The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.

Device Description

The vascular dilator is a catheter with smooth stainless steel tip(s) that enlarges the lumen of the artery and/or measures the caliber via the tip of the vessel. Access is either percutaneous (interventional through a sheath) or cut down (surgical, through an ateriotomy) procedure. The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.

AI/ML Overview

Acceptance Criteria and Device Performance Study for EndoVascular Instruments Inc.'s Peripheral Vascular Dilator

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly detail a list of quantitative "acceptance criteria" in the format of a modern performance study. Instead, the evaluation focuses on demonstrating "substantial equivalence" to predicate devices through qualitative and comparative assessments of physical characteristics and performance.

However, based on the submission, we can infer the implied acceptance criteria to be alignment with the performance and characteristics of the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Physical Characteristics:
Materials	EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in materials.
Construction	EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in construction.
Diameter and Length Dimensions	EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in diameter and length dimensions.
Configuration	EVI's Peripheral Vascular Dilator is substantially equivalent to Pilling Weck's Amato Dilator in configuration.
Strength of Joints/Connections	The strength of the Vascular Dilator's joints and connections is reported to be equal to or greater than the Amato dilator.
Intended Use/Performance:
Functionality (Vessel Dilation)	EVI's Vascular Dilator is substantially equivalent to Cook Inc.'s Dottering Set in intended use ("Both dilators are used to dilate atheromas and to calibrate vessels."). "Results of tests indicated that the Vascular Dilator effectively enlarged the vessels." This implies successful dilation of vessels as a primary functional criterion.
Safety & Efficacy	"posed no new safety or efficacy issue in any of the tests." This serves as a critical, albeit qualitative, acceptance criterion for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not specify a sample size for any test set. The submission focuses on a comparative analysis of the device's characteristics and performance against predicate devices. The phrase "Results of tests indicated that the Vascular Dilator effectively enlarged the vessels and posed no new safety or efficacy issue in any of the tests" suggests that some testing was performed, but the details of these tests (e.g., number of units tested, conditions, or methodology) are not provided.

The data provenance is internal to the manufacturer, EndoVascular Instruments Inc., and appears to be based on retrospective comparison to existing predicate devices and internal testing to confirm performance and safety. There is no mention of external or geographically specific data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The documentation does not mention the use of external experts to establish ground truth for a test set. The assessment of substantial equivalence appears to be based on the manufacturer's internal comparisons and testing, as reviewed by the FDA. There is no indication of a panel of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Since there is no mention of a formal test set with ground truth established by experts, an adjudication method is not applicable and not described in the provided document. The primary assessment method is a comparison against predicate devices by the manufacturer as part of the 510(k) submission process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This type of study, evaluating human reader performance with and without AI assistance, is not relevant to this device submission, which is for a physical medical instrument (a vascular dilator) rather than a diagnostic imaging or AI-driven decision support system.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was mentioned or performed. This device is a physical instrument, not an algorithm or software. Therefore, an algorithm-only performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly established by the performance and characteristics of the legally marketed predicate devices (Cook, Inc.'s Dotter Transluminal Dilator and Pilling Weck's Amato Dilators). The new device is deemed acceptable because it is substantially equivalent to these existing, approved devices. The "results of tests" performed internally by the manufacturer served to confirm that the device effectively enlarged vessels and posed no new safety or efficacy issues, aligning with the expected performance of the predicate devices.

8. Sample Size for the Training Set

No training set is applicable or mentioned. This submission is for a physical medical device, not a machine learning model or algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, the establishment of ground truth for a training set is not applicable to this device submission.

Summary

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K974617

DEC 1 1998

Endo Vascular Instruments Inc.'s Peripheral Vascular Dilator Premarket Notification Summary Of Data

Submitter: 1.

Tom Kelly

Director of Engineering
EndoVascular Instruments. Inc.
2501 SE Columbia Way, Suite 150
Vancouver, Washington 98661-8038
Tel: (360) 750-1150
Fax: (360) 750-1101

ri Device Name

2.1 Classification:

Common/Usual Name: 2.2

Proprietary Name: 2.3

Panel 70, Class II, 870,4475 (Surgical Vessel) Vascular Dilator Peripheral Vascular Dilator

3. Predicate Device:

3.1 Cook, Inc.'s Dotter Transluminal Dilator

3,2 Pilling Weck's Amato Dilators

4. Intended Use:

The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel

Device Description: ડ્

The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.

Substantial Equivalency Comparisons: 6.

EVI's Peripheral Vascular Dilator is substantially equivalent to Cook, Inc, 's Dotter Transluminal Dilator and Pilling Weck's Amato Dilators, which are preamendment device.

6.1 Comparison of Physical Characteristics:

A comparison of physical characteristics of EVI's Peripheral Vascular Dilator to Pilling Weck's Amato Dilator indicates that they are substantially equivalent in materials;

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EndoVascular Instruments Inc.'s Peripheral Vascular Dilator Premarket Notification Summary Of Data

construction; diametor and length dimensions, and configuration. The strength of the Vascular Dilator's joints and connections is equal to or greater than the Amato dilator.

Comparison of Physical Characteristics: 6.2

EVI's Vascular Dilator is substantially equivalent to Cook Inc. 's Dottering Set in intended use. Both dilators are used to dilate atheromas and to calibrate vessels. Results of tests indicated that the Vascular Dilator effectively enlarged the vessels and posed no new safety or efficacy issue in any of the tests.

7. Conclusions:

Comparison of EVI's Vascular Dilator to Cook's Dotter Dilator performance characteristics indicate that they are substantially equivalent. Comparison of EVI's Vascular Dilator and Pilling Weck's Amato Dilator physical characteristics indicates that they are substantially equivalent.

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Food and Drug Administration Rockville MD 20857

1 1998 DEC

Mr. Tom Kelly Director of Engineering EndoVascular Intruments, Inc. 2501 SE Columbia Way, Suite 150 Vancouver, WA 98661-8038

Re: K974617 Peripheral Vascular Dilator Trade Name: Requlatory Class: II DRE Product Code: Dated: November 6, 1998 Received: November 9, 1998

Dear Mr. Kelly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Tom Kelly

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Unknown

510(k) Number (if known):
	Peripheral Vascular Dilator
Device Name:
Indications For Use:

The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.

A.D. Dettloff
(Division Sign-Off)
TJ Callahan

Division of Cardiovascular, Respiratory, and Neurological Devices Kill 510(k) Number_

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).