(116 days)
The SpeedLock Knotless Fixation Device 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 SpeedLock Knotless Fixation Device 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 SpeedLock Knotless Fixation System. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting.
Therefore, many of the requested details, such as acceptance criteria in terms of accuracy, sensitivity, or specificity, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets, are not applicable to this type of regulatory submission. This document is primarily about demonstrating that a modified medical device is as safe and effective as a previously cleared device through an engineering and materials comparison.
Here's a breakdown of the available information with respect to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (from bench testing) |
|---|---|
| Substantial equivalence to predicate device (K090615) in intended use and technical characteristics. | Side-by-side comparison bench testing performed per the US FDA Guidance Document for Testing Bone Anchors demonstrated substantial equivalence. Differences between the proposed and predicate device do not raise questions regarding safety and effectiveness. Materials are well-characterized and used in predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of distinct "cases" or "samples" as would be relevant for a diagnostic or AI device study. The comparison was described as "side-by-side bench testing," which implies physical testing of the device itself and its predicate.
- Data Provenance: Not explicitly stated, however, "bench testing" typically occurs in a laboratory setting, not derived from patient data. It is a prospective test conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for this type of device comparison is established through engineering specifications, material properties, and mechanical performance tests, not expert clinical assessment of diagnostic output.
4. Adjudication Method for the Test Set:
- Not applicable. This was a direct comparison of physical device characteristics and performance, not a review of clinical or diagnostic outcomes requiring adjudication.
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 a diagnostic device involving human readers or AI assistance. It is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence for this device is based on engineering specifications, material compatibility, and mechanical performance standards outlined in the FDA Guidance Document for Testing Bone Anchors.
8. The Sample Size for the Training Set:
- Not applicable. This device does not utilize a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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K111044 #1/2
510(K) SUMMARY
AUG - 9 2011
ARTHROCARE CORPORATION SPEEDLOCK KNOTLESS FIXATION SYSTEM
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Establishment Registration No .:
Contact Person:
2951580 Laura N. Kasperowicz
Sr. Manager, Regulatory Affairs
Date Prepared:
April 14, 2011
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:
Model Name: Generic/Common Name:
Predicate Devices Opus® SpeedLock® Knotless Fixation Device SpeedLock Knotless Fixation Device Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue Class II per 21 CFR 888.3040, Product code: MBI
Drill, 3.0 mm Bone Drill
PathFinder® Obturator Bone Hole Locator
Sharp-Tipped Obturator Bone Hole Locator
Drill Guide, 3.5mm High Visibility Drill Guide
Drill Guide, 3.5mm Low Profile Drill Guide
K090615 (June 3, 2010)
Product Description
The SpeedLock Knotless Fixation Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
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K111044 **
510(K) SUMMARY
Indications For Use
The SpeedLock Knotless Fixation Device 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 SpeedLock Knotless Fixation device design and technology is substantially equivalent to the existing SpeedLock Knotless Fixation Device [K090615]. 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 SpeedLock 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 SpeedLock Knotless Fixation Device is substantially equivalent to the SpeedLock Knotless Fixation Device originally cleared under K090615.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers. The symbol is stylized and modern in appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Arthrocare Corporation % Ms. Laura Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
AUG - 9 2011
Re: K111044
Trade/Device Name: Speedlock® Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 30, 2011 Received: July 05, 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 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. Please note: CDRH does not evaluate information related to contract liability warrantics. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K 111044 |
|---|---|
| Device Name: | SpeedLock® Knotless Fixation System |
| Indications for Use: |
The SpeedLock Knotless Fixation Device 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)
AND/OR 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KL 111/044
page v
510(k) Number
§ 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.