(198 days)
K911837, K 931819
Not Found
No
The device description focuses on the material composition and bioresorbable properties of the implant, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device, SureTac, is a bioresorbable and biocompatible polymer used for rotator cuff repair. While its purpose is to aid in the repair of tissue, which can be considered therapeutic in a broad sense, it is described as a fixation device (similar to its predicate devices) rather than an active therapeutic agent (e.g., drug delivery, energy-based therapy). Fixation devices provide structural support during healing, but typically are not classified as therapeutic devices themselves in the same way.
No
The device description indicates it is a bioresorbable and biocompatible polymer used for Rotator Cuff Repair, which suggests it is a surgical implant or fixation device, not a diagnostic tool. There is no mention of it being used to identify or analyze a condition.
No
The device description explicitly states it is composed of bioresorbable and biocompatible polymers, indicating it 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 "Indicated for use in Rotator Cuff Repair." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The description details a bioresorbable implant made of polymers used in surgical procedures. This is consistent with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Smith & Nephew SURETAC® Fixation Device is indicated for rotator cuff repair.
Product codes
JDR
Device Description
The PGA/TMC SureTac is composed of bioresorbable and biocompatible polymers that have been used in various surgical procedures for many years. Polyglycolic Acid (PGA) and Trimethylene carbonate (TMC) copolymer degrades and resorb In Vivo by hydrolysis and are metabolized by the body. In animal studies PGA/TMC, also know as, Maxon have been shown to be biocompatible in both soft tissue and bone tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rotator Cuff
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)
K911837, K 931819
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0L0948 page 1/2
Section 7- 510k Summary
| 7.1 Statement | This 510k summary is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 |
|---|---|
| 7.2 Submitter | Smith and Nephew, Inc. |
| Endoscopy Division | |
| 160 Dascomb Rd. | |
| Andover, Ma. 01810 | |
| 7.3 Company | |
| Contact | Jason Bilobram |
| Regulatory Affairs Specialist | |
| (508) 261-3699 | |
| 7.4 Device | |
| Name | Proprietary Name: SURETAC® Expanded Indication II |
| Common Name: SURETAC® Fixation Device | |
| Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener (JDR) | |
| 7.5 Predicate | |
| Legally | |
| Marketed | |
| Devices | Smith & Nephew, SURETAC® Fixation Device (K911837)Smith & Nephew, SURETAC® Expanded Indication (K 931819) |
| 7.6 Device | |
| Description | The PGA/TMC SureTac is composed of bioresorbable and biocompatible polymers that have been used in various surgical procedures for many years. Polyglycolic Acid (PGA) and Trimethylene carbonate (TMC) copolymer degrades and resorbs In Vivo by hydrolysis and are metabolized by the body. In animal studies PGA/TMC, also know as, Maxon have been shown to be biocompatible in both soft tissue and bone tissue. |
| 7.7 Indications | |
| for Use | The Smith & Nephew SURETAC® Fixation Device is indicated for rotator cuff repair. |
1
Page 242
7.8 Substantial Equivalence
The SURETAC® Fixation Device is substantially equivalent in design, material, packaging materials and method of sterilization to the following currently marketed devices:
- Smith & Nephew, SURETAC® Fixation Device (K911837) ●
- Smith & Nephew, SURETAC® Expanded Indication (K 931819) .
- The only difference between the proposed and predicate devices is the expansion of the . patient population to include rotator cuff repair.
Applicant:
Jose Beloh
Jason Bilobram Regulatory Affairs Specialist
Date: 03/21/2002
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jason Bilobram Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road
Andover, Massachusetts 01810
Re: K020948
Trade/Device Name: SURETAC® Expanded Indications II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDR Dated: July 17, 2002 Received: July 18, 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. Iisting 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.
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,
Stpt Rlvorlu
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (If Known): K020948
Device Name: SURETAC® Expanded Indications II
.
:
Indications for Use: Indicated for use in Rotator Cuff Repair
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Rhodes
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020948
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use $\mathcal{N}$/6