The Dideco ATS Autotransfusion Cardiotomy Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.

Device Description

The Dideco ATS Autotransfusion Cardiotomy Reservoir (Dideco ATS) is a modification of the Dideco-Shiley ACR-40 Autotransfusion Reservoir (ACR-40) (K884872). The Dideco ATS is identical in intended use and fundamental technology to the previously cleared autotransfusion reservoir. Both the proposed and predicate devices consist of a reservoir with an internal filter system. The proposed device is available with two different means of removing fluids from the reservoir. The "draw tube configuration" has a draw tube attached to a fluid outlet port in the reservoir cover. Fluids may also be drained from this version of the reservoir via a piercable connector at the bottom of the reservoir housing. In the second form of the device, the "bottom outlet" version, the fluid outlet port is located on the bottom of the housing. In both configurations of the device, fluids enter the reservoir through an inlet port in the reservoir cover which is connected to the internal filter system. There is also a Luer lock connector on the reservoir cover which bypasses the filter system. Both versions of the reservoir also contain an overflow valve to prevent the volume of fluid in the reservoir from exceeding the maximum holding capacity.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Dideco ATS Autotransfusion Cardiotomy Reservoir

This 510(k) summary describes a device that is a modification of a previously cleared autotransfusion reservoir. The study presented aims to demonstrate substantial equivalence to the predicate device (Dideco-Shiley ACR-40) rather than establishing de novo performance targets. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably or acceptably to the predicate device for key functional and safety aspects.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a modified device, the acceptance criteria are not explicitly stated as numerical thresholds but rather as maintaining comparable performance or successful completion of safety tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993-1 for external communicating device, limited contact (<24 hrs) with circulating blood.
Sterility & Non-Pyrogenicity	Device is nonpyrogenic and sterile. ETO sterilization residuals are within specification.
Hemolysis and Cell Depletion (compared to predicate)	No depletion in platelet or white blood cell populations. No change in hematocrit or total plasma hemoglobin observed after six hours recirculation.
Reservoir Housing Integrity	Maintained physical integrity when pressurized to 1.5 times the maximum expected clinical operating levels without leakage or structural damage.
Breakthrough Time and Volume (compared to predicate)	Did not affect the time or volume of blood required to penetrate the filter material and enter the reservoir housing.
Residual Volume (compared to predicate)	Comparable to the predicate Dideco-Shiley ACR 40.
Filtration Efficiency (compared to predicate)	Comparable to that of the ACR 40 in the size range of 40 microns or larger specified in the Instructions for Use.
Connector Pull Strength	Sufficient to withstand a pull force of 50 Newtons for 15 seconds.
Shelf Life	Supported a five-year shelf life.

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

The document does not specify the sample sizes used for any of the performance tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a physical medical device (autotransfusion reservoir), the testing would typically involve in-vitro laboratory studies using blood samples, and potentially animal models for some biocompatibility aspects, rather than human patient data in the way an AI diagnostic device would.

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

This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics (e.g., filtration efficiency, housing integrity, hemolysis) would be established through established scientific methods and laboratory measurements, not through expert consensus on diagnostic images or clinical assessments.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods like "2+1" or "3+1" are relevant for establishing ground truth in clinical or diagnostic studies, particularly those involving human readers or interpretations. The tests conducted here are laboratory-based performance and safety evaluations.

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 primarily relevant for diagnostic devices, especially those involving human interpretation of medical images, where the AI system assists or replaces human readers. The Dideco ATS Autotransfusion Cardiotomy Reservoir is a physical medical device used for blood collection and filtration, not a diagnostic AI system.

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

This question is not applicable to this device. The Dideco ATS is a physical medical device (reservoir) and does not involve any algorithms or AI for standalone performance evaluation in the way a software-based diagnostic device would. All performance tests are inherently "standalone" in the sense that they evaluate the device itself, but not in the context of an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is derived from:

Established scientific methods and laboratory measurements: For tests like hemolysis, cell depletion, reservoir integrity, breakthrough time, residual volume, filtration efficiency, and connector pull strength, the ground truth is objective measurement against specified physical or biological parameters.
International standards: Biocompatibility is assessed against ISO 10993-1.
Predicate device comparison: For several metrics (hemolysis, cell depletion, breakthrough time, residual volume, filtration efficiency), the ground truth for "acceptability" is similarity or comparability to the performance of the legally marketed predicate device (Dideco-Shiley ACR-40).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this physical device.

Summary

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ABBREVIATED 510(k) SUMMARY FOR DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR

1. SPONSOR

Dideco S.P.A Via Statale 12 Nord 86 P.O. Box 87 41037 Mirandola (MO), Italy

Contact Person: Luigi Vecchi 01139 0535 29811 Telephone:

August 2, 1999 Date Prepared:

2. DEVICE NAME

Proprietary Name:	Dideco ATS Autotransfusion Cardiotomy Reservoir
Common/Usual Name:	Autotransfusion reservoir
Classification Name:	Accessory to an autotransfusion apparatus

3. PREDICATE DEVICE

Dideco-Shiley ACR-40 Autotransfusion Cardiotomy Reservoir (K884872)

4. DEVICE DESCRIPTION

The Dideco ATS Autotransfusion Cardiotomy Reservoir (Dideco ATS) is a modification of the Dideco-Shiley ACR-40 Autotransfusion Reservoir (ACR-40) The Dideco ATS is identical in intended use and fundamental (K884872). technology to the previously cleared autotransfusion reservoir. Both the proposed and predicate devices consist of a reservoir with an internal filter system.

The proposed device is available with two different means of removing fluids from the reservoir. The "draw tube configuration" has a draw tube attached to a fluid outlet port in the reservoir cover. Fluids may also be drained from this version of

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the reservoir via a piercable connector at the bottom of the reservoir housing. In the second form of the device, the "bottom outlet" version, the fluid outlet port is located on the bottom of the housing.

In both configurations of the device, fluids enter the reservoir through an inlet port in the reservoir cover which is connected to the internal filter system. There is also a Luer lock connector on the reservoir cover which bypasses the filter system. Both versions of the reservoir also contain an overflow valve to prevent the volume of fluid in the reservoir from exceeding the maximum holding capacity.

ട. INTENDED USE
The Dideco ATS is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Dideco ATS is modified from the Dideco-Shiley ACR-40 as follows:

. increased holding capacity of the reservoir
addition of a second configuration with the outlet port on the bottom of the . reservoir housing
. elimination of the need for a reusable outer shell
modification of the support system for the filter assembly .

7. PERFORMANCE TESTING

Biocompatibility testing was performed to meet the requirements of ISO 10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" for an external communicating device in limited (<24 hrs.) contact with circulating blood. Test results confirm that the device is biocompatible for its intended use. biological testing demonstrated that the finished device is Additional nonpyrogenic, sterile, and had ETO sterilization residuals within specification.

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Test	Results
Hemolysis and Cell Depletion	The design modifications incorporated into the proposed Dideco ATSdid not cause a depletion in platelet or white blood cell populations.No change in hematocrit or total plasma hemoglobin was observedafter six hours recirculation.
Reservoir Housing Integrity	The Dideco ATS reservoir maintained its physical integrity whenpressurized to 1.5 times the maximum expected clinical operatinglevels without exhibiting any leakage or structural damage.
Breakthrough Time and Volume	The modifications to the filter assembly incorporated into theproposed Dideco ATS did not affect the time or volume of bloodrequired to penetrate the filter material and enter the reservoirhousing.
Residual Volume	The residual volumes of the Dideco ATS are comparable to thepredicate Dideco-Shiley ACR 40.
Filtration Efficiency	The Dideco ATS had a filtration efficiency comparable to that of theACR 40 in the size range of 40 microns or larger specified in theInstructions for Use.
Connector Pull Strength	The integrity of the connections in the Dideco ATS is sufficient towithstand a pull force of 50 Newton for 15 seconds.
Shelf Life	Test results support a five-year shelf life for the Dideco ATSreservoir.

Summary of Performance Testing Conducted on the Dideco ATS

The results of the biological and performance testing demonstrate that the proposed Dideco ATS is substantially equivalent to the Dideco-Shiley ACR-40 and is safe for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

NOV 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynthia J.M. Nolte, Ph.D. Staff Consultant Medical Device Consultants, Inc. 49 Plain Street 02760 North Attleboro, MA

Re: ' K992599 Dideco ATS Autotransfusion Cardiotomy Reservoir Regulatory Class: II (Two) Product Code: 74 DTN Dated: Auqust 2, 1999 Received: August 3, 1999

Dear Dr. Nolte:

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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 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 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 requlations.

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Paqe 2 - Cynthia J.M. Nolte, Ph.D.

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

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K992599

Device Name: Dideco ATS Autotransfusion Cardiotomy Reservoir

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beau L. Grivielle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K992599

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use _

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.