(58 days)
No reference devices were used in this submission.
No
The 510(k) summary describes a physical implant and delivery tool, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on clinical outcomes related to the physical device.
Yes
The device is described as an absorbable nasal implant indicated for supporting nasal cartilage in patients with nasal valve collapse due to weakened lateral cartilage. This directly implies a therapeutic function by addressing a medical condition (nasal valve collapse) and providing physical support to the affected anatomical structure. The performance studies also highlight effectiveness in reducing the NOSE Score, which is a measure of nasal obstruction symptoms, further supporting its therapeutic nature.
No
The device is an implant intended for supporting nasal cartilage, not for diagnosing conditions. Its primary function is structural support, not the identification or measurement of disease states.
No
The device description clearly states it consists of a physical implant made of a PLLA-PDLA copolymer and a stainless steel delivery tool, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support nasal upper and lower lateral cartilage." This is a structural support function within the body.
- Device Description: The device is an implant designed to be placed within the nasal tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower cartilage.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an overall length of 24mm. The distal end of the implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal 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 upper and lower cartilage, nasal lateral wall
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Verification tests for the INEX Absorbable Implant included: a) Dimensional Inspections; b) Implant Migration; c) Flexural Rigidity; d) Bend Radius; and, e) Degradation Testing. Verification tests for the accessory Delivery Tool included: 1) Dimensional Inspections; 2) Plunger Force Verification; 3) System Functionality Verification; 4) Handle Joint Strength Verification; 5) Cannula Joint Strength Verification; and, 6) Plunger Bond Verification. These tests were conducted on gamma and e-beam sterilized devices at baseline and on devices aged to six (6) months. Passing results were obtained for all design verification tests.
Biocompatibility Testing: Biocompatibility tests were conducted in accordance with the standard recognized by FDA (AAMI/ANSI/ISO 10993-1) "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" and FDA's applicable guidance document ("Use of International Standard ISO 10993", draft document issued on 24 April 2013). Both the subject and predicate INEX devices are categorized as "tissue/bone" implant devices with a "permanent" duration of contact (>30 days). As such, the following tests were conducted pursuant to the standard and the Agency's guidance: 1) Cytotoxicity; 2) Sensitization; 3) Irritation; 4) Systemic Toxicity; 5) Genotoxicity; and, 6) Implantation. Biocompatibility testing was conducted on the predicate device and leveraged for the subject device. The justification for leveraging such test results included the following rationale: 1) both devices are comprised of the same raw material provided by the same vendor; and, 2) both devices are manufactured by the same contract manufacturer using the same manufacturing processes. The accessory Delivery Tool 304 Stainless Steel cannula is the only patient contacting portion of the accessory tool. Testing was conducted based on categorization of this portion of the Delivery Tool as a "surface" device in contact with "breached or compromised surfaces" with a "limited" duration of contact (≤24 hours). The patient contacting portion described above was subjected to cytotoxicity testing with acceptable results. No further biocompatibility tests were conducted because the subject material has a long history of use in medical devices, is exceptionally well characterized and has demonstrated adequate biocompatibility for a wide variety of intended uses, including "tissue/bone contacting" (
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2015
Spirox, Inc. Mr. Mike Rosenthal Chief Operating Officer 3475-0 Edison Way Menlo Park, CA 94025
Re: K152958
Trade/Device Name: Inex Absorbable Nasal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Regulatory Class: Class II Product Code: NHB Dated: October 5, 2015 Received: October 7, 2015
Dear Mr. Rosenthal:
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.
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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 devicerelated 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152958
Device Name INEX Absorbable Nasal Implant
Indications for Use (Describe)
The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower cartilage.
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)
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Section 6: 510(k) Summary (21 CFR § 807.92(c))
I: SUBMITTER INFORMATION
| Submitter: | Spirox, Inc.
3475-0 Edison Way
Menlo Park, CA 94025 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mike Rosenthal
Chief Operating Officer, Spirox, Inc.
Phone: 650.503.3329
Fax: 650.618.1440
Email: mrosenthal@spiroxmed.com |
| Date Summary Prepared: | 01 October 2015 |
II: SUBJECT DEVICE INFORMATION
| Device Trade Name: | INEX Absorbable Nasal Implant |
|---|---|
| Common Name: | Ear, nose and throat synthetic polymer material |
| Classification Name: | Polymer, Ear, Nose and Throat, Synthetic, Absorbable |
| (21 CFR §874.3620) | |
| Product Code: | NHB |
III: PREDICATE DEVICE INFORMATION
INEX Absorbable Sheet (K132920) Predicate Device:
No recalls, market withdrawals or safety alerts were identified in FDA's database for the above referenced predicate device.
No reference devices were used in this submission.
IV: DEVICE DESCRIPTION:
The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an overall length of 24mm. The distal end of the implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal Implant and accessory Delivery Tool are provided sterile and are intended for single-use only.
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V. INDICATIONS FOR USE:
The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The primary technological principle for the subject and predicate devices is to provide nasal cartilage support. The subject and predicate devices accomplish this function by similar means. At a high level, the subject and predicate devices are based on the following same technological characteristics:
- The devices both employ the use of the same PLLA/PDLA copolymer raw material.
- . The devices are sterilized via gamma irradiation pursuant to the applicable ISO standard and both devices have equivalent surface finishes.
- The devices were designed to have stiffness that is comparable to nasal cartilage.
The following technological differences exist between the subject and predicate devices:
- . The subject device is provided in a single "rod" configuration designed for lateral cartilage support. The predicate device for septal cartilage support is provided in a sheet configuration that is comprised of eight (8) "rod" subsets.
- The subject device can be implanted with an accessory Delivery Tool or off-the shelf surgical tools. The predicate device is implanted with off-the shelf surgical tools.
VII. PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Verification tests for the INEX Absorbable Implant included: a) Dimensional Inspections; b) Implant Migration; c) Flexural Rigidity; d) Bend Radius; and, e) Degradation Testing. Verification tests for the accessory Delivery Tool included: 1) Dimensional Inspections; 2) Plunger Force Verification; 3) System Functionality Verification; 4) Handle Joint Strength Verification; 5) Cannula Joint Strength Verification; and, 6) Plunger Bond Verification. These tests were conducted on gamma and e-beam sterilized devices at baseline and on devices aged to six (6) months. Passing results were obtained for all design verification tests.
Biocompatibility Testing
Biocompatibility tests were conducted in accordance with the standard recognized by FDA (AAMI/ANSI/ISO 10993-1) "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" and FDA's applicable guidance document ("Use of International Standard ISO 10993", draft document issued on 24 April 2013). Both the subject and predicate INEX devices are categorized as "tissue/bone" implant devices with a "permanent" duration of contact (>30 days). As such, the following tests were conducted pursuant to the standard and the Agency's guidance: 1) Cytotoxicity; 2) Sensitization; 3) Irritation; 4) Systemic Toxicity; 5) Genotoxicity; and, 6) Implantation. Biocompatibility testing was conducted on the predicate device and leveraged for the subject device. The justification for leveraging such test results included the following rationale: 1) both devices are comprised of the same raw material provided by the same vendor; and, 2) both devices are manufactured by the same contract manufacturer using the same manufacturing processes. The accessory Delivery Tool 304 Stainless Steel
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cannula is the only patient contacting portion of the accessory tool. Testing was conducted based on categorization of this portion of the Delivery Tool as a "surface" device in contact with "breached or compromised surfaces" with a "limited" duration of contact (≤24 hours). The patient contacting portion described above was subjected to cytotoxicity testing with acceptable results. No further biocompatibility tests were conducted because the subject material has a long history of use in medical devices, is exceptionally well characterized and has demonstrated adequate biocompatibility for a wide variety of intended uses, including "tissue/bone contacting" (