(28 days)
The Mini TightRope FT Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following:
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
- Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
- Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal - 2nd metatarsal intermetatarsal angle.
The Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice.
The provided text is a 510(k) summary for the Arthrex Mini TightRope FT Repair Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.
Here's a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
- This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics against defined 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)
- This information is not present. The document does not describe any clinical or pre-clinical performance testing with a specific test set.
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)
- This information is not present. No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not present. There is no mention of a test set or an adjudication method.
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
- This information is not present. The device is described as a medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not present. The device is a surgical repair kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not present. No ground truth for performance evaluation is discussed.
8. The sample size for the training set
- This information is not present. The device is not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not present. Not applicable as the device is not an algorithm.
Summary of available information:
The document describes the Arthrex Mini TightRope FT Repair Kit (K071978) and its intended use, which includes:
- Adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated.
- Adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
- Specifically, fixation during the healing process following:
- Syndesmotic trauma (e.g., fixation of dorsal distal radioulnar ligament disruptions).
- Tarasometatarsal (TMT) injury (e.g., fixation of foot soft tissue separations due to a Lisfranc injury).
- Hallux Valgus reconstruction (correction) by providing for the reduction of the 1st metatarsal - 2nd metatarsal intermetatarsal angle.
The entire 510(k) submission is based on demonstrating substantial equivalence to a predicate device, the Arthrex Mini TightRope Repair Kit (K061925). The key argument for equivalence is that "the basic features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness."
The FDA's letter confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed subject to general controls. It does not provide details of specific performance criteria or outcomes from a new study beyond the comparison to the predicate device.
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K. 071978 page 12
Arthrex SPECIAL 510(k); Arthrex Mini TightFlope FT Repair Kit
AUG 1-5 2007
| 4 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Sally Foust, RACRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1251Fax: 239/598.5508Email: sfoust@arthrex.com |
| Trade Name | Mini TightRope FT Repair Kit |
| Common Name | Button / Anchor / Suture |
| Product Code -Classification Name | HTN – Single/multiple component metallic bone fixation appliances and accessories |
| Predicate Device | Arthrex Mini TightRope Repair Kit, K061925 |
| Device Description and Intended Use | The Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice.The Mini TightRope FT Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.Specifically, the Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following:1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions:2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and |
| providing for the reduction of 1st metatarsal - 2nd metatarsal intermetatarsal angle. | |
| Substantial Equivalence Summary | The Mini TightRope™ FT Repair Kit is substantially equivalent to the predicate Mini TightRope™ Repair Kit in which the basic features and intended uses are the same. Any differences between the Mini TightRope™ FT Repair Kit and the predicate Mini TightRope™ Repair Kit is considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Mini TightRope™ FT Repair Kit is substantially equivalent to the currently marketed predicate device. |
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page 12
Arthrex SPECIAL 510(k): Arthrex Mini TightfRope FT Repair Kit
:
.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2007
Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
K071978 Trade/Device Name: Mini TightRope FT Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN & HWC Dated: July 13, 2007 Received: July 18, 2007
Dear Ms. Foust:
Re:
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
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Page 2 - Ms. Sally Foust
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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbene Buehup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex SPECIAL 510(K): Arthrex Mini TightFlope FT Repair Kit
Indications for Use
510(k) Number:
Ko71978
Device Name:
Mini TightRope FT Repair Kit
The Mini TightRope FT Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following:
-
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
- Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-
- Hallux Valgus reconstruction (correction) by providing for the reduction of 18t metatarsal -2nd metatarsal intermetatarsal angle.
Prescription Use _ X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
PAGE 1 of
Division of Ger estorative. and Neurological I
Mini TightRope FT Repair Kit 510(k)
7 of 41
510(k) Number K671978
§ 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.