(52 days)
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
The EZLoc™ Femoral Fixation Device is the same design as the predicate Femoral Hook (EZLoc™), deared in K041261, with additional sizes. The device includes a body, an arm, a passing pin and a pull suture. The implant will be available in three diameters: 5-6mm, 7-8mm and 9-10mm; and five lengths: 15mm, 20mm, 25mm, 30mm and 35mm. The sizes will account for the varying diameters and lengths of the replacement graft and femoral tunnel length. Currently the devices are packaged with a #2 polyethylene suture, but may also be used with any legally marketed, nonresorbable suture.
This document describes a 510(k) premarket notification for the EZLoc™ Femoral Fixation Device. This is a medical device submission seeking clearance based on substantial equivalence to predicate devices, not a study evaluating device performance against pre-defined acceptance criteria in a clinical setting.
Therefore, the requested information about acceptance criteria, detailed study design, and performance metrics is generally not applicable in the context of this 510(k) summary.
Here's why and what information is available based on the provided text:
- 510(k) Substantial Equivalence: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing similar technological characteristics, materials, design, and intended use as the predicate device(s). It does not typically involve proving that the device meets specific, pre-defined quantitative performance acceptance criteria through extensive clinical trials.
- "Non-Clinical Testing" vs. Clinical Trials: The document explicitly states "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This refers to bench testing and material characterization, not a clinical study with patients or human readers.
- "Clinical Testing: None provided as a basis for substantial equivalence.": This directly confirms that no human clinical data was used to support this 510(k) submission.
Given this, I cannot provide the requested information in the format you specified, as those details are typically found in documents describing clinical trials or performance studies that are not part of this specific 510(k) summary.
However, I can extract what is stated in relation to the non-clinical testing:
Relevant Information from the 510(k) Submission:
- Acceptance Criteria/Performance: The submission's non-clinical testing "indicated that the device was functional within its intended use." Specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary. The "acceptance criterion" in this context is the FDA's determination of substantial equivalence to the predicate devices.
- Study That Proves the Device Meets Acceptance Criteria: "Non-clinical laboratory testing was performed to determine substantial equivalence." This testing (presumably mechanical, material, and functional bench tests) supported the claim of substantial equivalence. No details on the methodology, sample sizes, or specific results of these tests are provided in this summary.
Therefore, the table and other requested sections would mostly be marked as "N/A" or "Not Provided in 510(k) Summary".
Here's a breakdown of why each point is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for materials, design, technological characteristics, and intended use. | "Non-clinical laboratory testing... indicated that the device was functional within its intended use." |
| Specific quantitative performance criteria (e.g., tensile strength, fatigue life) are not provided in this summary. | Specific quantitative performance data is not provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not provided. The "test set" in the context of device performance would refer to clinical study subjects or a specific number of devices tested in a lab. For non-clinical testing, the number of units tested is not disclosed.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. Since no clinical data was submitted, this doesn't apply. For non-clinical lab testing, the location is not specified, but typically conducted in-house or by accredited labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No clinical ground truth was established for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set or human interpretation was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. This device is a physical fixation device, not an AI diagnostic tool, and no clinical studies were performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Not applicable. This device is a physical fixation device, not an algorithm or software. The "non-clinical testing" could be considered "standalone" in the sense of lab tests without human "in-the-loop" clinical interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established engineering specifications, material properties, and functional benchmarks derived from predicate devices or established standards.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring training data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable.
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K053461 page 171
510(k) Summarv
FER 3 2006
Applicant/Sponsor: Arthrotek, Inc.
Contact Person: Susan Alexander
Proprietary Name: EZLoc™ Femoral Fixation Device
Common Name: Soft tissue anchor
Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue (888.3040)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Titanium Toggle Button (K033838) and Femoral Hook (K041261)
Device Description: The EZLoc™ Femoral Fixation Device is the same design as the predicate Femoral Hook (EZLoc™), deared in K041261, with additional sizes. The device includes a body, an arm, a passing pin and a pull suture. The implant will be available in three diameters: 5-6mm, 7-8mm and 9-10mm; and five lengths: 15mm, 20mm, 25mm, 30mm and 35mm. The sizes will account for the varying diameters and lengths of the replacement graft and femoral tunnel length. Currently the devices are packaged with a #2 polyethylene suture, but may also be used with any legally marketed, nonresorbable suture.
Intended Use: Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the EZLoc™ Femoral Fixation Device are similar to or identical to the predicate devices. The EZLoc™ Femoral Fixation Device has been modified to include new sizes.
Non-Clinical Testing: Non-cilnical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Arthrotek, Inc., a wholly-owned subsidiary of Biomet, Inc.
MARK MALING ANDRESS ラニ + _ _( \ _ _( \ _( \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
FEB 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Alexander Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K053461
Trade/Device Name: EZLoc™ Femoral Fixation Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: December 12, 2005 Received: December 13, 2005
Dear Ms. Alexander:
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 - Ms. Susan Alexander
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 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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
Sincercly yours,
2
/ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
EZLoc™ Femoral Fixation Device Device Name:
Indications For Use:
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Page 1 of 1 |
|---|---|
| Division of General, Restorative,Neurological Devices | |
| Number | K053461 |
| 8 |
§ 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.