The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

Device Description

The T-AnastaFic is a sterile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. Another silicone tubular shaft is attached perpendicular to the middle of the shunt, ending with a perfusion port stopcock. Each T-AnastaFlo is individually packaged sterile and non-pyrogenic in a sealed, peeltype pouch.

AI/ML Overview

The T-AnastaFlo device received FDA clearance (K990396) based on substantial equivalence to the Rivetti-Levinson Intraluminal Shunt (K972261). The clearance was based on demonstrating equivalence in intended use, technology, materials, and design, supported by performance testing.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Flow Rate	Not explicitly stated, but assumed to be equivalent to predicate.	Performed (details not provided in the summary).
Leak Characteristics	Not explicitly stated, but assumed to be equivalent to predicate.	Performed (details not provided in the summary).
Tensile Strength	Not explicitly stated, but assumed to be equivalent to predicate.	Performed (details not provided in the summary).
Materials	Equivalent to predicate device.	Demonstrated equivalence of materials.
Design	Equivalent to predicate device.	Demonstrated equivalence of design.
Intended Use	Equivalent to predicate device.	Demonstrated equivalence of intended use.

Note: The provided 510(k) summary (K990396) for the T-AnastaFlo device focuses on demonstrating substantial equivalence to a predicate device. It explicitly states that the conclusion is "based upon tests performed for device flow rate, leak characteristics, and tensile strength, and upon the equivalence of materials, design and intended use for the proposed and predicate devices." However, the document does not provide the specific acceptance criteria or the numerical results of these tests, nor does it specify the predicate device's performance numbers that were used for comparison. The assumption is that the new device met performance characteristics deemed equivalent to the predicate.

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

The provided 510(k) summary does not specify:

The exact sample sizes used for the flow rate, leak characteristics, and tensile strength tests.
The country of origin of the data.
Whether the data was retrospective or prospective.

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

This information is not applicable and not provided in the 510(k) summary. The T-AnastaFlo is a medical device (intraluminal shunt), not an AI or diagnostic imaging device that typically requires expert-established ground truths for performance evaluation. The evaluation was based on engineering and material performance tests.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical trials or studies involving human interpretation or subjective endpoints, which is not the primary focus of this type of device clearance (mechanical performance).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging devices where human readers' performance is augmented by AI. The T-AnastaFlo is a mechanical surgical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The T-AnastaFlo is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for its evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the T-AnastaFlo's performance was established through engineering and material testing standards, comparing its physical properties (flow rate, leak characteristics, tensile strength) and material/design specifications against the predicate device. It was not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on meeting pre-defined mechanical and material specifications assumed to be safe and effective based on the predicate.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The T-AnastaFlo is not an AI-driven device, so there is no "training set."

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

This information is not applicable and not provided. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

Summary

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K990396

T-AnastaFlo 510(k)

510(k) Summary IV.

Submitter / 510(k) Sponsor A.

John W. Smith, Manager of Regulatory Affairs

Baxter Research Medical, Inc. 6864 South 300 West Midvale, Utah 84047 USA

Phone (801) 565-6213

Fax (801) 565-6161

Date prepared: 1999-02-05

Device Name B.

T-AnastaFlo, IVS-T-xxxx

Classified by FDA under 21 CFR § 870.4210, Cardiopulmonary bypass vascular catheter, cannula, or tubing.

C. Predicate Device

Name: Rivetti-Levinson Intraluminal Shunt Manufacturer: Heyer-Schulte Neurocare 510(k) Number: K972261 SE Decision Date: 1997-09-15

Device Description D.

Each T-AnastaFlo is individually packaged sterile and non-pyrogenic in a sealed, peeltype pouch.

E. Intended Use

F. Summary of Comparison, Proposed and Predicate Devices

The proposed device is substantially equivalent to the cited predicate device in intended use, technology, materials, and design.

ОСТ

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This conclusion is based upon tests performed for device flow rate, leak characteristics, and tensile strength, and upon the equivalence of materials, design and intended use for the proposed and predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle with three heads, symbolizing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

1 1999 OCT -

Mr. John W. Smith Manager of Requlatory Affairs Baxter Healthcare Corporation Research Medical, Inc. 6864 South 300 West Midvale, UT 84047-1051

K990396 Re : T-AnastoFlo Requlatory Class: II (Two) Product Code: 74 DWF Dated: July 9, 1999 Received: July 12, 1999

Dear Mr. Smith:

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, Drug, 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 Requlation (QS) for Medical Devices: General requlation (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 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 regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. John W. Smith

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) 594-4648. 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. Callahan

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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D. Indications for Use Statement

510(k) Number (if known):

K 990396

Device Name:

T-AnastaFlo

Indications for use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette R. Lemperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K990396

Prescription Use_

(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).