(59 days)
Not Found
No
The 510(k) summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to treat fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus by providing optimal stabilization of the fracture, which directly contributes to healing and restoring function.
No
Explanation: The device is a Shoulder Nail Plate intended for the fixation of Humerus fractures, osteotomies, and non-unions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical implant (Shoulder Nail Plate) intended for surgical fixation of the humerus, which is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a "Shoulder Nail Plate" intended for the surgical fixation of fractures and other issues in the proximal humerus (upper arm bone). It is a physical implant used within the body.
- Intended Use: The intended use is for treating fractures and related conditions, which is a surgical intervention, not a diagnostic test performed on a sample.
This device is a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
Product codes
HRS
Device Description
The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to be attached to the metaphysis of the humerus. The nail segment of the Shoulder Nail Plate is intended to be inserted into the humeral diaphysis for optimal stabilization of the fracture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal Humerus
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)
The equivalence was confirmed through pre-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K052294 v°/i
0CT 2 1 2005
510(k) Summary of Safety and Effectiveness
| General
| Provisions | The name of the device is: | ||
|---|---|---|---|
| Proprietary Name | Common or Usual Name | ||
| Shoulder Nail Plate | Plate Fixation Bone | ||
| Name of | |||
| Predicate | |||
| Devices | The Shoulder Nail Plate is substantially equivalent to the following predicate | ||
| devices: | |||
| • Shoulder Fixation System, 510(k) No. K051728 - June 20, 2005 - Hand | |||
| Innovations, LLC | |||
| • Dorsal Nail Plate of the Distal Radius Fracture Repair System, 510(k) No. | |||
| K023007 - December 5, 2002 - Hand Innovations, LLC | |||
| • T2TM Proximal Humeral Nailing System, 510(k) No. K043404 - December | |||
| 27, 2004 - Stryker Corporation. | |||
| Classification | Class II. | ||
| Performance | |||
| Standards | Performance standards have not been established by the FDA under section 514 of | ||
| the Food, Drug and Cosmetic Act. | |||
| Indications for | |||
| Use | The Shoulder Nail Plate of the Shoulder Fixation System is intended for | ||
| fractures and fracture dislocations, osteotomies, and non-unions of the proximal | |||
| Humerus. | |||
| Device | |||
| Description | The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both | ||
| left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to | |||
| be attached to the metaphysis of the humerus. The nail segment of the Shoulder | |||
| Nail Plate is intended to be inserted into the humeral diaphysis for optimal | |||
| stabilization of the fracture. | |||
| Biocompati- | |||
| bility | The Shoulder Nail Plate do not require biocompatibility testing because the stainless | ||
| steel used in fabrications meets the requirements of ASTM F 138-03. | |||
| Summary of | |||
| Substantial | |||
| Equivalence | The Shoulder Nail Plate is substantially equivalent to the predicate Shoulder Side | ||
| Plate of the Shoulder Fixation System with regards to the intended use, materials, | |||
| biocompatibility, and overall performance characteristics. The equivalence was | |||
| confirmed through pre-clinical testing. |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ernesto Hernandez Vice President, RA/QA Hand Innovations, LLC. 8905 SW 87th Avenue, Suite 220 Miami. Florida 33176
Re: K052294 Trade/Device Name: Shoulder Nail Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 19, 2005 Received: August 30, 2005
Dear Mr. Hernandez:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ernesto Hernandez
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and n your e FDA finding of substantial equivalence of your device to a legally promaticated predicated 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), please n you don't the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micromational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Shoulder Nail Plate
Indications for Use Statement
The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K052294 |
|---|---|
| --------------- | --------- |
Shoulder Nail Plate 510(k) Premarket Notification