(62 days)
The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedFix Suture System, not a study involving acceptance criteria and device performance in the context of AI or a reader study.
The document states that a "side-by-side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors." However, it does not provide details of the acceptance criteria, the specific test results, sample sizes, or the other information requested in the prompt (e.g., data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets).
Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (SpeedFix Suture Implant cleared under K101437) rather than presenting a detailed performance study against defined acceptance criteria in the manner described by the prompt.
The document explicitly states: "The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices." This indicates a reliance on the predicate device's established safety and effectiveness, supported by bench testing, rather than a de novo performance study against explicit internal acceptance criteria.
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510(K) SUMMARY
JUL 20 2011
ARTHROCARE CORPORATION SPEEDFIX SUTURE SYSTEM
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Establishment Registration No.: 2951580
Contact Person:
Laura N. Kasperowicz Sr. Manager, Regulatory Affairs
Bone Anchor, Fastener, Fixation, Soft Tissue
Fastener, Fixation, Nondegradeable, Soft Tissue
Class II per 21 CFR 888.3040, Product code: MBI
Date Prepared:
May 19, 2011
Drill, 3.0mm
Bone Drill
SpeedFix Suture System
PathFinder® Obturator
Sharp-Tipped Obturator
Bone Hole Locator
Bone Hole Locator
Device Description
Model Name: Generic/Common Name: Classification Name: Device Classification:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Drill Guide, 3.5mm Low Profile Drill Guide
Drill Guide
Model Name: Generic/Common Name:
Predicate Devices
SpeedFix Suture Implant
K101437 (October 29, 2010)
Drill Guide, 3.5mm High Visibility
Product Description
The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
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510(K) SUMMARY
Indications For Use
The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Substantial Equivalence
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The SpeedFix Suture Implant design and technology is substantially equivalent to the existing SpeedFix Suture Implant [K101437]. Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices.
Summary and Reason for 510k Notification
The purpose of this 510(k) is to notify the Food and Drug Administration of a proposed modification to an existing product. The proposed device, the SpeedFix Suture Implant is substantially equivalent to the SpeedFix Suture Implant originally cleared under K101437.
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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 eagle with three lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
ArthroCare Corp. ArthorCare - The Opus Collection (Formerly Opus Medical) % Laura N. Kasperowicz Sr. Manager, Regulatory Affairs 15285 Alton Parkway Suite 200 Irvine, CA 92618
JUL 20 2011
Re: K111399
Trade/Device Name: SpeedFix™ Suture System Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 5, 2011 Received: July 6, 2011
Dear Ms. Kasperowicz:
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 for associated in the 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 I ou may, dierely mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 r lease of actives that i Drimination that your device complies with other requirements of the Act that I Dri has made a aventuations administered by other Federal agencies. You must or any I edelar statutes and registements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Laura N. Kasperowicz
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fall 607), labeling (21 CFR 803); good manufacturing practice requirements as set de rece related univers or many (2) CFR Part 820); and if applicable, the electronic form in the quality by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you desire sportio ao reaboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, ( )
Fr Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number:
KJ11399 log 1/1
Device Name: SpeedFix™ Suture System
Indications for Use:
The SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Prescription Use (Part 21 CFR 801 Subpart D) X
Over-The-Counter Use (21 CFR 801 Subpart C) NO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
for M.Molicem
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgical, Devices Division of possible Devices
510(k) Number K111399
page v
§ 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.