(64 days)
Not Found
No
The document describes a prosthetic shoulder system and its mechanical testing, with no mention of AI or ML.
Yes
The device is a prosthetic replacement indicated to relieve severe pain or significant disability caused by various degenerative pathologies and fractures, which aligns with the definition of a therapeutic device.
No
The device is described as a "Prosthetic replacement" used for "total shoulder arthroplasty," indicating it is an implant for treatment rather than a tool for diagnosis. The "Intended Use / Indications for Use" outlines specific conditions the device is used to treat, not to diagnose.
No
The device description clearly states it is a modular system consisting of physical components (humeral stem, humeral heads, glenoid) and surgical instruments, indicating it is a hardware medical device.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a prosthetic implant designed to replace components of the shoulder joint. Its intended use is to relieve pain and disability caused by various shoulder pathologies.
- Lack of Diagnostic Function: The device itself does not perform any tests on biological samples to diagnose a condition. It is a physical implant used for treatment.
- No Mention of Diagnostic Procedures: The description focuses on surgical implantation and the physical components of the shoulder replacement system. There is no mention of analyzing samples or providing diagnostic information.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 arthrosis, post traumatic arthrosis
- Primary and 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 PerFORM+ glenoids are intended for cemented use only.
The Aequalis monobloc stem is for cemented use
The Aequalis Press-Fit is for uncemented 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.
Product codes
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 |
|---|---|---|
| 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 |
| Endotoxin | ≤ 20 EU / device | Acceptable |
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
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
§ 888.3660 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.”
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Tornier, Incorporated Ms. Loucinda Biorklund Manager, Regulatory Affairs 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K160975
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: May 10, 2016 Received: May 11, 2016
Dear Ms. Bjorklund:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (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/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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160975
Device Name
Aequalis PerFORM+ Shoulder System
Indications for Use (Describe)
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 arthrosis, post traumatic arthrosis
- · Primary and 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 PerFORM+ glenoids are intended for cemented use only.
The Aequalis monobloc stem is for cemented use
The Aequalis Press-Fit is for uncemented use
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K160975
I. Submitter
Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437
| Date Prepared: | June 8, 2016 |
|---|---|
| Contact Person: | Loucinda Bjorklund |
| Manager, Regulatory Affairs | |
| Phone: | 952-683-7491 |
| 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 PerFORM+ Shoulder System, K150583
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
Indications For Use VI.
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 PerFORM+ glenoids are intended for cemented use only.
The Aequalis monbloc stem is for cemented use
The Aequalis press-fit is for uncemented 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 do not affect safety or effectiveness or raise new issues of safety or effectiveness.
Non-Clinical Performance Data VIII.
The following performance data were provided in support of the substantial equivalence determination.
| Validation and / or
| Verification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| 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 |
| Endotoxin | $ ≤ 20 EU / device $ | Acceptable |
Performance Data
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.