(83 days)
None
No
The device description and performance studies focus on the mechanical properties and design of a physical suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "Suture Anchor" used for "soft tissue re-attachment and capsular repair," indicating it is a surgical implant for repairing damaged tissue rather than a device for treating or preventing a disease or condition.
No
The device is a suture anchor used for re-attaching soft tissue and repairing capsules in the shoulder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical implantable device made of titanium alloy with sutures and needles, which is hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue re-attachment and capsular repair" in the shoulder. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "suture anchor," which is a physical implant used to secure tissue to bone.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
This device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.
Product codes
79 JDR
Device Description
The Catera Suture Anchor is a titanium 6Al-4V alloy, self-threading, cancellous screw available in diameters of 3.5mm and 4.5mm with a 0.030 inch diameter cylindrical eyelet at the end. The eyelet has two semicircular slots milled in the side of the head for suture clearance. A 34 inch U.S.P. #2 nonabsorbable polyester suture is supplied pre-threaded through the eyelet with a single loop at the end of the screw. The suture anchors that are supplied with needles attached to the suture will have a Sulzle needle #394475 swedged onto one or both ends of the suture. The suture anchor's tip threads are on an incline to the full diameter (body threads). The body threads which provide the main resistance to pullout are on a slight incline. The suture anchors are supplied either pre-loaded on a driver or separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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)
Mechanical testing in porcine and human cadaver bone showed that the pull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors. Mechanical testing in porcine bone showed that the maximum torque to failure results for the Catera Suture Anchor were better than those for the Statak anchors. Mechanical testing in porcine bone showed that the Catera Suture Anchor pull-out force results exceeded those for the Stryker and Mitek suture anchors.
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
1980595
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive, P.O. Box 988
Warsaw, IN 46581-0988 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Sally Foust
Regulatory Submissions Associate
DePuy Orthopaedics, Inc.
(219) 372-7455
FAX: (219) 267-7098
E-Mail: Sally_Foust@ccgate.depuy.com |
| TRADE NAME: | DePuy OrthoTech Catera Suture Anchor |
| CLASSIFICATION NAME: | Bone Fixation Staple |
| PRODUCT CODE: | 79 JDR |
| SUBSTANTIALLY EQUIVALENT DEVICES: | Zimmer Statak (K926384)
Stryker 2.7mm (K???????)
Mitek Surgical Products, Inc. (K902751, K920213) |
INTENDED USE AND DEVICE DESCRIPTION:
The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.
The Catera Suture Anchor is a titanium 6Al-4V alloy, self-threading, cancellous screw available in diameters of 3.5mm and 4.5mm with a 0.030 inch diameter cylindrical eyelet at the end. The eyelet has two semicircular slots milled in the side of the head for suture clearance. A 34 inch U.S.P. #2 nonabsorbable polyester suture is supplied pre-threaded through the eyelet with a single loop at the end of the screw. The suture anchors that are supplied with needles attached to the suture will have a Sulzle needle #394475 swedged onto one or both ends of the suture. The suture anchor's tip threads are on an incline to the full diameter (body threads). The body threads which provide the main resistance to pullout are on a slight incline. The suture anchors are supplied either pre-loaded on a driver or separately.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy OrthoTech Catera Suture Anchor is substantially equivalent to the Zimmer Statak in that both of these devices are threaded suture anchors manufactured from Ti-6Al-4V alloy which are intended for soft tissue re-attachment in the shoulder. Mechanical testing in porcine and human cadaver bone showed that the pull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors. Mechanical testing in porcine bone showed that the maximum torque to failure results for the Catera Suture Anchor were better than those for the Statak anchors. Mechanical testing in porcine bone showed that the Catera Suture Anchor pull-out force results exceeded those for the Stryker and Mitek suture anchors.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1998
Ms. Sally Foust Requlatory Submissions Associate DePuv Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana
Re : K980595 DePuy OrthoTech Catera Suture Anchor Trade Name: Requlatory Class: II Product Code: MBI February 13, 1998 Dated: Received: February 17, 1998
Dear Ms. Foust:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895... A.. 1. .. - - - substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Sally Foust
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.
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 (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
C. Colin M. Whitten, Ph.D.
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
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510(k) Number (if known) Ka80595
DePuy OrthoTech Catera Suture Anchor Device Name
Indications for Use:
... .. .. .. ..
... ... ... ... ... ... ... .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue reattachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.
Concurrence of CDRH, Office of Device Evaluation
==============================================================================================================================================================================
toledo
(Divisio Division દર્શને સ્ટે 510(k) Nu
ﺃﺷﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
Prescription Use _ × (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
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