(66 days)
Not Found
No
The 510(k) summary describes a mechanical implant for shoulder joint resurfacing and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are focused on mechanical testing of the implant.
Yes
The device is intended for the reconstruction of painful and/or severely disabled shoulder joints, which is a therapeutic purpose.
No
The device is described as an implant for the reconstruction of shoulder joints, specifically for avascular necrosis or degenerative disease. It is a resurfacing system and an intended use description for treatment, not diagnosis.
No
The device description clearly states it is an "articular resurfacing component and a taper post fixation component" which are physical implants, not software. The performance studies also describe mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical reconstruction of painful and/or severely disabled shoulder joints. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an implantable system for resurfacing the humeral head. This is a physical device implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for Use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSD
Device Description
The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joints
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)
In support of this submission, the following non-clinical tests and analyses have been performed on the Subject Device:
- o Static Compression Testing
- Cyclic Fatigue Testing ●
- . Axial Disassembly Testing
- Torsional Testing .
The results have demonstrated the safety and effectiveness of the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System Implants along with substantial equivalence to the predicate device (K023096).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K023096, K003044, K010664, K031971
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).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of what appears to be an abstract human figure or a bird-like shape, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Arthrosurface Incorporated Ms. Dawn J. Wilson Vice President of Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K142942
Trade/Device Name: HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 18, 2014 Received: November 20, 2014
Dear Ms. Wilson:
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. 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 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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
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Section 4 Indications for Use Statement
510(k) Number (if known):
- HemiCAP® Humeral Head XL (HHXL) Device Name: Articular Resurfacing System
Indications For Use:
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section 5 510(k) Summary
HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System
Special 510(k): Device Modification
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel:
508.520.3003
508.528.4604
Fax: | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Dawn Wilson
VP, Quality & Regulatory
508.520.3003
Tel:
508.528.4604
Fax:
dwilson@arthrosurface.com | |
| Establishment Registration
Number: | 3004154314 | |
| Date of Preparation: | October 9th, 2013 | |
| Confidentiality: | Reference Section 3 | |
| Proprietary Name: | HemiCAP® Humeral Head XL (HHXL)
Articular Resurfacing System | |
| Common Name: | Hemi-Shoulder Resurfacing Prosthesis | |
| Device: | Prosthesis, Shoulder, Hemi-, Humeral, Metallic
Uncemented | |
| Regulation Description: | Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis | |
| Requlation Number: | 888.3690 | |
| Device Class: | Class II | |
| Review Panel: | Orthopedic | |
| Product Code: | HSD | |
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Intended Use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.
Device Description
The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
Substantial Equivalence Information
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the HemiCAP® Humeral Head XL Articular Resurfacing System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:
- . The sponsor's previously cleared Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System (K023096, Cleared on 04/10/2003)
- Biomet Inc.'s Copeland Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on 04/05/2001)
- DePuy Orthopaedics Inc.'s Global CAP Resurfacing Replacement Shoulder ● (K031971, Cleared on 09/24/2003)
The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K023096).
- Has the same Indications for Use,
- o Has the same operating principle,
- Is manufactured using the same material,
- Has the same shelf life,
- ls packaged and sterilized using the same materials and processes. ●
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In support of this submission, the following non-clinical tests and analyses have been performed on the Subject Device:
- o Static Compression Testing
- Cyclic Fatigue Testing ●
- . Axial Disassembly Testing
- Torsional Testing .
The results have demonstrated the safety and effectiveness of the HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System Implants along with substantial equivalence to the predicate device (K023096).