I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document describes a 510(k) submission for a medical device (Gelbfish Flex Vascular Dilator) and its substantial equivalence to a predicate device.

The provided text focuses on:

Device Identification: Proprietary and generic names, classification, product code, and intended use.
Predicate Device: Identification of the predicate device.
Comparison to Predicate Device: Highlights two differences: the shaft material (polyurethane vs. stainless steel) and the bonding method for the tip (medical grade adhesive vs. laser welding).
Conclusion: States that the modified device is substantially equivalent to the predicate device and has no additional safety issues, based on physical properties, performance characteristics, and intended use.
FDA Communication: The FDA's letter granting substantial equivalence based on the submitted information.

There is no information in the provided text regarding:

A table of acceptance criteria or reported device performance.
Sample sizes used for test sets or data provenance.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This type of information is typically detailed in the full 510(k) submission, specifically in sections related to performance testing and clinical data, which are not included in this summary. The current text primarily addresses the regulatory path for a modified device claiming substantial equivalence to an existing one.

Summary

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030260

Summary of 510(k) Submission Section 11

FEB 2 0 2003

11.1 Type of Submission

Special 510(k) Date of Submission: January 9, 2003

11.2 Manufacturer

VascuMetrix, LLC 1058 N. Higley Rd. Suite 204 Mesa, AZ 85205 (480) 807-6300 Fax: (480) 807-6307

Establishment Registration Number: 2032423 Owner/Operator Number: 9046947

11.3 Contact Person

Nick Raible President

11.4 Device

510(k) Number:	Not yet assigned
Proprietary Name:	Gelbfish Flex Vascular Dilator
Generic Name:	Dilator, Vessel, For Percuteneous Catheterization
Classification:	Class II
Relevant Section:	870.1310
Product Code:	DRE
Intended Use:	These devices are intended to be used over a guidewire todilate or calibrate blood vessels.

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11.5 Predicate Device

510(k) Number:	K012256
Proprietary Name:	Gelbfish Vascular Dilators
Generic Name:	Dilator, Vessel, For Percuteneous Catheterization
Classification:	Class II
Relevant Section:	870.1310
Product Code:	DRE
Intended Use:	These devices are intended to be used over a guidewire todilate or calibrate blood vessels.

11.6 Comparison to Predicate Device

1. The original 510(k) on these dilators limited the shaft material to stainless steel. The modified device has a polyurethane shaft.
1. The original device uses laser welding to bond the tip to the shaft. The modified device will use a medical grade adhesive to bond the tip to the shaft.

11.7 Conclusion

Comparison of the original device with the modified device for physical properties, performance characteristics and intended use, indicate that these devices are substantially equivalent and that there are no additional safety issues.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Mr. Nick Raible President VascuMetrix, LLC 1058 N Higley Rd., Suite 204 Mesa, AZ 85205

Re: K030260

Trade/Device Name: Gelbfish Flex Vascular Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catherterization Regulatory Class: Class II Product Code: DRE Dated: January 8, 2003 Received: January 24, 2003

Dear Mr. Raible:

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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Nick Raible

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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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 vours,

J.Q. Carter

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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510(k) Number (if known):	K030260
Device Name:	Gelbfish Flex Vasalar Dilator

Indications For Use:

Statement of Indented Use Section 2

These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030260

Image /page/4/Picture/7 description: The image shows the words "Prescription Use" followed by the text "(Per 21 CFR 801.109)". There is a check mark above the text, indicating that the prescription use option has been selected. The text is in a simple, sans-serif font and is easy to read.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).