(90 days)
Not Found
Not Found
No
The 510(k) summary describes a simple mechanical device (suture washer and screw) and makes no mention of AI, ML, or any related computational or image processing technologies.
No
A therapeutic device is one that treats or cures a disease or condition. This device is used for fixation of soft tissue and bone, which is a structural support function, not a treatment.
No
Explanation: The "Intended Use / Indications for Use" section states the device is "intended for soft tissue fixation, small bone fixation, and large bone fixation," which describes a therapeutic or assistive function, not a diagnostic one. There is no mention of identifying or characterizing diseases or conditions.
No
The device description clearly states it is a physical washer made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Acumed Suture Washer is a physical implantable device used for fixing soft tissue and bone. It is used in the body, not to test samples from the body.
- Intended Use: The intended use clearly states "soft tissue fixation, small bone fixation, and large bone fixation," which are surgical procedures performed directly on the patient.
Therefore, based on the provided information, the Acumed Suture Washer is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Acumed Suture Washer has a post height of 2.6mm and an outer diameter of 8.0mm. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided sterile. Sterility is achieved by a minimum of 2.5 Mrads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility assurance level is 104.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Not Found
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
§ 888.3030 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
Image /page/0/Picture/0 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are all capitalized and black. There is a "TM" symbol in the upper right corner of the word. A thick black line is underneath the word.
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
MAR 17 1997
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.
The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine. This washer has a post height of 2.6mm and an outer diameter of 8.0mm. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided sterile. Sterility is achieved by a minimum of 2.5 Mrads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility assurance level is 104. We make no claims as to the pyrogenicity of this product. Packaging and labeling information have already been provided.
The Acumed Suture Washer is similar to the Linvatec Spiked Washer in material, design, and intended usage and is expected to perform as well as similar devices.
- 10950 SW 5th St., Suite 170 + Beaverton, OR 97005 + (503) 627-9957 + Fax: (503) 520-9618 + Form # FWSH-02 12/12/96 Page 9 of 11 © 1996, Acumed, Inc.