(19 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a suture implant used for fixation of soft tissue to bone to repair various injuries, which is a therapeutic intervention.
No
The device description and intended use clearly state that the ArthroCare Spartan PEEK Suture Implant is used for the fixation of soft tissue to bone in various surgical procedures, indicating it is an implantable device for treatment, not diagnosis. The performance studies focus on mechanical strength and substantial equivalence for its intended surgical use.
No
The device description explicitly states it is a "fullythreaded, corkscrew shape anchor" made of PEEK, which is a physical implantable material. It also mentions a disposable delivery driver and associated instruments, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture implant" and "suture anchor" used for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a surgical repair.
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 fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to 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)
Bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture 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)
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
K 110164 (1/2)
510(k) Summary
FEB - 7 2011
ArthroCare Corporation Spartan™ PEEK Suture Implant System
| General Information | |
|---|---|
| Submitter Name/Address: | ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng Director, Regulatory Affairs |
| Date Prepared: | January 18, 2011 |
| Device Description | |
| Trade Name: | ArthroCare Spartan PEEK Suture Implant System |
| Generic/Common Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040) |
| Device Classification: | Class II, 21 CFR 888.3040 Product Code MBI |
| Predicate Device | |
| Arthrocare 5.5mm Spartan PEEK Suture Implant System | K102262 (October 21, 2010) |
Product Description
The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.
1
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
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 device. Bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture 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 proposed modifications to the Spartan PEEK Suture Implant System are not substantial changes, and do not significantly affect the safety or efficacy of the proposed device.
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 eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
FEB - 7 201
Re: K110164
Trade/Device Name: ArthroCare® Spartan™ PEEK Suture Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 18, 2011 Received: January 19, 2011
Dear Mr. Defiesta-Ng:
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: 上一篇:
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
3
Page 2 - Ms. Valerie Defiesta-Ng
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 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 Patt 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html far the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 3 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.
https://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely vours.
Aty vs. Rh
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
X 110164 510(k) Number (if known):
Device Name:
ArthroCare® Spartan™ PEEK Suture Implant System
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)
M. Mulkerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110164
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