Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

This device is for short-term use only (< 6 h).

Device Description

The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch.

The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.

AI/ML Overview

Here's an analysis of the provided text regarding the Retrograde Cardioplegia Cannula with Duraflo Treatment, focusing on acceptance criteria and supporting studies.

It's important to note that the provided 510(k) summary (K991170) does not contain the detailed information typically associated with acceptance criteria and studies demonstrating device performance against those criteria as would be expected for an AI/ML or diagnostic device. This document is for a physical medical device (a catheter) and relies on substantial equivalence to predicate devices, rather than primary performance studies in the way you might be expecting.

Therefore, I will interpret your request within the context of what information is available in this 510(k) submission for a non-AI device.

Acceptance Criteria and Study for Retrograde Cardioplegia Cannula with Duraflo Treatment (K991170)

Given that this 510(k) is for a physical medical device (a cannula) rather than a software or diagnostic device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" is framed differently. The primary mechanism for clearance in this case is demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" being evaluated is whether the new device functions similarly and is as safe and effective as the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Review)	Reported Device Performance (Summary)
Intended Use Equivalence: Device indicates for same clinical purpose.	Indicated for "delivery of blood or cardioplegic solution intraoperatively" and "use in cardiopulmonary surgery when a heparin-treated blood path is desired." Matches or is consistent with predicate devices.
Technological Equivalence: Same fundamental technology.	"The proposed device consists of a device identical to the device cited as predicate Device A, which has been treated with the Duraflo treatment included in Predicate Device B." Uses established cannula design with an existing heparin coating.
Material Equivalence: Made of similar, safe, and biocompatible materials.	Materials are considered equivalent or safe, given its "identical" nature to Predicate A and the known safety of the Duraflo treatment (from Predicate B).
Design Equivalence: Similar structural and functional design.	"The proposed device consists of a device identical to the device cited as predicate Device A..." (RC-014 cannula design). The added Duraflo treatment is a surface modification, not a fundamental design change to the cannula's physical structure.
Safety and Effectiveness Equivalence: No new safety or effectiveness concerns.	The FDA granted clearance, indicating that the device is deemed "substantially equivalent" in safety and effectiveness to the predicate devices. No new questions of safety or effectiveness are raised.
Short-term Use: Device is acceptable for short-term use.	Indicated for "short-term use only (< 6 h)." This aligns with typical use cases for such cannulas and would be consistent with predicate devices.

Study Description (Basis for Clearance): A Comparison to Predicate Devices

The "study" that proves this device meets its acceptance criteria is a comparison to predicate devices to establish substantial equivalence.

Description: The submission argues that the proposed device is substantially equivalent to two predicate devices:
- Predicate Device A: Retroplegia Cannula, RC-014 (K880103) from Baxter Research Medical, Inc.
- Predicate Device B: Extracorporeal Circuit with Duraflo II Heparin Treatment (K932208) from Baxter Healthcare Corporation.
The argument is that the proposed device is Predicate Device A, but with the Duraflo treatment that is the subject of Predicate Device B. This combines an existing cannula design with an existing, cleared heparin coating technology. The core "proof" is that the individual components (the cannula design and the Duraflo treatment) have both been previously deemed safe and effective by the FDA.

Detailed Breakdown of Your Specific Questions (within the context of this 510(k)):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. This 510(k) does not describe a performance study with a "test set" in the sense of patient data or algorithm testing. The evaluation is based on comparison to legally marketed predicate devices and their established performance/safety profiles.
- Data Provenance: Not applicable for a new study. The provenance for the predicate devices' data would be from their original clearance submissions, which are not detailed here.
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. There was no "ground truth" to establish for a test set in the context of this 510(k) for a physical device. FDA regulators review the submission and make a determination of substantial equivalence based on the provided technical and comparative information.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication was described. The FDA's review process acts as the "adjudication" of the substantial equivalence claim.
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 or diagnostic device, so MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: The "ground truth" in this context is the FDA's prior determination of safety and effectiveness for the predicate devices. The new device is deemed substantially equivalent based on its shared characteristics with these already cleared devices. No new clinical "ground truth" was generated or used in this specific submission.
The sample size for the training set:
- Not applicable. This is not an AI or machine learning device and therefore does not have a "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.

Summary

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K991170 Page 1 of

Retrograde Cardioplegia Cannula with Duraflo Treatment

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

B. Date Prepared

1999-06-30

C. Device Name

Retrograde Cardioplegia Cannula with Duraflo Treatment, DII-RC-014

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

D. Predicate Devices

Predicate Device A:	Retroplegia Cannula, RC-014
Manufacturer:	Baxter Research Medical, Inc. (BRMI)
510(k) Number:	K880103

Extracorporeal Circuit with Duraflo II Heparin Treatment Predicate Device B: Baxter Healthcare Corporation Manufacturer: 510(k) Number: K932208

E. Device Description

The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.

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Intended Use F.

The Retrograde Cardioplegia Cannula with Duraflo Treatment is indicated for use in the delivery of blood or cardioplegic solution.

Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

Summary of Comparison, Proposed and Predicate Devices G.

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

The proposed device consists of a device identical to the device cited as predicate Device A, which has been treated with the Duraflo treatment included in Predicate Device B.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

JUL : 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K991170 Retrograde Cardioplegia Cannula with Duraflo Treatment Regulatory Class: II (Two) Product Code: DWF April 6, 1999 Dated: Received: April 7, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Number DII-RC-014, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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), promotion, or advertising, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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): K991170

Retrograde Cardioplegia Cannula with Duraflo Treatment Device Name:

Indications for use:

The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively.

Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

This device is for short-term use only (< 6 h).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Caroline Henry Leon

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 491170 510(k) Number

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).