(27 days)
No
The description focuses on mechanical steering and does not mention any computational or data-driven features indicative of AI/ML.
No
Explanation: The device is described as a guide catheter or delivery sheath, intended to facilitate the placement of other interventional devices. It does not provide any direct therapeutic benefit itself, but rather aids in the delivery of therapeutic devices.
No
The device is described as a guide catheter (delivery sheath) used to facilitate the placement of interventional devices. Its function is to steer and position other devices, not to diagnose a condition.
No
The device description clearly describes a physical guide catheter with a handle mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of interventional devices into the peripheral and coronary systems." 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 description details a "guide catheter (delivery sheath)" with a steerable tip. This is a medical device used during procedures, not a reagent, instrument, or system intended for the examination of specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Enpath Medical Steerable Sheath is a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
Product codes
DQY
Device Description
The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary systems
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 performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional testing of the articulation, deflection radius, deflection force, hemostatsis of the valve portion, deflection cycle testing and other testing as applicable to this device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
No clinical evaluations for this submission have been conducted.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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Enpath Medical, Inc. Steerable Sheath
Special 510(k) Submission Summary
Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K061119". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The sequence consists of a mix of uppercase letters and numbers.
510(k) Summary
Submitter
Enpath Medical Inc. 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-559-2613 763-559-0148 Fax: email: www.enpathmed.com
Contact Person
James Jenkins Regulatory Associate 952-653-2412
Date Prepared
April 20, 2006
Trade Name Enpath Medical Steerable Sheath
Common Name
Catheter Introducer
Classification Name
Percutaneous Catheter (21 CFR 870.1250, Product Code DQY)
MAY 18 2005
Predicate Device
Enpath Medical Steerable Sheath; K043489.
Device Description
The Enpath Steerable Sheath is a guide catheter (delivery sheath) which has a distal tip that deflects to create a variable curve shape. The deflection is controlled through a handle mechanism with the ability to lock at any point along the catheter tip curve travel. The handle incorporates a luer fitting or a hemostasis valve.
1
Special 510(k) Submission Summary
The Enpath Steerable Sheath will be used clinically in the same way that a guide catheter or sheath is used as part of an interventional procedure, to gain access to locations that are not easily accessed with existing tools. Certain parts of the vasculature are difficult to access because of occlusion, tortuosity, or simply because standard catheters do not provide the necessary curve angle(s). The Steerable Sheath, with its deflection capability, enables access to these areas. Primary applications for the product remain focused on access for Pulmonary Vein Ablation, Transseptal access, Renal Stenting, and Carotid Stenting.
Intended Use
The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
Comparison of Technological Characteristics
All technological characteristics of the Enpath Steerable Sheath are substantially equivalent to the predicate device (K043489) including biocompatibility, product design, function, packaging, sterilization and labeling. The molded handle configuration incorporates a handle material change and an integrated deflection and locking mechanism. The molded handle configuration does not alter the intended use or fundamental scientific technology of the device.
Summary of Studies
The performance testing for this device included testing to verify that the device functions in a safe and effective manner. The performance testing included the device specifications, functional testing of the articulation, deflection radius, deflection force, hemostatsis of the valve portion, deflection cycle testing and other testing as applicable to this device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.
No clinical evaluations for this submission have been conducted.
Substantial Equivalence
The molded handle Steerable Sheath is as safe, as effective, and performs as well as, and is substantially equivalent to the original "cleared" machined handle Enpath Steerable Sheath, K043489. The design modification of the sheath handle assembly does not affect the indications for use nor alter the fundamental scientific technology of the device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2006
Enpath Medical Inc. c/o Mr. James Jenkins Regulatory Associate 15301 Highway 55 West Minneapolis, MN 55447
Re: K061119 Enpath Medical Steerable Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DQY Dated: April 20, 2006 Received: April 21, 2006
Dear Mr. Jenkins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. James Jenkins
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I Dri 3 issualite or are device complies with other requirements of the Act that IDA has made a qeterimation administered by other Federal agencies. You must of any reaclar statutes and regulations and limited to: registration and listing (21 Comply with an the Hot 3 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herens (veting your device as described in your Section 510(k) This icher witi anow you to oegin mailing of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrinational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dring R. Lochines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Proprietary and Confidential
Enpath Medical, Inc. Steerable Sheath Special 510(k) Submission
VI Indications for Use
510(k) Number (if known): Not Assigned> K66 (! 1 9
Device Name: Enpath Medical Steerable Sheath
The Enpath Medical Steerable Sheath is intended to be used to Indications for Use: facilitate the placement of interventional devices into the peripheral and coronary systems.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vachner
(Division Sign-Off)
proveron Sign-Oir)
Division of Cardiovascular Devices
510(k) Number_K0 ( 1 | 9