(210 days)
No
The summary describes a mechanical device for vascular access and does not mention any software, algorithms, or AI/ML terms.
No.
The device is described as a 'sheath intended for percutaneous access' and designed to 'assist in the placement and removal of therapeutic instrumentation', meaning it facilitates the use of other therapeutic devices rather than being therapeutic itself.
No
The device is described as an access sheath for placing and removing therapeutic instrumentation, not for diagnosing conditions. Mechanical and safety tests were performed, but no diagnostic performance metrics are mentioned.
No
The device description clearly outlines physical components (sheath, obturator, hemostasis valve) and performance studies focus on mechanical, safety, and biocompatibility tests, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "percutaneous access to the peripheral vascular system" and assisting in the "placement and removal of therapeutic instrumentation." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The components (sheath, obturator, hemostasis valve) are consistent with a device used for vascular access and procedures, not for laboratory testing.
- 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 tests.
Therefore, the Applied Medical EVS is a medical device used for a procedural intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Applied Medical EVS is a single-use sheath intended for percutaneous access to the perioheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Applied Medical EVS is a single-use sheath intended for percutaneous access to the perioheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation. The device consists of three major components: a sheath with deployable mesh funnel, an obturator with deployable mesh umbrella and a hemostasis valve with luer port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
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)
Mechanical, safety and biocompatibility tests were performed to verify functional safety, structural integrity and material safety. All testing demonstrated that the AMR EVS is comparable to the predicate device and 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.
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.
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).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
K963886
April 24, 1997
APPENDIX IX
510(k) SUMMARY
510(k) NUMBER: PENDING Applied Medical Resources Corporation SUBMITTED BY: 26051 Merit Circle, Unit #103 Laguna Hills, California 92653 (714) 582-6120 EXT. 310 Howard V. Rowe CONTACT PERSON: September 21, 1996 DATE OF PREPARATION: Applied Medical Expanding Vascular Sheath. NAME OF DEVICE: CLASSIFICATION NAME: Catheter introducer Expanding Vascular Sheath TRADE NAME:
SUMMARY STATEMENT:
The Applied Medical EVS is a single-use sheath intended for percutaneous access to the perioheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation. The device consists of three major components: a sheath with deployable mesh funnel, an obturator with deployable mesh umbrella and a hemostasis valve with luer port.
Since the EVS is designed for percutaneous insertion, patient "cut down" is unnecessary. Percutaneous insertion may be accomplished with or without the use of a standard 9F vascular introducer sheath. The EVS may also be inserted into an exposed vessel.
The EVS is substantially equivalent to the Applied Medical "Catheter Introducer Sheath" covered by K890766. The hemostasis valve portion of this product was previously approved under K895214.
Mechanical, safety and biocompatibility tests were performed to verify functional safety, structural integrity and material safety. All testing demonstrated that the AMR EVS is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated.
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