(27 days)
Not Found
No
The 510(k) summary describes a mechanical implant (reverse shoulder prosthesis) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a prosthesis intended for use in patients with severe shoulder joint issues, specifically those with rotator cuff deficiency or failed joint replacements, which qualifies it as a therapeutic device designed to restore function and alleviate symptoms.
No
This device is a prosthesis (an implantable medical device) used for joint replacement, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (prosthesis) intended for surgical implantation, not a software application.
No, 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: The provided text describes a surgical implant (a reverse shoulder prosthesis) that is surgically placed into the body to replace a damaged joint.
- Intended Use: The intended use clearly states it's for treating specific conditions of the shoulder joint by replacing it with a prosthetic device. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The information provided about the device's design, intended use, and performance studies all point to it being a surgically implanted medical device, not an IVD.
N/A
Intended Use / Indications for Use
A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint . replacement with a grossly rotator cuff deficient 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. For US Use Only: All other components are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The Delta CTATM Reverse Shoulder is DePuy's first generation reverse shoulder system. In a reverse shoulder, the articulation is "inverted" compared to traditional, anatomical total shoulder prosthesis so that the "ball" of the articulation is incorporated into the glenoid prosthesis and the "cup" of the articulation is incorporated into the humeral prosthesis. This inverted design helps stabilize a shoulder in the absence of a functional rotator cuff.
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)
Non-clinical tests were conducted. Stack analyses demonstrated the subject device to be compatible with the existing mating components (Delta CTA epiphysis and Delta Xtend glenospheres). The results of the non-clinical testing demonstrate substantial equivalence to the predicate. No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
DePuy Orthopaedics Ms. Megan Burns Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46580
Re: K122442
Trade/Device Name: DePuy Delta CTA™ Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX. KWS Dated: August 9, 2012 Received: August 10, 2012
Dear Ms. Burns:
This letter corrects our substantially equivalent letter of September 6, 2012.
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. Iisting 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
1
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 Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4: Indications for Use Statement
510 (k) Number (if known):
Device Name: DePuy Delta CTA™ Reverse Shoulder System
Indications for Use:
A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
- Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint . replacement with a grossly rotator cuff deficient 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. For US Use Only: 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) |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off:
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K122442 |
|---|---|
| 00012 |
3
K 122442 (1/2)
SEP 6 2012
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Section 5: 510(k) Summary
.
(as required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopedic Drive |
| Phone number | 574-372-7745 |
| Fax number | 574-371-4987 |
| Establishment Registration | 1818910 |
| Name of contact person | Megan Burns |
| Date prepared | August 9, 2012 |
| Name of device | |
| Trade or proprietary name | Delta CTATM Reverse Shoulder System |
| Common or usual name | Shoulder Prosthesis |
| Class | II |
| Classification panel | 87 - Orthopedics |
| Regulation | 21 CFR 888.3660 - Shoulder joint metal/polymer semi- |
| constrained cemented prosthesis | |
| Product Code(s) | KWS |
| Legally marketed device(s) to | |
| which equivalence is claimed | Delta CTATM Reverse Shoulder System - Humeral Cups |
| (K050315, cleared May 16, 2005) | |
| Reason for 510(k) submission | Line Extension |
| Device description | The Delta CTATM Reverse Shoulder is DePuy's first generation |
| reverse shoulder system. In a reverse shoulder, the articulation is | |
| "inverted" compared to traditional, anatomical total shoulder | |
| prosthesis so that the "ball" of the articulation is incorporated | |
| into the glenoid prosthesis and the "cup" of the articulation is | |
| incorporated into the humeral prosthesis. This inverted design | |
| helps stabilize a shoulder in the absence of a functional rotator | |
| cuff. | |
| Intended use of the device | Reverse Shoulder Arthroplasty |
| Indications for use | A Delta CTA TM Reverse Shoulder Prosthesis is indicated for use |
| in | |
| • Grossly rotator cuff deficient joint with severe arthropathy or | |
| a previous failed joint replacement with a grossly rotator cuff | |
| deficient 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. For US Use Only: All other components are | |
| intended for cemented use only. |
4
| CHARACTERISTICS | Subject Device:
DePuy DELTA CTA™
Hybrid Humeral cups. | Predicate Device:
DePuy DELTA CTA™
Humeral cups (K0503- | |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|
| Intended Use | Reverse Shoulder Arthroplasty
A Delta CTA™ Reverse Shoulder | SAME | |
| Indications for Use | Prosthesis is indicated for use in
• Grossly rotator cuff deficient joint
with severe arthropathy or a
previous failed joint replacement
with a grossly rotator cuff deficient
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. For
US Use Only: All other
components are intended for
cemented use only. | SAME | |
| Material | UHWMPE | SAME | |
| Sizes | Diameters: 38 mm and 42mm
Thickness: +3mm, +6mm, +9mm | Diameters: 36mm and 42mm
Thickness: +3mm and +9mm | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| | Stack analyses demonstrated the subject device to be compatible with the existing mating
components (Delta CTA epiphysis and Delta Xtend glenospheres). | | |
| COMPARATIVE PERFORMANCE INFORMATION SUMMARY | | | |
| Characteristic | Requirement | New Device Predicate Dev | |
| | The results of the non-clinical testing demonstrate substantial equivalence to the predicate | | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| | No clinical tests were conducted to demonstrate substantial equivalence. | | |
. .