(290 days)
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Not Found
No
The document describes a mechanical shoulder replacement system and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as a "Shoulder Replacement System" intended for the "reconstruction of painful and/or severely disabled shoulder joints" due to various arthritic conditions or failed prostheses, which are all therapeutic interventions aimed at treating a medical condition.
No
Explanation: The device is a shoulder replacement system intended for reconstruction of shoulder joints, not for diagnosing conditions.
No
The device description clearly indicates a "Modular Salvage Shoulder Replacement System," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "Modular Salvage Shoulder Replacement System" for the "reconstruction of painful and/or severely disabled shoulder joints." This is a surgical implant used directly in the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Lack of IVD Characteristics: The provided information does not mention any testing of samples from the body, analysis of biological markers, or diagnostic purposes in the sense of identifying a disease or condition through laboratory analysis.
This device is a surgical implant used for the treatment of shoulder joint issues, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.
Product codes
MJT, KWT, HSD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder joints
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines underneath them. The profiles and lines are contained within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Jerry D'Alessio, MSBME Applications Enqineer Endotec, Inc. 20 Valley Street 07079 South Orange, New Jersey
K982418 Re: Buechel-Pappas Modular Salvage Shoulder Replacement System Requlatory Class: III Product Codes: MJT, KWT, and HSD Dated: October 15, 1998 Received: October 19, 1998
Dear Mr. D'Alessio:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Jerry D'Alessio, MSBME
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with the word "ENDOTEC" in white letters against a black circle. The text is bold and sans-serif, with each letter clearly defined. The circle is positioned to the left of the text, partially overlapping the first few letters. The overall design is simple and modern, with a focus on readability and brand recognition.
INDICATIONS FOR USE
510(k) Number (if known):_ K982418
Device Name: BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System
Indications For Use:
The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.
(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 General Restorative Devices 510(k) Number KG X 24)
Prescription Use
OR
Over-The-Counter Use --------
20 Valley Street South Orange, NJ 07079 Tel. 973 762 0095 Fax. 973 762 2279