(51 days)
No
The summary does not mention AI, ML, or any related technologies, and the device description focuses on mechanical components.
Yes
The device is a Discovery™ - Mosaic™ Total Humerus System, which is an artificial joint system intended for cemented use in various medical conditions impacting the humerus, including degenerate joint disease, rheumatoid arthritis, fractures, and oncology applications. These applications are inherent to therapeutic devices, which are designed to treat or alleviate disease, injury, or disability.
No
The device is an orthopedic implant (Total Humerus System) intended for surgical replacement in various joint conditions and injuries, not for diagnosing them.
No
The device description clearly states it includes physical components (Discovery Elbow, 3 Piece Proximal Humeral Replacement System, intercalary segment, modular heads, glenoid components), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly indicate that the Discovery™ – Mosaic™ Total Humerus System is a surgical implant designed to replace parts of the humerus bone (in the elbow and shoulder). It is used for treating various bone and joint conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical implant/prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the Discovery™ – Mosaic™ Total Humerus System include:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
-
- Oncology applications
The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.
Product codes
KWT
Device Description
The Discovery™ - Mosaic™ Total Humerus System includes the components of the Discovery Elbow, the components of the 3 Piece Proximal Humeral Replacement System, and an intercalary segment designed to connect them. The Discovery™ - Mosaic™ Total Humerus System uses the same modular heads and glenoid components that were cleared for use in the predicate 3 Piece Proximal Humeral Replacement System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral epicondyle (elbow), humeral head (shoulder)
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)
Non-Clinical Testing:
The performance data indicated that the Discovery™ - Mosaic™ Total Humerus System is I ric performally equivalent to the predicate devices for the uses indicated.
Clinical Testing:
It Testing was not required for these components to support substantial equivalence.
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
§ 888.3650 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
FEB - 9 2005
510(k) Summary
Applicant/Sponsor:
Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Contact Person:
Gary Baker Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (574) 267-6639 FAX: (574) 372-1683
Proprietary Name: Discovery™ - Mosaic™ Total Humerus System
Shoulder Prosthesis Common Name:
Classification Name: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer, Cemented (21 CFR 888.3650)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System: K033280 -Biomet Inc. 3 Piece Proximal Humeral Replacement System: K020045 - Biomet Inc.
Device Description:
The Discovery™ - Mosaic™ Total Humerus System includes the components of the Discovery Elbow, the components of the 3 Piece Proximal Humeral Replacement System, and an intercalary segment designed to connect them. The Discovery™ - Mosaic™ Total Humerus System uses the same modular heads and glenoid components that were cleared for use in the predicate 3 Piece Proximal Humeral Replacement System.
MAHING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()FFICE 574.267.6639
ト・ヘ× 574.267.8137
E-MAIL biomet@biomet.com
86
1
K043565 Lot 2
Intended Use:
The indications for use for the Discovery™ – Mosaic™ Total Humerus System include:
- leations for use for the degencrative joint disease including osteoarthritis and avascular necrosis
- 2. Rheumatoid arthritis
- Revision where other devices or treatments have failed 3.
- Correction of functional deformity 4.
- Correction of famononal deformic fractures with humeral epicondyle (elbow) ર્ડ . involvement or humeral head (shoulder), which are unmanageable using other treatment methods
-
- Oncology applications
The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.
Summary of Technologies:
al your recimiologies:
The Discovery™ - Mosaic™ Total Humerus System components have the same intended The Discovery - - Hosare - and are manufactured from the same materials as the predicate devices.
Non-Clinical Testing:
illical Testing.
The performance data indicated that the Discovery™ - Mosaic™ Total Humerus System is I ric performally equivalent to the predicate devices for the uses indicated.
Clinical Testing:
It Testing was not required for these components to support substantial equivalence.
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of three overlapping lines that resemble a person.
FEB - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gary Baker Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581
Re: K043505
Trade/Device Name: Discovery™ - Mosaic ™ Total Humerus System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT Dated: December 17, 2004 Received: December 20, 2004
Dear Mr. Baker:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millanvor
Celia M. Witten, Ph.D., M.D. Director, Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Statement of Indications For Use
510(k) Number (IF KNOWN): Kby 3500
Device Name: Discovery™ - Mosaic™ Total Humerus System
Indications for Use:
The indications for use for the Discovery™ - Mosaic™ Total Humerus System include:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or న్న humeral head (shoulder), which are unmanageable using other treatment methods
-
- Oncology applications
The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.
Prescription Use ズ (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Per 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)
Mark M. Millinson
510(k) Number