(90 days)
No
The summary describes a physical implant device made of metal, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes
The device is intended to treat osteoarthritis, which is a medical condition, making it a therapeutic device.
No
The device is described as an implant for osteoarthritis, designed to replace parts of the great toe joint, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description explicitly states it is manufactured from ASTM F75 Cobalt Chrome and has a porous coating of ASTM F75 sintered beads, indicating it is a physical implant, 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 information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that this device is a Great Toe Implant. It's a physical implant made of Cobalt Chrome intended to be surgically placed within the body to replace a joint.
- Intended Use: The intended use is to treat osteoarthritis in the great toe by replacing the joint. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the description and intended use, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indications for use
- Osteoarthritis .
- Where the use of a more conservative procedure has failed or is unacceptable.
The device is intended for non-cemented use.
Product codes
KWD
Device Description
The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Toe / Great Toe
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
JUL 1 2002
page loft
510K SUMMARY OF SAFETY AND EFFECTIVENESS
The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).
Indications for use
- Osteoarthritis .
- Where the use of a more conservative procedure has failed or is unacceptable.
Contact Information
If further information is required please contact Dr. Louis Serafin, Signal Medical Corporation, 3777 Lapper Road Suite 3C, Port Huron, Michigan 48060, phone (810) 966-3917.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 JUL
Louis A. Serafin, Jr., M.D. Signal Medical Corporation 3777 Lapeer Road. Suite 3C Port Huron, Michigan 48060
Re: K021063
Trade/Device Name: Great Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: March 19, 2002 Received: April 2, 2002
Dear Dr. Serafin, Jr .:
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.
2
Page 2 - Dr. Louis A. Serafin
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stipt Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page i of 1
510(k) Number (if known):__________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Osteoarthritis
Where the use of a more conservative procedure has
failed or is unacceptable failed or is unacceptable.
The device is intended for non-cemented use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Rurly
Division of General, Restorative and Neurological Devices Over-The-Counter Use___ 510(k) Number (Optional Formal 1-2-96)
Prescription Use_ (Per 21 CFR 801.109)