The VascuMetrix Gelbfish™ Vascular Dilators consist of a small diameter stainless steel tube with a smooth stainless steel tip welded to one end. The lumen of the tube sicer tube with a slide over an 0.035" guidewire. The tips are available in ten sizes and can be used to dilate or calibrate the lumen of a blood vessel.
The dilator can be inserted into a blood vessel either through a surgical cutdown or I he unator can of inserted int for use only by physicians using sterile technique. It is shipped sterile and intended as a single use device.

AI/ML Overview

The provided text is a 510(k) submission for the Gelbfish™ Vascular Dilator, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria and performance metrics typically associated with AI/ML devices. Therefore, a direct answer to all points of the request in the context of an AI/ML study is not applicable.

However, I can extract the relevant information from the document that pertains to the device's acceptance as substantially equivalent.

Acceptance Criteria and Device Performance (in the context of substantial equivalence):

The "acceptance criteria" here are not performance metrics in the AI sense, but rather a demonstration that the new device is as safe and effective as a legally marketed predicate device.

Acceptance Criteria (Demonstration of Equivalence)	Reported Device Performance (Comparison)
Physical Chemistry, Wall Thickness, Temper, Nominal Tensile Strength, % Elongation: Must be identical or similar to predicate.	Constructed of identical material. Results of these tests are "really strong" (interpreted as strong evidence of equivalence). The strength is "equal to or greater than" the predicate device.
Flexibility Characteristics: Must be similar to predicate.	Has "similar flexibility characteristics."
New Safety or Efficacy Issues: Must pose no new issues compared to predicate.	"Pose no new safety or efficacy issues."
Indications for Use: Must be identical to predicate.	"The indications for use are identical."

Study Details (in the context of substantial equivalence):

Given this is a 510(k) for a physical medical device, not an AI/ML product, many of the requested points ("sample sized used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set") are not applicable or documented in the provided text. The "study" here is a series of physical and material tests comparing the new device to a predicate.

Sample size used for the test set and the data provenance: The document mentions "Physical testing has demonstrated..." and "results of the really strong..." for material characteristics like physical chemistry, wall thickness, etc. It does not specify the sample size for these physical tests or the provenance of the materials used in the tests, beyond stating the new device and predicate are constructed of "identical material."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device submission. The "ground truth" is established by comparing the physical and material properties to the predicate device.
Adjudication method: Not applicable. Assessment is based on direct physical and material property comparison, not expert adjudication of outputs.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI/ML device.
The type of ground truth used: For the physical device, the "ground truth" for comparison is the established physical properties and performance characteristics of the legally marketed predicate device (Peripheral Vascular Dilator, K974617). The comparison is based on direct measurement of manufacturing specifications and performance, not expert consensus or pathology in the clinical sense.
The sample size for the training set: Not applicable. There is no concept of a "training set" for this physical device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a traditional medical device, the Gelbfish™ Vascular Dilator. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device through comparison of physical properties, material composition, and intended use, rather than clinical performance metrics in the context of an AI/ML system.

Summary

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DEC 2 0 2001

K012256

Summary of 510(k) Submission

Image /page/0/Picture/3 description: The image shows a logo with a large, bold letter 'M' as its central element. Above the 'M', there is a stylized graphic resembling a plumb bob or a teardrop shape, with radiating lines extending upwards from it. Below the 'M', the word 'VascuMetrix' is written in a smaller, sans-serif font. The overall design is simple and monochromatic, with a focus on the letter 'M' and the accompanying text.

VascuMetrix 2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215

Tel: (480) 807-6300 Fax: (480) 807-6307

Contact Person 1.1

Mike Hammons Director of Operations

Manufacturer 1.2

VascuMetrix, LLC

2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215 Phone: (480)807-6300 Fax: (480)807-6307

Type of Submission 1.3

Traditional 510(k) Date of submission: August 10, 2001 Date of revision: November 1, 2001

1.4 Device

510(k) Number:	K012256
Proprietary Name:	Gelbish™ Vascular Dilator
Common/Generic Name:	DILATOR, VESSEL, FOR PERCUTENEOUSCATHETERIZATION
Classification:	Class II
Relevant section:	870.1310
Product Code:	DRE
Intended Use:	The VascuMetrix Gelbfish™ Vascular Dilators are tobe used over a guidewire to dilate or calibrate bloodvessels.

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1.5 Predicate Device

510(k) Number:	K974617
Device Name:	Peripheral Vascular Dilator
Manufacturer:	EndoVascular Instruments, Inc.
Common/Generic Name:	DILATOR, VESSEL, FOR PERCUTENEOUSCATHETERIZATION
Classification:	Class II
Relevant section:	870.1310
Product Code:	DRE
Intended Use:	The EndoVascular Instrument Peripheral VascularDilator is intended to be used to enlarge or calibratevessel.

Description of the device 1.6

The dilator can be inserted into a blood vessel either through a surgical cutdown or I he unator can of inserted int for use only by physicians using sterile technique. It is shipped sterile and intended as a single use device.

Comparison to the Predicate Device 1.7

The physical chemistry, wall thickness, temper, nominal tensile strength and % The physical chemisury, wan thickless, temper, nominal was results of the really crongation of the share of are constructed of identical matterial and the shapes are predicate device. The strength of the Gelbfish™ Vascular Dilators is equal to or greater than that of the predicate device.

Physical testing has demonstrated that the Gelbfish™ Vascular Dilators and the I hyslour cosing has desimilar flexibility characteristics and are both adequately predicals device have simmal nextonity only and issues of the Vascular Dilators pose no new safety or efficacy issues.

The indications for use are identical.

Conclusion: 1.8

Comparison of the Gelbfish™ Vascular Dilators to EndoVascular Instrument's Comparison of the Golonial
Peripheral Vascular Dilator for physical properties, performance characteristics and intended use, indicate that these devices are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The text is in all caps and arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

Mr. Mike Hammons Director of Operations VascuMetrix, LLC 2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215

Re: K012256

Trade Name: Gelbish™ Vascular Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catherization. Regulatory Class: II Product Code: DRE Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Hammons:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Mike Hammons

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html

Sincerely yours,

Dr. Bram Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use Section 4

510(k) Number: K012256

Device Name: Gelbfish™ Vascular Dilator

Indications for Use:

The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.

iratory D

Division of Cardiovascular & Respiratory Devices
510(k) Number K012356

Prescription Use
(Per 21 CFR 801.109)

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).