(45 days)
Not Found
No
The document describes a modular shoulder implant system and its intended use and testing, with no mention of AI or ML technology.
No.
A therapeutic device is typically understood as a device that delivers some form of therapy (e.g., radiation, electrical stimulation, drug delivery). This device is a prosthetic replacement, which is a surgically implanted device designed to replace a diseased or damaged body part, not to deliver a therapy.
No
Explanation: The device is a prosthetic replacement system (shoulder implant) intended for surgical treatment of severe shoulder pain and disability, not for diagnosing medical conditions.
No
The device description clearly states it is a modular system consisting of physical components (humeral stem, heads, glenoid) and surgical instruments, indicating it is a hardware medical device. The performance studies also focus on physical properties and testing of these hardware components.
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: The description clearly states that this is a "Prosthetic replacement" for the shoulder joint, consisting of "humeral component" and "glenoid component." These are implanted devices used to replace damaged parts of the body.
- Intended Use: The intended use describes the conditions for which the device is indicated, all of which relate to replacing the shoulder joint due to various pathologies. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- . Degenerative pathologies: arthrosis, rheumatoid arthritis, posttraumatic arthrosis. Primary or secondary necrosis of the humeral head.
- . Displaced 4-part upper humeral fracture
- Humeral head fracture .
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis press-fit is for uncemented use. Glenoid component is for cemented use.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.
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)
The following performance data were provided in support of the substantial equivalence determination.
| Validation and / or
| Verification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| Dimensional comparison | The profile and anchorage of the Aequalis PerFORM+ to be the same as to the predicate device design. | Acceptable |
| Dimensional comparison | The geometric shape of the articular surface must be compatible with existing humeral heads. | Acceptable |
| Dimensional comparison | Posterior build up must be equivalent to the currently marketed devices. | Acceptable |
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Simulated use of | ||
| instrumentation | Successful preparation of cadaveric specimens. | Acceptable |
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.
Aequalis Shoulder System, K111902, Depuy Steptech, K092122, Exactech Equinoxe, K121220
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 & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Public Health Service
May 8, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tornier, Incorporated Kris Miller Senior Regulatory Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K150583
Trade/Device Name: Aequalis PerFORM+ Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: March 25, 2015 Received: March 26, 2015
Dear Kris Miller:
This letter corrects our substantially equivalent letter of April 23, 2015.
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
1
Page 2 - Kris Miller
(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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
K150583 510(k) Number (if known):
Device Name: Aequalis PerFORM+ Shoulder System
Indications for Use:
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- . Degenerative pathologies: arthrosis, rheumatoid arthritis, posttraumatic arthrosis. Primary or secondary necrosis of the humeral head.
- . Displaced 4-part upper humeral fracture
- Humeral head fracture .
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis press-fit is for uncemented use. Glenoid component is for cemented use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use __
AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Page 1 of 3
510(k) Summary
I. Submitter
Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437
| Date Prepared: | March 4, 2014 |
|---|---|
| Contact Person: | Kris Miller |
| Senior Regulatory Affairs Specialist | |
| Phone: | 952-426-7652 |
| Fax: | 952-426-7601 |
II. Device
| Name of Device: | Aequalis PerFORM+ Shoulder System |
|---|---|
| Common or Usual Name: | Shoulder Prosthesis, humeral head |
| Classification Name: | 21 CFR 888.3660, shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II |
| Product Code: | KWS |
III. Predicate Device
Aequalis Shoulder System, K111902 Depuy Steptech, K092122 Exactech Equinoxe, K121220
IV. Device Description
The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.
V. Intended Use
The Tornier shoulder prostheses are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
4
Page 2 of 3
VI. Indications For Use
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
- . Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
- Primary or secondary necrosis of the humeral head. ●
- Displaced 4-part upper humeral fracture .
- Humeral head fracture ●
- Other pathologies where arthrodesis or resectional arthroplasty of the humeral . head are not acceptable.
- . Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis press-fit is for uncemented use. Glenoid component is for cemented use.
VII. Comparison of Technological Characteristics with the Predicate Device
The Aequalis PerFORM+ Shoulder System has the same intended use and fundamental scientific technology as the predicate device. The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Table 1 Performance Data
| Validation and / or
| Verification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| Dimensional comparison | The profile and anchorage of the Aequalis PerFORM+ to be the same as to the predicate device design. | Acceptable |
| Dimensional comparison | The geometric shape of the articular surface must be compatible with existing humeral heads. | Acceptable |
| Dimensional comparison | Posterior build up must be equivalent to the currently marketed devices. | Acceptable |
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Simulated use of | ||
| instrumentation | Successful preparation of cadaveric specimens. | Acceptable |
5
Page 3 of 3
IX. Clinical Study
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
X. Conclusions
The Aequalis PerFORM+ Shoulder System described in this section has the same intended use and the same fundamental scientific technology as the cleared Aequalis Shoulder System. Based on the testing presented for the design differences between the subject and predicate devices, Tornier concludes that subject device is substantially equivalent to the predicate device.