(153 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a deflectable catheter, with no mention of AI or ML capabilities.
No
The device is described as a "guide catheter (delivery sheath)" intended "to facilitate the placement of interventional devices." It does not directly treat a disease or condition.
No
The device is a guide catheter used to facilitate the placement of interventional devices, not to diagnose a condition.
No
The device description clearly details a physical catheter with a handle mechanism, luer fitting, hemostasis valve, and various material components (Pebax, PTFE, Barium Sulfate, Nylon 12, silicone rubber, ABS, MDPE, HDPE). This is a hardware medical device.
Based on the provided information, the Enpath Deflectable Catheter is not an In Vitro Diagnostic (IVD) device.
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).
- Device Description: The description details a physical catheter designed for insertion into blood vessels, with features like a deflectable tip, handle, and luer fitting/hemostasis valve. These are characteristics of a surgical or interventional tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect analytes, or provide diagnostic information based on laboratory testing.
Therefore, the Enpath Deflectable Catheter is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Enpath Deflectable Catheter 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. The product specifications, drawings and photographs are located in Appendix E of this submission.
The Enpath Deflectable Catheter 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 Deflectable Catheter, with its deflection capability, enables access to these areas. Primary applications for product focus on access for Pulmonary Vein Ablation, Transseptal access, Renal Stenting, and Carotid Stenting.
The deflectable catheter shaft is constructed of Pebax, lined with PTFE and filled with Barium Sulfate as a radiopacifier. The catheter hub is overmolded Nylon 12 (10% glass filled). The catheter hub houses a hemostasis valve which is molded silicone rubber.
The deflectable catheter handle is made of machined ABS, and is cyanoacrylate bonded onto the deflectable shaft. The handle configuration may vary based on specific user requirements. The handle modifications will not effect the functionality or safety of the device. For example, the shape of the handle, method of deflection (i.e. slide, rotate etc) may change, but the curve of the deflection and the shaft of the device will remain the same. Any handle changes will be validated and appropriately tested to ensure safety and effectiveness.
The dilator tube is made of MDPE (high density/low density polyethylene blend) and has a hub made of HDPE resin overmolded onto the dilator tube. The dilator assembly is coated with silicone lubricant to reduce insertion force through the sheath hemostasis valve.
The deflectable tip sheath size range is from 7 FR (ID) to 14 FR. The materials and construction are the same for all French sizes.
The Deflectable Tip Sheath will be packaged and EtO sterilized for single use in a Tyvek pouch. The sterile kit packaging configuration will include the deflectable catheter and the dilator. The product may be provided as a bulk non-sterile device to OEM customers for further processing and packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary systems, vasculature
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, hemostasis of the valve portion, deflection cycle testing and testing consistent with the requirements in FDA 'Guidance on premarket notification [510(k)] submission for shortterm and long-term intravascular catheters (3/19/1995)' as applicable to this device. Test results verify that the device performs per specification requirements.
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.
Medtronic Model 10600 Deflectable Catheter System 510(k) K013517
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.
Not Found
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
§ 870.1250 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).
0
K643489
510(k) Summary IV.
MAY 1 9 2005
Submitter
Enpath Medical Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 Fax: 763-559-0148 email: www.enpathmed.com
Date Prepared
December 12, 2004
Trade Name
Enpath Deflectable Catheter
Submission Correspondent
Karyl Haskell Regulatory Affairs Manager
Submission Correspondent Telephone, Fax, and Email
Office: (952) 653-2410 FAX: (952) 943-1087 email: khaskell(@enpathmed.com
Common Name
Catheter Introducer
Intended Use
The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
Predicate Device
· Medtronic, Inc: Medtronic Model 10600 Deflectable Catheter System 510(k) K013517
Device Description
The Enpath Deflectable Catheter 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. The product specifications, drawings and photographs are located in Appendix E of this submission.
The Enpath Deflectable Catheter 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
1
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 Deflectable Catheter, with its deflection capability, enables access to these areas. Primary applications for product focus on access for Pulmonary Vein Ablation, Transseptal access, Renal Stenting, and Carotid Stenting.
The deflectable catheter shaft is constructed of Pebax, lined with PTFE and filled with Barium Sulfate as a radiopacifier. The catheter hub is overmolded Nylon 12 (10% glass filled). The catheter hub houses a hemostasis valve which is molded silicone rubber.
The deflectable catheter handle is made of machined ABS, and is cyanoacrylate bonded onto the deflectable shaft. The handle configuration may vary based on specific user requirements. The handle modifications will not effect the functionality or safety of the device. For example, the shape of the handle, method of deflection (i.e. slide, rotate etc) may change, but the curve of the deflection and the shaft of the device will remain the same. Any handle changes will be validated and appropriately tested to ensure safety and effectiveness.
The dilator tube is made of MDPE (high density/low density polyethylene blend) and has a hub made of HDPE resin overmolded onto the dilator tube. The dilator assembly is coated with silicone lubricant to reduce insertion force through the sheath hemostasis valve.
The deflectable tip sheath size range is from 7 FR (ID) to 14 FR. The materials and construction are the same for all French sizes.
The Deflectable Tip Sheath will be packaged and EtO sterilized for single use in a Tyvek pouch. The sterile kit packaging configuration will include the deflectable catheter and the dilator. The product may be provided as a bulk non-sterile device to OEM customers for further processing and packaging.
Technological Characteristics / substantially equivalent devices
The Enpath Deflectable Catheter is technologically equivalent to the predicate device:
| Enpath Deflectable
Catheter | Predicate Device | Predicate Device
Manufacturer | 510(k) |
|-------------------------------------------------------------------|---------------------------------------------------------|-------------------------------------------|---------|
| Deflectable Catheter | Medtronic Model
10600 Deflectable
Catheter System | Medtronic, Inc
Minneapolis MN
55432 | K013517 |
| Deflectable Catheter
Dilator
Adjustable
Hemostasis Valve | Medtronic Model
10600 Catheter
System | Medtronic, Inc
Minneapolis MN
55432 | K013517 |
In addition, the sterilization process and biocompatibility of the Enpath Deflectable Catheter are substantially equivalent to the above documented predicate device, the Medtronic Model 10600 510(k) K013517
2
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, hemostasis of the valve portion, deflection cycle testing and testing consistent with the requirements in FDA 'Guidance on premarket notification [510(k)] submission for shortterm and long-term intravascular catheters (3/19/1995)' as applicable to this device. Test results verify that the device performs per specification requirements.
Statement of Substantial Equivalence
Through the data and information presented, Enpath concludes that the Enpath Deflectable Catheter is substantially equivalent to the predicate device:
Medtronic Model 10600 Deflectable Catheter System 510(k) K013517
3
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Enpath Medical Incorporated c/o Ms. Karyl Haskell Regulatory Affairs Manager Enpath Medical Incorporated 15301 Highway 55 West Minneapolis, MN 55447
MAY 1 9 2005
Re: K043489
Trade/Device Name: Enpath Deflectable Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 15, 2005 Received: April 18, 2005
Dear Ms. Haskell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have love ready our occared the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass sumed in also enoted as ) the Medical Device Amendments, or to devices that prior to may 26, 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic liate ooch recidentive approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thereofe, maniel me de rios, backed sequirements for annual registration, listing of devices, good controll provisions or a 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 if your device to such additional controls. Existing major regulations affecting your device can be finay of subject to sam adaments, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I DX is issualite t your device complies with other requirements of the Act or that F 271 has mude a determilations administered by other Federal agencies. You must comply with ally i cocrar statutes and regardants abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) increasing practice requirements as set forth in the quality
4
Page 2 – Ms. Karyl Haskell
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation in systems (QS) regalation (21-531-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 551-942 of the Fee), 21 US is described in your Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA miding of sucstantal equice 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 specific advice for your at (240) 276-0120. Also, please note the regulation entitled, contact the Office of Compliance at (210) 21 0 120. Press. 12.97. You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misoranding by relefected to premail.or institution in Division of Small
general information on your responsibilities under the Act from the 1900 for general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, International Consumer Prosition Prospectivindustry/support/index.html.
Sincerely yours,
Blzommerna for
Brad D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use V.
Indications for Use
510(k) Number (if known):__Not Assigned
Device Name: Enpath Deflectable Catheter
Indications For Use: The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
.
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blmrmema
Sign-C lloyascular Devices 04.241