(153 days)
The Enpath Deflectable Catheter is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
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 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 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.
Here's a breakdown of the acceptance criteria and study information for the Enpath Deflectable Catheter, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The submission statement indicated that the device performs per specification requirements, however specifics criteria and performance metrics were not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Specifications | Performs per requirements (details not provided) |
| Functional Testing of Articulation | Performs per requirements (details not provided) |
| Deflection Radius | Performs per requirements (details not provided) |
| Deflection Force | Performs per requirements (details not provided) |
| Hemostasis of the Valve Portion | Performs per requirements (details not provided) |
| Deflection Cycle Testing | Performs per requirements (details not provided) |
| Consistent with FDA Guidance (3/19/1995) for Intravascular Catheters (as applicable) | Performs per requirements (details not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It refers generally to "performance testing" and "test results" without specific numbers of devices tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The ground truth for the performance testing appears to be based on engineering specifications and in-house testing rather than expert clinical assessment.
4. Adjudication Method for the Test Set
This information is not provided. It's likely that the testing involved objective measurements against established specifications rather than a consensus-based adjudication process typical for clinical or image-based studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted or reported. This type of study typically involves human readers analyzing cases with and without AI assistance, and it's not applicable to a device like a catheter where the primary assessment is mechanical and functional performance.
6. Standalone (i.e., algorithm-only without human-in-the-loop performance) Study
Yes, in essence, the described "performance testing" is a standalone evaluation of the device's mechanical and functional properties without human intervention during the measurement process. The "algorithm" in this context refers to the device's design and manufacturing, and its performance was assessed independently of a human operator's influence on the test outcome (beyond initiating the test).
7. Type of Ground Truth Used
The ground truth used for the device's performance testing was based on engineering specifications and established functional requirements derived from the device's intended use and relevant FDA guidance.
8. Sample Size for the Training Set
This information is not applicable and is not provided. The Enpath Deflectable Catheter is a physical medical device, not an AI/software algorithm that requires a "training set" in the machine learning sense. The development and verification of such devices rely on engineering design, material science, and physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this is a physical device, not an AI/software algorithm, so there is no "training set" or "ground truth for the training set" in the context of machine learning. The design and manufacturing process would involve engineering principles, material selection, and iterative prototyping and testing to meet performance objectives.
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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
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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 DeflectableCatheter | Predicate Device | Predicate DeviceManufacturer | 510(k) |
|---|---|---|---|
| Deflectable Catheter | Medtronic Model10600 DeflectableCatheter System | Medtronic, IncMinneapolis MN55432 | K013517 |
| Deflectable CatheterDilatorAdjustableHemostasis Valve | Medtronic Model10600 CatheterSystem | Medtronic, IncMinneapolis MN55432 | 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
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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
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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
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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
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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
§ 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).