(27 days)
The Magnum MP bone anchor 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 Magnum MP device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text is a 510(k) premarket notification for a medical device (Magnum MP Fixation Device) and a clearance letter from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about a specific study designed to prove the device meets acceptance criteria or detailed performance metrics.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on substantial equivalence to a predicate device, rather than specific performance metrics against pre-defined acceptance criteria for a new study. | Not provided. The document does not present quantitative performance data for the Magnum MP Fixation Device against specific acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not applicable, as no specific study data is presented. The submission discusses the device's design and materials in comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not provided.
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
- MRMC study: Not performed or reported. This type of study is typically related to diagnostic AI devices, and the Magnum MP is a fixation device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This concept is relevant for AI algorithms, not for a physical fixation device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable, as no "ground truth" in the context of diagnostic accuracy is discussed for this physical device. The submission relies on demonstrating substantial equivalence in design, materials, and intended use as evidence of safety and effectiveness.
8. The sample size for the training set
- Sample size for training set: Not applicable, as this device is a physical medical device, not an AI or algorithmic system requiring a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary of available information from the provided text:
The provided document is a 510(k) summary, which aims to demonstrate that the new device (Magnum MP Fixation Device) is "substantially equivalent" to an already legally marketed predicate device (Magnum PI Knotless Fixation Device, K070227). The core argument is based on:
- Same intended use: "fixation of soft tissue to bone."
- Similar technical characteristics: The document states, "The Magnum MP design and technology is substantially equivalent to the existing Magnum PI Knotless Fixation Device." It also mentions "The materials are well characterized and have been used in predicate devices with similar indications."
- No new questions of safety or effectiveness: "The differences between the Magnum MP and the predicate device do not raise any questions regarding the safety and effectiveness of the implant."
In essence, the "study" for this 510(k) is the comparison and argument for substantial equivalence to a device already cleared by the FDA, rather than a de novo clinical or performance study with defined acceptance criteria and performance results for the new device.
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510(K) SUMMARY
ARTHROCARE CORPORATION MAGNUM M FIXATION DEVICE
General Information
Submitter Name/Address:
JUN 17 2009
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Laura N. Kasperowicz
May 19, 2009
Establishment Registration No .: 2951580
Contact Person:
Date Prepared:
Device Description
Trade Name: Device Model Name:
Magnum® MP Fixation Device
Sr. Manager, Regulatory Affairs
Generic/Common Name:
Bone Anchor, Fastener, Fixation, Soft Tissue
Classification Name:
Fastener, Fixation, Nondegradeable, Soft Tissue (Class II per 21 CFR 888.3040, Product code: MBI)
Predicate Devices Opus Magnum PI
K070227 (Cleared April 16, 2007)
Product Description
The Magnum MP device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
Indications For Use
The Magnum MP bone anchor 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, bicens 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
page vi
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510(K) SUMMARY
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 Magnum MP design and technology is substantially equivalent to the existing Magnum PI Knotless Fixation Device cleared by the Food and Drug Administration [K070227]. The differences between the Magnum MP 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 Magnum MP Fixation Device is substantially equivalent to the Magnum PI Knotless Fixation Device originally cleared under K070227.
page vii
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 17 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrocare Corporation % Ms. Laura N. Kasperowicz Senior Manager, Regulatory Affairs 15285 Alton Parkway, Suite 200 Irvine, California 92618
Re: K091503
Trade/Device Name: Magnum MP Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: MBI Dated: May 19, 2009 Received: May 21, 2009
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.
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
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Page 2 - Ms. Laura N. Kasperowicz
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson 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 STATEMENT
510(k) Number:
K091503
Device Name:
Magnum MP Fixation Device
Indications for Use:
The Magnum MP bone anchor 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 coilateral 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 AND/OR (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)
Soneta
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091503
§ 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.