(191 days)
No
The device description and summary of performance studies focus on the mechanical aspects of a shoulder implant and its components, with no mention of AI or ML technologies.
Yes
Explanation: The device is a semi-constrained modular component designed to address proximal fractures and arthritis of the shoulder joint, which are therapeutic interventions.
No
The device description indicates that the Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures and arthritis of the shoulder joint, functioning as an implant rather than a diagnostic tool.
No
The device description clearly details physical components made of cobalt chrome and titanium, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended to address proximal fractures and arthritis of the shoulder joint. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The description details a surgical implant (a shoulder system) designed to be placed within the body to replace or support damaged bone and joint structures. This is characteristic of a medical device used in surgery, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease state.
In summary, the Acumed Modular Shoulder System is a surgical implant used for treatment, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.
Product codes (comma separated list FDA assigned to the subject device)
HSD
Device Description
The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement. It incorporates a cobalt chrome modular head, a titanium body, and a selles of the components may be mixed and matched in order to best duplicate the patient's anktomy. Several strategic holes for suturing are in the body the surgeon to tie down the greater- and lesser-tuberosities, which are frequently displaced during these types of fractures. Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire. The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head. Targeting instrumentation is provided to allow accurate of the screws through the component.
The Acumed Modular Shoulder System is provided both non-sterile. The sterile version is packaged in inner and outer PETO blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10 . We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation and implant can be successfilly steam sterilized under specific process parameters which will obtain a resulting SAL of 104. Information regarding has been provided. Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength for this application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint
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)
Not Found
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.
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.
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
K992525
FEB 4 2000
Appendix F - 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
| Classification Name: | Prosthetic, shoulder, humeral (hemi-shoulder), uncemented, metallic |
|---|---|
| Common Name: | Modular shoulder system |
| Proprietary Name: | Acumed Modular Shoulder System |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | HSD |
| Manufacturing Facility: | Acumed, Inc. |
| 10950 SW 5th Street, Suite 170 | |
| Beaverton, OR 97005 U.S.A. | |
| Establishment Registration No .: | 3025141 |
| Contact: | Shari Jeffers |
| Labeling/Promotional Materials: | See Appendix D |
| Substantial Equivalence: | This device is similar in size, material, and intended use to the Atlas |
| Modular Shoulder (K961260) and the Select Shoulder System | |
| (K962224). This device is most similar in design to the Atlas Modular | |
| shoulder in that both devices consist of a head, body, and stem | |
| components, have holes for suturing, and have a Morse tapered stem | |
| Literature on the Atlas and Select Shoulder Systems are included in | |
| Appendix E. |
The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement. It incorporates a cobalt chrome modular head, a titanium body, and a selles of the components may be mixed and matched in order to best duplicate the patient's anktomy. Several strategic holes for suturing are in the body the surgeon to tie down the greater- and lesser-tuberosities, which are frequently displaced during these types of fractures. Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire. The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head. Targeting instrumentation is provided to allow accurate of the screws through the component.
The Acumed Modular Shoulder System is provided both non-sterile. The sterile version is packaged in inner and outer PETO blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterlity is performed using the AAMI - Method 1. Sterllity assurance level is 10 . We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation and implant can be successfilly steam sterilized under specific process parameters which will obtain a resulting SAL of 104. Information regarding has been provided. Test data provided concludes that the taper selected for the Acumed Modular Shoulder System will provide adequate locking strength for this application.
Predicate devices that are substantially equivalent to the Acumed Modular System are the Atlas Modular Shoulder and the Intermedics Select Shoulder. All the devices mentioned above are manufactured from similar materials and have the same intended use. The design of the Acumed Shoulder is most similar to the Atlas Shoulder in that both devices consist of a head, body, and stem components, have holes for suturing, and have a Morse rapered stem. The Acumed Shoulder and the Atlas Shoulder have similar surgical techniques. Based on the similarities between the Acumed Modular System and the predicate devices studied, the safety and effectiveness of the Acumed Modular System is expected to be similar to the prodicate devices mentioned above.
10950 SW Sth Street, Suite 170, Beaverton, OR 97005 U.S.A. . (503) 627;9957 . ● Fax: (503) 520-9618 Page 11 © 1999, Acumed, Inc.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Ms. Shari Jeffers Regulatory Affairs Manager Acumed. Inc. 10950 SW 5th Street, Suite 170 Beaverton, Oregon 97005
Re: K992525/S1
Trade Name: Acumed Modular Shoulder System Regulatory Class: II Product Code: HSD Dated: November 5, 1999 Received: November 8, 1999
Dear Ms. Jeffers:
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 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 regulations.
2
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) 594-4595. 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 vours.
Neil R. Ogden
James E. Dillard III
James E. Di Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
S10(k) Number (if known):_K992 S Z S
Device Name: ___ Acumed Shoulder Implany
Indications For Use:
Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| NPO for JZD | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992525 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
. •
·
(Optional Format 1-2-96)
.