(76 days)
LIGACLIP™ ERCA Clip Applier
Not Found
No
The device description and intended use focus on mechanical function and visual indicators, with no mention of AI/ML terms or capabilities.
No.
The device is used for ligation (tying off) of tubular structures or vessels in surgical procedures, which is a procedural function rather than a therapeutic one aiming to treat or cure a disease or condition.
No
Explanation: The device is intended for ligation of tubular structures or vessels in surgical procedures, which is a therapeutic rather than diagnostic function. It is a tool for performing a medical procedure, not for identifying a condition or disease.
No
The device description clearly outlines physical components such as a handle, trigger, shaft, jaws, and a pre-loaded cartridge with clips, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ligation of tubular structures or vessels in laparoscopic and general surgical procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device used for applying clips during surgery. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristic typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for a therapeutic purpose (ligation).
N/A
Intended Use / Indications for Use
The Applied Medical Clip Applier is a sterile single use device intended for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Product codes
Not Found
Device Description
The Applied Medical Clip Applier consists of a molded plastic clip applier handle with an actuating trigger, a 360° adjustable rotational knob on the shaft, an applicator shaft and clip applier jaws which provide secure placement of the clip to the desired vessel. The applier is sold with a pre-loaded cartridge containing 20 implantable clips. The distal tip of the shaft is a clear material which provides a color coded visual indication of the last four clips. Following release of the last clip, a lockout mechanism is activated which neutralizes the jaw actuating mechanism and prevents unanticipated cutting or pinching from the applier jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Functional performance and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing demonstrated the Applied Medical Clip Applier introduces no new safety and effectiveness issues when used as indicated.
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.
LIGACLIP™ ERCA Clip Applier
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
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
JAN 22 1997
Image /page/0/Picture/1 description: The image shows a sequence of bold, black, stylized numbers. The numbers appear to be '1984470'. The numbers are written in a way that makes them appear connected and somewhat abstract. The style of the numbers is consistent throughout the sequence.
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: | November 5, 1996 |
| NAME OF DEVICE: | Applied Medical Clip Applier |
| CLASSIFICATION NAME: | Manual Surgical Instrument for General Use, 21 CFR 878.4800 and Implantable Clip, 21 CFR 878.4300 |
| TRADE NAME: | Not established to date. |
SUMMARY STATEMENT: The Applied Medical Clip Applier is substantially equivalent to the predicate LIGACLIP™ ERCA Clip Applier device manufactured by Ethicon. The Applied Medical Clip Applier is a sterile single use device intended for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The Applied Medical Clip Applier consists of a molded plastic clip applier handle with an actuating trigger, a 360° adjustable rotational knob on the shaft, an applicator shaft and clip applier jaws which provide secure placement of the clip to the desired vessel. The applier is sold with a pre-loaded cartridge containing 20 implantable clips. The distal tip of the shaft is a clear material which provides a color coded visual indication of the last four clips. Following release of the last clip, a lockout mechanism is activated which neutralizes the jaw actuating mechanism and prevents unanticipated cutting or pinching from the applier jaws. Functional performance and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing demonstrated the Applied Medical Clip Applier introduces no new safety and effectiveness issues when used as indicated.