(28 days)
No
The document describes a mechanical implant and surgical instruments, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an implant designed to facilitate the attachment of tissue to bone, specifically for fixation of soft tissue to bone in various orthopedic procedures. It is a fixation device, not a therapeutic one that delivers therapy.
No
The device is an implant designed for the physical fixation of soft tissue to bone, as described in the "Device Description" and "Intended Use / Indications for Use" sections. It is not used to diagnose a medical condition or disease.
No
The device description explicitly states it is an "implant" and includes "associated instruments for installation," indicating it is a physical medical device, not software only.
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 described as an "implant" that facilitates the attachment of tissue to bone. Implants are devices placed within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The SpeedScrew Knotless Fixation Device is a surgical implant used in vivo (within the living body) for mechanical fixation, not a diagnostic test performed in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The SpeedScrew Knotless Fixation Device 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 attachment
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
HWC, MBI
Device Description
The SpeedScrew Knotless Fixation Device is an implant that facilitates the attachment of tissue to bone. The SpeedScrew implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. The Opus SpeedScrew System consists of a 5.5 mm implant and a 6.5 mm implant, and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.
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)
Side by side bench testing was performed on the proposed and predicate devices per the US FDA Guidance Document for Testing Bone Anchors. The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing. The differences between the Opus SpeedScrew System and the predicate system do not raise questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed system, as designed, is as safe and effective as the predicate system.
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
510(K) SUMMARY
ARTHROCARE CORPORATION
OPUS SPEEDSCREW SYSTEM
General Information
JUN 2 1 2010
ﻟﺘﻘ
.
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-3523 |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 2951580 |
| Contact Person: | Laura N. Kasperowicz
Sr. Manager, Regulatory Affairs |
| Date Prepared: | May 11, 2010 |
| Device Description | |
| Trade Name:
Device Model Name:
Generic/Common Name:
Classification Name: | Opus SpeedScrew System
Opus 6.5 SpeedScrew Knotless Fixation Device
Bone Anchor
Screw, Fixation, Bone
(Class II per 21 CFR 888.3040, Product code: HWC) |
| Predicate Devices
Opus Magnum SpeedScrew
Knotless Fixation Device | K081893 (Cleared October 1, 2008) |
K100457 (Cleared March 19, 2010 Opus SpeedScrew System (Opus 5.5 SpeedScrew Knotless Fixation Device and ancillary instruments)
Product Description
The SpeedScrew Knotless Fixation Device is an implant that facilitates the attachment of tissue to bone. The SpeedScrew implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. The Opus SpeedScrew System consists of a 5.5 mm implant and a 6.5 mm implant, and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.
Indications For Use
The SpeedScrew Knotless Fixation Device 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 attachment
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
$$
\Delta \ni \succ \ll \ll \text{>}
$$
1
510(K) SUMMARY
Substantial Equivalence
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus SpeedScrew System design and technology is substantially equivalent to the existing Opus SpeedScrew System cleared by the Food and Drug Administration (K081893 and K100457). Side by side bench testing was performed on the proposed and predicate devices per the US FDA Guidance Document for Testing Bone Anchors. The in vitro testing conducted involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing. The differences between the Opus SpeedScrew System and the predicate system do not raise questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed system, as designed, is as safe and effective as the predicate system.
Summary and Reason for 510k Notification
For the purpose of this premarket notification [510(k)], ArthroCare proposes an additional size implant (Opus 6.5 mm SpeedScrew Knotless Fixation Device) and additional ancillary instrumentation (6.5 mm Punch/Tap) to be used in conjunction with the existing system cleared under the trade name, Opus SpeedScrew System.
page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle-like symbol with three stylized wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ArthroCare Corporation % Ms. Laura N. Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
JUN 2 1 2010
Re: K101448
Trade/Device Name: Opus SpeedScrew System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: May 11, 2010 Received: May 24, 2010
Dear Ms. Kasperowicz:
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. Laura N. Kasperowicz
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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Qaulau buelup
1ark 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
510(k) Number:
Device Name:
K j01448
Opus SpeedScrew System
Indications for Use:
The SpeedScrew Knotless Fixation Device 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 attachment
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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) NO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sanita for mxn
Division Sign, Inc.
X
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101448