(27 days)
The Enpath Medical Steerable Sheath is intended to be used to facilitate the placement of interventional devices into the peripheral and coronary systems.
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.
The provided document is a 510(k) Summary for the Enpath Medical Steerable Sheath. It describes a Special 510(k) Submission, meaning it's for a modification to a previously cleared device (K043489). Therefore, the study focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo evaluation of efficacy against acceptance criteria in the same way a novel device might.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it states that "Test results verify that the device performs per specification requirements." The "specification requirements" are not detailed in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions safely and effectively | Test results verify that the device performs per specification requirements. |
| Articulation functions correctly | Functional testing of the articulation was performed and passed. |
| Deflection radius meets specifications | Deflection radius testing was performed and passed. |
| Deflection force meets specifications | Deflection force testing was performed and passed. |
| Hemostasis of valve portion meets specifications | Hemostasis of the valve portion testing was performed and passed. |
| Deflection cycle endurance meets specifications | Deflection cycle testing was performed and passed. |
| Other applicable device specifications are met | "Other testing as applicable to this device" was performed and passed. |
| Device is equivalent to the predicate device (K043489) without creating additional risk. | "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." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for the test set for any of the performance tests (articulation, deflection radius, deflection force, hemostasis, deflection cycle testing, etc.). It only mentions that "The performance testing for this device included testing..."
- Data Provenance: Not explicitly stated, but given this is a U.S. FDA submission for a U.S.-based company (Enpath Medical Inc., Minneapolis, MN), it can be inferred that the testing and data likely originated from the U.S. The testing appears to be prospective as it's described as "performance testing" to "verify that the device functions."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was an engineering performance study for a medical device modification, not a study involving human interpretation of data where expert consensus would establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this was an engineering performance study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Steerable Sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the device itself (not an algorithm) was performed. The document states: "The performance testing for this device included testing to verify that the device functions in a safe and effective manner." This refers to laboratory-based functional and mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance testing would be the established engineering and design specifications for the device's functional and mechanical properties. For example, the specified range for deflection radius, the maximum deflection force, and the number of cycles the sheath must withstand. These specifications are determined during the device's design and development phase to ensure it functions as intended and safely.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of this submission. The training set for the manufacturing process (e.g., quality control samples) is not discussed here.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
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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.
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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.
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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
§ 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).