(68 days)
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissues.
The provided text describes a 510(k) summary for the Smith & Nephew TwinFix Ti Quick T, a suture anchor device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a clinical or analytical validation study for an AI/CADe device.
Therefore, many of the requested categories are not applicable to this type of submission. This 510(k) is for a physical medical device (suture anchor), not an AI/CADe system.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A):
1. Table of Acceptance Criteria and Reported Device Performance
This information is typically found in performance testing reports for new medical devices, which are often summarized in the 510(k) submission but not explicitly detailed with acceptance criteria and results in this format. The 510(k) submission for the Smith & Nephew TwinFix Ti Quick T focuses on demonstrating substantial equivalence to predicate devices based on design, function, and intended use, rather than specific performance metrics against pre-defined acceptance criteria for a new clinical study.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Explanation: The 510(k) summary provided does not contain a table of acceptance criteria or specific performance data from a new study designed to meet those criteria. The submission aims to show that the new device is "substantially equivalent in design, function, and intended use" to existing predicate devices (Acufex T-Fix Rotator Cuff Guide System, K941364 and PEBA Anchor/Suture Combination, K972326). Such submissions typically rely on descriptive comparisons, material safety data, and potentially mechanical testing data (not included here) rather than detailed clinical performance against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a physical medical device (suture anchor) and focuses on establishing substantial equivalence via comparison to predicate devices, not on a clinical "test set" in the context of an AI/CADe study. There is no mention of a test set, data provenance, or study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This information pertains to studies establishing ground truth for diagnostic or AI/CADe performance, which is not relevant to this 510(k) submission for a physical surgical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there is no "test set" and no diagnostic performance evaluation in the context of this 510(k) submission, adjudication methods are not relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This type of information is relevant for diagnostic performance studies, not for the substantial equivalence demonstration of a physical surgical device like a suture anchor.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/CADe device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or ground truth establishment relevant in the context of an AI/CADe system for this 510(k) submission.
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K02015-9
page 1 of 2
510(k) Summary
Smith & Nephew TwinFix Ti Quick T
MAR 2 6 2002
Date Prepared:
January 7, 2002
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Submitter A.
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810
B. Company Contact
William McCallum Regulatory Affairs Specialist
C. Device Name
Trade Name: Smith & Nephew TwinFix Ti Quick T
Common Name: Suture Anchor Suture, Nonabsorbable, Polyester
Classification Name: Screw, Fixation, Bone
D. Predicate Devices
Acufex T-Fix Rotator Cuff Guide System, K941364 PEBA Anchor/Suture Combination K972326
E. Description of Device
The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissues.
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Page 2 of 2
F. Indications For Use
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
G. Comparison of Technological Characteristics
The Smith & Nephew TwinFix Ti Quick T is substantially equivalent in design, function, and intended use to the following predicate devices:
Acufex T-Fix Rotator Cuff Guide System, K941364 (May 16, 1994). T-Bar
PEBA Anchor/Suture Combination, K972326 (June 23, 1997). Anchor and Suture
W. Shin. M. Calhoun
William McCallum Regulatory Affairs Specialist
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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 three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
Mr. William McCallum Regulatory Affairs Specialist Smith & Nephew, Inc Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810
Re: K020159
Trade/Device Name: Smith & Nephew TwinFix Ti quick T Regulation Number: 888.3040 Regulation Name: Screw, Fixation, Bone Regulatory Class: II Product Code: HWC Dated: January 16, 2002 Received: January 17, 2002
Dear Mr. McCallum:
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.
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Page 2 - Mr. William McCallum
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,
R. Mark N. Millbern, Ph.D.
elia 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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KO)O S 510(k) Number :
Device Name: Smith & Nephew TwinFix Ti Quick T
Indications for Use:
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.
Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use her (Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
Over-the-Counter No
Mark N Mulkerson
(Division Sign-Off)
General, Restorative and Neurological Devices
025
51 % ) Numb
§ 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.