(291 days)
No
The description mentions airway segmentation from CT scans, which is a common image processing task. However, it explicitly states the physician uses the segmented airway to design the stent, implying manual or rule-based design, not an AI/ML driven process. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.
Yes
The device is indicated for the "treatment of adults ≥22 years of age with symptomatic stenosis of the airway," which is a therapeutic purpose.
No
The device is an implantable stent system designed to treat symptomatic airway stenosis, not to diagnose it. While it uses CT scans for design, it does not provide a diagnosis.
No
The device description explicitly states that the subject device is comprised of a cloud-based software suite and the patient-specific airway stent, which is a physical, implantable device. The performance studies also include testing on the physical stent (e.g., tear strength, radial compression, fatigue, migration, biocompatibility).
Based on the provided information, the VisionAir Patient-Specific Airway Stent is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- VisionAir Device Function: The VisionAir system is comprised of software for designing a patient-specific airway stent and the stent itself. The stent is an implantable device used to treat symptomatic stenosis of the airway. The software uses CT scans (imaging data) to guide the design of the stent, which is then physically implanted into the patient's airway.
The device's function is to provide a physical treatment (a stent) based on anatomical information derived from imaging, not to perform a diagnostic test on a biological sample.
Therefore, the VisionAir Patient-Specific Airway Stent falls under the category of an implantable medical device rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The VisionAir Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the arway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.
Product codes (comma separated list FDA assigned to the subject device)
NWA
Device Description
The subject device, VisionAir Patient-Specific Airway Stent is comprised of a cloudbased software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician nonsterile, to be sterilized before use.
The implantable patient-specific airway stent includes the following general features:
- Deployed through a compatible rigid bronchoscope system
- Made of biocompatible, implant-grade silicone
- Steam sterilizable by the end user
- Anti-migration branched design
- Anti-migration studs on anterior surface of main branch
- Single-use
The cloud-based software suite has the following general features:
- Upload of CT scans
- Segmentation of the airway
- Design of a patient specific stent from segmented airway
- Order management of designed stents
The purpose of this submission is to introduce design modifications to the Patient-Specific Airway Stent, originally cleared in 510(k) K182743.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
airway
Indicated Patient Age Range
adults ≥22 years of age
Intended User / Care Setting
physician
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)
Nonclinical performance and functional testing were performed to demonstrate that the subject VisionAir Patient-Specific Airway Stent is substantially equivalent to its predicate device. The following testing was performed:
- Sterilization Validation (per ANSI/AAMI ST79:2017)
- Tear Strength Testing (per ISO 34-1:2015)
- Radial Compression Testing (per ISO 25539-1:2017)
- Fatigue Testing (per ISO 25539-1:2017)
- Migration Testing
- Stent Deployment Testing
- Biocompatibility Testing (per ISO 10993-1:2018)
- Accelerated Aging Testing (per ASTM F1980-16:2016)
- Dimensional Testing of Airway Segmentation (reference device Mimics K073468 used for performance reference specification)
- Software Verification and Validation Testing
- Human Factors and Usability Testing for Web Software
- Airway Segmentation Process Testing
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.
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
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
New COS Inc. DBA VisionAir Solutions Keith Grafmeyer Director of Product Development 7100 Euclid Ave. Ste 180 Cleveland, Ohio 44103
Re: K213969
Trade/Device Name: VisionAir Patient-Specific Airway Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: Class II Product Code: NWA Dated: September 2, 2022 Received: September 6, 2022
Dear Keith Grafmeyer:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
for James Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213969
Device Name
VisionAir Patient-Specific Airway Stent
Indications for Use (Describe)
The VisionAir Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the arway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
510(k) Summary
K213969
Submitted by: A.
Keith Grafmeyer Director of Product Development New COS, Inc. d.b.a. VisionAir Solutions 7100 Euclid Ave; Ste 180 Cleveland OH, 44103 Tel: (216) 800-5905 x 102
Date Prepared: 06-Oct-2022
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:
VisionAir Patient-Specific Airway Stent Prosthesis, Tracheal, Preformed/Molded Tracheal Prosthesis Class II 21 CFR § 878.3720 NWA
C. Predicate Device
The subject VisionAir Patient-Specific Airway Stent is substantially equivalent to the primary predicate device, Patient-Specific Airway Stent, cleared in 510(k) K182743. Additionally, reference devices, Mimics and Osirix MD, cleared under K073468 and K101342 respectively were used for reference software performance specifications.
D. Device Description:
The subject device, VisionAir Patient-Specific Airway Stent is comprised of a cloudbased software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician nonsterile, to be sterilized before use.
The implantable patient-specific airway stent includes the following general features:
- Deployed through a compatible rigid bronchoscope system ●
- Made of biocompatible, implant-grade silicone ●
- Steam sterilizable by the end user ●
- Anti-migration branched design ●
- Anti-migration studs on anterior surface of main branch ●
4
-
. Single-use
The cloud-based software suite has the following general features: -
Upload of CT scans .
-
Segmentation of the airway ●
-
Design of a patient specific stent from segmented airway ●
-
Order management of designed stents .
The purpose of this submission is to introduce design modifications to the Patient-Specific Airway Stent, originally cleared in 510(k) K182743.
Indications for Use E.
The VisionAir Patient-Specific Airway Stent is indicated for the treatment of adults ≥22 years of age with symptomatic stenosis of the airway. The silicone stent is intended for implantation into the airway by a physician using the recommended deployment system or an equivalent rigid bronchoscope and stent placement system that accepts the maximum stent diameter being placed. The stent is intended to be in the patient up to 12 months after initial placement.
F. Technological Characteristics
The table below provides a comparison of technological characterics between the Subject and Predicate Devices:
| Technological
Characteristics | Predicate Device
K182743 | Subject Device
K213969 | Comparison |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended
Use/Indications
for Use | The Patient-Specific Airway
Stent is indicated for the
treatment of adults ≥22 years
of age with symptomatic
stenosis of the airway. The
silicone stent is intended for
implantation into the airway
by a physician using the
recommended deployment
system or an equivalent rigid
bronchoscope and stent
placement system that accepts
the maximum stent diameter
being placed. The stent is
intended to be in the patient
up to 12 months after initial
placement. | The VisionAir Patient-
Specific Airway Stent is
indicated for the treatment of
adults ≥22 years of age with
symptomatic stenosis of the
airway. The silicone stent is
intended for implantation into
the airway by a physician
using the recommended
deployment system or an
equivalent rigid bronchoscope
and stent placement system
that accepts the maximum
stent diameter being placed.
The stent is intended to be in
the patient up to 12 months
after initial placement. | Equivalent |
| Design Concept | Branched (Y) stent
configurations for a specific
patient designed by a
physician using cloud-based
software | Branched (Y) stent
configurations for a specific
patient designed by a
physician using cloud-based
software | Equivalent |
5
| Technological
Characteristics | Predicate Device
K182743 | Subject Device
K213969 | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Deployment
method | Common applicator system in
conjunction with an
appropriate rigid
bronchoscope system | Common applicator system in
conjunction with an
appropriate rigid
bronchoscope system | Equivalent |
| Period of
implantation | Up to 12 months | Up to 12 months | Equivalent |
| Single use | Yes | Yes | Equivalent |
| Material | Implant-grade silicone | Implant-grade silicone | Equivalent |
| Sterilization
Method | Moist heat | Moist heat | Equivalent |
| Wall Thickness | Uniform 1.0mm | Uniform 1.0mm | Equivalent |
| Surface
finishing | Smooth interior and exterior
surfaces of device with anti-
migration studs on anterior
surface of main branch of
stent | Smooth interior and exterior
surfaces of device with anti-
migration studs on anterior
surface of main branch of
stent | Equivalent |
| Diameter,
length and
angles | Ability to vary the inner
diameter, length and angles
along the stent in cloud-based
software | Ability to vary the inner
diameter, length and angles
along the stent in cloud-based
software | Equivalent |
| Jailed airway
location | Visual estimation during
intraoperative stent
fenestration | Indicator on stent
preoperatively determined to
assist in intraoperative
fenestration | Equivalent |
| Segmentation | CT scan uploaded into cloud-
based software for 3D airway
model for manual
segmentation by trained
technician | CT scan uploaded into cloud-
based software for 3D airway
model for semi-automated
segmentation by trained
technician | Equivalent* |
| Workflow | CT upload → segmentation
stent design > stent
manufacturing | CT upload → segmentation
stent design with enhanced
features → stent
manufacturing | Equivalent |
*Reference devices, Mimics (K073468) and Osirix MD (K101342) were used to establish substantial equivalence for software performance specifications
Performance Data G.
Nonclinical performance and functional testing were performed to demonstrate that the subject VisionAir Patient-Specific Airway Stent is substantially equivalent to its predicate device. The following testing was performed:
- Sterilization Validation (per ANSI/AAMI ST79:2017) ।
- Tear Strength Testing (per ISO 34-1:2015) |
- Radial Compression Testing (per ISO 25539-1:2017)
- Fatigue Testing (per ISO 25539-1:2017) |
- Migration Testing —
- । Stent Deployment Testing
- । Biocompatibility Testing (per ISO 10993-1:2018)
- Accelerated Aging Testing (per ASTM F1980-16:2016) —
6
- Dimensional Testing of Airway Segmentation (reference device Mimics K073468 । used for performance reference specification)
- Software Verification and Validation Testing l
- Human Factors and Usability Testing for Web Software -
- Airway Segmentation Process Testing —
Conclusions H.
Based on the indications for use, technological characteristics, performance testing, and comparison to Predicate Device, the Subject VisionAir Patient-specific Airway Stent has been demonstrated to be substantially equivalent to its Predicate Device cleared by the Agency for commercial distribution in the U.S.