Oniko nail brace

K162525 · Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti · MQZ · Apr 25, 2018 · SU

Device Facts

• Record ID: K162525
• Device Name: Oniko nail brace
• Applicant: Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti
• Product Code: MQZ · SU
• Decision Date: Apr 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.

Device Story

Oniko nail brace is a non-surgical mechanical device designed to correct overcurved, thickened, or pincer nails. The device consists of metal hooks and silicone bands. The metal hooks are applied to the sides of the nail to exert tension, which gradually reshapes the nail plate. It is intended for use as an over-the-counter device to alleviate pain and improve nail morphology without the need for anesthesia or invasive procedures. By mechanically loosening and reshaping the nail, the device aims to provide a non-operative alternative for nail correction.

Clinical Evidence

Assessment included biocompatibility testing (non-cytotoxic, non-sensitizer, non-irritant) supported by clinical results. No specific study metrics or sample sizes provided.

Technological Characteristics

Composed of metal hooks and silicone bands. Mechanical tension-based correction. Permanent contact (>30 days).

Indications for Use

Indicated for patients with overcurved, thickened, or painful nails requiring shape correction without surgical intervention.

Predicate Devices

• Stop-n-grow (K960843)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 25, 2018

Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti Fatma Erdogan Official Correspondent Sanatkarlar Cad. No:5 Angora Evleri Beysukent Cayyolu, 06800 TR

Re: K162525

Trade/Device Name: Oniko nail brace Regulatory Class: Unclassified Product Code: MOZ Dated: March 5, 2018 Received: March 5, 2018

Dear Fatma Erdogan:

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.

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 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K162525

Device Name Oniko nail brace

Indications for Use (Describe)

To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.

| 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

| Applicant: | Begum Saglik, Tıbbi Malzemeler & Danısmanlık Ltd Sti<br>Resit Galip cad. No: 124/10 GOP Cankaya 06700 Ankara Turkey<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Fatma Gülru Erdogan<br>[e-mail] |
| Date Summary Prepared:<br>510(k) Number: | April 17, 2018<br>K162525 |
| Trade Name:<br>Name of device: | Oniko nail brace<br>Nail brace |
| Classification:<br>Product code:<br>Device Contact Class:<br>Advisory Panel: | Unclassified<br>MQZ<br>Permanent (>30 days)<br>General & Plastic Surgery |
| Predicate Device: | K960843- Stop-n-grow, European Touch Co., Inc. |
| Device Description: | Oniko nail brace is a device for correcting the shape for painful and/or<br>overcurved nails without the use of any operation or anesthesia. |
| Intended Use: | To correct the shape of overcurved and/or painful nails without operation. To<br>loosen and give shape to thickened nails, overcurved nails and pincer nails<br>without operation. |
| Technological Characteristics: | Oniko nail brace is composed of metal hooks and silicone bands. The<br>metal hooks grasp the nail sides open to correct the shape or painful and/or<br>overcurved nails. |
| Performance Data: | Assessment of the Oniko nail brace demonstrated that the device is non-cytotoxic<br>non-sensitizer, and non-irritant, which are supported with clinical results. |
| Substantial Equivalence Discussion/Conclusion: | Oniko nail brace is substantially equivalent to the Stop-<br>n-grow (K960843). Oniko nail brace does not raise different questions of safety<br>and effectiveness compared to the predicate device. The Oniko Nail Brace has<br>similar intended use and principles of operation as the predicate device. The<br>minor differences between Oniko nail brace and Stop-n-grow do not raise<br>different questions of safety and effectiveness. |