(72 days)
No
The summary describes a mechanical suture anchor and its associated instruments, with no mention of AI or ML capabilities in its function or intended use.
No.
A therapeutic device is typically understood as a device used to treat or cure a disease or condition. This device, a suture implant, is used for fixation of soft tissue to bone and reconstruction, which are surgical procedures, but it does not actively treat or cure a disease in the way a therapeutic device would. It aids in the structural repair following injury or surgical intervention.
No
This device is designed for the fixation of soft tissue to bone, serving as an implant for surgical repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of PEEK, a suture anchor, and associated instruments. It is a hardware device, not software.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ArthroCare Spartan PEEK Suture Implant is a physical implant designed to fix soft tissue to bone during surgical procedures. It is implanted directly into the body and does not interact with or analyze specimens taken from the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Product codes
MBI
Device Description
The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Foot, Elbow, Knee
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)
Additionally, bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to the predicate Speedscrew implant in accordance with FDA Guidance Document Testing for Bone Anchors. The in vitro testing performed involved insertion of the anchors in a simulated human bone substrate followed by both ultimate strength and cyclic loading tests. The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081893, K100457, K092133, K101184
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
K102267 PG. 1/2
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Valerie Defiesta-Ng
Screw, Fixation, Bone
Fastener (21 CFR 888.3040)
Class II, 21 CFR 888.3040
Product Code MBI
August 9, 2010
Director, Regulatory Affairs
ArthroCare Spartan PEEK Suture Implant
Smooth or Threaded Metallic Bone Fixation
OCT 2:1 2010
510(k) Summary
ArthroCare® Corporation ArthroCare® Spartan™ PEEK Suture Implant
2951580
General Information Submitter Name/Address:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description Trade Name:
Generic/Common Name:
Classification Name:
Device Classification:
Predicate Devices
| ArthroCare Opus Magnum Speedscrew
| Knotless Fixation Device | K081893 (cleared 10/02/08) |
|---|---|
| Arthrocare Opus Speedscrew System | K100457 (cleared 03/19/10) |
| ArthroCare Titan Ti Suture Anchor | K092133 (cleared 11/05/09) |
| ArthroCare Titan Ti Suture Anchor System | K101184 (cleared 05/18/10) |
Product Description
The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.
1
PG. 2/2
Intended Uses/Indications for Use
The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Substantial Equivalence
7
In establishing substantial equivalence to the predicate devices, ArthroCare compared the intended use, device design, technology, and device components of the subject device with the predicate devices. Additionally, bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to the predicate Speedscrew implant in accordance with FDA Guidance Document Testing for Bone Anchors. The in vitro testing performed involved insertion of the anchors in a simulated human bone substrate followed by both ultimate strength and cyclic loading tests. The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
Summary of Safety and Effectiveness
The ArthroCare Spartan PEEK Suture Implant, as described in this premarket notification 510(k), is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is 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 simple and monochromatic, with a focus on conveying the department's mission and identity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ArthoCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085
Re: K102262
Trade/Device Name: ArthoCare® Spartan™ PEEK Suture Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: August 9 2010 Received: August 10, 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-Ng
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/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/ReportaProblem/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.
Sincerely yours,
Sincerely yours,
Mark M. Molkerson
Mark N. Meikersor Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
ArthroCare® Spartan™ PEEK Suture Implant
Indications For Use:
The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omtu
(Division Sign-Off) for mxn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102262
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