(122 days)
K021019, Class I Exempt Medtronic Xomed Internal Nasal Splints
Not Found
No
The description focuses on a physical stent and its mechanical function, with no mention of AI/ML terms or capabilities.
Yes
The device is described as "supporting the lateral nasal wall during the post-operative healing period" and "supports and immobilizes intranasal tissues and cartilage during the post-operative healing period," which are actions aimed at maintaining health and aiding recovery after surgery, thereby providing a therapeutic benefit.
No
Explanation: The device is a stent used to support nasal tissues post-surgery, not to diagnose a condition. Its function is purely therapeutic/supportive.
No
The device description clearly describes a physical, implantable stent made of fluoroplastic with attached suture and needle, indicating it is a hardware medical device.
Based on the provided information, the ALAR™ Nasal Valve Stent is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ALAR™ Nasal Valve Stent Function: The ALAR™ Nasal Valve Stent is a physical device intended to be implanted or placed within the nasal cavity to provide structural support and immobilization during the post-operative healing period. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states its purpose is to support and immobilize tissues during the healing process, not to diagnose or provide information about a disease or condition based on a sample.
- Device Description: The description details a physical stent with features for placement and anchoring, not components for analyzing biological samples.
Therefore, the ALAR™ Nasal Valve Stent falls under the category of a surgical or implantable device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.
The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAT, LYA
Device Description
The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal valve, intranasal tissues, 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)
Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence.
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.
K021019, Class I Exempt Medtronic Xomed Internal Nasal Splints
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three intertwined figures that suggest human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Medtronic Xomed Inc. Ms. Gabriela Anchondo Regulatory Affairs Manager 6743 Southpoint Drive North Jacksonville, FL 32216
Re: K151758
Trade/Device Name: ALAR™ Nasal Valve Stent Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, LYA Dated: September 25, 2015 Received: October 1, 2015
Dear Ms. Anchondo:
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.
1
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
Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151758
Device Name ALAR™ Nasal Valve Stent
Indications for Use (Describe)
The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K151758 - 510(k) Summary
| I. | Submitter: | Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, Florida 32216 USA |
|-------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Gabriela Anchondo
Regulatory Affairs Manager
Telephone Number: 904-279-7550
Fax Number: 904-296-2386 |
| | Date Summary Prepared: | June 24, 2015 |
| | Trade Name: | ALAR™ Nasal Valve Stent |
| II. | Common Name: | Surgical Suture with Needle
Intranasal Splint |
| III. | Classification Name: | Nonabsorbable poly(ethylene terephthalate) surgical
suture (21 CFR 878.5000) |
| IV. | Classification: | Class II |
| V. | Predicate Devices: | K021019 Tevdek® Suture with Needle (GAT)
Class I Exempt Medtronic Xomed Internal Nasal Splints
(LYA) |
| VI. | Device Description: | The elliptically shaped fluoroplastic stent is approximately
20 mm long and 16 mm wide. Slits symmetrically spaced
along the stent's lateral edges allow for left and right nostril
usage. The suture and needle attached to the stent
provide stent anchoring and hold cartilage plates stable
during post-operative healing. |
| VII. | Indications for Use: | The ALAR™ Nasal Valve Stent supports and immobilizes
intranasal tissues and cartilage during the post-operative
healing period following intranasal and nasal valve
surgery. |
| VIII. | Technological
Characteristics: | The ALAR™ Nasal Valve Stent system components have
similar technological characteristics as the Medtronic
Xomed Internal Nasal Stents and Tevdek® Suture with
Needle including intended use, design, materials,
principles or operation and performance. |
4
IX. Discussion of the Performance Testing
Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence.
X. Conclusions
The indications for use, technology and performance characteristics of the ALAR™ Nasal Valve Stent system components are the same as the Medtronic Xomed Internal Nasal Splints and Tevdek® Suture with Needle. Based on this, Medtronic Xomed claims substantial equivalence to the predicate device.