(25 days)
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Not Found
No
The 510(k) summary describes a mechanical catheter and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for medical purposes such as the removal of arterial thromboemboli, temporary catheter occlusion, and fluid infusion, which are therapeutic interventions.
No
The device is indicated for the removal of arterial thromboemboli, temporary catheter occlusion, and infusion of fluids, which are therapeutic and interventional actions, not diagnostic ones.
No
The device description clearly outlines physical components such as a catheter body, lumens, ports, a Y connector, a balloon, marker bands, and syringes, 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 the removal of arterial thromboemboli, temporary catheter occlusion, and infusion of fluids. These are all procedures performed within the body (in vivo).
- Device Description: The description details a catheter with a balloon designed for insertion into arteries. This is a surgical or interventional device, not a device used to examine specimens outside the body (in vitro).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo.
N/A
Intended Use / Indications for Use
The Applied Medical Dual-Lumen Embolectorny Catheter is a sterile disposable balloon It is indicated for the removal of arterial thromboemboli, for temporary catheter. occlusion, and for infusion of fluids. It may be used with or without a guidewire.
Product codes
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Device Description
The catheter body features two channels through the length of its main body and includes access ports on the inflation and fluid infusion lumens, a Y connector, and a latex balloon on the distal end. Radiopaque marker bands are proximal and distal to the balloon. A 1cc syringe is supplied with the 3F, 4F and 5F models while a 3cc syringe is supplied with the 6F and 7F models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
arterial
Indicated Patient Age Range
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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
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Summary of Performance Studies
Mechanical and biocompatibility tests were performed to verify functional and structural integrity as well as material safety. All testing demonstrates the Applied Medical Dual-Lumen Embolectomy Catheter to be equivalent to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
APPENDIX IX
510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources |
| 26051 Merit Circle # 103 | |
| Laguna Hills, Ca 92653 | |
| (714) 582-6120 Ext. 310 | |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | February 27, 1997 |
| NAME OF DEVICE: | Applied Medical Dual Lumen Embolectomy Catheter |
| CLASSIFICATION NAME: | Embolectomy Catheter |
SUMMARY STATEMENT:
The Applied Medical Dual-Lumen Embolectorny Catheter is a sterile disposable balloon It is indicated for the removal of arterial thromboemboli, for temporary catheter. occlusion, and for infusion of fluids. It may be used with or without a guidewire. The catheter body features two channels through the length of its main body and includes access ports on the inflation and fluid infusion lumens, a Y connector, and a latex balloon on the distal end. Radiopaque marker bands are proximal and distal to the balloon. A 1cc syringe is supplied with the 3F, 4F and 5F models while a 3cc syringe is supplied with the 6F and 7F models.
The Applied Medical Dual-Lumen Embolectorny Catheter is used in the same manner as a conventional embolectomy catheter when only the inflation lumen is utilized. The diseased artery is exposed, clamped, and an arteriotomy is performed. The catheter is inserted into the arteriotomy with or without a guidewire and passed through the clot. The second lumen may then be used for infusion. The balloon is inflated and the clot is extracted.
The Applied Medical Dual-Lumen Embolectomy Catheter is substantially equivalent to the Fogarty® Thru-Lumen Embolectomy Catheter marketed by Baxter Healthcare The performance of the balloon is substantially equivalent to the Applied Corporation. Medical Regular Tip Embolectorny Catheter. Mechanical and biocompatibility tests were performed to verify functional and structural integrity as well as material safety.
All testing demonstrates the Applied Medical Dual-Lumen Embolectomy Catheter to be equivalent to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.