(24 days)
Not Found
No
The summary describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a modular shoulder prosthesis used in hemiarthroplasty and revision surgery for conditions like severe arthropathy or failed joint replacements, directly addressing a medical condition.
No.
The device is a modular shoulder prosthesis intended for surgical implantation, not for diagnosing medical conditions.
No
The device description clearly states it is a "modular shoulder prosthesis," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this is a shoulder prosthesis intended for surgical implantation in the human body to replace or augment a joint. It is a physical implant, not a device used to analyze biological samples.
Therefore, the Delta CTA Reverse Shoulder System Humeral Head falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended Use:
The Delta CTA Reverse Shoulder System Humeral Head is intended for use in hemi arthroplasty procedures (without the humeral cup or glenoid components) if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
Indications for Use:
A Delta CTA™ Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
Product codes
87 KWS, 87 HSD
Device Description
The Delta CTA Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
K063116 page 142
AUG 1 8 2006
510 (k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer
Regulatory Affairs
Telephone: (574) 371-4927
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@dpyus.jnj.com |
| DATE PREPARED: | July 17, 2006 |
| PROPRIETARY NAME: | Delta CTA™ Reverse Shoulder System Humeral
Heads |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3660:
Prosthesis, Shoulder, Semi-Constrained,
Metal/Polymer Cemented; and
888.3690: Shoulder Joint Humeral (hemi-
shoulder) Metallic Uncemented Prosthesis |
| DEVICE PRODUCT CODE: | 87 KWS
87 HSD |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Delta CTA Reverse Shoulder System,
K021478
DePuy Global Advantage CTA Head. K000525 |
DEVICE DESCRIPTION:
The Delta CTA Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.
INTENDED USE AND INDICATIONS:
Intended Use:
The Delta CTA Reverse Shoulder System Humeral Head is intended for use in hemi arthroplasty procedures (without the humeral cup or glenoid components) if the glenoid is
1
page 2/2
fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
Indications for Use:
A Delta CTA™ Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the Delta CTA Reverse Shoulder System Humeral Head is substantiated by its similarity in intended use, indications for use, materials and design to the DePuy Delta CTA Reverse Shoulder System (K021478) and the DePuy Global Advantage CTA Head (K000575).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K062116
Trade/Device Name: Delta CTA™ Reverse Shoulder Humeral Heads Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: July 24, 2006 Received: July 25, 2006
Dear Ms. Myer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA
3
Page 2 - Ms. Rhonda Myer
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Barbara Buechner
fark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510 (k) Number (if known): K062116
Device Name: Delta CTA™ Reverse Shoulder Humeral Heads
Indications for Use:
A Delta CTA Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C) Nu
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbare Buch
(Posted November 13, 2003) (Division Sign-Off) Page 1 of 1
Division of General, Restorative,
and Neurological Devices
510(k) Number K062110
4