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.

Device Description

The NailLift is a device for correcting the shape for painful and/or deformed nails without surgery. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the NailLift device, focusing on its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pain relief upon NailLift application	99% of patients experienced pain relief upon NailLift application

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 149 patients.
Data Provenance: Not explicitly stated, but the context of "Before coming into the clinic" suggests it was a clinical study, likely prospective, where patients were evaluated at specific intervals. The country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth for the test set (pain relief) was established directly by patient self-reporting using a Visual Analogue Scale (VAS), not by experts.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on patient self-reported pain levels using a VAS, not expert adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs Without AI Assistance

Not applicable. The NailLift is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. As noted above, the NailLift is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was patient-reported outcomes (PROs), specifically pain levels measured via a Visual Analogue Scale (VAS).

8. The Sample Size for the Training Set

Not applicable. The NailLift is a physical device, not a machine learning algorithm that requires a training set. The clinical feedback from 149 patients served as the performance evaluation data, not a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary of the Study:

The study evaluated the effectiveness of the NailLift device in providing pain relief for ingrown toenails.

Study Design: Clinical feedback was collected from 149 patients.
Methodology: Patients rated their pain on a Visual Analogue Scale (VAS) from 0 to 10 at various intervals:
- Before coming into the clinic
- Immediately after NailLift application
- After NailLift removal
Performance Metric: The primary metric was the "difference of pain" between these intervals.
Results: The study showed that "99% of patients experienced pain relief upon NailLift application" (comparing pain before clinic vs. immediately after application). Further data presented in a table illustrates the distribution of pain differences across the patient cohort at different stages of the treatment.

Conclusion:

The study demonstrated that the NailLift device significantly reduces patient-reported pain associated with ingrown toenails upon application, meeting the implied acceptance criterion of providing pain relief.

Summary

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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"

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(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

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Enclosure

Office of Product Evaluation and Quality

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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 CorporationToho Edogawabashi Bldg. 3F1-24-8 Sekiguchi, Bunkyo-ku Tokyo112-0014 JapanMail: info@jps.ac
Contact Person:	Kelli AndersonPrinciple Regulatory ConsultantOffice: (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

(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

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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	<1
1	Before coming intothe clinic VSImmediately afterNailLift application.	0	0	2	11	35	24	44	27	4	0	2	0
2	Immediately afterNailLift applicationVS After NailLiftremoval	0	0	0	0	2	2	1	3	3	7	128	0
3	Before coming to theclinic VS AfterNailLift removal	0	1	6	10	43	23	38	25	3	0	0	0

The difference of pain is the difference of the scale of pain the patients answered between the times. Eg.) The scale of pain was 8 before coming to the clinical and 6 immediately after NailLift application, yielding a -2 as the difference of pain.

(b)(3). Substantial Equivalence - Conclusions

The NailLift device is substantially equivalent to the Oniko Nail Brace (K162525). The NailLift device has the same intended use and principles of operation as the predicate device. The minor differences between the NailLift device and the Oniko Nail Brace do not raise different questions of safety and effectiveness.

Regulation Number and Section

N/A