(220 days)
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No
The provided text describes a mechanical snare device for removing foreign objects and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used for the removal of foreign objects from the body, which is a diagnostic/interventional procedure, not a therapeutic treatment.
No
The device is described as a snare for the removal of objects, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is supplied sterile and intended for one-time use, indicating a physical, hardware-based medical device.
Based on the provided information, 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, tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Description and Intended Use: The Needle's Eye Snare is described as a device for the "percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects." "Percutaneous" means through the skin, and the removal of these items is an interventional procedure performed directly on the patient's body.
- Lack of Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens.
Therefore, the Needle's Eye Snare is an interventional medical device used for removing objects from within the body, not an in vitro diagnostic device used for testing specimens.
N/A
Intended Use / Indications for Use
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
74DXE
Device Description
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Needle's Eye Snare is provided by their established history of use in medical devices manufactured by the Cook Pacemaker Corporation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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
K961992
11
510(k) Premarket Notification Needle's Eye Snare
DEC 27 1996
510 (K) SUMMARY I.
Submitted By:
Neal E. Fearnot, President MED Institute, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (317) 463-7537 May 16, 1996
Device:
Trade Name:
Common/Usual Name:
Needle's Eye Snare
Snare, Retrieval Basket, Basket Introducer
Proposed Classification Name:
Embolectomy Catheter 21 CFR Part 870.5150 (74DXE)
Predicate Devices:
The Needle's Eye Snare is similar to predicate devices which are used for the intravascular retrieval of foreign bodies, and is also of similar technology in terms of material composition and method of operation.
Device Description:
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Needle's Eye Snare is provided by their established history of use in medical devices manufactured by the Cook Pacemaker Corporation.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Pacemaker Corporation. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.