(46 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the implant and delivery system, with no mention of AI or ML algorithms for image processing, diagnosis, or any other function.
Yes
The device is intended to support nasal cartilage, which is a structural function aimed at improving physical well-being.
No
Explanation: The device is an implant system designed to support nasal cartilage, not to diagnose medical conditions.
No
The device description clearly outlines physical components: an absorbable nasal implant made of a PLLA-PDLA copolymer and a delivery device made of stainless steel. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "supporting upper and lower lateral nasal cartilage." This describes a structural support function within the body.
- Device Description: The device is an implant and a delivery system designed for placement within the nasal cartilage.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a therapeutic implant used for structural support.
N/A
Intended Use / Indications for Use
The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 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. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower lateral nasal 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)
Performance testing of the LATERA Absorbable Nasal Implant System consisted of design verification testing and distribution testing to support the additional implant size. Design verification testing, shelf life testing, and sterilization testing were completed to support the device modifications made since the predicate clearance. All testing passed and showed that the device meets design specifications and performed as intended.
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.
LATERA Absorbable Nasal Implant [K161191]
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 10, 2019
Stryker ENT Karen Peterson Vice President, Clinical, Regulatory & Quality 3600 Holly Lane North, Suite 40 Plymouth, Minnesota 55447
Re: K192661
Trade/Device Name: LATERA Absorbable Nasal Implant System Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: NHB Dated: September 24, 2019 Received: September 25, 2019
Dear Karen Peterson:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192661
Device Name
LATERA Absorbable Nasal Implant System
Indications for Use (Describe)
The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal 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) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
|__ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Stryker ENT
510(k) Summary - K192661
| Date Prepared: | November 7, 2019 |
|---|---|
| Submitter Information: | Stryker ENT |
| 3600 Holly Lane North, Suite 40 | |
| Plymouth, MN 55447 | |
| Establishment Registration: | 3006345872 |
| Contact Information: | Karen Peterson |
| Vice President Clinical, Regulatory & Quality | |
| (763) 463-7066 | |
| karen.peterson@stryker.com | |
| Device Information: | |
| Trade Name: | LATERA® Absorbable Nasal Implant System |
| Common Name: | Ear, Nose, Throat Synthetic Polymer Material |
| Classification Name: | Polymer, Ear, Nose and Throat, Synthetic, Absorbable |
| Product Code: | NHB |
| Classification: | Class II |
| Regulation Number: | 21 CFR 874.3620 |
| Predicate Device: | LATERA Absorbable Nasal Implant [K161191] |
Device Description:
The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 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. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.
Indication for Use:
The LATERA® Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.
Contraindications:
- Presence of an active infection at the implantation site.
- Patients known or suspected to have an allergy to PLA or absorbable materials.
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Stryker ENT
Technological Characteristics:
The LATERA Absorbable Nasal Implant System (subject device) has the same indications for use and fundamental scientific technology as the predicate device LATERA Absorbable Nasal Implant System [K161191].
The subject device has the same technological characteristics (i.e., principle of operation, basic design, manufacture process, functionality, materials, biocompatibility, and sterile packaging) as the predicate device. The subject device adds an additional implant size (length of 20mm). Other changes made since the predicate clearance include modified implant geometry, extended shelf life, and modified sterilization process.
Substantial Equivalence:
The LATERA Absorbable Nasal Implant System has the same indications for use and fundamental scientific technology as the predicate device. LATERA Absorbable Nasal Implant System is substantially equivalent to the predicate device.
Performance Data:
Performance testing of the LATERA Absorbable Nasal Implant System consisted of design verification testing and distribution testing to support the additional implant size. Design verification testing, shelf life testing, and sterilization testing were completed to support the device modifications made since the predicate clearance. All testing passed and showed that the device meets design specifications and performed as intended.
Conclusion:
In conclusion, the indications for use and technological characteristics are the same as or equivalent to the predicate device. Performance testing has demonstrated that the device is as safe and as effective as the predicate device and that its performance is substantially equivalent to the predicate device.