(85 days)
No
The description focuses on the mechanical properties and intended use of a physical implant for soft tissue reattachment. There is no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is intended for soft tissue reattachment and repair in various joints, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is an implant designed for reattaching soft tissue to bone, serving a therapeutic purpose rather than a diagnostic one. Its intended use and description focus on surgical repair and fixation.
No
The device description clearly states the RC Tack is a "polymer implant" consisting of physical components (tip, sleeve, and pin) intended for surgical implantation. This is a hardware 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 reattachment to host bone" in specific anatomical locations (shoulder, knee, and ankle). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "polymer implant" designed for mechanical fixation of tissue to bone. This is a physical device used in surgery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used for repair within the body.
N/A
Intended Use / Indications for Use
The proposed RC Tack 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
Device Description
The RC Tack is a polymmer implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three components: a tip, sleeve, and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The RC Tack 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
Prescription Use (Per 21 CFR 801.109)
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: the ultimate holding strength of the proposed RC Tack was compared to Innovasive's currently marketed ROC EZ Suture Bone Fastener and the ConTack Fastener. The ConTack Fastener was chosen as a second comparison device because it tack soft tissue to bone, although its materials and design differ from the proposed RC Tack. The proposed RC Tack holding strength was greater than that of the predicate device and the ConTack Fastener, demonstrating substantially equivalent performance between the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for Innovative Devices. The logo consists of a large, stylized "A" formed by two overlapping triangles. To the right of the "A" is the word "INNOVASIVE" in a bold, italicized font. Below "INNOVASIVE" is the word "DEVICES" in a smaller, non-italicized font.
OCT 8 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 9, 1999
2. DEVICE:
Trade Name: RC Tack
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 Tack is a polymmer implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three components: a tip, sleeve, and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The RC Tack is a sterile single use device offered in one size, 4.5mm.
5. INTENDED USE:
The proposed RC Tack is intended for soft tissue reattachment to host bone for the following indications:
SHOULDER
1
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 Tack and the predicate ROC EZ Suture Bone Fastener implants utilize the same materials. Both devices also utilize the same method of bone fixation: radially expansion of the sleeve. Lastly, the indications being requested for the proposed RC Tack are already cleared for the 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 Tack was compared to Innovasive's currently marketed ROC EZ Suture Bone Fastener and the ConTack Fastener. The ConTack Fastener was chosen as a second comparison device because it tack soft tissue to bone, although its materials and design differ from the proposed RC Tack. The proposed RC Tack holding strength was greater than that of the predicate device and the ConTack Fastener, demonstrating substantially equivalent performance between the devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a staff with a serpent entwined around it, representing healing and medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT
Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices Incorporated 734 Forest Street Marlborough, Massachusetts 01752
Re: K992377 Trade Name: RC Tack Bone Anchor Product Code: MBI Regulatory Class: II Dated: July 9, 1999 Received: July 15, 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 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 (OS) 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. 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.
3
Page 2 Ms. Kathleen Morahan
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 at (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 Tack 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
Prescription Use
(Per 21 CFR 801.109)
besle
Division of General Restorative Device 510(k) Num