(57 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical implant and delivery system, with no mention of AI or ML technologies.
Yes
The device is described as an "Absorbable Nasal Implant" used for "supporting nasal upper and lower lateral cartilage," indicating it is directly involved in treating or alleviating a condition by providing physical support to biological structures.
No
The device, a nasal implant, is intended for structural support, not for diagnosing medical conditions.
No
The device description clearly states it includes a physical implant made of a PLLA-PDLA copolymer and a disposable delivery device made of stainless steel. These are hardware components, not software.
Based on the provided information, the Spirox Latera Absorbable Nasal Implant is not an IVD (In Vitro Diagnostic) device.
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 implantable material (PLLA-PDLA copolymer) delivered via a cannula. This is a physical device used for surgical intervention.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVD devices are used to diagnose diseases or conditions.
Therefore, the Spirox Latera Absorbable Nasal Implant is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal upper and lower lateral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
INEX Absorbable Nasal Implant (K152958)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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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 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: | 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
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.
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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.