(181 days)
Not Found
No
The summary describes a mechanical intramedullary nailing system and its components, with no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is intended for the fixation of long bone fractures, which is a therapeutic intervention aimed at healing and restoring the function of injured bones.
No
The device, an intramedullary nailing system, is intended for the fixation of long bone fractures, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly details hardware components such as nails, an insertion handle, a pump, and accessory tools, indicating it is a physical medical device system, 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 clearly states the device is for the "fixation of long bone fractures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (nail) and surgical instrumentation (handle, pump) used for insertion and expansion within the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose (fixing fractures).
N/A
Intended Use / Indications for Use
- The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of 1. long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
- The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the 2. fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.
Product codes
HSB
Device Description
The Meta-Fix and Fixion FA Intramedullary Nailing Systems consist of the following main components:
The nail is an expandable, stainless steel, cylindrical rod without interlocking holes. It is supplied in a reduced diameter.
The instrumentation includes, mainly, an insertion handle and a pump. The insertion handle is connected to the nail proximal end; the instrumentation is used for nail insertion and expansion.
In addition the system consists of accessory tools.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpal and metatarsal bones, radius and ulna
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990717, K010901, K010988, K012967, K023437, K042135, K902264, K913949
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
K071679 pg 1 of 3
510(K) Summary
Disc-O-Tech Medical Technologies Ltd. Meta-Fix - Metacarpal/Metatarsal Fixion® Intramedullary Nailing System Fixion® FA - Radius/Ulna Fixion® Intramedullary Nailing System
Submitter Name
Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel
DEC 17 2007
Contact Person
Yael Rubin Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
November 2007
Trade/Proprietary Name
- Metacarpal/Metatarsal Intramedullary Nailing System (Meta-Fix 1. Fixion Intramedullary Nailing System)
- Radius/Ulna Fixion Intramedullary Nailing System (Fixion FA Intramedullary 2. Nailing System, or - RU-Fix Intramedullary Nailing System)
Common Name
Intramedullary Fixation Rod
1
Classification Name
Intramedullary Fixation Rod Class 11: 21 CFR §888.3020
Product Code
HSB
Predicate Devices
- √ Fixion Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (K990717, K010901)
KU71679
2.11
- √ Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (K010988, K012967, K023437)
- V Titanium Elastic Nail System by Synthes (K042135)
- V True/Flex Nail by Encore (K902264, K913949)
Intended Use
- The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of 1. long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
- The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the 2. fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.
System Description
:
The Meta-Fix and Fixion FA Intramedullary Nailing Systems consist of the following main components:
The nail is an expandable, stainless steel, cylindrical rod without interlocking holes. It is supplied in a reduced diameter.
2
KU 11674
The instrumentation includes, mainly, an insertion handle and a pump. The insertion handle is connected to the nail proximal end; the instrumentation is used for nail insertion and expansion.
In addition the system consists of accessory tools.
Substantial Equivalence
In general, the Meta-Fix and Fixion FA Intramedullary Nailing Systems intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, line-art style, and the text is in a sans-serif font. The seal is black and white.
DEC 1 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Disc-O-Tech Medical Technologies, Ltd. % Mr. Yael Rubin 11 Ha'Hoshlim Street Herzliya 46724 Israel
Re: K071679
Trade/Device Name: MetaFix and Fixion FA Intramedullary Nailing Systems Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 2, 2007 Received: December 7, 2007
Dear Mr. Rubin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Pagc 2 - Mr. Yael Rubin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(K) Number (if known): K071679
Device Name:
-
- Metacarpal/Metatarsal Fixion Intramedullary Nailing System (MetaFix Intramedullary Nailing System)
-
- Radius/Ulna Fixion Intramedullary Nailing System (Fixion FA Intramedullary Nailing System)
Indication for Use:
-
- The MetaFix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
-
- The Fixion FA Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (Part 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brechum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices _____________________________________________________________________________________________________________________________________________________
510(k) Number K071679