URESIL VASCU-FLO INFUSION CATHETER by URESIL CORP.

It's important to note that the provided documents are a 510(k) summary letter and an Indications for Use statement for a medical device. These types of documents do not typically contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way a clinical study report or a pre-market approval (PMA) submission would.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving efficacy and safety through extensive clinical trials for new device types. Therefore, many of the requested details about acceptance criteria, study data, and ground truth establishment are not present in these documents.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not explicitly available in the provided documents. The 510(k) letter states: "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..." This indicates that the device met the criteria for substantial equivalence, which is the core "acceptance criteria" for a 510(k) submission. However, the specific performance metrics used to demonstrate this equivalence are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not explicitly available in the provided documents. The letter mentions a "510(k) notification of intent to market," which refers to a submission with performance data, but does not provide details of any test set sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not available. For a 510(k) submission, the "ground truth" is typically established by comparing the new device's performance to the predicate device's established performance, often through bench testing and sometimes limited clinical data. There is no mention of expert consensus for ground truth establishment in these documents as one might find in an AI/imaging device submission for diagnostics.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not available. Adjudication methods are typically relevant for studies involving human interpretation (e.g., clinical trials or radiology reading studies). This information is not present in the provided 510(k) letter.

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/Not available. The Uresil® VASCU-FLO® Infusion Catheter is a physical infusion catheter, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance comparisons are not relevant to this device type.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not available. As above, this device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implicitly established by comparison to a predicate device. For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence often relies on:
- Bench testing data: Comparing physical properties, material compatibility, flow rates, and other engineering specifications to the predicate device.
- Biocompatibility data: Showing the device materials are safe.
- Sterilization validation: Ensuring the device can be sterilized.
- Performance data: Showing the device performs as intended for its stated Indications for Use, often by demonstrating similar functional characteristics to the predicate.
The documents do not specify the exact nature of this comparative data.

8. The sample size for the training set

Not applicable/Not available. "Training set" is a concept primarily used in machine learning and AI development. This is a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable/Not available. As above, this is not an AI algorithm.

Summary of available information from the provided documents:

Device Name: Uresil® VASCU-FLO® Infusion Catheter
Regulatory Class: II
Product Code: DQY
Indications For Use: "This device is intended to infuse therapeutic agents into the extra-cardiac vasculature."
Regulatory Outcome: Substantial equivalence determined by the FDA to legally marketed predicate devices available prior to May 28, 1976. This determination allows the device to be marketed.
Implicit Acceptance Criteria Met: The device demonstrated sufficient equivalence to a predicate device as required for a 510(k) clearance, covering aspects like safety, fundamental technology, and performance for its indications. Specific numeric criteria are not detailed in these overview documents.

Summary

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Food and Drug Administration Rockville MD 20857

NOV 20 1998

Mr. Matthew Curtis, CQE Quality Assurance and Regulatory Affairs Manager Uresil Technology Center 5418 West Toughy Avenue Skokie, IL 60077

K980278 Re: Uresil® VASCU-FLO® Infusion Catheter Trade Name: Requlatory Class: II Product Code: DQY Dated: Auqust 28, 1998 Received: September 1, 1998

Dear Mr. Curtis:

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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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. Curtis Matthew

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, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 3

Page 1 of 1

510(k) Number (if known): unknown

Device Name: Uresil® VASCU-FLO® Infusion Catheter

Indications For Use:

This device is intended to infuse therapeutic agents into the extra-cardiac vasculature.

(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)

Over-The-Counter Use
(Optional Format 1-2-96)

D. Gatt for TJ Callahan
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K986278

Regulation Number and Section

§ 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).