(79 days)
No
The document describes a mechanical screw implant and surgical instruments, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to treat a medical condition (subtalar joint dysfunction and flat foot) by physically blocking excessive pronation, which is a therapeutic action.
No
Explanation: The device is a surgical screw intended to block displacement of the talus, treating flat foot by allowing subtalar joint motion and blocking excessive pronation. It is a therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a conical, threaded cannulated screw made from medical grade titanium alloy, which is a physical hardware implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Normed® Vario Subtalar Screw System is an implantable surgical device. It is a physical screw inserted into the foot to treat a specific anatomical issue (flat foot).
- Intended Use: The intended use is to physically block movement of the talus and allow normal subtalar joint motion, not to analyze biological samples.
The description clearly indicates a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Normed® Vario Subtalar Screw System is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents.
Product codes
HWC
Device Description
The Normed Vario Subtalar Screw is a conical, threaded cannulated screw. It is designed to be inserted into the sinus tarsi of the foot for subtalar arthoroereisis. It is made from medical grade titanium alloy, Ti-6Al-4V (ASTM F136). The implant is offered in 2 sizes: Small (10mm - 13mm) and Large (13mm -16mm). The implants are provided nonsterile and single-use only. The instruments are non-sterile and reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus tarsi of the foot
Indicated Patient Age Range
adult, children and adolescent patients.
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)
Non-clinical testing demonstrated for the Normed Vario Subtalar Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy. Summary of testing is as follows:
- Vario Screws Static Compression Load (Custom Test)
- In-vitro cytotoxicity (ISO 10993-5)
- Sterility validation (Custom Test)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Normed Pellegrin Calcaneus Stop Screw, K133035
Reference Device(s)
Memometal Technologies SubFix Arthroereisis Implant. K093820, Metasurg Subtalar Implant, K111265
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Premarket Notification Normed Vario Subtalar Screw
510(k) Summary Pursuant to 21 CFR 807.92
General Company Information
| Company Name: | Normed® Medizin-Tecknik GmbH |
|---|---|
| Company Address: | Ulrichstrasse 7 |
| D-78532 | |
| Tuttlingen, Germany | |
| Company Telephone: | +(011) 49 7461 93 43 0 |
| +(011) 49 7461 93 43 20 | |
| Contact: | David Furr, MS |
| FDC Services, LLC | |
| Principal Regulatory Affairs Consultant | |
| Contact Address: | 8708 Capehart Cove |
| Austin, Texas 78733 | |
| (512) 906-9654 |
April 10, 2014 Date:
Normed Vario Subtalar Screw Device Trade Name:
II
HWC
Common Name:
Subtalar Arthroereisis Implant
Classification Name: Smooth & threaded metallic bone fixation fasteners (21 CFR 888.3040)
Class:
Product Code:
Predicate Device:
Normed Pellegrin Calcaneus Stop Screw, K133035 (cleared 12/13/13)
15
ﻟﺮ
1
510(k) Premarket Notification Normed Vario Subtalar Screw
Memometal Technologies SubFix Arthroereisis Implant. K093820 (cleared 5/19/10)
Metasurg Subtalar Implant, K111265 (cleared 8/9/11)
Device Description:
Intended Use:
The Normed Vario Subtalar Screw is a conical, threaded cannulated screw. It is designed to be inserted into the sinus tarsi of the foot for subtalar arthoroereisis. It is made from medical grade titanium alloy, Ti-6Al-4V (ASTM F136). The implant is offered in 2 sizes: Small (10mm - 13mm) and Large (13mm -16mm). The implants are provided nonsterile and single-use only. The instruments are non-sterile and reusable.
The Vario Subtalar Screw System is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents.
Technological Characteristics:
The Vario Subtalar Screw System is similar to legally marketed predicate devices listed previously. The screws share
2
510(k) Premarket Notification Normed Vario Subtalar Screw
similar indications of use, are manufactured from the same materials and incorporate similar technological characteristics.
Performance Data (Nonclinical and/or Clinical):
Non-clinical testing demonstrated for the Normed Vario Subtalar Screw System meets performance requirements as defined by Design Control activities and are substantially equivalent to the predicate devices in terms of safety and efficacy. Summary of testing is as follows:
| Testing | Standard |
|---|---|
| Vario Screws Static Compression Load | Custom Test |
| In-vitro cytotoxicity | ISO 10993-5 |
| Sterility validation | Custom Test |
17
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
July 3, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring MD 20993-0002
Normed® Medizin Technik GmbH % David Furr Principal Regulatory Affairs Consultant FDC Services,LLC 8708 Capehart Cove Austin, Texas 78733
Re: K140962
Trade/Device Name: Normed Vario Subtalar Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 12, 2014 Received: May 14. 2014
Dear Mr. Furr:
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 10 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 (reporting of medical device-related adverse events} (21 CFR 803): good manufacturing practice requirements as set
4
Page 2 -Mr. David Furr
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" (21CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K140962 page 1 of 1
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013 |
|-------------------------------------------------------------------------|------------------------------------------------------------------------|
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number ( if known ) | K140962 |
|---|---|
| Device Name | Normed Vario Subtalar Screw |
| Indications for Use (Describe) |
The Normed® Vario Subtalar Screw System is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents.
Type of Use (Select one or both, as applicable)
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)
Elizabeth|© Brank -S
Division of Orthopedic Devices
FORM FDA 3881 (9/13)
PO, Pass ar Servator (J61) 413-678