(50 days)
The Comprehensive® Reverse Shoulder 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.
The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
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.
The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. The glenoid baseplate features a medial boss through which a Central Screw is placed to hold the component in place. Additionally, there are four peripheral screw holes through the baseplate for screw fixation. The screws are available in both locking and non-locking styles. Both sterile and non-sterile versions of the screws will be marketed.
This 510(k) is for a design modification to the peripheral screws as well as the inclusion of non-sterile central and peripheral screw options to allow sterilization of the screws at the user facility in a screw caddy.
This document is a 510(k) premarket notification for the Comprehensive® Reverse Shoulder - Screws. It's a regulatory filing for a medical device, not a study evaluating an AI algorithm or diagnostic tool. Therefore, the information requested about acceptance criteria, study details, and AI performance is not applicable to this document.
Here's why each of your requested points cannot be answered from this document:
- 1. A table of acceptance criteria and the reported device performance: This document reports on a physical medical device (shoulder screws) and evaluates its substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Torque to Failure). It does not present performance data in the context of diagnostic accuracy, sensitivity, or specificity, which are typical for AI-based medical devices or diagnostic studies.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The "test set" here refers to the physical screws subjected to mechanical testing. There is no mention of data provenance in the context of patient data, as this is not a clinical study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): "Ground truth" in this context would implicitly be the engineering specifications and performance limits for the screws, not established by medical experts for diagnostic purposes.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing of screws.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device or a diagnostic reading study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As mentioned, the "ground truth" relates to mechanical engineering specifications and performance, not clinical outcomes or pathology from patient data.
- 8. The sample size for the training set: Not applicable, as there is no AI algorithm being trained.
- 9. How the ground truth for the training set was established: Not applicable, as there is no AI algorithm being trained.
In summary, this document is a regulatory submission for a physical orthopedic implant (screws for a shoulder replacement), not a study evaluating an AI device or diagnostic algorithm. Therefore, the requested information pertaining to AI performance and clinical study design for AI is not present. The document focuses on demonstrating that the modified screws are substantially equivalent to previously marketed screws based on design and non-clinical performance data (specifically torque to failure).
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K132239
Trade/Device Name: Comprehensive® Reverse Shoulder - Screws Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, PAO Dated: July 30, 2013 Received: July 31, 2013
Dear Ms. Beres:
This letter corrects our substantially equivalent letter of September 6, 2013.
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 Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Patricia Sandborn Beres
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
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Indications for Use
510(k) Number (if known):
Device Name: Comprehensive® Reverse Shoulder - Screws
Indications For Use:
The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder ioint 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.
The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
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.
Prescription Use ___ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
・
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| 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 | July 29, 2013 | |
| NAME OF DEVICE | ||
| Trade name | Comprehensive® Reverse Shoulder Screws | |
| Common name | Glenoid prosthesis | |
| Classification name | Regulation | Product Code |
| Shoulder joint, metal/polymer, semi- | 21 CFR 888.3660 | KWS |
| constrained, cemented prosthesis | ||
| Shoulder joint metal/polymer (+additive) semi- | 21 CFR 888.3660 | PAO |
| constrained cemented prosthesis | ||
| Classification panel | Orthopedics | |
| Legally marketed device(s) to which | Comprehensive® Reverse Shoulder (K080642) | |
| equivalence is claimed | ||
| Reason for 510(k) submission | New device | |
| Device descriptionSEP 06 2013 | The Comprehensive® Reverse Shoulder is intended fortotal shoulder replacement in a reverse shoulderconfiguration. Unlike traditional total shoulderreplacement, a reverse shoulder employs a ball forarticulation on the glenoid side of the joint and apolyethylene bearing surface on the humeral side of thejoint. The glenoid baseplate features a medial bossthrough which a Central Screw is placed to hold thecomponent in place. Additionally, there are fourperipheral screw holes through the baseplate forscrew fixation. The screws are available in bothlocking and non-locking styles. Both sterile and non-sterile versions of the screws will be marketed.This 510(k) is for a design modification to the peripheralscrews as well as the inclusion of non-sterile central andperipheral screw options to allow sterilization of thescrews at the user facility in a screw caddy. |
Malling Address:
Production More More More More More More More More Morrison Morrison Morrison Morrison Monte Morrison Monte Morrol Monte Blommer Monto Blombia Morro Blombia
Shipping Address:
56 East Bell Drive ત્ત્વજ્યના IN 45582
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510(K) Summary
Comprehensive® Reverse Shoulder Screws
Page 2 of 2
K132239 (2/2)
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| Indicationsfor use | The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder jointhas a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulderjoint replacement with a grossly deficient rotator cuff. The patient must be anatomically andstructurally suited to receive the implants and a functional deltoid muscle is necessary.The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision totalshoulder replacement for the relief of pain and significant disability due to gross rotatorcuff deficiency.Glenoid components with Hydroxyapatite (HA) coating applied over the porous coatingare indicated only for uncemented biological fixation applications. The Glenoid Baseplatecomponents are intended for cementless application with the addition of screw fixation.Interlok finish humeral stems are intended for cemented use and the MacroBond coatedhumeral stems are intended for press-fit or cemented applications. Humeral componentswith porous coated surface coating are indicated for either cemented or uncementedbiological fixation applications. |
|---|---|
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE | |
| There is no difference between the new devices and the predicate devices with respect to indications foruse, principles of operation, or manufacturing. Design differences have been demonstrated to not affectsafety or effectiveness or raise new issues of safety or effectiveness. | |
| PERFORMANCE DATA | |
| Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Torque to Failure | |
| 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 indicatedthe devices performed within the intended use, did not raise any new safety and efficacy issues and werefound to be substantially equivalent to the predicate devices. |
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§ 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.”