The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and 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 Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.

AI/ML Overview

This document, K161191, describes the Spirox Latera Absorbable Nasal Implant, a medical device intended to support nasal upper and lower lateral cartilage. It is a Special 510(k) submission, meaning it describes modifications to an already cleared predicate device (INEX Absorbable Nasal Implant K152958), and therefore focuses on demonstrating that the modified device remains substantially equivalent to the predicate.

Given this context, the document does not describe a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against quantitative metrics for efficacy or diagnostic accuracy. Instead, the acceptance criteria are related to validating the changes made to the device and demonstrating that these changes do not alter the safety and effectiveness profile such that it is no longer substantially equivalent to the predicate.

Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, ground truth establishment for training set) are not applicable as this is not an AI/ML device or a device requiring a new clinical efficacy study under this 510(k) pathway.

Here's the breakdown of the information that is available in the document related to acceptance criteria and validation:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria and reported device performance in the way one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the verification and validation tests undertaken to confirm that the modifications do not negatively impact the device's safety or functionality and that it remains substantially equivalent to the predicate.

I will formulate a table based on the described design control activities and their implied "acceptance criteria" (i.e., successful completion of the tests).

Acceptance Criteria Category	Reported Device Performance (as implied by successful testing)
Verification Testing	Performed successfully, details not provided.
Sterilization Validation	Device shown to be sterile via gamma (Implant) and e-beam (Delivery Device) irradiation, conforming to ISO standards as previously described for the predicate device.
Packaging and Shelf-Life Testing	Packaging and shelf-life maintained, accommodating modifications and protecting the implant during shipping.
Transit Testing	Packaging and device integrity maintained during transit.
Biocompatibility Testing	Device materials (PLLA-PDLA copolymer, stainless steel for cannula) confirmed to be biocompatible, as previously established for the predicate.
Human Factors/Usability Testing	Usability aspects of the system (e.g., positioning guide, prominent orientation features) validated.
Risk Analysis (FMEA)	Performed; no new or increased risks identified (implied by the conclusion of substantial equivalence).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the verification and validation tests. It states that the "methods used for the verification and validation tests for the modified device are the same as those submitted in the original 510(k) application for the predicate device," but does not provide details on those methods or sample sizes in this submission. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. 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)

This is not applicable as this is a physical implant and delivery system, not an interpretive diagnostic device requiring expert-established ground truth on a test set of medical images or patient data. The "ground truth" for this device relates to engineering specifications, material properties, sterility, and usability, which are validated through laboratory and simulated use testing, not expert adjudication of clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic test set requiring human adjudication.

5. 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

This is not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or AI assistance effect size is relevant or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical implant, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a physical device like this, "ground truth" refers to established engineering standards, material specifications, biocompatibility requirements, and performance characteristics (e.g., mechanical strength, ease of delivery, sterility). The validation tests (e.g., sterilization validation, packaging tests, biocompatibility tests) establish that the device meets these pre-defined engineering and material "truths" or standards. There is no biological or diagnostic "ground truth" as might be found in clinical studies of diagnostic tools.

8. The sample size for the training set

This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2016

Spirox, Inc. Mr. Mike Rosenthal Chief Operating Officer 3475-O Edison Wav Menlo Park, CA 94025

Re: K161191

Trade/Device Name: Latera Absorbable Nasal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: NHB Dated: May 27, 2016 Received: May 31, 2016

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) K161191

Device Name Latera Absorbable Nasal Implant

Indications for Use (Describe)

The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K161191: Special 510(k) Summay

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:	26 April 2016

II: SUBJECT DEVICE INFORMATION

Device Trade Name:	Latera 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

Predicate Device: INEX Absorbable Nasal Implant (K152958)

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 Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.

VI. MODIFICATIONS OF SUBJECT DEVICE

The INEX Absorbable Nasal Implant, which includes the INEX Absorbable Nasal Implant) and Accessory Delivery Tool (Delivery Tool), was cleared on December 4, 2015 (K152958). The cleared device has been modified to include changes to device packaging and enhance usability aspects of the system. Importantly, the modified device, the Latera Absorbable Nasal Implant and Accessory Delivery Device, has the same fundamental scientific technology and intended use/indications for use as the cleared predicate device. The following characteristics remain unchanged between the modified and predicate device:

. No modifications are being made to the Implant device itself; the Implant retains the same dimensional and material attributes previously described under K152958.
. No changes are being made to the sterilization methods; the Implant is sterilized via gamma irradiation and the Delivery Device is sterilized via e-beam irradiation pursuant to the applicable ISO standards previously described under K152958.
. No modifications are being made to the shelf-life; both the Implant and the Delivery Device will retain the same shelf-life previously described under K152598.

The proposed modifications to the subject device include:

The addition of a silicone coating to the cannula portion of the Delivery Device. ●
The addition of a positioning guide "Implant Positioning Guide" to facilitate pre-procedure planning including external visualization of the internal target implant site.
. The inclusion of more prominent Implant orientation features on the Delivery Device handle distal end.
. Changes to the Implant packaging to accommodate an implant tray to facilitate implant handling and further protect the implant during shipping.
. Changes to the Delivery Device packaging to accommodate modifications to handle shape, inclusion of the Implant Positioning Guide.

VII. DESIGN CONTROL ACTIVITIES

The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA). The verification and validations tests that were performed as a result of this risk analysis assessment included: 1) Verification Testing; 2) Sterilization Validation; 3) Packaging and Shelf-Life Testing; 4) Transit Testing; 5) Biocompatibility Testing; and 6) Human Factors/Usability Testing. The methods used for the verification and validation tests for the modified device are the same as those submitted in the original 510(k) application for the predicate device.

VIII CONCLUSION

Based on the same intended use / indications for use and fundamental scientific technology, the modified Latera Absorbable Nasal Implant Device has a safety and effectiveness profile that is substantially equivalent to the predicate device.

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.