← Product Code [FXY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXY) · K140588
# FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (K140588)
_Stryker Corporation · FXY · Jun 26, 2014 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXY/K140588
## Device Facts
- **Applicant:** Stryker Corporation
- **Product Code:** [FXY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXY.md)
- **Decision Date:** Jun 26, 2014
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Intended Use
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.
## Device Story
Stryker Flyte Hybrid Hoods are surgical apparel components of a personal protection system; worn over Flyte Helmet to protect user's head/face during surgery. Hoods feature three main parts: hood, filter, and lens (standard or peel-away). Used in conjunction with surgical gowns; hood material extends over upper back/shoulders while gown covers lower portion. Operated by OR personnel; provides barrier against contamination, infectious fluids, and particulates. Benefits include reduced risk of cross-contamination and exposure during surgical procedures. Provided sterile for single-use.
## Clinical Evidence
Bench testing only. Testing included biocompatibility (ISO 10993-1), CO2 levels, flammability (16 CFR 1610), linting (ISO 9073-10), tensile strength (BS EN 29073-3), water spray impact penetration (AATCC 42), tear resistance (ASTM D5587-08), evaporative resistance (ASTM F1868-12), seam strength (ASTM D1683), and filtration efficiency (Bacterial ASTM F2101-07; Particulate ASTM F2299-03). All tests met acceptance criteria.
## Technological Characteristics
Hood region: Polypropylene; Filter: Polypropylene and Acrylic; Lens: Polycarbonate or PET laminate. Energy source: None (passive barrier). Connectivity: None. Sterilization: Ethylene oxide (EO) per ISO 11135-1:2007. Form factor: Hood worn over helmet. Standards: ANSI/AAMI/ISO 10993-1, ASTM D5587-08, ASTM F1868-12, ASTM D1683, AATCC 42, ISO 9073-10.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- Stryker T6 Hoods and Togas ([K063005](/device/K063005.md))
## Submission Summary (Full Text)
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{0}------------------------------------------------
4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 329 7000 f: 269 389 5412
www.stryker.com
K140588
### 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 < 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 lbf
Filter ≥ 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 lbf
Lens to Hood shear ≥ 6.00 lbf
All other seams ≥ 4.00 lbf | Pass |
#### Additional Tests Performed as a Result of Material Change
{2}------------------------------------------------
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 Togas
K063005
(Predicate) | Stryker Flyte Hybrid Hoods
(Subject) | Explanation of Difference |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification/
Regulation | Class II | Class II | Identical |
| Regulation | 21 CFR 878.4040 Surgical
Apparel | 21 CFR 878.4040 Surgical
Apparel | Identical |
| Product Code | FXY | FXY | Identical |
| Intended Use | The Stryker T6 Hood; T6
Hood, Peel-away; T6 Hood,
S95; T6 Toga, Pullover; T6
Toga, Zippered; and the T6
Toga with Peel-away Lens,
Zippered are components of
a personal protection system
and are intended to protect
the patient, health care
personnel and operating
room personnel against
contamination, exposure of
infectious bodily fluids, the
transfer of microorganisms
and particulate materials. | 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
single-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 Hybrid
Hoods utilizes a more
breathable material in
the 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: Blue
Filter material: White | Hood region material: Light blue
Filter material: White | Similar. Stryker Flyte
Hybrid hood region
material is light blue in
color instead of blue. |
| Physical/Mechanical Specifications | | | |
| Lint Level (ISO 9073
part 10 ) | Compliant - Pass | Compliant - Pass | Specification met. Stryker
Flyte Hybrid Hoods use a
different hood region
material. The filter
material was not tested
as part of the predicate
510k but was tested for
the subject 510k. |
510(k) Summary, Rev. 2
{3}------------------------------------------------
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 Togas
K063005
(Predicate) | Stryker Flyte Hybrid Hoods
(Subject) | Explanation of Difference |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength (BS
EN 29073-3) | Compliant - Pass | Compliant - Pass | Specification met. Stryker
Flyte Hybrid hood region
material has a lower
tensile strength, but it
still meets the
specification. The filter
material was not tested
as part of the predicate
510k but was tested for
the subject 510k. |
| Tear Resistance
(Flyte Hybrid: ASTM
D 5587-08; Flyte:
ASTM D 5733) | Compliant - Pass | Compliant - Pass | Specification met. ASTM
D5733 was withdrawn in
2008; therefore, different
test standards were
followed. The filter
material was not tested
as part of the predicate
510k, but was tested for
the subject 510k. |
| Evaporative
resistance (ASTM F
1868 ) | Not Previously Tested | Compliant - Pass | Specifications met.
Evaporative Resistance
was not previously tested
as part of the predicate
510k. |
| Bacterial Filtration
Efficiency
per ASTM F2101-07 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Particulate Filtration
Efficiency
per ASTM F2299-03 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Barrier Performance | | | |
| Water Resistance:
Impact Penetration
(per AATCC 42)
Level 1 Critical Zone
as defined in
AAMI/ANSI PB70 | Hood Material:
Pass AAMI/ANSI PB70
Requirements for Level 4
Protection. | Hood Material:
Pass AAMI/ANSI PB70
Requirements for Level 1
Protection. | Specification met. Stryker
Flyte Hybrid Hood
material offers a lower
level of protection when
compared to the
predicate Hood material. |
| General Safety and Performance | | | |
| Biocompatibility | | | |
| in vitro cytotoxicity | Under the conditions of the
study, non-cytotoxic | Under the conditions of the
study, non-cytotoxic | Identical |
| primary skin
irritation | Under the conditions of the
study, not an irritant | Under the conditions of the
study, not an irritant | Identical |
| skin sensitization | Under the conditions of the
study, not a sensitizer | Under the conditions of the
study, not a sensitizer | Identical |
.
{4}------------------------------------------------
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 Togas
K063005
(Predicate) | Stryker Flyte Hybrid Hoods
(Subject) | Explanation of Difference |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Flammability | No Flame Spread per 16 CFR
Part 1610 | No Flame Spread per 16 CFR
Part 1610 | Identical |
| Shelf Life | 3 years | 1 year | Similar – the intent is to
extend the shelf life for
the subject device upon
successful completion of
aging studies |
| Finished (Terminal)
Product Sterilization
Method | SAL 10-6
Terminally sterilized via
Ethylene Oxide in accordance
with ISO 11135-1 | SAL 10-6
Terminally sterilized via
Ethylene Oxide in accordance
with ISO 11135-1 | Identical |
| Packaging | Individually packaged in a
Poly-Tyvek pouch | Individually packaged in a Poly-
Tyvek pouch | Identical |
| Labeling | Adhesive backed label placed
on carton and pouch label
printed directly onto the
Tyvek.
Label specified part
description, quantity,
sterilization method, lot
number, expiration date, and
contact information.
No known contraindications. | Adhesive backed label placed
on carton and pouch label
printed directly onto the Tyvek.
Label specified part
description, quantity,
sterilization method, lot
number, expiration date, and
contact 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.
{5}------------------------------------------------
#### 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.
{6}------------------------------------------------
#### 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
{7}------------------------------------------------
#### 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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> 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)
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXY/K140588](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXY/K140588)
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