(177 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant system and its components. There is no mention of software, algorithms, image processing, or any other indicators of AI/ML technology. The performance studies are entirely based on engineering analysis and mechanical testing.
Yes
The device is a medical implant (system of components for humeral replacement) that is intended to treat and alleviate various conditions such as degenerative joint disease, arthritis, fractures, and bone loss due to tumor resection, which are clearly therapeutic uses.
No
Explanation: The Comprehensive® Segmental Revision System is described as a replacement system for various parts of the upper extremity, intended for treatment of conditions like degenerative joint disease, fractures, and oncology applications. Its purpose is to physically replace or repair structures, not to diagnose medical conditions. The performance studies listed are mechanical and engineering tests, not diagnostic accuracy studies.
No
The device description clearly outlines physical components such as humeral heads, stems, and segments, indicating it is a hardware-based implant system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing parts of the upper extremity bones (shoulder and elbow) due to various conditions like arthritis, fractures, and bone loss. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details components of a physical implant (humeral heads, stems, segments, etc.) designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
N/A
Intended Use / Indications for Use
The Comprehensive® Segmental Revision System is intended for use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
The Comprehensive® Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive® Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment.
Product codes
KWT, KWS, MBF, JDC
Device Description
The Comprehensive® SRS address the needs of the upper extremity, especially in cases where there is marked bone loss. Applications of the system include proximal humeral (shoulder) replacements distal humeral (elbow) replacements and total humeral replacements. Components of the system include humeral heads, proximal humeral bodies, intercalary segments, humeral stems, total humeral couplers, distal bodies with a modular flange, and modular tissue attachment augments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper extremity, proximal humeral (shoulder), distal humeral (elbow), total humeral.
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
- Engineering analysis to determine weakest point of the construct
- Engineering analysis to determine range of motion
- Engineering analysis to justify smaller diameter long stems
- Cantilever fatigue testing to compare stem strength to predicate
- Cyclic loading followed by screw torque out to confirm augment stability
- Engineering analysis for flange loading determination
- Cyclic fatigue testing of humeral flange
- Static Axial Separation of SRS taper junction
- Static Axial Separation of Comprehensive® taper junction
- Shear testing to determine elbow condyle strength
- MR Compatibility to ASTM F2182-09
Summary Of Clinical Tests Conducted For Determination Of Substantial Equivalence And/Or 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 analysis and mechanical testing indicated the devices 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)
K043505- Discovery® - Mosaic® Total Humeral System, K042321- Mosaic® Non-Modular Proximal Body and EAS Offset Modular Humeral Head, K033280 -- Discovery® Elbow - Mosaic® Proximal Humeral Replacement System, K020045 - 3-Piece Proximal Humeral Replacement System, K022079 - Short and Long Tissue Attachment Sleeves, K925613 - Proximal Humeral Replacement System, K030710 - Bio-Modular® Shoulder System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “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/0 description: The image shows a blurry, black and white image of what appears to be Arabic text. The text is written in a calligraphic style, with the letters connected to each other. Due to the blurriness of the image, it is difficult to read the text. The background of the image is white.
DEC 1 5 2011
・・
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Image /page/0/Picture/3 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with the letters connected. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black on a white background.
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| 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 | ||
| Date prepared | December 5, 2011 | |
| DEVICE INFORMATION | ||
| Name of device | ||
| Trade or proprietary name | Comprehensive® Segmental Revision System (SRS) | |
| Common or usual name | Shoulder, elbow and total humeral replacement prosthesis | |
| Classification name | Shoulder joint metal/polymer non-constrained cemented prosthesis Shoulder joint metal/polymer semi-constrained cemented prosthesis Shoulder joint metal/polymer/metal non-constrained or semi-constrained porous coated uncemented prosthesis Elbow joint metal/polymer constrained cemented prosthesis | |
| Classification panel | Orthopedics | |
| Regulation | 21 CFR§888.3650/3660/3670/3150 | |
| Product Code(s) | KWT, KWS, MBF, JDC | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | K043505- Discovery® - Mosaic® Total Humeral System K042321- Mosaic® Non-Modular Proximal Body and EAS Offset Modular Humeral Head K033280 -- Discovery® Elbow - Mosaic® Proximal Humeral Replacement System K020045 - 3-Piece Proximal Humeral Replacement System K022079 - Short and Long Tissue Attachment Sleeves K925613 - Proximal Humeral Replacement System K030710 - Bio-Modular® Shoulder System | |
| Reason for 510(k) submission | Update of existing product line | |
| Device description | The Comprehensive® SRS address the needs of the upper extremity, especially in cases where there is marked bone loss. Applications of the system include proximal humeral (shoulder) replacements distal humeral (elbow) replacements and total humeral replacements. Components of the system include humeral heads, proximal humeral bodies, intercalary segments, humeral stems, total humeral couplers, distal bodies with a modular flange, and modular tissue attachment augments. | |
| Indications for use | The Comprehensive® Segmental Revision System is intended for use | |
| in cases of: |
- Non-inflammatory degenerative joint disease including
osteoarthritis and avascular necrosis. - Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the
Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head
(shoulder) involvement, which are unmanageable using other
treatment methods.
When used as a distal or total humeral replacement, the
Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle
(elbow) involvement, which are unmanageable using other
treatment methods. | |
| Intended use of the device | The Comprehensive® Segmental Revision System is intended for use
with or without bone cement in the proximal shoulder.
The Comprehensive® Segmental Revision System is intended for use
with bone cement in distal humeral and total humeral applications.
Tissue Attachment Augments provide the option for tissue
stabilization and attachment. | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE
COMPARED TO THE PREDICATE | | |
| Characteristic | Comprehensive® SRS | Predicate |
| Materials | Ti-6Al-4V
Co-Cr-Mo | K020045
K020045 |
| Principal of Operation | Proximal humeral, distal humeral
or total humeral replacement | K925613, K020045, K033280,
K043505 |
| Proximal Bodies | Resection Levels - 42-71mm | K020045 |
| Humeral Stems | Taper Head Attachment | K030710 |
| | Diameters - 4-20mm | K020045, K033280, K925613 |
| | Lengths - 75-200mm | K020045, K033280, K925613 |
| | Porous Coating Proximally | K020045, K033280, K030710 |
| Intercalary Segments and Couplers | Diameter - 19mm | K020045, K033280, K043505 |
| | Lengths - 30-120mm | K020045, K033280, K043505 |
| Tissue Attachment | Augments | K022079 |
| Humeral Heads | Diameters - 40-54mm | K030710 |
| | Extended Articular Surface | K042321, K030710 |
| Distal Humeral Bodies | Resection Height - 50, 60, 70mm | K033280, K043505 |
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510(k) Summary
Comprehensive® Segmental Revision System (SRS)
Page 2 of 3
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510(k) Summary
Comprehensive® Segmental Revision System (SRS)
Page 3 of 3
| PERFORMANCE DATA |
|---|
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence |
| Engineering analysis to determine weakest point of the construct |
| Engineering analysis to determine range of motion |
| Engineering analysis to justify smaller diameter long stems |
| Cantilever fatigue testing to compare stem strength to predicate |
| Cyclic loading followed by screw torque out to confirm augment stability |
| Engineering analysis for flange loading determination |
| Cyclic fatigue testing of humeral flange |
| Static Axial Separation of SRS taper junction |
| Static Axial Separation of Comprehensive® taper junction |
| Shear testing to determine elbow condyle strength |
| MR Compatibility to ASTM F2182-09 |
| Summary Of Clinical Tests Conducted For Determination Of Substantial Equivalence And/Or 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 analysis and mechanical testing indicated the devices 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. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
DEC 1 5 2011
Re: K111746
Trade/Device Name: Comprehensive® Segmental Revision System (SRS) Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, KWS, MBF, JDC Dated: December 12, 2011 Received: December 13, 2011
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Patricia Sandborn Beres
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincercly yours,
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: _Comprehensive® Segmental Revision System (SRS)
İndications For Use:
The Comprehensive® Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
. ")
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
The Comprehensive® Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive® Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment.
AND/OR
Prescription Use __ X (Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K111746