(137 days)
No
The device description and performance studies focus on the physical properties, delivery mechanism, and biocompatibility of a bioabsorbable implant. There is no mention of AI or ML in the intended use, device description, or performance testing sections.
Yes
The device is described as an implant used to support and straighten minor deviations in septal cartilage, which directly addresses a medical condition or ailment, aligning with the definition of a therapeutic device.
No
The device is an implant used to support and straighten nasal septal cartilage. It does not gather information about a patient's health condition or diagnose any diseases.
No
The device description clearly details a physical implant (polydioxanone ribbon) and a delivery tool (handle, cannula, trocar), indicating it is a hardware medical device, not software-only.
Based on the provided information, the SeptAlign device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support and straighten minor deviations in septal cartilage" during nasal surgery. This is a surgical implant used directly on the patient's tissue.
- Device Description: The device is a bioabsorbable ribbon implanted into the nasal septum. It is a physical device used for structural support.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The SeptAlign does not perform any such testing.
The SeptAlign is a surgical implant used for structural support within the body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
Product codes
NHB
Device Description
The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.
The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal septal cartilage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: The biocompatibility evaluation SeptAlign was conducted in accordance with ISO 10993-1, Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (2018) and FDA Guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, September 8, 2023. This evaluation determined that the materials in the Nasal Septal Strap and accessory delivery tool do not pose a risk of negative interaction with patients.
The implantable portion of SeptAlign was assessed as a Permanent Implant (>30 Day). The surgical needle and patient contacting components of the delivery tool were assessed as Externally Communicating: Tissue/bone/dentin with Limited (
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 22, 2024
Spirair, Inc. Tracey Henry Regulatory Consultant 415 Grand Avenue Suite 201 San Francisco, California 94080
Re: K233569
Trade/Device Name: SeptAlign Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: NHB Dated: February 27, 2024 Received: February 27, 2024
Dear Tracey Henry:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233569
Device Name SeptAlign
Indications for Use (Describe)
SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
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
SPII
510(k) Summary
I. SUBMITTER
Spirair, Inc. 415 Grand Avenue, Suite 201 San Francisco, CA 94080 Phone: (844) 434-9673
Contact Person: James Kintzing, CEO Date Prepared: November 6, 2023
II. DEVICE
| Name of Device: | SeptAlign |
|---|---|
| Common or Usual Name: | Ear, Nose, Throat Synthetic Polymer Material |
| Classification Name: | Polymer, Ear, Nose and Throat, Synthetic, Absorbable |
| Regulatory Class: | Class II |
| Product Code: | NHB |
| Regulation Number: | 21 CFR 874.3620 |
III. PREDICATE/REFERENCE DEVICE
| Predicate Device: | Spirair Nasal Septal Strap (K223167) |
|---|---|
| Reference Device: | Spirox INEX Absorbable Nasal Implant (K152958) |
IV. DEVICE DESCRIPTION
The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.
The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.
4
Image /page/4/Picture/0 description: The image shows the word "SPIRAIR" in a bold, sans-serif font. The color of the text transitions from a dark blue on the left to a teal color on the right. To the right of the word is a circular design made up of small, diamond shapes in the same teal color.
V. INDICATIONS FOR USE
SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The primary technological principle for the subject and predicate devices is to support and straighten minor deviations in healthy septal cartilage during septoplasty procedures. There has been no change to the implantable portion of the subject device, thus the subject device has the same principle of operation, mechanical properties, bioabsorbable material, biocompatibility, sterility and performance characteristics as the predicate device. The subject device differs from the predicate device in that it can be implanted with an accessory delivery tool in addition to off-the-shelf surgical tools. This feature is similar to the reference device, Spirox INEX Absorbable Nasal Implant (K152958) and performance testing was successfully completed using similar testing methodologies as the reference device in support of substantial equivalence.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Performance
| Testing | Data provided |
|---|---|
| Biocompatibility | |
| Testing | The biocompatibility evaluation SeptAlign was conducted in accordance with |
| ISO 10993-1, Biological Evaluation of medical devices – Part 1: Evaluation | |
| and testing within a risk management process (2018) and FDA Guidance: | |
| Use of International Standard ISO 10993-1, Biological evaluation of medical | |
| devices - Part 1: Evaluation and testing within a risk management process, | |
| September 8, 2023. This evaluation determined that the materials in the Nasal | |
| Septal Strap and accessory delivery tool do not pose a risk of negative | |
| interaction with patients. |
The implantable portion of SeptAlign was assessed as a Permanent Implant
(>30 Day). The surgical needle and patient contacting components of the
delivery tool were assessed as Externally Communicating: Tissue/bone/dentin
with Limited (