(73 days)
No
The device description and performance studies focus on a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for arthroscopic fixation of meniscus lesions, which directly treats a medical condition.
No
The device is a system for arthroscopic fixation of meniscus lesions, indicating it is a therapeutic or surgical device, not a diagnostic one.
No
The device description clearly details a physical implant (cylindrical shaft with barbs and a T-shaped head) and associated physical application instruments made of medical grade stainless steel. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the arthroscopic fixation of meniscus lesions. This is a surgical procedure performed directly on the patient's body to repair damaged tissue.
- Device Description: The device is a physical implant (an arrow) designed to hold tissue in place. It is used with surgical instruments for implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with biological specimens for diagnostic purposes.
The information clearly describes a surgical implant used for therapeutic purposes, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., "red-red" and "red-white" area) in conjunction with appropriate immobilization.
Product codes
Not Found
Device Description
The BIOFIX® Meniscus Arrow consists of a cylindrical shaft with barbs in one end and a T-shaped head at the other end. The barbs assure that the shaft is kept in place in the capsule and the peripheral part of the meniscus, while the T-shaped head keeps the loose part of the meniscus in close proximity to the periphery. The device has a shaft diameter of 1.1 mm and is available in lengths of 10 mm, 13 mm, and 16 mm. The dimensions of the T-shaped head are 1.0 mm x 1.1 mm x 3.5 mm. A specially designed set of application instruments, made of medical grade stainless steel, are required for implantation of BIOFIX® Meniscus Arrows. The set consists of six cannulae, a blunt obturator a small drill or needle, and a piston.
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
Nonclinical Testing: Mechanical testing was carried out to determine the initial separation force between the head and shaft of the arrow and the initial pull-out force of the barbs on the arrow shaft, and these same properties under in vitro hydrolytic conditions that simulate the hydrolytic degradation of the BIOFIX® Meniscus Arrow in vivo.
Clinical Testing: Study type: prospective, randomized, controlled trial. Sample size: 34 patients were enrolled in each treatment group (BIOFIX® Meniscus Arrow group and suture group). Results: Of the 32 patients in the BIOFIX® Meniscus Arrow group for whom 12-week healing assessment results were available, 26 were found to have healed lesions, three to have partially healed, stable lesions, two to have partially healed, unstable lesions, and one to have an unhealed lesion. Of the 31 patients in the suture group for whom 12-week healing assessment results were available, 17 were found to have healed lesions, seven to have partially healed, stable lesions, two to have partially healed, unstable lesions, and five to have an unhealed lesion. When the "healed" versus "not healed" results were grouped, there was a statistically significant difference in favor of the BIOFIX® Meniscus Arrow group (p == 0.032). Knee function scores were comparable in the two groups at each assessment (12 week, six month, and one year visits). Patients rated their status as "excellent," "acceptable," or "unacceptable." There were no significant differences in the number of excellent or acceptable assessments at any visit in the two groups, nor in the number of unacceptable assessments. No deep or superficial infections related to meniscal repair in the BIOFIX® Meniscus Arrow group, nor were there any serious neurological problems. There were two deep infections in the suture group and two cases of superficial infection related to meniscal repair in the suture group; no serious neurological problems were reported in this group. Key results: operative time was considerably less, more lesions were healed 12 weeks postoperatively, and there were fewer meniscal repair-related complications in the BIOFIX® Meniscus Arrow group than in the suture group, while functional results were comparable.
Key Metrics
p == 0.032 for healed vs. not healed results between groups.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1955763
MAR - 4 1996
K 455X8
510(k) SUMMARY
BIOSCIENCE, INC. BIOFIX® Biodegradable Meniscus Arrow System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910 as Regulatory Counsel to Bioscience, Inc.
Contact Person: same as above
Date Prepared: December 20, 1995
Name of Device and Name/Address of Sponsor
BIOFIX® Biodegradable Meniscus Arrow System
Bioscience, Inc. 279 B Great Valley Parkway Malvern, PA 19355
Classification Name
Bioabsorbable orthopedic fixation device
Predicate Devices
- Davis & Geck Maxon Monofilament Polyglyconate Synthetic Absorbable Surgical Sutures (PMA G840051) (Maxon sutures)
Acufex Microsurgical, Inc. T-Fix Suture Bar (K925573) and implantation instruments (K942442) (T-Fix Meniscus Fixation System)
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Intended Use
The BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., "red-red" and "red-white" area) in conjunction with appropriate immobilization.
Technological Characteristics and Substantial Equivalence
BIOFIX® Meniscus Arrows are bioabsorbable orthopedic fixation devices composed of self-reinforced poly-L-lactide (SR-PLLA). They possess physical and chemical properties necessary for secure fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., "red-red" and "red-white" area) in combination with suitable immobilization. The surgically implanted BIOFIX® Meniscus Arrows lose strength over 20 to 50 weeks in vivo; within a corresponding period of time, the meniscus rupture is healed. The implant material degrades by hydrolysis rather than by enzymatic action. The degradation product is lactic acid, a normal body metabolite, that is readily eliminated as carbon dioxide during respiration.
The BIOFIX® Meniscus Arrow consists of a cylindrical shaft with barbs in one end and a T-shaped head at the other end. The barbs assure that the shaft is kept in place in the capsule and the peripheral part of the meniscus, while the T-shaped head keeps the loose part of the meniscus in close proximity to the periphery. The device has a shaft diameter of 1.1 mm and is available in lengths of 10 mm, 13 mm, and 16 mm. The dimensions of the T-shaped head are 1.0 mm x 1.1 mm x 3.5 mm. A specially designed set of application instruments, made of medical grade stainless steel, are required for implantation of BIOFIX® Meniscus Arrows. The set consists of six cannulae, a blunt obturator a small drill or needle, and a piston.
The BIOFIX® Meniscus Arrow System is substantially equivalent to two predicate devices: (1) Davis & Geck's Maxon sutures, approved under PMA
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G840051; and (2) Acufex Microsurgical's T-Fix Suture Bar and implantation instruments (T-Fix Meniscus Fixation System), cleared under K925573 and K942442. The BIOFIX® Meniscus Arrow System is substantially equivalent to these predicate devices in that its intended use is a use subsumed within the broader indication of the Maxon sutures for soft tissue approximation and within the broader indication of the T-Fix Meniscus Fixation System for meniscal repair, and in that BIOFIX® Meniscus Arrows and its predicate devices are designed to stabilize the meniscus during the healing period.
The BIOFIX® Meniscus Arrow System, like the two predicate devices, uses standard arthroscopic portals for implantation. Both the BIOFIX® Meniscus Arrow System and the T-Fix Meniscus Fixation System are implanted with precise delivery instruments. Both BIOFIX® Meniscus Arrows and Maxon sutures are absorbed by the body, unlike the T-Fix device which is permanent unless removal is necessary because of an adverse situation.
BIOFIX® Meniscus Arrows, like the predicate devices, are supplied sterile and require good surgical technique and proper postoperative immobilization.
Although there are some differences in materials and implantation instruments and technique between the BIOFIX® Meniscus Arrows and its predicate devices, no new issues of safety and efficacy have been raised.
Nonclinical and Clinical Testing
Nonclinical Testing
Mechanical testing was carried out to determine the initial separation force between the head and shaft of the arrow and the initial pull-out force of the barbs on the arrow shaft, and these same properties under in vitro hydrolytic conditions that simulate the hydrolytic degradation of the BIOFIX® Meniscus Arrow in vivo. These results and the results of the clinical study described below demonstrated that the arrows possess sufficient strength for the period needed for healing and stabilization of the fixation site.
3
Clinical Testing
Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) with BIOFIX® Meniscus Arrows was compared in a prospective, randomized, controlled trial to inside-out arthroscopic suturing with the Acufex Double Barrel System using Maxon-0 sutures. Patients returned for evaluation at two weeks, five weeks, nine weeks, 12 weeks, six months, and at one year following surgery. Complete healing was defined as healing in the full length of the former rupture, while partial healing was defined as a residual rupture of less than 10 mm in an otherwise stable meniscus.
Thirty-four patients were enrolled in each treatment group. Of the 32 patients in the BIOFIX® Meniscus Arrow group for whom 12 week healing assessment results were available, 26 were found to have healed lesions, three to have partially healed, stable lesions. two to have partially healed, unstable lesions, and one to have an unhealed lesion. Of the 31 patients in the suture group for whom 12 week healing assessment results were available, 17 were found to have healed lesions, seven to have partially healed, stable lesions, two to have partially healed, unstable lesions, and five to have an unhealed lesion. Results were also analyzed for each treatment group by length of tear, distance from joint capsule to lesion, and operative location of meniscal tear. When the "healed" versus "not healed" results were grouped, there was a statistically significant difference in favor of the BIOFIX® Meniscus Arrow group (p == ().032).
Knee function scores were analyzed for each treatment group at the 12 week, six month, and one year visits; scores were comparable in the two groups at each assessment. In addition, patients evaluated their own status at the follow-up visits and rated their status as "excellent," "acceptable," or "unacceptable." There were no significant differences in the number of excellent or acceptable assessments at any visit in the two groups, nor in the number of unacceptable assessments.
4
There were no deep or superficial infections related to meniscal repair in the BIOFIX® Meniscus Arrow group, nor were there any serious neurological problems. There were two deep infections in the suture group and two cases of superficial infection related to meniscal repair in the suture group; no serious neurological problems were reported in this group.
In summary, BIOFIX® Meniscus Arrows were shown to be at least as good as sutures in the treatment of bucket-handle lesions. In this study, operative time was considerably less, more lesions were healed 12 weeks postoperatively, and there were fewer meniscal repair-related complications in the BIOFIX® Meniscus Arrow group than in the suture group, while functional results were comparable.
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