(128 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML algorithms for image analysis, diagnosis, or any other function.
No
The device is used for temporary vessel occlusion, which is a procedural function, not a therapeutic treatment.
No
Explanation: The device is an occlusion catheter used for temporary vessel occlusion, a therapeutic procedure, not for diagnosing a condition. Its performance studies focus on mechanical properties relevant to its occluding function.
No
The device description clearly outlines a physical catheter with a balloon, lumen, stopcock, and radiopaque markers, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary vessel occlusion." This is a therapeutic or interventional procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a catheter with a balloon designed for physical occlusion of a vessel. This is a mechanical device used for a physical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically block a vessel, which is a procedural action, not a diagnostic test.
N/A
Intended Use / Indications for Use
The LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.
Product codes
MJN
Device Description
The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.
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)
The following tests have been completed to evaluate the safety and performance of LeMaitre 8F occlusion catheter compared with the predicate device:
- Volume Required to Inflate Balloon to IFU Indicated Diameter
- Inflation Pressure
- Radial Force
- Contact Area
- Inflation Time
- Deflation Time
- Burst Volume
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
§ 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
510 (k) Summary
Submitter's information:
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA USA 01803 | |
| Phone: | 781-425-1727 |
| Fax: | 781-425-5049 |
| NOV 0 6 2013 | |
| Contact Person: | Bryan Cowell, MSc., RAC |
| Date of preparation: | June 24, 2013 |
| Device Name: | LeMaitre 8F Occlusion Catheter |
| Trade Name. | LeMaitre 8F Occlusion Catheter |
| Common/ Classification Name: | Catheter, intravascular occluding, temporary |
| Classification Panel: | 21CFR §870.4450 |
| Class: | II (2) |
| Product Code: | MJN |
Establishment Registration: 1220948
Establishment: LeMaitre Vascular, Inc., 63 Second Avenue, Burlington, MA USA 01803
Owner/Operator: 1220948
Device Description:
The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.
Intended Use:
The LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.
1
Predicate Device:
1
K093911 510(k): Device Name: Fogarty Occlusion Catheter
Substantial Equivalence:
Fundamental Scientific Technological Characteristics:
The LeMaitre 8F Occlusion Catheter maintains the same intended use and fundamental scientific technology as the predicate device.
Functional/ Safety testing:
The verification activities conducted indicate that LeMuitre 8F Occlusion Catheter device meets the product performance requirements of the device specifications and does not raise any additional safety issues.
Sterilization:
The device is validated for ethylene oxide (EO) sterilization according to ANSI/AAMI/ISO 11135-1:2007, "Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization".
Biocompatibility:
All blood contact portions of the device were subjected to biocompatibility testing according to ISO 10993 guidelines for an externally communicating device with limited contact duration (