The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.

Device Description

The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS) is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the bulbs allow blood to flow through the shunt and distal to the anastomotic site. A radiopaque tab, which identifies the outer diameter of the bulbs, is attached to the shunt by a tether to facilitate positioning and removal of the shunt.

AI/ML Overview

The provided text describes a medical device, the Flo-Thru Intraluminal Shunt, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with AI/algorithm-based device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies).

The text focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than proving specific performance metrics against pre-defined acceptance criteria through detailed clinical or performance studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Functional Equivalence	"Functional testing conducted on the Flo-Thru intraluminal shunt and predicate samples show the Flo-Thru performs in a manner substantially equivalent with regard to strength, and flow rate."
Handling Characteristics	"Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements."
Flexibility	"Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements."
Radiopacity	"Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements."
Kinking/Manipulation Memory	"Also, the Flo-Thru has no memory of kinking or manipulation."
Sterility	"The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS)..." (Implied acceptance criterion: device is sterile)
Single-Use	"The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS)..." (Implied acceptance criterion: device is single-use)
Radiopaque	"a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end." (Implied acceptance criterion: device is radiopaque)

Missing Information (Not available in the provided text):

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

Not specified. The text mentions "functional testing" but provides no details on 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 specified. This device is a mechanical shunt, not an AI or diagnostic imaging device that typically requires expert ground truth for performance evaluation in the way described.

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

Not applicable/Not specified.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm-based device. Functional testing was done on the physical device. The "standalone" performance here would refer to the device itself as described in the table above.

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

For the functional tests, the "ground truth" would be the engineering specifications and performance benchmarks of the predicate devices. For sterility, it would be lab tests proving sterility. For radiopacity, it would be observation under fluoroscopy or X-ray. The document doesn't detail the how for each test.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address:	Bio-Vascular, Inc.2575 University Ave.St. Paul, MN 55114-1024
Contact:	D. E. Gardner, Ph.D.VP, Regulatory Affairs / Quality Assurance
Date Prepared:	May 4, 1998
Common or Usual Name:	Intraluminal shunt
Device Classification Name:	Clamp, vascular; 870.4450; Class II

Substantial Equivalence:

The device is substantially equivalent to the BVI Flo-Rester vessel occluder, the CTS MIDCAB Coronary Shunt (CTS FloCoil Shunt), the AnastaFLO Intravascular Shunt, DLP Intravascular Arteriotomy Cannula, the Rivetti-Levinson Intraluminal Shunt, and the Chase Blood Vessel Shunt.

Device Description:

Statement of Intended Use:

Summary/Comparison of Technological Characteristics:

Functional testing conducted on the Flo-Thru intraluminal shunt and predicate samples show the Flo-Thru performs in a manner substantially equivalent with regard to strength, and flow rate. Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements. Also, the Flo-Thru has no memory of kinking or manipulation.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

D.E. Gardner, Ph.D. VP, Regulatory Affairs / Quality Assurance Bio-Vascular, Inc. 2575 University Avenue St. Paul, MN 55114-1024

Re : K981624 Trade Name: Flo-Thru™ Requlatory Class: II Product Code: DXC Dated: May 4, 1998 Received: May 7, 1998

Dear Dr. Gardner:

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 leqally 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, qood 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 Regulations, 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 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 you might have under sections 531 through 542 of the Act

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Page 2 - Dr. Gardner

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510(k) Number (if known):

K98 1624

Device Name: Flo-Thru™

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Tu A.R.

(Division Sign-Off) (Division Sign On)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number .

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).