(136 days)
No
The 510(k) summary describes a physical implant (interference screw) used for surgical fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The submission is a Special 510(k) for a device modification, focusing on design control and performance testing of the physical device.
Yes
The device is described as an implant designed to fix soft tissue or bone-tendon-bone grafts during cruciate ligament reconstruction, which directly addresses a medical condition (ligament damage) to improve patient health.
No
This device is an interference screw used for the fixation of grafts during ligament reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a sterile, disposable implant designed to secure soft tissue to bone, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fixation of grafts during knee surgery. This is a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description clearly states it is a "sterile, disposable implant designed to secure soft tissue to bone." This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and structural within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
87 HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K990454, K993975, K993630, K002070
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, and |
| Cosmetic 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.
1
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.
2
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
3
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