Not Found
No
The device description and performance studies do not mention any AI or ML components or capabilities. The device is described as a mechanical brace.
Yes
The device is intended to correct the shape of painful/overcurved nails, which is a therapeutic purpose. It directly addresses a medical condition to alleviate pain and reshape affected nails.
No
The device description and intended use clearly state its purpose is to "correct the shape" and "loosen and give shape" to nails, which are therapeutic actions, not diagnostic. There is no mention of identifying or detecting a condition.
No
The device description explicitly states it is composed of "metal hooks and silicone bands," indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to correct the shape of nails and address pain associated with them. This is a physical intervention on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical brace composed of metal hooks and silicone bands that physically manipulate the nail. This is a mechanical device, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MOZ
Device Description
Oniko nail brace is a device for correcting the shape for painful and/or overcurved nails without the use of any operation or anesthesia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Assessment of the Oniko nail brace demonstrated that the device is non-cytotoxic non-sensitizer, and non-irritant, which are supported with clinical results.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle with three heads.
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.
1
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.
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
510(k) Summary
| Applicant: | Begum Saglik, Tıbbi Malzemeler & Danısmanlık Ltd Sti
Resit Galip cad. No: 124/10 GOP Cankaya 06700 Ankara Turkey
Phone: +90 312 4461919
Fax: +90 312 4475444 |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Fatma Gülru Erdogan
gulruer@gmail.com |
| Date Summary Prepared:
510(k) Number: | April 17, 2018
K162525 |
| Trade Name:
Name of device: | Oniko nail brace
Nail brace |
| Classification:
Product code:
Device Contact Class:
Advisory Panel: | Unclassified
MQZ
Permanent (>30 days)
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
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
loosen and give shape to thickened nails, overcurved nails and pincer nails
without operation. |
| Technological Characteristics: | Oniko nail brace is composed of metal hooks and silicone bands. The
metal hooks grasp the nail sides open to correct the shape or painful and/or
overcurved nails. |
| Performance Data: | Assessment of the Oniko nail brace demonstrated that the device is non-cytotoxic
non-sensitizer, and non-irritant, which are supported with clinical results. |
| Substantial Equivalence Discussion/Conclusion: | Oniko nail brace is substantially equivalent to the Stop-
n-grow (K960843). Oniko nail brace does not raise different questions of safety
and effectiveness compared to the predicate device. The Oniko Nail Brace has
similar intended use and principles of operation as the predicate device. The
minor differences between Oniko nail brace and Stop-n-grow do not raise
different questions of safety and effectiveness. |