(483 days)
Not Found
No
The summary describes a mechanical fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Meniscal Fixation Device" intended for "fixation of longitudinal vertical meniscus (bucket handle) lesions," which directly treats a medical condition.
No
This device is a Meniscal Fixation Device, which is used for the physical fixation of meniscal lesions. It is a surgical implant designed to treat an injury, not to diagnose a condition.
No
The device description explicitly states it is an "arthroscopically implanted, cannulated, bioabsorbable (PLA) device" and mentions physical sizes (5 to 14 mm long), indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the BioDuct's Meniscal Fixation Device is an "arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture." This describes a device that is surgically placed within the body to repair tissue.
- Intended Use: The intended use is for "fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture." This is a surgical repair procedure, not a diagnostic test performed on a sample outside the body.
The device is an implantable surgical device used for tissue repair.
N/A
Intended Use / Indications for Use
BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.
Product codes (comma separated list FDA assigned to the subject device)
87 MAI
Device Description
BioDuct's Meniscal Fixation Device is an arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture, and is available in sizes ranging from 5 to 14 mm long. The Meniscal Fixation Device is designed to be placed between the synovium and a lesion located in less well vascularized (red-white) areas of the meniscus. Mechanical testing results indicate that the Meniscal Fixation Device, when used with suture (i.e. 5-0 Ethilon), improves the 3 month fixation strength of the lesion compared to trephination and suture (i.e. 5-0 Ethilon) alone as shown in the canine model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing results indicate that the Meniscal Fixation Device, when used with suture (i.e. 5-0 Ethilon), improves the 3 month fixation strength of the lesion compared to trephination and suture (i.e. 5-0 Ethilon) alone as shown in the canine model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002406, K991715, K980681, K955768, K003070, K983577
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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K053492 (pg 1 of 1)
510(k) Summary
| Trade Name: | Meniscal Fixation Device |
|---|---|
| Name of Sponsor: | BioDuct, LLC |
| 3201 Stellhorn Road | |
| Fort Wayne, Indiana, 46815. | |
| APR 12 2007 | |
| 510(k) Contact: | Herb Schwartz, Ph.D. |
| Telephone: (260) 407-6468 | |
| FAX: (260) 492-0452 | |
| Common Name: | Biodegradable soft tissue fixation device |
| Classification: | 21 CFR 888.3030 - Single/multiple component metallic bone |
| fixation appliances and accessories, Class II | |
| Product Code: | 87 MAI |
| Predicate Devices: | K002406 - DePuy Mitek RapidLoc™ Meniscal Repair System |
| K991715 - Linvatec BioStinger™ Meniscal Fixation System | |
| K980681 - Innovasive Devices Meniscal Screw | |
| K955768 - Bionx Biofix® Meniscus Arrow | |
| K003070 - Ethicon Ethibond Excel Suture | |
| K983577 - Arthrex Meniscal Dart System |
Indications for use:
BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.
Device Description:
BioDuct's Meniscal Fixation Device is an arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture, and is available in sizes ranging from 5 to 14 mm long. The Meniscal Fixation Device is designed to be placed between the synovium and a lesion located in less well vascularized (red-white) areas of the meniscus. Mechanical testing results indicate that the Meniscal Fixation Device, when used with suture (i.e. 5-0 Ethilon), improves the 3 month fixation strength of the lesion compared to trephination and suture (i.e. 5-0 Ethilon) alone as shown in the canine model.
Substantial Equivalence:
Based on similarities in indications, design and materials and the results of comparative testing, BioDuct's Meniscal Fixation Device is substantially equivalent to other biodegradable soft tissue fixation devices, including the predicates listed above,
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioDuct, LLC c/o Herb Schwartz, Ph.D. President 3201 Stellhorn Road Fort Wayne, Indiana 46815
APR 1 2 2007
Re: K053492
Trade/Device Name: BioDuct's Meniscal Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: February 20, 2007 Received: February 22, 2007
Dear Dr. Schwartz:
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
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Page 2 - Herb Schwartz, Ph.D.
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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Barbara Bachner
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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510(k) Number (if known): K053492
Device Name: BioDuct's Meniscal Fixation Device
Indications for Use:
BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of 1
Barbara Buchup
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K053492