(20 days)
Not Found
No
The device description and intended use clearly describe a mechanical suture anchor and associated instruments, with no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a suture anchor used for fixation of soft tissue to bone, which is a structural component for repair, not a device that provides therapy for a disease or condition.
No
The device is a suture anchor used for fixation of soft tissue to bone in various surgical procedures, not for diagnosing medical conditions.
No
The device description clearly describes a physical, implantable suture anchor made of titanium, along with associated hardware for delivery and implantation. It is not a software-only device.
Based on the provided information, the Titan Ti Suture Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device for fixing suture to bone during surgical procedures in various anatomical locations. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implantable device (suture anchor) and its delivery system. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. There is no mention of diagnostic testing, laboratory procedures, or providing diagnostic information.
Therefore, the Titan Ti Suture Anchor is a surgical device, specifically a suture anchor, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps . Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, . Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, 트 Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament ■ Reconstruction, Radial Collateral Ligament Reconstruction;
- 트 Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- 트 Hip: Capsular Repair, Acetabular Labral Repair
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, hip, knee, hand/wrist, 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)
Efficacy of the device was shown in cadaver shoulder bone. The proposed system is safe and effective as the predicate device.
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.
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
K101/84.
510(k) Summary
ArthroCare Corporation Titan™ Ti Suture Anchor System
MAY 1 8 2010
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
2951580
April 27, 2010
Valerie Defiesta-Ng Director, Regulatory Affairs
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
5.5/6.5mm Titan Ti Suture Anchor Titan Bone Punch Titan Removal Tool Driver Titan Removal Tool Capture Sleeve
Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)
Class II, 21 CFR 888.3040 Product Code MBI and HWC
Predicate Devices
Arthrocare Titan Ti Suture Anchor
K092133 (November 5, 2009)
Product Description
The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor.
Intended Uses/Indications for Use
The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
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1
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps . Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, . Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, 트 Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament ■ Reconstruction, Radial Collateral Ligament Reconstruction;
- 트 Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- 트 Hip: Capsular Repair, Acetabular Labral Repair
Substantial Equivalence
The Titan Ti Suture Anchor design and technology is identical to the existing Titan Ti Suture Anchor devices cleared in K092133. The addition of ancillary instruments does not raise new questions regarding the safety and effectiveness of the Titan Ti Suture Anchor system. Efficacy of the device was shown in cadaver shoulder bone. The proposed system is safe and effective as the predicate device.
Summary of Safetv and Effectiveness
The proposed modifications to the Titan Ti Suture Anchor System are not substantial changes, and do not significantly affect the safety or efficacy of the predicate device.
p. 2-ot 2
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized eagle-like symbol with three curved lines forming its body and wings. The symbol is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
ArthroCare Corporation % Ms. Valerie Defiesta-Ng Regulatory Affairs Director 680 Vaqueros Avenue Sunnyvale, California 94085-3523
MAY 1 8 2010
Re: K101184
Trade/Device Name: ArthroCare® Titan™ Ti Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 27, 2010 Received: April 28, 2010
Dear Ms. Defiesta-Ng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Valerie Defiesta ~No
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
cerely yours.
Barbara Briemd
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K WIT 84 510(k) Number:
ArthroCare® Titan™ Ti Suture Anchor System Device Name:
Indications for Use:
The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- l Knee: Anterior Cruciate Ligament Repair. Medial Collateral Ligament Repair. Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- I Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction;
- 포 Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair. Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- Hip: Capsular Repair, Acetabular Labral Repair
Prescription Use Over-the-Counter Use X AND/OR (Part 21 CFR 801 (21 CFR 807 Subpart Subpart D) C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Qutta for mxn
(Division Sign Off) Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K101184