(83 days)
No
The provided text describes a mechanical suture anchor and its intended use and performance testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance study focuses on mechanical holding strength.
No
The device is an implant for tissue fixation, not a therapeutic device designed to treat a disease or condition through non-surgical means. It is used in surgical repair.
No
The device is an implantable anchor for soft tissue to bone fixation, used for repair and reconstruction, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "three-piece polymer implant assembled onto a delivery shaft" and is a "sterile, single use device," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue to bone fixation" in specific anatomical locations (shoulder, knee, ankle) for various repairs and reconstructions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "polymer implant assembled onto a delivery shaft" and is "delivered manually using a delivery handle." This describes a physical implant used in surgery.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The RC Multi-Suture Anchor is a surgical implant used in vivo (within the living body), not a test performed in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
The proposed RC Multi-Suture Anchor is intended for soft tissue reattachment to host bone for the following indications:
SHOULDER
Repair of rotator cuff tears Acromio-clavicular separation 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
Product codes
MBI, GAT
Device Description
The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knee, ankle
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
Bone Model Testing: the ultimate holding strength of the proposed RC Multi-Suture Anchor was compared to the currently marketed ROC EZ Suture Bone Fastener. The holding strength of the proposed RC Multi-Suture Anchor was greater than that of the predicate device, demonstrating substantially equivalent performance between the devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the number '9'. The sequence continues with the numbers '92458'.
Image /page/0/Picture/1 description: The image shows the logo for Innovative Devices. The logo consists of two triangles that are connected at the base. The word "INNOVASIVE" is written in bold, sans-serif font to the right of the triangles. The word "DEVICES" is written in a smaller, sans-serif font below the word "INNOVASIVE".
OCT 1 4 1999
510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Fax: 508-460-6661
Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: July 2, 1999
2. DEVICE:
Trade Name: RC Multi-Suture Anchor
Common Name: Bone Anchor
Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"
3. PREDICATE DEVICE:
The Innovasive ROC EZ Suture Bone Fastener (K970089, K971922).
4. DEVICE DESCRIPTION:
The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.
5. INTENDED USE:
The proposed RC Multi-Suture Anchor is intended for soft tissue reattachment to host bone for the following indications:
1
SHOULDER
Repair of rotator cuff tears Acromio-clavicular separation 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
6. COMPARISON OF CHARACTERISTICS:
The proposed RC Multi-Suture Anchor utilizes the same materials as the predicate ROC EZ Suture Bone Fastener and the same method of bone fixation. The indications being requested for the proposed RC Multi-Suture Anchor are cleared for the predicate ROC EZ Suture Bone Fastener.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
Bone Model Testing: the ultimate holding strength of the proposed RC Multi-Suture Anchor was compared to the currently marketed ROC EZ Suture Bone Fastener. The holding strength of the proposed RC Multi-Suture Anchor was greater than that of the predicate device, demonstrating substantially equivalent performance between the devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Ms. Kathleen Morahan Requlatory Affairs Specialist Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
Re: K992458 RC Multi-Suture Bone Anchor Regulatory Class: II Product Codes: MBI and GAT Dated: July 19, 1999
Received: July 23, 1999
Dear Ms. Morahan:
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. ਸਿ 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 requlations.
3
Page 2 - Ms. Kathleen Morahan
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,
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
4
INDICATIONS FOR USE
The RC Multi-Suture Anchor is intended for soft tissue to bone fixation for the following indications:
SHOULDER
Repair of rotator cuff tears Acromio-clavicular separation 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
bicolede
Division ivision of General Restorative De 510(k) Numb
Prescription Use J (Per 21 CFR 801.109)