(27 days)
Not Found
No
The summary describes a bioabsorbable fixator for soft tissue to bone approximation and does not mention any AI or ML capabilities.
No
The device is a bioabsorbable fixator used for soft tissue to bone approximation, specifically for repairs in the shoulder. While it assists in the healing process, its primary function is fixation rather than direct therapy or treatment of a disease.
No
The device is described as a bioabsorbable fixator intended for soft tissue to bone approximation in shoulder repairs. It is a surgical implant used for treatment, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "bioabsorable fixator utilized for soft tissue to bone approximation," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue to bone approximation" for surgical procedures like rotator cuff repair and shoulder dislocation repair. This is a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The description confirms it's a "bioabsorable fixator utilized for soft tissue to bone approximation." This further supports its use as a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. The SURETAC III is a surgical device used to physically repair tissue within the body.
N/A
Intended Use / Indications for Use
SURETAC III is intended for soft tissue to bone approximation. The indications for the SURETAC III are rotator cuff repair, repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The SURETAC® III is a bioabsorable fixator utilized for soft tissue to bone approximation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue to bone approximation (specifically, rotator cuff, shoulder for dislocation/subluxation)
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): 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.
SURETAC ® Fixation Device (K911837), SURETAC ® Expanded Indication (K931519), SURETAC® Expanded Indication II (K020948)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 handwritten text on a white background. The text includes the alphanumeric string "K023417" on the top line. Below that, the phrase "page 1 of 2" is written in a cursive style. The handwriting appears to be done with a dark ink or marker, creating a clear contrast against the white background.
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: (978) 749-1000 Toll Free: 1-800-343-8386 Fax: (978) 749-1599
Smith® III |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | SURETAC ® Fixation Device |
| Classification Name: | Class II, Smooth or Threaded Metallic bone fixation fastener
Product Code JDR (prior classification)
Class II, Fastener, Fixation, Biodegradable, Soft Tissue
Product Code MAI (current classification) |
D. Predicate Devices
| | SURETAC ® Fixation Device (K911837)
SURETAC ® Expanded Indication (K931519) |
-- | ------------------------------------------------------------------------------------------------------ |
---|
SURETAC® Expanded Indication II (K020948)
1
K023417
page 2 of 2
E. Description of Device
The SURETAC® III is a bioabsorable fixator utilized for soft tissue to bone approximation.
F. Intended Use
SURETAC III is intended for soft tissue to bone approximation.
The indications for the SURETAC III are rotator cuff repair, repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.
G. Comparison of Technological Characteristics
Both the SURETAC Fixation Device and the SURETAC III are intended for approximation of soft tissue to bone.
Jason Bilobran
Jasón Bilobram Regulatory Specialist
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 7 2002
Mr. Jason Bilobram Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810
Re: K023417
Trade/Device Name: SURETAC® III Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDR Dated: October 10, 2002 Received: October 11, 2002
Dear Mr. Bilobram:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Jason Bilobram
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,
Muriam C. Provost
forCelia 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
4
Page 1 of 1
510(k) Number :
Device Name: SURETAC® III
Indications for Use :
The SURETAC III is indicated for rotator cuff repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.
(PLEASE DO 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 U0
(Optional Format 1-2-96)
Muriam C. Provost
(Division Sign Off)
(Division Sign-6 Division of General. Restorative and Neurological Devices
510(k) Number Kc 23417