(146 days)
No
The document describes a physical implant made of shape memory alloy and does not mention any software, algorithms, or data processing related to AI or ML.
Yes
The device is described as a "bone fastener" and "bone fixation appliance" intended for "small bone reconstruction," which are therapeutic interventions.
No
Explanation: The device is described as a bone fixation appliance intended for permanent implantation, used for reconstruction and fusion, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of a nickel titanium alloy, not software.
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 about a person's health. This testing is done outside the body (in vitro).
- Device Description: The MEMOMETAL INTRA MEDULLARY BONE FASTENER is a physical implantable device used for bone fixation within the body. It is a "double X-shape K-Wire" made of a specific alloy.
- Intended Use: The intended use is for "small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion." This is a surgical procedure involving the physical manipulation and fixation of bones, not the analysis of bodily specimens.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
Product codes
HTY
Device Description
MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER are single-use bone fixation appliances intended to be permanently implanted. Intramedulary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers and toes, small bones
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)
The MEMOMETAL INTRAMEDULARY MEMORY BONE The FASTENER (SMART TOE & X-FUSE) conform to ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples and to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K070578 page id2
510k Premarket Notification Intra medulary implants MEMOMETAL TECHNOLOGIES
JUL 26 2007
SECTION 5: 510(K) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c) Submitter MEMOMETAL TECHNOLOGIES Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France Phone : + 33 (0)2 99 05 50 66 Fax :+ 33 (0)2 99 05 95 62 Contacts Gilles AUDIC Quality Manager Bernard PRANDI General Manager e-mail: gilles.audic@memometal.com bernard.prandi@memometal.com Preparation date 02/26/2007 MEMOMETAL INTRAMEDULARY ARTHRODESIS DEVICE Trade Name (SMART TOE & X-FUSE) INTRAMEDULARY BONE FASTENER Common Name Classification Name Smooth or threaded metallic bone fastener K022599 NEWDEAL K-Wire Legally marketed K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) predicate devices Description MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER are single-use bone fixation appliances intended to be permanently implanted. Intramedulary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy. Intended Use The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion Inter-digital fusion of fingers and toes and small bones fusion Indication for use Performance data MEMOMETAL INTRAMEDULARY MEMORY BONE The FASTENER (SMART TOE & X-FUSE) conform to ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples and to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
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page 272
510k Premarket Notification Intra medulary implants MEMOMETAL TECHNOLOGIES
...
:
--
:
| Substantial equivalence | The MEMOMETAL INTRAMEDULARY MEMORY BONE
FASTENER (SMART TOE & X-FUSE) are substantially
equivalent to their predicate device K-WIRE in terms of
intended use and indications for use, design and function and
their predicate device MEMORY STAPLE in term of material.
Any minor differences between these two devices do not raise
new questions of safety and effectiveness. |
| ------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized manner.
JUL 26 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Memometal Technologies % Mr. Bernard Prandi General Manager Campus de Ker Lann - Rue Blaise Pascal Bruz, France F35170
Re: K070598
Trade/Device Name: Memometal Intramedulary Arthrodesis Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: June 18, 2007 Received: June 21, 2007
Dear Mr. Prandi:
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.
100 - 100 -
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Page 2 - Mr. Benard Prandi
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 the reporting 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 vours.
Sincerely yours,
Вашаувишир
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510k Premarket Notification |
|---|
| Intra medulary implants MEMOMETAL |
| TECHNOLOGIES |
INDICATIONS FOR USE
510(k) Number (if known): K070598
Device Name: MEMOMETAL INTRA MEDULARY BONE FASTENER (SMART TOE & X-FUSE) .
Indications for Use:
The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Boudur
Division of General, Restorative, and Neurological Devices
510(k) Number K070598
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