(76 days)
Not Found
No
The description focuses on a mechanical fixation device (a self-tapping wire) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an implantable hardware (self-tapping wire) for fixation of bone fractures or for bone reconstructions. It is a surgical tool, not a therapeutic device.
No
The TAC'pin® is an implantable device used for fixation of bone fractures and reconstructions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "self tapping wire" and is "implanted for fixation of bone fractures," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- TAC'pin® Function: The TAC'pin® is a surgical implant used for the physical fixation of bone fractures and reconstructions. It is a physical device inserted into the body, not a test performed on a sample outside the body.
The provided information clearly describes a surgical implant for orthopedic use, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TAC'pin® is intended to be implanted for fixation of bone fractures or for bone reconstructions.
The TAC'pin® is indicated for synthesis of small bones fragments, in the foot only. Examples include:
-Akin type osteotomy
-first MP Arthrodesis
-phalangeal arthrodesis
-small bones osteosynthesis requiring compression.
Product codes (comma separated list FDA assigned to the subject device)
87JDW
Device Description
The TAC'pin® is a self tapping wire. One part K is fixed on a standard surgical power tool equipment and when the threaded wire is introduced and positioned as required, the surgeon has to cut the wire at the bone surface. The lengths of threads available are the following : 15 - 20 - 25 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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): 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
§ 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
Image /page/0/Picture/0 description: The image shows the logo and contact information for a company called Newdeal. The logo is in a stylized font, and the contact information includes the company's address, phone number, fax number, and email address. The address is 31 Rue de la Convention, Parc D'Activités Garigliano, 38200 Vienne, France. The phone and fax numbers are (33) 04 74 78 15 15 and (33) 04 74 78 15 16, respectively, and the email address is NEWDEALFR@AOL.COM.
3. SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION A.
NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE
Tél. : (33) 4 74 78 15 15 Fax : (33) 4 74 78 15 16
B. ESTABLISHMENT REGISTRATION NUMBER: 9615741
OFFICIAL CONTACT PERSON C.
Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854
Tel. : (301) 519-1098 Fax : (301)519-1389
D. DATE OF PREPARATION OF THIS SUMMARY: November 15, 1999
- E. PROPRIETARY (TRADE) NAME: TAC'pin®
- F. COMMON NAME: Bone fixation wire self tapping threaded wire
1 2000
1
K9939/6
pg 2082
- CLASSIFICATION NAME AND REFERENCE ઉં, Smooth or threaded metallic hone fixation fastener (21 CFR, Section 888.3040)
- PROPOSED REGULATORY CLASS: Class II BL
- DEVICE PRODUCT CODE: 87JDW I.
- 87 OR PANEL CODE: J.
- DESCRIPTION OF DEVICE: The TAC'pin® is a self tapping wire. One part K is fixed on a standard surgical power tool equipment and when the threaded wire is introduced and positioned as required, the surgeon has to cut the wire at the bone surface. The lengths of threads available are the following : 15 - 20 - 25 mm.
- The TAC'pin® is intended to be implanted for fixation of INTENDED USE: L. bone fractures or for bone reconstructions.
- INDICATIONS FOR USE: The TAC'pin® is indicated for synthesis of small M. bones fragments, in the foot only. Examples include: -Akin type osteotomy -first MP Arthrodesis -phalangeal arthrodesis -small bones osteosynthesis requiring compression.
- N. The TAC'pin® is substantially equivalent to the PREDICATE DEVICE Threaded fixation pin manufactured by Sgarlato laboratories (K982931), and the Kirschner wires and Steinmann pins manufactured by Syntec-Taichung Medical Instruments (K983121).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 0.
Both the TAC'pin®, the Sgarlato threaded fixation pin, and the Kirschner wires and Steinmann pins from Syntec-Taichung Medical are intended to be implanted for fixation of small bone fragments. Both the TAC'pin® and the Sgarlato threaded fixation pin are made from the same titanium alloy, whereas the Kirschner wires and Steinmann pins from Syntec-Taichung Medical are made from stainless steel. This difference has no significant consequences on the safety or effectiveness of the product. The TAC pin®, the Sgarlato Threaded fixation pin, and the Kirschner wires and Steinmann pins manufactured by Syntec-Taichung Medical Instruments are all threaded pins with comparable ranges of sizes and diameters.
000010
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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 1 2000
NewDeal SA C/O Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K993910
Trade Name: TAC' pin® Regulatory Class: II Product Code: JDW Dated: November 15, 1999 Received: November 17, 1999
Dear Dr. Estrin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
3
Page 2 - Norman F. Estrin, Ph.D., RAC
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Sage
Ser James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K993910
Page 1 of 1
510(k) Number (if known):
TAC' pin ® Device Name:
Indications for Use:
The TAC'pin® is indicated for synthesis of small bones fragments, in the foot only. Examples include:
-Akin type osteotomy -first MP Arthrodesis -phalangeal arthrodesis -small bones osteosynthesis requiring compression.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
ell Payne Surr
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
000008