(111 days)
Not Found
No
The device description and performance studies focus on physical properties and filtration, with no mention of AI or ML.
No.
The device is a personal protection system designed to protect against contamination and transfer of microorganisms, not to treat or cure a disease or condition.
No
Explanation: The device description states its purpose is to protect personnel from contamination and exposure during surgery, not to diagnose a medical condition. Performance studies focus on protection and safety metrics, not diagnostic accuracy.
No
The device description clearly states it is comprised of physical components (Hood, Filter, Lens) and is intended to be worn, indicating it is a hardware device. The performance studies also focus on physical properties and sterilization, not software validation.
Based on the provided text, the Stryker Flyte Hybrid Hoods are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for personal protection to prevent contamination and exposure to infectious bodily fluids and microorganisms. This is a barrier function, not a diagnostic function.
- Device Description: The description details a physical barrier worn over a helmet, comprised of a hood, filter, and lens. This aligns with personal protective equipment, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide diagnostic information. The performance studies focus on physical properties and barrier effectiveness, not analytical performance related to biological samples.
Therefore, the Stryker Flyte Hybrid Hoods are classified as personal protective equipment, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Flyte Hybrid Hoods are devices within a personal protection system and are intended to protect the patient, healthcare personnel, and operation room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganisms and particulate material. The hoods are provided sterile and for single-use only.
Product codes (comma separated list FDA assigned to the subject device)
FXY
Device Description
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.
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
Operating room personnel
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)
Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Flyte Hybrid Hoods are sufficient for their intended use and support a determination of substantial equivalence.
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.
Tests Performed: CO₂ Level Inside the Hood (Internal test to aid in determining user comfort); Flammability (16 CFR Part 1610); Linting (ISO 9073-10); Tensile Strength (BS EN 29073-3:1992); Water Spray Impact Penetration (AATCC Test Method 42-2007); Tear Resistance (ASTM D5587-08); Evaporative Resistance (ASTM F1868-12 Part B); Seam Strength Testing (ASTM D1683/D1683M – 11a).
All tests passed their acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Instruments
4100 E. Milham Avenue
Kalamazoo, MI 49001
(p) 269-329-7000
(f) 269-389-5412 | | | | JUN 2 6 2014 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------|-------|---------------------------------|
| Contact Person: | Julia L. Helgeson
Sr. 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 | Regulation
Number | Class | Review
Panel |
| | FXY | Hood, Surgical | 21 CFR 878.4040 | II | General &
Plastic
Surgery |
| 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 and
are intended to protect the patient, healthcare personnel, and operation room
personnel against contamination, exposure of infectious bodily fluids, and the
transfer of microorganisms and particulate material. The hoods are provided
sterile and for single-use only. | | | | |
| Device Description: | 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. | | | | |
| Hood Models: | 0408-801-400 Stryker Flyte Hybrid Hood
0408-801-500 Stryker Flyte Hybrid Hood with Peelaway Lens | | | | |
.
.
ﺮ
510(k) Summary, Rev. 2
1
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 in | ||
| determining user comfort) | CO₂ Level Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)