(163 days)
Not Found
Not Found
No
The device description focuses on mechanical components and their interaction for fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for the reattachment of soft tissue to bone for various orthopedic indications, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a bone fastener intended for the reattachment of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components like fasteners, drills, guides, and handles, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical implant used to reattach soft tissue to bone. It is a physical device inserted into the body during a surgical procedure.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical fixation within the body.
Therefore, based on the provided information, the BioROC EZ Suture Bone Fastener is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 2.8mm and 3.5mm BioROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
SHOULDER
- Repair of rotator cuff tears 1.
- Capsular instability 2.
- Slap lesion repair 3.
- Acromio-clavicular separation 4.
- Capsule shift/capsulolabral reconstruction.
- Biceps tenodesis.
- Deltoid repair 7.
KNEE
- Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, posterior oblique ligament, joint capsule closure.
- Patellar ligament and tendon avuision repairs. 2.
-
- Extra-capsular reconstruction, ITB tenodesis
ANKLE
-
- Lateral instability
- Medial instability 2.
-
- Achilles tendon reconstruction and repair
-
- Mid-foot reconstructions
FOOT
-
- Hallux valgus reconstruction
ELBOW
-
- Tennis elbow repair
- Biceps tendon reattachment 2.
- Medial and lateral repairs 3.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The BioROC EZ suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.
In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.
The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
SHOULDER, KNEE, ANKLE, FOOT, ELBOW
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)
- Bone Model Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive BioROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
- Animal Testing: The testing demonstrated the efficacy of the Innovasive BioROC EZ Suture Bone Fastener and confirmed that the device functions adequately to meet its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
510(K) SUMMARY
g73381
FEB 1 8 1998
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: December 10, 1997
2. DEVICE:
Innovasive 2.8mm and 3.5mm BioROC EZ Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices BioROC EZ Suture Bone Fastener
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the Innovasive Devices BioROC EZ Suture Bone Fastener were (1) the 2.8mm and 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener marketed by Innovasive Devices, Marlborough, MA, and (2) the Bio-Anchor marketed by Linvatec, Largo, FL.
4. DEVICE DESCRIPTION:
The BioROC EZ suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.
1
In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.
The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
5. INTENDED USE:
The 2.8mm and 3.5mm BioROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
SHOULDER
- Repair of rotator cuff tears 1.
- Capsular instability 2.
- Slap lesion repair 3.
- Acromio-clavicular separation 4.
- Capsule shift/capsulolabral reconstruction ડ.
- Biceps tenodesis ર્.
- Deltoid repair 7.
KNEE
- Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, ﻨﺴ posterior oblique ligament, joint capsule closure.
- Patellar ligament and tendon avuision repairs. 2.
-
- Extra-capsular reconstruction, ITB tenodesis
ANKLE
-
- Lateral instability
- Medial instability 2.
-
- Achilles tendon reconstruction and repair
-
- Mid-foot reconstructions
FOOT
-
- Hallux valgus reconstruction
ELBOW
-
- Tennis elbow repair
- Biceps tendon reattachment 2.
- Medial and lateral repairs 3.
2
6. COMPARISON OF CHARACTERISTICS:
The existing Innovasive Devices ROC EZ Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure a suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.
The BioROC EZ device is comprised of L-PLA. As with the predicate device, the BioROC EZ uses an expander fitted on a shear pin which is drawn up into an expandable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
-
- Bone Model Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive BioROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
-
- Animal Testing: The testing demonstrated the efficacy of the Innovasive BioROC EZ Suture Bone Fastener and confirmed that the device functions adequately to meet its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Mr. Stephen M. Page Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
K973381 Re: Innovasive 2.8mm and 3.5mm Trade Name: BioROC™ EZ Suture Bone Fastener Regulatory Class: II MAI and HWC Product Code: Dated: December 10, 1997 December 11, 1997 Received:
Dear Mr. Page:
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 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 (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 In addition, FDA may publish further announcements action. 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.
4
Page 2 - Mr. Stephen M. Page
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,
a M. Witten, Ph.D., M.D. Celli Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE 2.8mm/3.5mm BioROC EZ
SHOULDER
- Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair
KNEE
Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis.
ANKLE
Lateral and medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions.
FOOT
Hallux valgus reconstruction
ELBOW
Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs
Prescription Use
(Per 21 CFR 801.109)
colefo
(Division Sign-On)
Division of General Restorative Devices
510(k) Number K97338/