(49 days)
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Not Found
No
The summary describes a prosthetic shoulder system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated to relieve severe pain or significant disability, which are therapeutic claims.
No
The provided text describes a "Prosthetic replacement" device and its indications for use (e.g., to relieve pain, address fractures, avascular necrosis). It does not mention any function related to diagnosing a condition.
No
The device description clearly states "OTI Modular Shoulder System (Hemi humeral component)", which is a physical implant, not software.
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 prosthetic replacement of the shoulder joint to relieve pain and disability caused by various conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a "Hemi humeral component" of a shoulder system, which is a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens outside the body.
Therefore, the OTI Modular Shoulder System (Hemi humeral component) is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component)may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.
Product codes
HSD
Device Description
OTI Modular Shoulder System
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 joint, humeral head, humerus
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures representing health, services, and the human aspect of the department's mission.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1998
Mr. Sam Son Vice President of Technical Affairs Osteoimplant Technology, Inc. 11201 Pepper Road Hunt Valley, Maryland 21031
Re: K982886 OTI Modular Shoulder System Regulatory Class: II Product Code: HSD Dated: August 12, 1998 Received: August 17, 1998
Dear Mr. Son:
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 Requlation (QS) for Medical Devices: General regulation (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 requlations.
1
Page 2 - Mr. Sam Son
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 regulation (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Celra M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): 510(k) K 982886 Device Name: OTI Modular Shoulder System
Indications For Use:
Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component)may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
D. Seela
OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982886
510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)