(75 days)
Not Found
No
The device description focuses on the mechanical design and function of a suture bone fastener and associated instrumentation. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the reattachment of soft tissue to bone for various indications across multiple anatomical sites, which is a therapeutic intervention.
No
The device is a surgical fastener intended for the reattachment of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical implant (fastener) and associated surgical instruments (drill guide, deployment handle, hole finder), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the reattachment of soft tissue to bone for various orthopedic and surgical procedures. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a mechanical implant designed to be inserted into bone for fixation. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances in these samples for diagnostic purposes.
Therefore, the 3.5mm Metal ROC XS Suture Bone Fasteners are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3.5mm Metal ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
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 repair 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
BLADDER NECK SUSPENSION
Bladder neck suspension for female urinary incontinence due to urethral hypermobility
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The 3.5mm Metal 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 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 3.5mm Metal ROC XS 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
Shoulder, Knee, Ankle, Foot, Elbow, Bladder Neck
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)
Not Found
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, K981193, The 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener, K981193
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
JUN 1 6 1998
510(K) SUMMARY
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: March 31, 1998
2. DEVICE:
Innovasive 3.5mm Metal ROC XS Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices 3.5mm Metal ROC XS Suture Bone Fastener
3. PREDICATE DEVICES:
The predicate devices used to determine substantial equivalence for the modified Innovasive Devices 3.5mm Metal ROC XS Suture Bone Fastener were:
- The 3.5mm Innovasive Devices ROC XS Suture Bone Fastener, a. marketed by Innovasive Devices, Marlborough, MA, and
- b. The 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener marketed by Innovasive Devices, Marlborough, MA.
4. DEVICE DESCRIPTION:
The 3.5mm Metal 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 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.
1
The 3.5mm Metal ROC XS will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.
5. INTENDED USE:
The 3.5mm Metal ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
SHOULDER
KNEE
Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair
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 repair 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
BLADDER NECK SUSPENSION
Bladder neck suspension for female urinary incontinence due to urethral hypermobility
6. COMPARISON OF CHARACTERISTICS:
The existing Innovasive Devices 3.5mm ROC XS and 3.5mm ROC EZ Suture Bone Fasteners are comprised of plastic. The devices are used to secure a suture in a predrilled hole in bone. They remain fixed in the bone through radial compression as the device is deployed.
The proposed 3.5mm Metal ROC XS, as the name suggests, is made of stainless steel. The proposed Indications for Use are identical to those of the existing 3.5mm ROC EZ. As with the existing devices, the proposed 3.5mm Metal ROC XS will be offered with #2 Suture, both with and without stainless steel needles.
290
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three human profiles incorporated into its design.
్లాల్లో వైద్యశాల గ్రామం
నుండి 10 కి.మ
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Mr. Stephen M. Page Manager of Requlatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
Re: K981193 Innovasive 3.5 mm Metal ROC XS Suture Bone Fastener Regulatory Class: II Product Codes: MBI and HWC Dated: March 31, 1998 April 2, 1998 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. ದ 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 GMF 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.
3
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 Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener 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,
fu
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ার পর
4
INDICATIONS FOR USE
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
ﺔ ﺍﻟﻤﺘﺤﺪﺓ
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
BLADDER NECK SUSENSION -
Bladder neck suspension for female urinary incontinence due to urethral hypermobility.
Prescription Use
(Per 21 CFR 801.109)
241
A
(Division Sign-Off)
Division of
Division of General Restorative Devices 510(k) Number _ K9811
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