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.

AI/ML Overview

The provided document details the 510(k) summary for the Spirox INEX Absorbable Nasal Implant, focusing on its substantial equivalence to a predicate device. The information primarily addresses device performance and safety rather than AI algorithm performance.

Therefore, many of the requested categories related to AI-specific study design (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this document as it describes a physical medical device.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Summary)
Primary Safety Endpoint: Adverse event rate comparable to published studies for similar alloplastic materials and expected types of adverse events. Specifically, a per-subject device-related adverse event rate of 13% for 3 months with expected types of events.	Met. The per-subject device-related adverse event rate was 13% (5 events in 4 subjects) at 3 months. Events included hematoma (1), inflammation (1), and extrusions (3). These were deemed comparable to published studies for other alloplastic materials and were expected. Extrusions were internal nasal cavity extrusions related to implantation technique or patient manipulation, resolved without surgical intervention or clinical sequelae.
Primary Efficacy Endpoint: Mean NOSE Score reduction comparable to published literature for more invasive surgical procedures, normal external physical exam findings with no implant migration, and no adverse cosmetic effects (or resolved).	Met.- Mean NOSE Score reduction of 64.8% (n=30) at 1 month.- Mean NOSE Score reduction of 63.4% (n=29) at 3 months.- Mean NOSE Score reduction of 56.4% (n=22) at 6 months.These reductions were comparable to those reported for more invasive surgical procedures. External physical exam findings were normal with no evidence of implant migration. An independent physician review of photographs showed 1 adverse cosmetic effect at 3 months, which was resolved or not observed at 6 months.
Bench Testing: Verification tests for implant (Dimensional Inspections, Implant Migration, Flexural Rigidity, Bend Radius, Degradation Testing) and Delivery Tool (Dimensional Inspections, Plunger Force, System Functionality, Handle Joint Strength, Cannula Joint Strength, Plunger Bond Verification) must yield "passing results" at baseline and up to 6 months aged.	Met. "Passing results were obtained for all design verification tests."
Biocompatibility Testing: Conducted according to AAMI/ANSI/ISO 10993-1 and FDA guidance for "tissue/bone" implant devices with "permanent" duration of contact (>30 days). Tests include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, and Implantation for the implant, and Cytotoxicity for the Delivery Tool cannula. Must obtain "acceptable results."	Met. Biocompatibility testing was conducted on the predicate device and leveraged for the subject device due to shared material and manufacturing. The Delivery Tool cannula underwent cytotoxicity testing with acceptable results. The material has a long history of use and demonstrated adequate biocompatibility.
Sterilization Data: Compliance with ISO 11137-1:2006 and ISO 11137-2:2006, supporting an SAL of 10^-6 for both gamma (implant) and e-beam (Delivery Tool) radiation.	Met. Validation results support an SAL of 10^-6 for gamma radiation of the implant and a minimum radiation dose of 25kGy and SAL of 10^-6 for e-beam radiation of the Delivery Tool.
Packaging and Shipping Validation: Compliance with ASTM F88, ASTM F2096, ASTM F1929, ISO 11607-1 for packaging integrity (seal peel, bubble emission, dye migration) and ISTA 3A for simulated transport conditions. Must meet "acceptance criteria."	Met. "All tests results met the acceptance criteria demonstrating that the packaging process and the packaging materials maintained their integrity throughout the shelf-life." ISTA 3A standard also met acceptance criteria. An equivalency analysis confirmed applicability of predicate device's packaging tests, and comparable testing was done for the accessory Delivery Tool, supporting its shelf-life.

Study Details

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Clinical Performance Data): 30 subjects for safety and effectiveness analysis.
  - Follow-up: 30 at 1 month, 29 at 3 months, 22 at 6 months, and 10 at 12 months.
  - A total of 56 implants were placed (26 bilateral, 4 unilateral).
- Data Provenance:
  - Country of Origin: Germany (3 investigational sites).
  - Study Design: Prospective, multi-center, non-randomized, single-arm study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for a physical device. Ground truth for clinical performance was established through patient outcomes (NOSE scores, reported adverse events) and clinical evaluations by study investigators, and an independent physician review of photographs. Qualifications of these clinical investigators are not specified beyond "independent physician."
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a physical device. Clinical outcomes were measured directly based on patient reports (e.g., NOSE score) and investigator observations. The only mention of external review is "an independent physician review of the collected photographs," but no adjudication process is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a physical medical implant, not an AI device or a comparative effectiveness study involving human readers with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a physical medical implant, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Clinical Performance Ground Truth: Patient-reported outcomes (validated NOSE scores), clinician observations of physical exams, reported adverse events, and an independent physician review of photographs.
- Bench Testing Ground Truth: Predetermined engineering and material science specifications, applicable ASTM and ISO standards.
- Biocompatibility Ground Truth: Standards from AAMI/ANSI/ISO 10993-1 and FDA guidance documents.
- Sterilization Ground Truth: ISO 11137-1:2006 and ISO 11137-2:2006 standards.
- Packaging Ground Truth: ASTM and ISO standards for packaging integrity and transport simulation.
The sample size for the training set
- Not applicable. This document describes a physical medical implant, not an AI device requiring a training set. The device's design and performance were developed through engineering processes, bench testing, and clinical studies, not machine learning training.
How the ground truth for the training set was established
- Not applicable. As above, no AI training set is involved.

Summary

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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 WayMenlo Park, CA 94025
Contact:	Mike RosenthalChief Operating Officer, Spirox, Inc.Phone: 650.503.3329Fax: 650.618.1440Email: 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:

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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" (< 24 hours) devices, and "skin/breached surface contacting" devices (e.g. scalpels, retractors).

Sterilization Data

The gamma radiation sterilization parameters for the INEX Absorbable Nasal Implant Device comply with the requirements prescribed in the applicable standards ISO 11137-1:2006 "Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", and ISO 11137-2:2006 "Sterilization of heath care products – Radiation – Part 2: Establishing the sterilization dose". The validation results support an SAL of 10 °. Sterilization validation for the accessory Delivery Tool using e-beam radiation was also validated per the same standard and supported a minimum radiation dose of 25kGy and a SAL of 10 °.

Packaging and Shipping Validation

Packaging and shipping validation studies were successfully conducted on the predicate INEX Implantable Sheet pursuant to the applicable ASTM guidelines. These tests included seal peel, bubble emission and dye migration tests per ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; ASTM F2096 "Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)"; ASTM F1929 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"; and ISO 11607-1 "Packaging Materials and Systems for Medical Devices which are to be Sterilized - Part 1: General Requirements and Test Methods". All tests results met the acceptance criteria demonstrating that the packaging process and the packaging materials maintained their integrity throughout the shelf-life. Additionally, the ISTA 3A standard was used to evaluate package performance under simulated transport conditions. All tests results met the acceptance criteria. An equivalency analysis between the subject and predicate implant devices confirm the applicability of the completed verification tests for the predicate device to the subject device. Comparable packaging and shipping validation testing was completed for the accessory Delivery Tool. Such test results along with performance data on aged product also support the specified shelf-life for the accessory Delivery Tool.

Clinical Performance Data

Clinical testing of the INEX Absorbable Nasal Implant device and accessory Delivery Tool included a study of thirty (30) subjects. The study was conducted at three (3) investigational sites in Germany. The study was a prospective, multi-center, non-randomized, single arm study of which thirty (30), 29, 22 and 10 subjects were available for safety and effectiveness analysis at one (1), 3, 6 and 12 months respectively. The device was used to support upper and lower lateral nasal cartilage in subjects with nasal valve collapse due to weakened lateral cartilage. A total of 56 implants were placed in 30 subjects (26 bilateral and 4 unilateral placements).

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Primary Safety Endpoint

The three (3) month safety results meet the criteria outlined for the primary safety endpoint for this study. Specifically, this endpoint is met because there were five (5) implant/device related events reported in four (4) subjects. Such events included hematoma (1); inflammation (1); and extrusions (3). A per subject device related adverse event rate of 13% is comparable to the adverse event rate reported in published studies where other alloplastic materials are used in accordance with their commercial labeling to provide lateral cartilage support in similar study populations. Additionally, the types of reported adverse events are expected and comparable to those reported for other long-term absorbable implants. The three (3) extrusions reported in the Spirox study were internal nasal cavity extrusions related to implantation technique or patient nasal manipulation. None of these events were associated with any signs of tissue rejection or adverse foreign body response and all occurred within the first post-operative month. The implant devices were easily removed with tweezers at the time of observation requiring no surgical intervention and resolved with no clinical sequelae.

Primary Efficacy

Performance and effectiveness criteria were met based on subjects showing a mean NOSE Score reduction of 64.8% (n=30) through the one (1) month follow-up, 63.4% (n=29) through the three (3) month follow-up period and 56.4% (N=22) through the six (6) month follow-up period. NOSE Score reductions were comparable to those reported in published literature for more invasive and extensive surgical procedures for nasal obstruction. Additionally, external physical exam findings were normal and showed no evidence of implant migration. Finally, the results from an independent physician review of the collected photographs showed that of the thirty (30) subjects one (1) showed an adverse cosmetic effect at a three (3) month follow-up visit which was resolved or not observed at the six (6) month time point.

Summary

The results from the above described clinical study demonstrate the safety and effectiveness of the INEX Absorbable Nasal Implant and its ability to support nasal upper and lower lateral cartilage.

VIII CONCLUSIONS:

Based on the intended use, technological characteristics, bench and clinical performance data provided in this premarket notification, the INEX Absorbable Nasal Implant Device has a safety and effectiveness profile that is substantially equivalent to the predicate device. The information included in this 510(k) submission demonstrates the same intended use, similar indications for use and technological characteristics of the INEX Nasal Implant Device as compared to the predicate device. The differences between the subject and predicate devices do not raise different types of safety or effectiveness questions and the performance data demonstrate substantial equivalence.

Regulation Number and Section

§ 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.