(88 days)
The 3.5mm Innovasive Devices ROC XS Suture Bone Fastener, The 1.9mm/2.3mm Innovasive Devices ROC Suture Bone Fastener, The 1.8mm Mitek Mini Anchor
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a suture bone fastener, with no mention of AI or ML technologies.
Yes
The device is a surgical implant intended to reattach soft tissue to bone for various orthopedic conditions, which is a therapeutic purpose.
No
The device description indicates that the ROC XS Suture Bone Fasten`ers are implants used for surgical reattachment of soft tissue to bone, making them therapeutic devices, not diagnostic ones. Its purpose is to fix issues, not to identify or diagnose them.
No
The device description clearly details physical components like a shear pin, crown, anvil, drill, drill guide, deployment handle, and hole finder, which are hardware.
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, 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 clearly states that this device is a suture bone fastener intended for the reattachment of soft tissue to bone in various anatomical locations (ankle, hand, wrist, foot, elbow). It is a surgical implant used directly within the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical, providing fixation within the bone.
Therefore, based on the provided information, the 2.3mm ROC XS Suture Bone Fasteners are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 2.3mm ROC XS 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 XS suture bone fastener implant tip portion consists of a shear pin, crown and anvil. The crown and anvil are fitted onto the shear pin component such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during the device deployment, the anvil forces it open. The anvil is tapered such that it will fit into the crown component as the deployment action progresses. As the crown is forced open by the anvil, the crown expands to make contact with the surrounding bone. This expanding crown results in the final fixation properties of the device. Once the anvil is completely seated inside the crown, 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 a 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. 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
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)
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 XS 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 XS 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.
The 3.5mm Innovasive Devices ROC XS Suture Bone Fastener, The 1.9mm/2.3mm Innovasive Devices ROC Suture Bone Fastener, The 1.8mm Mitek Mini Anchor
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
SEP 2 6 1997
510(K) SUMMARY
K9 72436
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 27, 1997
2. DEVICE:
Innovasive 2.3mm ROC XS Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC XS Suture Bone Fastener
3. PREDICATE DEVICES:
The predicate devices used to determine substantial equivalence for the modified Innovasive Devices 2.3mm ROC XS Suture Bone Fastener were:
- The 3.5mm Innovasive Devices ROC XS 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 XS suture bone fastener implant tip portion consists of a shear pin, crown and anvil. The crown and anvil are fitted onto the shear pin component such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during the device deployment, the anvil forces it open. The anvil is tapered such that it will fit into the crown component as the deployment action progresses. As the crown is forced open by the anvil, the crown expands to make contact with the surrounding bone. This expanding crown results in the final fixation properties of the device. Once the anvil is completely seated inside the crown, 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 a 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. Both sutured and sutureless versions will be marketed.
5. INTENDED USE:
t
The 2.3mm ROC XS 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 3.5mm ROC XS Suture Bone Fastener components are comprised of 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.
20151
2
The 2.3mm ROC XS device incorporates the same design as the existing 3.5mm ROC XS. The only differences are the size (2.3mm) and the material composition of the anvil (polysulfone). As with the predicate device, the 2.3mm ROC XS uses a crown and anvil fitted on a shear pin such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during device deployment, the anvil forces it open. 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 XS 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 XS Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate devices.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen M. Page Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street Marlborough, Massachusetts 01752
EP 26 1997
K972438 Re: Innovasive 2.3mm ROC™ XS Suture Bone Anchor Regulatory Class: II Product Code: MBI June 27, 1997 Dated: Received: June 30, 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 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 General regulation (21 CFR Part 820) and that, Devices: 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 requlations.
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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
P
Enclosure
5
INDICATIONS FOR USE
ANKLE
Lateral instability Medial instability Medial inistability
Achilles tendon reconstruction and repair Midfoot reconstructions
HAND
HAND
Ulnar or lateral collateral ligament reconstruction
WRIST
WKIST
Scapholunate ligament reconstruction
FOOT Hallux valgus reconstruction
ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs
bioll
Division Sign-Off
(Division Sign-Off) Division of General Restorative I 510(k) Number
Prescription Use Prescription -----------------------------------------------------------------------------------------------------------------------------------------------------------------
000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000