(359 days)
Not Found
No
The document describes a mechanical implant (shoulder prosthesis) and its materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthesis implanted to address severe shoulder conditions, directly treating and alleviating a pathological condition, which falls under the definition of a therapeutic device.
No
Explanation: The device is a shoulder prosthesis, which is an implant used to replace a damaged joint, not to diagnose a condition.
No
The device description clearly states it is a physical shoulder prosthesis composed of various hardware components made of stainless steel and UHMWPE, intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Duocentric® Reversed shoulder prosthesis is a physical implant designed to replace a damaged shoulder joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for the surgical treatment of specific shoulder conditions by replacing the joint with a prosthesis. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgically implanted medical device, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.
The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).
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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.
Product codes
PHX, KWS
Device Description
The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.
The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate. The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile.
The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating (Vault-en-Velin, FR) according to their Master File MAF-1633.
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
older population (e.g. 65 years of age or older)
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product and its components met all pre-determined specifications and are adequate for their intended use.
Clinical data were not required for this device. This product has been commercialized since 2003 in Europe and has shown to be safe and effective as shown by post-market data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091751, K021478, K100142, K053274
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Aston Medical % Ms. Catherine Gloster Gloster Biomedical International 577 North Hope Avenue Santa Barbra, California 93110
Re: K103251
Trade/Device Name: Duocentric® Reversed Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: September 30, 2011 Received: October 3, 2011
Dear Ms. Gloster:
This letter corrects our substantially equivalent letter of October 28, 2011.
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 for associated in the Merceans)76, 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 If your device 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 I hat 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 (21 CFR 801); as only (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/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
Indication for Use
510(k): K103251
Duocentric® Reversed shoulder prosthesis: Aston® Medical
Indications for Use:
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.
The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).
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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.
Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
/Concurrenceof CDRH, Office of Device Evaluation (ODE)
Michael. Oues to mxm
Page 1 of l
ivision Sign-Off)
vision of Surgical, Orthopedic,
id Restorative Devices
ASTON® Neer Duocentric® Reversed Shoulder Prosthesis
Update October 2011
Page 1
3
K103251
SECTION 5: 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
| Submitted by: | Aston® Medical
19, rue Victor Grignard
Zone Industrielle de Montreynaud
42000 Saint-Etienne
France |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared By/Contact Person: | Catherine Gloster, M.Sc. RAC
Regulatory Consultant
Gloster Biomedical International
577 North Hope Ave
Santa Barbara, CA 93110 - USA
Phone: 805-679-1258
Email: c.gloster@GlosterBiomedical.com |
| Date Prepared: | October 28, 2011 |
| Proprietary Name: | DUOCENTRIC® Reversed |
| Common Name: | Reverse shoulder prosthesis |
| Classification: | Class II, 21 CFR 888.3660
Shoulder joint metal/polymer semi-constrained
cemented prosthesis
KWS |
| Predicate Devices: | K091751 - Depuy Orthopaedic, Inc. USA - Depuy
Delta Xtend Reverse Shoulder - cleared 7/14/2009
K021478 - Depuy Orthopaedic, Inc. USA - Delta
Shoulder - cleared 11/18/2003
K100142 - Tornier, France - Aequalis Reversed
Shoulder Prosthesis - cleared 5/6/2010
K053274 - Zimmer, Inc. USA - Anatomical |
Device Description:
The Duocentric® Reversed shoulder prosthesis is a prosthesis that uses the biomechanical concepts of reverse shoulder arthroplasty as originally described by Paul Grammont.
Shoulder™ Inverse/Reverse - cleared 1/25/2006
1 8 + 3
4
The Duocentric® Reversed shoulder prosthesis is composed of a humeral stem, a humeral baseplate, a humeral insert, a gleonosphere (Duoglene), and a glenoid baseplate. The humeral insert is made of ultra-high-molecular-weight polyethylene (UHMWPE), while all other components are made of wrought high nitrogen stainless steel M30NW. The humeral stem is intended for cemented use unless coated with hydroxyapatite (HA). The glenoid baseplate is coated with a double coating of pure titanium and hydroxyapatite (Ti/HA), is intended for cementless use, and is fixated with wrought high nitrogen stainless steel screws. The device is provided sterile.
The HA and Ti/HA coatings conform to ASTM standards ASTM F1185, ASTM F1609, and ASTM F1580 and are performed by Medical Coating (Vault-en-Velin, FR) according to their Master File MAF-1633.
Indication for Use:
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.
The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).
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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The glenoid baseplate is intended for cementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite on its posterior side.
Page 2 of 3
5
Pose 3 of 3
Basis for substantial equivalence:
The Duocentric® Reversed shoulder prosthesis is substantially equivalent to the previously cleared devices: Depuy Delta Xtend Reversed Shoulder (K091751), Depuy Delta Shoulder (K021478), Tornier Aequalis Reverse Shoulder (K100142), and Zimmer Anatomical Reverse/Inverse Shoulder (K053274). This assessment is based on similarities in indications for use, materials, dimensions, design, packaging and sterilization processes and results of pre-clinical testing. The subject device does not raise any new issues of safety and effectiveness.
Performance Data:
Pre-clinical performance testing concluded that the Duocentric® Reversed shoulder finished product and its components met all pre-determined specifications and are adequate for their intended use.
Clinical data were not required for this device. This product has been commercialized since 2003 in Europe and has shown to be safe and effective as shown by post-market data.