(118 days)
Not Found
No
The summary describes a mechanical clamp and its physical characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to partially occlude coronary vessels, which is a surgical tool function, not a direct therapeutic action on the body.
No
The device is described as a clamp for partially occluding coronary vessels, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical clamp made of stainless steel with disposable inserts, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "partially occlude coronary vessels." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a clamp designed for physical manipulation of blood vessels during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool used in vivo (within the body).
N/A
Intended Use / Indications for Use
The AMR-ACV clamp is indicated for use as a clamp for partially occluding coronary vessels.
Product codes
Not Found
Device Description
The AMR Atraumax® Coronary Vascular (ACV) low profile clamps and inserts are a line extension to an existing Applied Medical vascular clamp, model G5048. The AMR-ACV clamp is of a side-bite configuration and consists of a reusable stainless steel clamp body and a set of disposable soft pad inserts. Inserts mount to the clamp via a snap fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vessels
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
Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing has demonstrated that the AMR ACV Clamp is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
4 1000 APPENDIX VIII
510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 26051 Merit Circle, Unit# 103 | |
| Laguna Hills, California 92653 | |
| (714) 582-6120 EXT. 310 | |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | July 8, 1996 |
| NAME OF DEVICE: | Applied Medical Atraumax ® Coronary Vascular Low |
| Profile Clamps and Inserts. | |
| CLASSIFICATION NAME: | Vascular Clamp |
TRADE NAME:
Not Determined
The AMR Atraumax® Coronary Vascular (ACV) low SUMMARY STATEMENT: profile clamps and inserts are a line extension to an existing Applied Medical vascular clamp, model G5048. The G5048 clamp was previously approved under K901565. Differences between the ACV clamp and the predicate G5048 clamp include an expansion of the line to 5 models with sizes ranging from 45mm to 100mm and a reduction in the clamp profile. The AMR-ACV clamps are by design substantially equivalent to the G5048 clamp.
The AMR-ACV clamp is indicated for use as a clamp for partially occluding coronary vessels. The AMR-ACV clamp is of a side-bite configuration and consists of a reusable stainless steel clamp body and a set of disposable soft pad inserts. Inserts mount to the clamp via a snap fit. Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing has demonstrated that the AMR ACV Clamp is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated.