VisionAir Patient-Specific Airway Stent

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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. 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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). 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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<br>Characteristics | Predicate Device<br>K182743 | Subject Device<br>K213969 | Comparison | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intended<br>Use/Indications<br>for Use | The Patient-Specific Airway<br>Stent is indicated for the<br>treatment of adults ≥22 years<br>of age with symptomatic<br>stenosis of the airway. The<br>silicone stent is intended for<br>implantation into the airway<br>by a physician using the<br>recommended deployment<br>system or an equivalent rigid<br>bronchoscope and stent<br>placement system that accepts<br>the maximum stent diameter<br>being placed. The stent is<br>intended to be in the patient<br>up to 12 months after initial<br>placement. | The VisionAir Patient-<br>Specific Airway Stent is<br>indicated for the treatment of<br>adults ≥22 years of age with<br>symptomatic stenosis of the<br>airway. The silicone stent is<br>intended for implantation into<br>the airway by a physician<br>using the recommended<br>deployment system or an<br>equivalent rigid bronchoscope<br>and stent placement system<br>that accepts the maximum<br>stent diameter being placed.<br>The stent is intended to be in<br>the patient up to 12 months<br>after initial placement. | Equivalent | | Design Concept | Branched (Y) stent<br>configurations for a specific<br>patient designed by a<br>physician using cloud-based<br>software | Branched (Y) stent<br>configurations for a specific<br>patient designed by a<br>physician using cloud-based<br>software | Equivalent | {5}------------------------------------------------ | Technological<br>Characteristics | Predicate Device<br>K182743 | Subject Device<br>K213969 | Comparison | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------| | Deployment<br>method | Common applicator system in<br>conjunction with an<br>appropriate rigid<br>bronchoscope system | Common applicator system in<br>conjunction with an<br>appropriate rigid<br>bronchoscope system | Equivalent | | Period of<br>implantation | Up to 12 months | Up to 12 months | Equivalent | | Single use | Yes | Yes | Equivalent | | Material | Implant-grade silicone | Implant-grade silicone | Equivalent | | Sterilization<br>Method | Moist heat | Moist heat | Equivalent | | Wall Thickness | Uniform 1.0mm | Uniform 1.0mm | Equivalent | | Surface<br>finishing | Smooth interior and exterior<br>surfaces of device with anti-<br>migration studs on anterior<br>surface of main branch of<br>stent | Smooth interior and exterior<br>surfaces of device with anti-<br>migration studs on anterior<br>surface of main branch of<br>stent | Equivalent | | Diameter,<br>length and<br>angles | Ability to vary the inner<br>diameter, length and angles<br>along the stent in cloud-based<br>software | Ability to vary the inner<br>diameter, length and angles<br>along the stent in cloud-based<br>software | Equivalent | | Jailed airway<br>location | Visual estimation during<br>intraoperative stent<br>fenestration | Indicator on stent<br>preoperatively determined to<br>assist in intraoperative<br>fenestration | Equivalent | | Segmentation | CT scan uploaded into cloud-<br>based software for 3D airway<br>model for manual<br>segmentation by trained<br>technician | CT scan uploaded into cloud-<br>based software for 3D airway<br>model for semi-automated<br>segmentation by trained<br>technician | Equivalent* | | Workflow | CT upload → segmentation<br>> stent design > stent<br>manufacturing | CT upload → segmentation<br>> stent design with enhanced<br>features → stent<br>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.