(304 days)
Not Found
Not Found
No
The description focuses on the mechanical design and performance of a surgical implant for meniscal repair, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the "repair of meniscal tears," which directly treats a medical condition.
No
Explanation: The device is described as a system for repairing meniscal tears, focusing on physical implantation and comparison of pull-out forces, which are characteristics of a therapeutic or surgical device, not a diagnostic one.
No
The device description clearly describes a physical medical device (Arthrex Meniscal Dart System) used for surgical repair of meniscal tears, comparing its physical characteristics and performance (pull-out force) to other physical devices (Bionx Arrow). There is no mention of software as the primary or sole component.
Based on the provided text, the Arthrex Meniscal Dart System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "repair of meniscal tears." This is a surgical procedure performed directly on the patient's tissue.
- Device Description: The description details a physical device designed for implantation into the meniscus to fix tears. It discusses mechanical properties like pull-out force and comparison to other fixation devices.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or calibrators.
The Arthrex Meniscal Dart System is a surgical implant used for the mechanical repair of damaged tissue within the body. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Meniscal Dart System is intended for the repair of meniscal tears that would otherwise be considered for standard repair using suture
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The meniscus aids in load transmission, shock absorption, and joint lubrication, as well as contributing to joint stability. As such, it is desirable to keep the meniscus intact. In the past, a partial meniscectomy was the treatment of choice; however, more recently, instead of removing the damaged or detached meniscal tissue, various suturing techniques have been utilized to repair it. In order to for this to be successful, though, the tear must exist in a vascular region ("red-red" and "red-white").
A majority of meniscal tears occur in the posterior horn of the meniscus. Meniscal suturing in this region increases the risk of neurovascular complications, including saphenous and peroneal nerve and popliteal injury. In this case, due to concerns with needle placement, all inside meniscal fixation devices provide a safe alternative.
The meniscal fixation device of choice at the moment is the Bionx Arrow. It has barbs to secure the tissue and a "T" head that rests on top of the meniscus. Studies have shown that the Arrow performs similar to suture depending on the chosen technique, horizontal vs. vertical (Albrecht-Olsen et al., 1997). Although the vertical suture method is superior to using a horizontal method or meniscal fixation device, according to Albrecht-Olsen et al. this technique may be difficult to use when space is limited as is the case for the location of many bucket-handle lesions.
Additional testing was performed comparing the Arthrex Mensical Dart to the Bionx Arrow. Three repair locations were tested, medial posterior and lateral central. There were no significant differences between the Dart and the Arrow for the average pull-out force of all repair locations combined. Furthermore, when comparing the results for the medial posterior location (i.e. the area most commonly associated with meniscal tears), the Dart had the same average pull-out (30 N) as the Arrow and a smaller standard deviation.
With respect to pull-out, all but one Arrow pulled out at the pointed end, whereas the Darts pulled out at both the pointed end and the flat end. This is to be expected considering the fact that the Arrow has a "T" head design. However, since the "T" head sits proud on the meniscus, there is the increased potential for damage to femoral condyle articular cartilage. In order to eliminate this concern, the Arthrex device does not have a head and is implanted flush with the surface of the meniscus.
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)
Additional testing was performed comparing the Arthrex Mensical Dart to the Bionx Arrow. Three repair locations were tested, medial posterior and lateral central. There were no significant differences between the Dart and the Arrow for the average pull-out force of all repair locations combined. Furthermore, when comparing the results for the medial posterior location (i.e. the area most commonly associated with meniscal tears), the Dart had the same average pull-out (30 N) as the Arrow and a smaller standard deviation.
With respect to pull-out, all but one Arrow pulled out at the pointed end, whereas the Darts pulled out at both the pointed end and the flat end. This is to be expected considering the fact that the Arrow has a "T" head design. However, since the "T" head sits proud on the meniscus, there is the increased potential for damage to femoral condyle articular cartilage. In order to eliminate this concern, the Arthrex device does not have a head and is implanted flush with the surface of the meniscus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pull-Out (overall)
Pull-Out (medial posterior)
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.
Not Found
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.
0
510(k) Summary
10/5/98
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. Durlacher |
| Director of Regulatory Affairs and Quality Assurance (ext. 117) | |
| Trade Name: | Arthrex Meniscal Dart System |
| Trade Name: | Arthrex Meniscal Dart System |
| Common Name: | NA |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
Description:
The meniscus aids in load transmission, shock absorption, and joint lubrication, as well as contributing to joint stability. As such, it is desirable to keep the meniscus intact. In the past, a partial meniscectomy was the treatment of choice; however, more recently, instead of removing the damaged or detached meniscal tissue, various suturing techniques have been utilized to repair it. In order for this to be successful, though, the tear must exist in a vascular region ("red-red" and "red-white").
A majority of meniscal tears occur in the posterior horn of the meniscus. Meniscal suturing in this region increases the risk of neurovascular complications, including saphenous and peroneal nerve and popliteal injury. In this case, due to concerns with needle placement, all inside meniscal fixation devices provide a safe alternative.
The meniscal fixation device of choice at the moment is the Bionx Arrow. It has barbs to secure the tissue and a "T" head that rests on top of the meniscus. Studies have shown that the Arrow performs similar to suture depending on the chosen technique, horizontal vs. vertical (Albrecht-Olsen et al., 1997). Although the vertical suture method is superior to using a horizontal method or meniscal fixation device, according to Albrecht-Olsen et al. this technique may be difficult to use when space is limited as is the case for the location of many bucket-handle lesions.
Additional testing was performed comparing the Arthrex Mensical Dart to the Bionx Arrow. Three repair locations were tested, medial posterior and lateral central. There were no significant differences between the Dart and the Arrow for the average pull-out force of all repair locations combined. Furthermore, when comparing the results for the medial posterior location (i.e. the area most commonly associated with meniscal tears), the Dart had the same average pull-out (30 N) as the Arrow and a smaller standard deviation.
With respect to pull-out, all but one Arrow pulled out at the pointed end, whereas the Darts pulled out at both the pointed end and the flat end. This is to be expected considering the fact that the Arrow has a "T" head design. However, since the "T" head sits proud on the meniscus,
1
there is the increased potential for damage to femoral condyle articular cartilage. In order to eliminate this concern, the Arthrex device does not have a head and is implanted flush with the surface of the meniscus.
Intended Use:
The Arthrex Meniscal Dart System is intended for the repair of meniscal tears that would otherwise be considered for standard repair using suture
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
The material for the Meniscal Dart, Poly (L,DL-Lactide), has undergone extensive in-vitro and in-vivo testing. Further evaluation of the material was conducted by Claes et. al. ("New bioresorbable pin for the reduction of small bony fragments: design, mechanical properties and in vitro degradation" - Biomaterials, 1996, Vol. 17 No. 16).
A substantial equivalence comparison is given in Table A. The Arthrex Meniscal Dart System is as safe and effective as the predicate device. Furthermore, it does not raise any different questions regarding safety and effectiveness from the predicate device.
162
2
| Company | Device | Material | Size(s) | Insertion | Pull-Out
(overall) | Pull-Out
(medial posterior) |
|-----------------------|---------------|-----------------------------|--------------------------------------------|-----------|-----------------------|--------------------------------|
| Arthrex | Meniscal Dart | Poly (L, DL-lactide) | Diameter: 1.3 mm
Length: 10, 12, 14 mm | Impact | 24.9 lbs. | 29.9 lbs. |
| Bionx | Arrow | Poly-L-lactide
(SR-PLLA) | Diameter: 1.1 mm
Length: 10, 13, 16 mm | Impact | 33.3 lbs. | 30.9 lbs. |
| Innovasive
Devices | Clearfix | Poly-L-lactide | Diameter: unknown
Length: 10, 11, 13 mm | Screw | unkown | unkown |
(9))
:
Table A: Substantial Equivalence Comparison
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 1999
Mr. Vernon Brown Manager of Regulatory Affairs Arthrex, Incorporated 2885 South Horseshoe Drive Naples, Florida 34104
Re: K983577
Trade Name: Arthrex Meniscal Dart System Regulatory Class: II Product Code: MAI Dated: August 4, 1999 Received: August 5, 1999
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may. therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Vernon Brown
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical tool, possibly scissors. The logo is simple and professional, and it is likely used to represent the company's brand.
Indications for Use
The Arthrex Meniscal Dart System is intended for the repair of meniscal tears that would otherwise be considered for standard repair using suture
Prescription Use
(Per 21 CFR 801.109)
eep
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Islon Sign-Off) on of General Restorative Devices 48 35 510(k) Number