(235 days)
No
The summary describes a surgical implant system and its intended use, device description, and performance testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The focus is on the physical components and their mechanical performance.
Yes
The device is a system for total shoulder replacement indicated for the relief of pain and significant disability due to gross rotator cuff deficiency, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a shoulder joint replacement system, not a diagnostic tool. Its intended use is for surgical implantation to relieve pain and disability, not to diagnose a condition.
No
The device description explicitly states it is a "glenoid baseplate for reverse shoulder arthroplasty," which is a physical implant. The performance studies also include tests on physical components like "Baseplate Fixation Testing" and "Axial Separation Testing." While "Software Validation" is mentioned, it appears to be validation of software used in the design or manufacturing process, not the device itself being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a glenoid baseplate for reverse shoulder arthroplasty, which is a physical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies listed are related to the mechanical properties and fixation of the implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Biomet Comprehensive Vault Reconstruction System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Vault Reconstruction System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component.
Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Interlok finish humeral stems are intented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Product codes
PHX
Device Description
The Comprehensive Vault Reconstruction System (VRS) is a glenoid baseplate for reverse shoulder arthroplasty designed to match the anatomy of an individual patient.
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)
Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Performance Test Summary-New Device
Compressed Shear Load to Failure Testing
Baseplate Fixation Testing
Axial Separation Testing
Torsional Separation Testing
Software Validation
Cadaver Validation
Summary of clinical tests conducted for determination of substantial equivalence and/or of clinical information
No clinical data submitted
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical data was necessary for a determination of substantial equivalence. The results of testing indicated the device performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
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.”
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 image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
May 16, 2016
Re: K152754
Trade/Device Name: Comprehensive Vault Reconstruction System (VRS) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: March 29, 2016 Received: March 31, 2016
Dear Ms. Beres:
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 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
2
Indications for Use
510(k) Number (if known) K152754
Device Name
Comprehensive Vault Reconstruction System
Indications for Use (Describe)
Biomet Comprehensive Vault Reconstruction System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Vault Reconstruction System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component.
Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Interlok finish humeral stems are intented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Type of Use (Select one or both, as applicable)
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Comprehensive Vault Reconstruction System (VRS) 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| SUBMITTER INFORMATION | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46582 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment Registration Number | 1825034 |
| Name of contact person | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Biomet Manufacturing Corp. | |
| Date prepared | May 10, 2016 |
| NAME OF DEVICE | |
| Trade or proprietary name | Comprehensive Vault Reconstruction System (VRS) |
| Common or usual name | Shoulder Prosthesis |
| Classification name | Shoulder joint, metal/polymer, semi-constrained, cemented |
| prosthesis | |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3660 |
| Product Code(s) | PHX |
| Legally marketed device(s) to which equivalence is claimed | Comprehensive Reverse Shoulder |
| 510(k) K120121 | |
| Reason for 510(k) submission | New Device |
| Device description | The Comprehensive Vault Reconstruction System (VRS) is a |
| glenoid baseplate for reverse shoulder arthroplasty designed | |
| to match the anatomy of an individual patient. | |
| Intended use of the device | Shoulder Replacement |
| Indications for use | Biomet Comprehensive Vault Reconstruction System is indicated |
| for use in patients whose shoulder joint has a grossly deficient | |
| rotator cuff with severe arthropathy and/or previously failed | |
| shoulder joint replacement with a grossly deficient rotator cuff. | |
| The patient must be anatomically and structurally suited to | |
| receive the implants and a functional deltoid muscle is | |
| necessary. | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE GLENOSPHERE BASEPLATE | |
| primary, fracture, or revision total shoulder replacement for the | |
| relief of pain and significant disability due to gross rotator cuff | |
| deficiency. | |
| The Comprehensive Vault Reconstruction System glenoid | |
| baseplate components are intended for cementless | |
| application with the addition of screw fixation in patients with | |
| unusual anatomy and/or extensive bone loss which precludes | |
| the use of a standard glenoid baseplate component. | |
| Titanium glenospheres are intended for patients with Cobalt | |
| Alloy material sensitivity. The wear of these devices has not | |
| been tested but, based on pin on disk testing, the wear rate is | |
| inferior to that of cobalt alloy glenospheres. A Cobalt Alloy | |
| glenosphere is the recommended component for reverse | |
| shoulder arthroplasty patients without material sensitivity to | |
| cobalt alloy. | |
| Interlok finish humeral stems are intended for cemented use and | |
| the MacroBond coated humeral stems are intended for press-fit | |
| or cemented applications. Humeral components with porous | |
| coated surface coating are indicated for either cemented or | |
| uncemented biological fixation applications. |
4
COMPARED TO THE PREDICATE
The new device is identical or similar in design, materials and intended use as the predicate device. Design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.
| Proposed Device | Predicate Device - K120121 | |
|---|---|---|
| Glenoid Baseplate | ||
| Materials | same | Titanium Alloy per ASTM F136 |
| Titanium Alloy plasma spray coating | ||
| per ASTM F1580 | ||
| Hydroxyapatite coating per ASTM | ||
| F1185 | ||
| Glenoid Baseplate Size | ||
| Range | Envelope of sizes | |
| M/L and A/P dimension ≥ 25mm | ||
| varied thickness 4.5mm to 50mm | Round | |
| 25mm diameter | ||
| single thickness of 4.5mm | ||
| Manufacturing Process | Same | Machined from wrought Titanium |
| with Plasma Spray and HA coating | ||
| Other Design Feature | Patient matched tray back | |
| 3-10 peripheral screw holes to | ||
| accept locking and non-locking | ||
| screws | ||
| Medial Boss with 6.5mm screw | Flat tray back | |
| 4 peripheral screw holes to accept | ||
| both locking and non-locking | ||
| screws | ||
| Medial Boss with 6.5mm screw | ||
| Glenosphere attachment | same | Mini Taper, requires taper adapter |
| Other | Pre-assembled with F.A.S.T. Guide | |
| Inserts |
5
Image /page/5/Picture/0 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The font is clean and modern, with even spacing between the letters. The overall impression is one of simplicity and clarity.
PERFORMANCE DATA
Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Performance Test Summary-New Device
Compressed Shear Load to Failure Testing
Baseplate Fixation Testing
Axial Separation Testing
Torsional Separation Testing
Software Validation
Cadaver Validation
Summary of clinical tests conducted for determination of substantial equivalence and/or of clinical information
No clinical data submitted
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical data was necessary for a determination of substantial equivalence. The results of testing indicated the device performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.