(168 days)
No
The summary describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a shoulder prosthesis indicated to relieve severe pain or significant disability, which is a therapeutic purpose.
No
The device is a shoulder prosthesis designed for replacement, not for diagnosing conditions. Its purpose is to treat by replacing damaged joint structures, not by identifying or characterizing disease.
No
The device description clearly details physical components made of Co-Cr-Mo alloy and titanium plasma spray, which are hardware.
Based on the provided text, 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: The SEVIIN Surface Replacement Shoulder is a physical implant designed to replace parts of the shoulder joint. It is a surgical device, not a test performed on a sample.
- Intended Use: The intended use is to relieve pain and disability caused by various shoulder conditions through surgical replacement, not to diagnose these conditions using a sample.
The description clearly indicates a medical device used in vivo (within the body) for surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.
Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:
- Rheumatoid arthritis .
- Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
- Correction of functional deformity .
- Humeral head fractures . ●
- Traumatic arthritis .
The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.
Product codes
HSD, KWS, KWT
Device Description
The SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis designed for use in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. Additionally, the SEVIIN Surface Replacement Shoulder can be revised to a longer stemmed total shoulder if necessary.
The Resurfacing Humeral Heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F799 and have a polished spherical surface for atticulation. The inner surface of the humeral heads is coated with titanium plasma spray. Three sizes of humeral heads are available: 42mm, 48mm and 52mm diameter with a stem that is tapered and fluted to provide stability in the humerus.
The Surface Replacement humeral heads are compatible with the previously cleared SEVIIN Total Shoulder Glenoids (K043346) for total shoulder replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / humeral head and neck
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
Non-Clinical Testing: Substantial equivalence analysis and torsional testing of the Resurfacing Humeral Head fixation indicate that all components are adequate for their intended use. Substantial equivalence was based on a comparison of intended use, indications, materials, sizes and design.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SEVIIN Surface Replacement Shoulder to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
| 510(k) Summary | |
|---|---|
| Prepared: | March 8, 2013 |
| Submitter: | Ingen Orthopedics, LLC |
| 2650 US Highway 130 | |
| Cranbury, NJ 08512 | |
| Contact: | Perry A. Geremakis |
| President, Chief Executive Officer | |
| Ingen Orthopedics, LLC | |
| P: 609/409-3316 | |
| F: 609/409-3317 | |
| E: pgeramakis@ingenortho.com | |
| Proprietary Name: | SEVIIN Surface Replacement Shoulder |
| Common Name: | Resurfacing Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) |
| metallic uncemented prosthesis; Class II | |
| 21 CFR 888.3660: Shoulder joint metal/polymer semi- | |
| constrained cemented prosthesis; Class II | |
| Product Codes: | HSD, KWS, KWT |
| Substantially | |
| Equivalent Devices: | Copeland MB Resurfacing Humeral Heads, K010657, |
| cleared Sept 14, 2001 | |
| Tornier Aequalis Resurfacing Head, K062661, cleared | |
| December 22, 2006 | |
| AUG 2 6 2013 |
Device Description:
The SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis designed for use in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. Additionally, the SEVIIN Surface Replacement Shoulder can be revised to a longer stemmed total shoulder if necessary.
1
The Resurfacing Humeral Heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F799 and have a polished spherical surface for atticulation. The inner surface of the humeral heads is coated with titanium plasma spray. Three sizes of humeral heads are available: 42mm, 48mm and 52mm diameter with a stem that is tapered and fluted to provide stability in the humerus.
The Surface Replacement humeral heads are compatible with the previously cleared SEVIIN Total Shoulder Glenoids (K043346) for total shoulder replacement.
Intended Use / Indications:
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.
Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:
- Rheumatoid arthritis .
- Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
- Correction of functional deformity .
- Humeral head fractures . ●
- Traumatic arthritis .
The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.
Summary of Technologies/Substantial Equivalence:
The SEVIIN Surface Replacement Shoulder is substantially equivalent to the predicate devices in regards to its intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.
Non-Clinical Testing:
Substantial equivalence analysis and torsional testing of the Resurfacing Humeral Head fixation indicate that all components are adequate for their intended use. Substantial equivalence was based on a comparison of intended use, indications, materials, sizes and design.
2
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the SEVIIN Surface Replacement Shoulder 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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ci609 Silver Spring, MI) 20993-0002
August 26, 2013
Ingen Orthopedics, LLC % Mr. Perry Geremakis President. Chief Executive Officer 2650 US Highway 130 Cranbury, New Jersey 08512
Re: K130635
Trade/Device Name: SEVIIN Surface Replacement Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (heni-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, KWS, KWS, KWT Dated: June 26, 2013 Received: July 18, 2013
Dear Mr. Geremakis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 complics 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 -- Mr. Perry Geremakis
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K130635 510(k) Number (if known): _
Device Name: SEVIIN Surface Replacement Shoulder
Indications for Use:
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.
Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:
- . Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
- Correction of functional deformity ◆
- Humeral head fractures .
- Traumatic arthritis .
The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.
Over-The-Counter Use Prescription Use __ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices