrid Hoods
Indications for Use (Describe)
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The devices are provided sterile and for single use only.
Type of Use (Select one or both, as epplicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth Gutala -S
Digitally signed by Sreekanth Gulala -S DN: caUS, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300,100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.06.25 07:54:16 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (1/14)
§ 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.