(62 days)
Not Found
Not Found
No
The device description focuses on mechanical components and their function for tissue reattachment to bone. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies are based on mechanical strength testing.
Yes
The device is described as an implantable fastener intended for the reattachment of soft tissue to bone, serving a therapeutic purpose by repairing injuries.
No
The device, ROC EZ Suture Bone Fasteners, is described as an implant for reattaching soft tissue to bone and is used in surgical procedures, not for diagnosing conditions.
No
The device description clearly details physical components like a shear pin, expander, sleeve, drill, drill guide, obturator, deployment handle, and hole finder, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reattachment of soft tissue to bone for various orthopedic indications (ankle, hand, wrist, foot, elbow). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (suture bone fastener) and associated surgical instruments (drill, drill guide, obturator, deployment handle, hole finder). These are used to perform a surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The 2.3mm ROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
ANKLE
- Lateral instability
- Medial instability
- Achilles tendon reconstruction and repair
- Mid-foot reconstructions
HAND
- Ulnar or lateral collateral ligament reconstruction
WRIST
- Scapholunate ligament reconstruction
FOOT
- Hallux valgus reconstruction
ELBOW
- Tennis elbow repair
- Biceps tendon reattachment
- Medial and lateral repairs
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The ROC 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, 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
Ankle, Hand, Wrist, Foot, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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 devices. The Innovasive 2.3mm ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices.
- Cadaver testing: Comparison of the ultimate holding strength in cadaver compared to the predicate device. Again, the Innovasive 2.3mm ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices.
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.
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
§ 888.3040 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
510(K) SUMMARY
AUG 26 1997
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: June 20, 1997
2. DEVICE:
Innovasive 2.3mm ROC EZ Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC EZ Suture Bone Fastener
3. PREDICATE DEVICES:
The predicate devices used to determine substantial equivalence for the modified Innovasive Devices 2.3mm ROC EZ Suture Bone Fastener were:
- The 2.8mm/3.5mm Innovasive Devices ROC EZ Suture Bone Fastener, a. marketed by Innovasive Devices, Marlborough, MA,
- The 1.9mm/2.3mm Innovasive Devices ROC Suture Bone Fastener b. marketed by Innovasive Devices, Marlborough, MA, and
- The 1.8mm Mitek Mini Anchor marketed by Mitek Products, 60 Glacier C. Drive, Westwood, MA.
4. DEVICE DESCRIPTION:
The ROC 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, 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 2.3mm ROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
ANKLE
-
Lateral instability
-
Medial instability
-
Achilles tendon reconstruction and repair
-
Mid-foot reconstructions
HAND
- Ulnar or lateral collateral ligament reconstruction
WRIST
- Scapholunate ligament reconstruction
FOOT
- Hallux valgus reconstruction
ELBOW
-
Tennis elbow repair
-
Biceps tendon reattachment
-
Medial and lateral repairs
6. COMPARISON OF CHARACTERISTICS:
The existing Innovasive Devices 2.8mm/3.5mm 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.
2
The 2.3mm ROC EZ device incorporates the same design and materials as the existing 2.8mm/3.5mm ROC EZ. The only difference is the size. As with the predicate device, the 2.3mm ROC 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 devices. The Innovasive 2.3mm ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices.
-
- Cadaver testing: Comparison of the ultimate holding strength in cadaver compared to the predicate device. Again, the Innovasive 2.3mm ROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
. . . .
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen M. Page Manager of Requlatory Affairs · Innovasive Devices, Inc. 734 Forest Street Marlborough, Massachusetts 01752
AUG 26 1097
Re: K972356 Innovasive 2.3mm ROC™ EZ Suture Bone Fastener Regulatory Class: II Product Code: MBI Dated: June 20, 1997 Received: June 25, 1997
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ 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.
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 requlation (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,
C. Sheldon M. Kuitjen Ph.D., M.
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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INDICATIONS FOR USE
ANKLE
Lateral instability Medial instability Achilles tendon reconstruction and repair Midfoot reconstructions
HAND
Ulnar or lateral collateral ligament reconstruction
WRIST Scapholunate ligament reconstruction
FOOT Hallux valgus reconstruction
ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs
Prescription Use
(Per 21 CFR 801.109)
to coello
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_Ka7 235