(30 days)
The Constrained Elbow is indicated for use in the following conditions:
- Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revisions where other treatments or devices have failed
- Correction of severe functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
This device is intended for cemented use.
The Constrained Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. The humeral components are available with or without an anterior flange. All ulnar and humeral components are manufactured with or without Bond coat.
The device design allows the load to be carried at the primary articulation. The primary articulation is the spherical interface between the humeral condyles and the ulnar bearing. The secondary articulation is the axle attached to one condyle, which fits into the hole of the opposite condyle. The geometry of the components is designed to minimize bone loss and eliminate sharp resection cuts.
The humeral stem has been designed to incorporate a five degree carrying angle with a five degree internal rotation to closely match the anatomical morphology. The ulnar component incorporates a bowed stem and neck angle also designed to closely match the anatomical morphology.
The provided document is a 510(k) premarket notification for a medical device called the "Discovery Elbow." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing new performance criteria through clinical trials. Therefore, the document does not contain the information required to populate a table of acceptance criteria and reported device performance based on a study of the device itself.
Here's why and what information is available:
- No Acceptance Criteria and Reported Performance Table: The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence." This means there was no study conducted on the Discovery Elbow to measure its performance against predefined acceptance criteria. Instead, substantial equivalence was established through non-clinical testing (Finite Element Analysis) and by comparing its technological characteristics (materials, design, sizing, and indications) to a predicate device.
Therefore, I cannot provide the requested table or answer most of the detailed questions about a study on the Discovery Elbow.
However, I can extract information relevant to how substantial equivalence was determined:
1. A table of acceptance criteria and the reported device performance:
- Not applicable. No clinical study was performed on the Discovery Elbow to generate performance data against acceptance criteria. Substantial equivalence was based on comparison to a predicate device.
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical "test set" was used for the Discovery Elbow itself. The evaluation relied on non-clinical data (Finite Element Analysis) and comparison to a predicate device for which clinical data presumably existed but is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical "test set" was established for the Discovery Elbow.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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. This device is an elbow prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an elbow prosthesis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For substantial equivalence, the "ground truth" was the performance and characteristics of the legally marketed predicate device (Constrained Elbow, K003253). The Discovery Elbow was deemed equivalent based on its design, materials, and intended use aligning with that predicate, supported by Finite Element Analysis.
8. The sample size for the training set:
- Not applicable. No training set was used as this is not a machine learning device, and no clinical study was conducted.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Equivalence Information from the document:
- Device Name: Discovery Elbow
- Predicate Device: Constrained Elbow, K003253
- Intended Use (for both Discovery Elbow and implied for predicate):
- Non-Inflammatory Degenerative Joint Disease (osteoarthritis, avascular necrosis)
- Rheumatoid arthritis
- Revisions where other treatments or devices have failed
- Correction of severe functional deformity
- Treatment of acute or chronic fractures with humeral epicondyle involvement unmanageable by other methods
- Method of Substantial Equivalence Demonstration:
- Non-Clinical Testing: Finite Element Analysis was performed.
- Clinical Testing: Explicitly stated: "Clinical testing was not used to establish substantial equivalence."
- Technological Characteristics Comparison: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.
This document serves as an FDA clearance letter based on substantial equivalence, not a report of a performance study with acceptance criteria.
{0}------------------------------------------------
OCT 1 0 2001
loF 2
CORPORATE HEADQUARTERS SUMMARY OF SAFETY AND EFFECTIVENESS
Discovery Elbow
Elbow Prosthesis
Applicant or Sponsor:
Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Contact Person:
Sara B. Shultz Biomet Manufacturing, Corp. P.O. Box 587 Warsaw, IN 46581-0587 Phone: (219) 267-6639 Fax: (219) 372-1683
Proprietary Name:
Common Name:
Class II
Classification Name:
Product Classification:
Elbow joint metal/polymer constrained cemented prosthesis (888.3150)
Device Product Code: 87JDC
Legally Marketed Devices To Which Substantial Equivalence is Claimed: Constrained Elbow, K003253
Intended Use: The Constrained Elbow is indicated for use in the following conditions:
- 에 Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis
- 트 Rheumatoid arthritis
- I Revisions where other treatments or devices have failed
- I Correction of severe functional deformity
- 트 Treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
This device is intended for cemented use.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
행
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
Image /page/0/Picture/24 description: The image shows a sequence of numbers, specifically "000271". The numbers are written in a bold, handwritten style, with each digit clearly distinguishable. The digits appear to be part of a label or identifier, possibly from a document or record.
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL blomet@biomet.com
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20F2
Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, sans-serif font with a unique design, where the letters are connected and have a geometric appearance. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, serif font, spread out to match the width of the logo above.
Device Description: The Constrained Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. The humeral components are available with or without an anterior flange. All ulnar and humeral components are manufactured with or without Bond coat.
The device design allows the load to be carried at the primary articulation. The primary articulation is the spherical interface between the humeral condyles and the ulnar bearing. The secondary articulation is the axle attached to one condyle, which fits into the hole of the opposite condyle. The geometry of the components is designed to minimize bone loss and eliminate sharp resection cuts.
The humeral stem has been designed to incorporate a five degree carrying angle with a five degree internal rotation to closely match the anatomical morphology. The ulnar component incorporates a bowed stem and neck angle also designed to closely match the anatomical morphology.
Summary of Technologies: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.
Non-Clinical Testing: Finite Element Analysis was performed to establish substantial equivalence.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
00272
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
OFFICE
219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three wavy lines or a caduceus, which is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2001
Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K013042
Trade/Device Name: Biomet Discovery Elbow Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: September 5, 2001 Received: September 10, 2001
Dear Ms. Shultz:
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.
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Page 2 - Ms. Sara B. Shultz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Mark N Milburn
Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known) : _ KO | 3040
Device Name: Discovery Elbow
Indications For Use:
The Discovery Elbow is indicated for use with the following conditions:
- · Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis 에
- Revisions where other treatments or devices have failed 피
- Correction of severe functional deformity 내
- Treatment of acute or chronic fractures with humeral epicondyle involvement which 대 are unmanageable using other treatment methods
This device is intended to be used with bone cement.
fo Mark N. Milkers
neral. Restorative and Neurolo, cal Devices 013042
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
0000008
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”