(68 days)
The Sleeve with ZipLoop™ Fixation Devices are intended for fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
The Sleeve with ZipLoop™ Fixation Devices are a three component assembly consisting of two sleeves and a ZipLoop™ construct. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop is pulled tight, the sleeve locks against the bone fixating the soft tissue. The Sleeve with ZipLoop™ Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.
The provided text describes a 510(k) summary for the "Sleeve with ZipLoop™ Fixation Devices". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a clinical study. Therefore, much of the requested information (like acceptance criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or not provided in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance (Summary) |
|---|---|
| Equivalent pullout strength to predicate devices | "The test results indicate that the Sleeve with ZipLoop™ Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use." |
| Functional within intended use | "The test results indicate that the Sleeve with ZipLoop™ Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use." |
Explanation: The document explicitly states that non-clinical laboratory testing was performed to verify the fixation strength and functionality. The acceptance criterion was implicitly equivalence in pullout strength to the predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "non-clinical laboratory testing" without detailing the number of samples or tests performed.
- Data Provenance: Not applicable, as this was non-clinical laboratory testing, not human data. The testing was performed by Biomet Sports Medicine.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of clinical studies and expert review for AI devices, is not relevant here. The evaluation was based on physical property testing (pullout strength).
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are used in clinical studies or expert reviews to resolve disagreements, not for mechanical testing.
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
- No. An MRMC study was not done. This device is a surgical fixation device, not an AI-powered diagnostic or decision support tool. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm. Standalone performance refers to AI algorithms.
7. The type of ground truth used
- Mechanical Test Results (Pullout Strength): The "ground truth" for the non-clinical testing was the objective measurement of pullout strength, compared against the pullout strength of predicate devices.
8. The sample size for the training set
- Not Applicable. This device did not involve machine learning or AI, so there was no training set. The "training" for such devices would typically involve design and engineering processes, material selection, and iterative physical testing, which don't have "training sets" in the AI sense.
9. How the ground truth for the training set was established
- Not Applicable. No training set as it's not an AI/ML device.
In summary, this 510(k) submission primarily relies on non-clinical laboratory testing to demonstrate mechanical equivalence to existing predicate devices, rather than clinical efficacy or AI performance metrics.
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K101063 (1/2)
Image /page/0/Picture/1 description: The image contains the words "SPORTS MEDICINE". The word "SPORTS" is on the left side of the image, and the word "MEDICINE" is on the right side of the image. The words are in all capital letters and are in a sans-serif font. The words are black and the background is white.
'JUN 2 8 2010
510(k) Summary
| Preparation Date: | June 17, 2010 |
|---|---|
| ------------------- | --------------- |
Applicant/Sponsor: Biomet Sports Medicine
Contact Person: Robert Friddle Regulatory Affairs Specialist
Proprietary Name: Sleeve with ZipLoop™ Fixation Devices
- Common Name: Soft tissue fixation device
Classification Name:
- MBI (888.3040): Fastener, fixation, nondegradable, soft tissue ●
- JDR (888.3030): Staple, Fixation, Bone
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K071704 | Sleeve and Button Soft Tissue Devices |
|---|---|
| K973015 | Multitak SS Suture System™ |
| K053344 | BioRaptor™ Suture Anchors |
Device Description:
The Sleeve with ZipLoop™ Fixation Devices are a three component assembly consisting of two sleeves and a ZipLoop™ construct. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeve locks against the bone fixating the soft tissue. The Sleeve with ZipLoop™ Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.
Intended Use/Indications for Use:
The Sleeve with ZipLoop™ Fixation Devices are intended for fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
" Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomei.com
Shipping Address: 56 East Bell Drive Warsaw. IN 45582
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Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the Sleeve with ZipLoop™ Fixation Devices are similar or identical to the predicate devices or other previously cleared devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to verify the fixation strength of the Sleeve with ZipLoop™ Fixation Devices in pullout tests as compared to the predicate devices for specific indications for use. The test results indicate that the Sleeve with ZipLoop™ Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are the property of Biomer, Inc. except Multich is a trademark of Bonutt Research and BioRaptor™ which is a trademark of Smith & Nephew.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Sports Medicine % Mr. Robert Friddle 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
JUN 2 3 2010
Re: K101063
Trade/Device Name: Sleeve with ZipLoop™ Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 15, 2010 Received: April 16, 2010
Dear Mr. Friddle:
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 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
{3}------------------------------------------------
Page 2 - Mr. Robert Friddle
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/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 Division 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,
Mark A. Millan
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
510(k) Number (if known): K|0|063
Device Name: Sleeve with ZipLoop™ Fixation Devices
Indications for Use:
The Sleeve with ZipLoop™ Fixation Devices are intended for fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
.
تقييم سي
Acetabular labral repair
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
Smitu for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K10163
Page 1 of 1
§ 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.