(136 days)
The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
The provided text is a 510(k) summary for the Mitek Biocryl Interference Screws, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against defined acceptance criteria in the typical sense for a new, novel device.
Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, which are common for algorithms or diagnostic devices, is not applicable to this specific document as it describes a modification to an existing device type and relies on demonstrating equivalence through design control and performance testing, not clinical outcome studies.
Here's why and what information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification."
- This indicates that performance was assessed against internal design control requirements and validation tests, not external, publicly defined acceptance criteria with reported metrics like sensitivity/specificity. The focus is on demonstrating that the modified device performs as intended and is equivalent to the predicate devices.
2. Sample Size for Test Set and Data Provenance:
- Not Applicable. No explicit "test set" in the context of clinical data or algorithm evaluation is mentioned. The "performance testing" referenced would likely involve bench testing (e.g., mechanical strength, degradation properties) for the device modification. The sample size for such engineering tests is not provided in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This type of information is relevant for studies involving human interpretation or subjective assessment, typically with diagnostic algorithms or imaging. This document describes an orthopedic implant, not a diagnostic device requiring expert ground truth establishment in this manner.
4. Adjudication Method:
- Not Applicable. No adjudication method is described as there's no "ground truth" to adjudicate in the context of this device type and submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not a diagnostic device or an AI-assisted interpretation tool. Therefore, an MRMC study is irrelevant.
6. Standalone Algorithm Performance:
- Not Applicable. This is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used:
- Not Applicable. For a physical implant, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical properties demonstrated through various engineering tests and material analyses, not clinical outcomes in the same way an algorithm is evaluated. The document states validation testing and compliance with design controls were performed.
8. Sample Size for Training Set:
- Not Applicable. This is a physical implant, not an algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not Applicable. As above, it's not an algorithm requiring a training set and associated ground truth.
Summary of what is provided:
- Device Name: Mitek Biocryl Interference Screws
- Indication for Use: Fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
- Study/Basis for Equivalence: Special 510(k) submission based on device modification. Demonstrated substantial equivalence through:
- Certification of compliance to 21 CFR 820.30 Design Control requirements.
- Descriptions of Mitek's Design Control and Risk Analysis procedures.
- Results of validation testing (performance testing) for the device modification.
- Conclusion: Based on indications for use, technological characteristics, and comparison to predicate devices, substantial equivalence was shown.
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MAR 1 4 2002
October 26, 2001
510(k) Summary
Pursuant to $513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Products chooses to submit a summary of information respecting safety and effectiveness. According to $513(i)(3){B). "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the modified device, Mitek Biocryl Interference Screws is as follows:
| Trade Name: | Mitek Biocryl Interference Screws |
|---|---|
| Sponsor: | Mitek Products |
| 249 Vanderbilt Avenue | |
| Norwood, MA 02062 | |
| Registration #1221934 | |
| Device Generic Name: | Bone Fixation Screw |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
| Product Code: | 87 HWC |
| Predicate Devices: | K990454 Bio-Interference Screw |
| K993975 Absolute Absorbable Interference Screw | |
| K993630 BioLok®Screw | |
| K002070 BioLok® Screw |
Device Description: The device described in this 510(k) is sterile, disposable implant designed to secure soft tissue to bone. The Mitek Biocryl Interference Screws are indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
Safety and Performance:
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Mitek Biocryl Interference Screws have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
Ms. Christine Kuntz-Nassif Regulatory Affairs Project Manager Mitek® Products 249 Vanderbilt Avenue Norwood, MA 02062
Re: K013572 -
Trade/Device Name: Mitek Biocryl Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 11, 2002 Received: February 12, 2002
Dear Ms. Kuntz-Nassif:
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. Christine Kuntz-Nassif
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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). 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
Sincerely yours,
Sincerely yours,
O. Mark N. Milkeison
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
K013572 510(k) Number (if known):
Device Name: Mitek Biocryl™ Interference Screw
Indications for Use:
The Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or I ho Mick Droch I and I during cruciate ligament reconstruction surgeries of the knee
(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 General, Restorative
and Neurological Devices
510(k) Number K013572
| Labels | Values |
|---|---|
| Prescription Use | yes |
| Over-the-Counter Use | No |
(Per 21 CFR 801.109) OR
§ 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.