(300 days)
Not Found
No
The device description and performance studies focus on the mechanical action of the Nitinol wires and steel clips to correct nail curvature, with no mention of AI or ML technologies.
Yes.
The device corrects nail curvature and is indicated for decreasing pain caused by ingrown toenails, which aligns with the definition of a therapeutic device.
No
The device is described as a 'corrector' and its function is to 'lift curved toenails into a more natural shape', which is a treatment. While it monitors pain relief, it does not diagnose a condition.
No
The device description explicitly states it utilizes physical components like Nitinol alloy wires and steel clips to correct nail shape, indicating it is a hardware device, not software-only.
Based on the provided information, the NailLift device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the NailLift is applied directly to the toenail to correct its shape. It does not involve the analysis of any biological samples like blood, urine, tissue, etc.
- IVDs are used to provide information about a patient's health status. The NailLift is a physical device that provides a mechanical correction to the nail, aiming to alleviate pain. It doesn't provide diagnostic information about a disease or condition.
The NailLift is a physical medical device intended for the treatment of ingrown toenails.
N/A
Intended Use / Indications for Use
NailLift is an ingrown toenail corrector that corrects nail curvature by lifting the curved toenails into a more natural shape upon application. The correction of nail curvature results in decreased pain.
Product codes (comma separated list FDA assigned to the subject device)
MQZ
Device Description
The NailLift is a device for correcting the shape for painful and/or deformed nails without surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
toenails
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)
Clinical feedback supporting pain relief when utilizing the NailLift device was collected from 149 patients utilizing a Visual Analogue Scale (VAS). Patients were asked how much pain they have on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain possible. Patient's were asked for pain feedback at the various intervals provided in the table below. Feedback showed 99% of patients experienced pain relief upon NailLift application.
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.
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2024
JPS Corporation % Kelli Anderson President & Owner Tech2Med, LLC 6450 Old Darby Trl NE Ada, Michigan 49301
Re: K230841
Trade/Device Name: NailLift Regulatory Class: Unclassified Product Code: MQZ Dated: March 27, 2023 Received: March 28, 2023
Dear Kelli Anderson:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Enclosure
Office of Product Evaluation and Quality
3
Indications for Use
510(k) Number (if known) K230841
Device Name NailLift
Indications for Use (Describe)
NailLift is an ingrown toenail corrects nail curvature by lifting the curved toenails into a more natural shape upon application. The correction of nail curvature results in decreased pain.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY - K230841
| (a)(1). Submitted By: | JPS Corporation
Toho Edogawabashi Bldg. 3F
1-24-8 Sekiguchi, Bunkyo-ku Tokyo
112-0014 Japan
Mail: info@jps.ac |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kelli Anderson
Principle Regulatory Consultant
Office: (574) 527-9214 |
| Date: | January 17, 2024 |
| (a)(2). Proprietary Name: | NailLift |
| Common Name(s): | Prosthesis, Nail |
| Classification Name: | Unclassified |
| Regulatory Class: | Unclassified |
| Product Codes: | MQZ |
| (a)(3). Predicate Device: | K162525 - Oniko Nail Brace, Begum Saglik, Tibbi Malzemeler
& Danismanlik Ltd Sti |
(a)(4). Device Description
The NailLift is a device for correcting the shape for painful and/or deformed nails without surgery.
(a)(5). Indications for Use
NailLift is an ingrown toenail corrector that corrects nail curvature by lifting the curved toenails into a more natural shape upon application. The correction of nail curvature results in decreased pain.
(a)(6). Technological Characterizes
The NailLift device utilizes Nitinol alloy wires to lift the outer edges of the ingrown or deformed nail. The device uses steel clips to attach the wire form to the nail.
(b)(1). Substantial Equivalence: - Non-Clinical Evidence Performance Data
Performance evaluation of the NailLift device demonstrated that the device functions in a similar manner to the predicate. Cytotoxicity, sensitization and irritation testing completed per ISO 10993 show the materials used do not illicit a biological response.
(b)(2). Substantial Equivalence: - Clinical Evidence
Clinical feedback supporting pain relief when utilizing the NailLift device was collected from 149 patients utilizing a Visual Analogue Scale (VAS). Patients were asked how much pain they have on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain possible. Patient's were
5
asked for pain feedback at the various intervals provided in the table below. Feedback showed 99% of patients experienced pain relief upon NailLift application.
| Question | Difference of pain* | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| -10 | -9 | -8 | -7 | -6 | -5 | -4 | -3 | -2 | -1 | 0 |