(10 days)
The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and redwhite zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of a size 2-0 polyethylene/polypropylene ZipLoop™ construct with two #5 polyester sleeves. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeves lock against the meniscal tissue, pulling the tear together. The sleeves control the size of the knot ensuring that the anchor does not become too small and pull through the meniscal tissue. The anchors are pre-loaded onto an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. The insertion device is available as an in-line inserter or a pistol-grip inserter, the MaxFire™ MarXmen™ Meniscal Repair Device. This allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the knotted end of the ZipLoop™ construct is gently pulled by the surgeon, allowing the meniscal tear to be compressed. The Maxfire™ anchor sits on the back side of the meniscus.
The medical device referenced is the "MaxFire™ and MaxFire™ MarXmen™ Meniscal Repair Devices".
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fixation Strength | Meets acceptance criteria as set by predicate fixation strength. | Meets acceptance criteria as set by predicate fixation strength. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data. The performance data provided is from non-clinical (mechanical) testing. No information is given about the sample size (number of devices or tests performed) for the fixation strength testing. The provenance of the data is also not stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical implant, and the assessment is based on physical performance (fixation strength) rather than expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication was required for mechanical testing results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "None provided as a basis for substantial equivalence" under the "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This is not an AI/algorithm-based device. It is a mechanical medical implant.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's main performance characteristic (fixation strength) was based on mechanical test results comparing it to a legally marketed predicate device. The acceptance criteria were derived from the performance of the predicate device (Arthrotek® MaxFire™ Meniscal Repair Device - K061776).
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device. The mechanical properties were evaluated against pre-defined acceptance criteria based on the predicate device's performance.
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K111564 (1/2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The word "BIOMET" is in a stylized font with a box around each letter. Below the word "BIOMET" is the phrase "SPORTS MEDICINE" in a simple sans-serif font.
JUN 1 6 2011
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Sports Medicine |
| Address | 56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0857 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 372-1718 |
| Establishment | 1825034 |
| Registration Number | 1825034 |
| Name of contact person | Elizabeth Wray / Regulatory Project ManagerVictor Rodgers / Director of Quality, Clinical, and RegulatoryAffairs |
| Date prepared | May 31, 2011 |
| Name of device | |
| Trade or proprietary name | MaxFire™ and MaxFire™ MarXmen™ Meniscal Repair Devices |
| Common or usual name | Suture Anchor |
| Classification name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification panel | Orthopedic |
| Regulation | 888.3040 |
| Product Code(s) | MBI |
| Legally marketed device(s) to which equivalence is claimed | Arthrotek® MaxFire™ Meniscal Repair Device - K061776 |
| Reason for 510(k) submission | Device Modification |
| Device description | The Maxfire™ Meniscal Repair Device is a permanent fixationanchor composed of a size 2-0 polyethylene/polypropyleneZipLoop™ construct with two #5 polyester sleeves. TheZipLoop™ construct is an adjustable loop created with a singlepiece of fiber material. When the ZipLoop™ is pulled tight, thesleeves lock against the meniscal tissue, pulling the tear together.The sleeves control the size of the knot ensuring that the anchordoes not become too small and pull through the meniscal tissue.The anchors are pre-loaded onto an insertion instrument. Theinserter allows for single entry into the joint. Once in the joint,the inserter will pierce the meniscus at the desired location. Theinsertion device is available as an in-line inserter or a pistol-gripinserter, the MaxFire™ MarXmen™ Meniscal Repair Device. Thisallows separate deployment of the anchors, one on each side ofthe tear. After the second anchor has been deployed, the |
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Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a code or identifier. The text includes the characters 'KII1564' followed by '(2/2)'. The characters are written in a clear, legible manner.
Image /page/1/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The word "BIOMET" is in a bold, outlined font on the top line. Below that, the words "SPORTS MEDICINE" are written in a smaller, non-outlined font.
| knotted end of the ZipLoop™ construct is gently pulled by the surgeon, allowing the meniscal tear to be compressed. The Maxfire™ anchor sits on the back side of the meniscus. | |||
|---|---|---|---|
| Intended use of the device | Meniscal Repair | ||
| Indications for use | The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus. | ||
| Summary of the technological characteristics of the device compared to the predicate | |||
| Characteristic | MaxFire™ and MaxFire™MarXmen™ Meniscal Repair Device(Modified Device) | Predicate - MaxFire™ Meniscal Repair Device (K061776) | |
| Design | Two sleeves with a ZipLoop™ Construct. | Two loops with a sliding knot. | |
| Material | PolyesterPolyethylene/Polypropylene | K061776 | |
| Principal of operation | Deployment of anchors on each side of meniscal tear. | K061776 | |
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | |||
| Summary of Technologies | |||
| The MaxFire™ and MaxFire™ MarXmen™ Meniscal Repair Devices have the same technological characteristics as the predicate except for slight modifications described within this 510(k). Testing was conducted to support the modifications and to determine substantial equivalence. | |||
| Characteristic | Standard/Test | Results (Criteria Meets or Exceeds) | |
| Fixation Strength | Pull-out Testing in comparison to predicate | Meets acceptance criteria as set by predicate fixation strength. | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| None provided as a basis for substantial equivalence. | |||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |||
| The results of the mechanical testing indicated that the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate device. |
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All trademarks are the property of Biomet, Inc.
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P.O. Blox 581
Temper III 465681-0507
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Sports Medicine % Ms. Elizabeth Wray Regulatory Product Manager 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
JUN 1 6 2011
Re: K111564
Trade/Device Name: Maxfire™ MarXmen™M Meniscal Repair Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 31, 2011 Received: June 7, 2011
Dear Ms. Wray:
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
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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 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 vours.
E. L. Keith
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
510(k) Number (if known): K111564
Device Name: Maxfire™ MarXmen™ Meniscal Repair Device
Indications for Use:
The Biomet Sports Medicine™ Maxfire™ MarXmen™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and redwhite zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
Prescription Use _ YES (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)
E. L. Keith
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111564
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.