The ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect, defoam, filter, and store blood prior to processing.

Device Description

The Fresenius ATR 40 and ATR 120 are 3 liter blood collection reservoirs, with 40 or 120 micron filters respectively. They are used for the collection of blood lost intra- or postoperalively in surgical procedures. Collection is performed by vacuum suction via appropriate tubing systems e.g. double lumen suction lines for aspiration and simultaneous anticoagulation or drainage adapters connected to wound drains. They are connected to the respective inlet connectors on top of the reservoir: two 1/4"-connectors (one vertical, one horizontal), luer female connector. All inlet connectors drain the fluid into a filter via a filter holder. The ATR 40 contains a three-layer filter and the ATR 120 contains a two-layer filter that traps particulates greater than 40 and 120 microns, respectively. In both filters, the PUR foam is treated with a defoaming agent to dissolve bubbles generated in the blood collection process by mixing blood with air. Except for the filter ATR 40 and ATR 120 are identical. The filters are attached to the filter holder by a cable tie and hang like a pouch in the reservoir lumen. The vacuum is applied via a separate vacuum line attached to a 1/4" vacuum port. Positive and negative pressure level within the reservoir is limited by a pressure relief valve that opens in the range of approximately -300 mmHg and + 100 mmHg. Up to 3 liters of aspirated blood can pass through the filter and be stored in the reservoir lumen at one time. The volume of collected blood can be controlled by calibration marks on both sides of the reservoir; the calibration marks are in increments of 100 ml to 3000 ml. Collected blood can be transferred to an autotransfusion device via the outlet line attached to the reservoir. The flow of blood through the outlet line can be controlled with a pinch clamp. A universal adapter, compatible with 1/4" male adapters and 3/8" female connectors, it attached to the distal end of the outlet line for connection to autotransfusion tubing sets. The reservoir can be attached to an IV pole using a compatible reservoir holder or the hanger on top of the reservoir. The ATR 40 and ATR 120 Autotransfusion Devices are supplied as sterile (ETO) disposable devices with a non-pyrogenic fluid path.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes substantial equivalence testing against predicate devices. The acceptance criteria are framed as "equal quality" or "substantially equivalent" to the predicate devices for specific performance aspects.

Acceptance Criteria (Stated Goal)	Reported Device Performance
ATR 40 (compared to Medtronic EL240 Blood Collection Reservoir):
Satisfies AAMI/ANSI standards for structural integrity.	Demonstrated that "The Fresenius ATR 40 satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device."
Materials suitable for intended use (biocompatibility).	Biocompatibility testing consistent with FDA's modified ISO standards. Adherence to AAMI/ANSI standards for materials.
Shelf-life validation (biocompatibility, structural integrity, packaging, sterility).	"Shelf-life validation studies pertinent to the Fresenius ATR 40 have determined that the biocompatibility, structural integrity, packaging integrity and sterility of the Fresenius ATR 40 will be maintained for the labeled shelf-life."
Equal quality in filtration efficiency.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to filtration efficiency... as the Medtronic EL240."
Equal quality in defoaming.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to ... defoaming... as the Medtronic EL240."
Equal quality in hemolysis.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to ... hemolysis... as the Medtronic EL240."
Equal quality in retention of cellular components.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to ... retention of cellular components as the Medtronic EL240."
ATR 120 (compared to Haemonetics Cell Saver® Collection Reservoir):
Satisfies AAMI/ANSI standards for structural integrity.	Demonstrated that "The Fresenius ATR 120 satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device."
Materials suitable for intended use (biocompatibility).	Biocompatibility testing consistent with FDA's modified ISO standards. Adherence to AAMI/ANSI standards for materials.
Shelf-life validation (biocompatibility, structural integrity, packaging, sterility).	"Shelf-life validation studies pertinent to the Fresenius ATR 120 have determined that the biocompatibility, structural integrity, packaging integrity and sterility of the Fresenius ATR 120 will be maintained for the labeled shelf-life."
Equal quality in filtration efficiency.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to filtration efficiency... as the Haemonetics Cell Saver ®."
Equal quality in defoaming.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to ... defoaming... as the Haemonetics Cell Saver ®."
Equal quality in hemolysis.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to ... hemolysis... as the Haemonetics Cell Saver ®."
Equal quality in retention of cellular components.	"Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to ... retention of cellular components as the Haemonetics Cell Saver ®."

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

Sample Size: The document does not explicitly state the sample sizes used for the comparative testing (e.g., number of devices tested, number of blood samples). It refers to "comparative testing" and states that "Data is provided to the Agency."
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. The testing was comparative against legally marketed predicate devices (Medtronic EL240 and Haemonetics Cell Saver®).

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

This type of information is not applicable to this submission. The device is a physical medical device (autotransfusion reservoir) undergoing performance and safety testing, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" here is the measured performance of the predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable. As it's a performance and safety test for a physical device, there's no "adjudication" in the sense of reconciling multiple expert opinions on a diagnostic outcome. The assessment is based on objective measurements against established standards and predicate device performance.

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:

This information is not applicable. This is a medical device (autotransfusion reservoir), not an AI or imaging diagnostic device. Therefore, MRMC studies or AI assistance for human readers are irrelevant to its evaluation.

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

This information is not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate. The device performs its function directly.

7. The Type of Ground Truth Used:

The ground truth used for comparison was the performance parameters of legally marketed predicate devices (Medtronic EL240 and Haemonetics Cell Saver®) and compliance with relevant industry standards (AAMI/ANSI for autotransfusion devices, FDA's modified ISO standards for biocompatibility).

8. The Sample Size for the Training Set:

This information is not applicable. This device is not an AI/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 an AI model, there is no ground truth to establish for it.

Summary

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X. 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR $807.3 (Federal Register, Vol. 59, No. 239, Dec. 14, 1994, pg. 64295).

Premarket Notification for the Fresenius ATR 40 and ATR 120 Autotransfusion Reservoirs: 106 Section X: 510(k) Summary of Safety and Effectiveness Information

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510(k) Summary for the Fresenius ATR 40 and ATR 120 Autotransfusion Reservoirs

Submitter's Name and Address:	Fresenius Hemotechnology, Inc.110 Mason Circle, Suite A
	Concord, CA 94520
Phone Number:	(925) 688-0990
Telefax Number:	(925) 688-0999
Contact Person:	Virginia Singer
Date Summary Prepared:	December 22, 1998
Device Trade Name:	Fresenius ATR 40 and ATR 120 AutotransfusionReservoirs
Common name:	Autotransfusion Blood Collection Reservoir
Classification Name:	Autotransfusion Blood Collection Reservoir
Legally Marketed Devices to whichsubstantial equivalence is claimed:	Haemonetics Cell Saver Collection Reservoir (K802674)Medtronic EL240 Blood Collection Reservoir (K915737

The Fresenius ATR 40 and ATR Autotransfusion Reservoirs are intended for Intended Use: use as autotransfusion reservoirs to collect, defoam, filter, and store blood prior to processing.

Device Features:

Collection is performed by vacuum suction via appropriate tubing systems e.g. double lumen suction lines for aspiration and simultaneous anticoagulation or drainage adapters connected to wound drains. They are connected to the respective inlet connectors on top of the reservoir: two ¼"-connectors (one vertical, one horizontal), luer female connector. All inlet connectors drain the fluid into a filter via a filter holder.

The ATR 40 contains a three-layer filter and the ATR 120 contains a two-layer filter that traps particulates greater than 40 and 120 microns, respectively. In both filters, the PUR foam is treated with a defoaming agent to dissolve bubbles generated in the blood collection process by mixing blood with air. Except for the filter ATR 40 and ATR 120 are identical. The filters are attached to the filter holder by a cable tie and hang like a pouch in the reservoir lumen.

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The vacuum is applied via a separate vacuum line attached to a ¼" vacuum port. Positive and negative pressure level within the reservoir is limited by a pressure relief valve that opens in the range of approximately -300 mmHg and + 100 mmHg.

Up to 3 liters of aspirated blood can pass through the filter and be stored in the reservoir lumen at one The volume of collected blood can be controlled by calibration marks on both sides of the time. reservoir; the calibration marks are in increments of 100 ml to 3000 ml. Collected blood can be transferred to an autotransfusion device via the outlet line attached to the reservoir. The flow of blood through the outlet line can be controlled with a pinch clamp. A universal adapter, compatible with ¼" male adapters and 3/8" female connectors, it attached to the distal end of the outlet line for connection to autotransfusion tubing sets. The reservoir can be attached to an IV pole using a compatible reservoir holder or the hanger on top of the reservoir.

The ATR 40 and ATR 120 Autotransfusion Devices are supplied as sterile (ETO) disposable devices with a non-pyrogenic fluid path.

Substantial Equivalence of the ATR 40

The Fresenius ATR 40 Autotransfusion Reservoir is substantially equivalent to the Medtronic EL240 Blood Collection Reservoir. The Medtronic EL240 was previously marketed under the trade name Electromedics EL40, cleared under K915737. For purposes of this discussion the Medtronic EL240 will be referred to as the "predicate device".

Technological Characteristics of the Subject Device Compared with Predicate Device

The 510(k) "Substantial Equivalence Decision Making Process (Detailed)" decision tree (ODE Guidance Memo #K86-3) was used to make a determination of substantial equivalence. The answers to questions identified on this decision tree lead to a determination of substantial equivalence of the ATR 40 Autotransfusion Reservoir.

1.0 Does the New Device Have the Same Indication Statements?

Yes. The Fresenius ATR 40 and the Medtronic EL240 reservoirs are collection reservoirs intended to be used during autotransfusion procedures to collect, filter, defoam and store blood; both should not be used as cardiotomy reservoirs.

2.0 Does the New Device Have Same Technological Characteristics (e.g., design, materials etc.)?

Yes. Both reservoirs are designed for and operated by the same principles. Blood is drawn into the reservoir using a suction handpiece; vacuum applied to the reservoir aspirates the blood from the operative field into the cavity of the reservoir. The filter is capable of filtering particles greater than 40 microns in diameter. Filtered blood leaves the reservoir via an outlet port adapter at a rate established by the autotransfusion device that further processes the blood.

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The materials used to manufacture the reservoir are rigid plastics that sustain sufficient negative and positive pressure to prevent implosion. The filter materials are virtually identical.

Are the Descriptive Characteristics Precise Enough to Ensure Equivalence? 3.0

No. Although, the Fresenius ATR 40 and the Medtronic EL240 reservoirs are very similar, there may be differences in the design, materials used to manufacture the assemblies and in the manufacturing methods employed to build the assemblies. These differences could impact the biocompatibility, performance, structural integrity and shelf-life of the Fresenius ATR 40 Autotransfusion Reservoir.

4.0 Are Performance Data Available to Assess Equivalence?

Yes. All blood/fluid-contacting materials in the Fresenius ATR 40 have been subjected to biocompatibility testing consistent with FDA's modified ISO standards for biological evaluation of medical devices. Information pertinent to the structural integrity of the ATR 40 and shelf-life validation has been provided.

Data is provided to the Agency that demonstrates that the blood collection, filtration, defoaming, level of hemolysis produced during use, and retention of cellular components during filtration using the Fresenius ATR 40 is substantially equivalent to the Medtronic EL240. Comparative testing was performed on the Medtronic EL240, the currently marketed version of the Electromedics EL40.

5.0 Does Performance Data Demonstrate Equivalence?

Yes. Based on the results of the testing cited above, Fresenius has demonstrated that:

. The Fresenius ATR 40 satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device,
. Shelf-life validation studies pertinent to the Fresenius ATR 40 have determined that the biocompatibility, structural integrity, packaging integrity and sterility of the Fresenius ATR 40 will be maintained for the labeled shelf-life.
. Testing demonstrated that the blood products prepared using the Fresenius ATR 40 device are of equal quality with respect to filtration efficiency, defoaming, hemolysis, and retention of cellular components as the Medtronic EL240.

CONCLUSION: Based on the information and test results provided in this premarket notification, the Fresenius ATR 40 Autotransfusion Reservoir is substantially equivalent to the currently marketed Medtronic EL240 Blood Collection Reservoir.

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Substantial Equivalence of the ATR 120

The Fresenius ATR 120 Autotransfusion Reservoir is substantially equivalent to the Haemonetics Cell Saver ® Collection Reservoir (K802674). For purposes of this discussion the Haemonetic Cell Saver ® is referred to as the "predicate device".

1.0 Does the New Device Have the Same Indication Statements?

Yes. The Fresenius ATR 120 and the Haemonetics Cell Saver ® are collection reservoirs intended to be used during autotransfusion procedures to collect, filter, defoam and store blood; neither should be used as a cardiotomy reservoir.

2.0 Does the New Device Have Same Technological Characteristics (e.g., design, materials etc.)?

Yes. Both reservoirs and designed for are operated by the same principles. Blood is drawn into the reservoir using a suction handpiece; vacuum applied to the reservoir aspirates the blood from the operative field into the cavity of the reservoir. The filter is capable of filtering particles greater than 120 microns in diameter. Filtered blood leaves the reservoir via an outlet port adapter at a rate established by the autotransfusion device that further processes the blood.

The materials used to manufacture the reservoir are rigid plastics that sustain sufficient negative and positive pressure to prevent implosion. The filiter materials are virtually identical.

3.0 Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

No. Although, the Fresenius ATR 120 and the Haemonetics Cell Saver ® reservoirs are very similar, there may be differences in the design, materials used to manufacture the assemblies and in the manufacturing methods employed to build the assemblies. These differences could impact the biocompatibility, performance, structural integrity and shelf-life of the Fresenius ATR 120 Autotransfusion Reservoir.

4.0 Are Performance Data Available to Assess Equivalence?

Yes. All blood/fluid-contacting materials in the Fresenius ATR 120 have been subjected to biocompatibility testing consistent with FDA's modified ISO standards for biological evaluation of medical devices. Information pertinent to the structural integrity of the ATR 120 and shelf-life validation has been provided.

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Data is provided to the Agency that demonstrates that the blood collection, filtration, defoaming, level of hemolysis produced during use, and retention of cellular components during filtration using the Fresenius ATR 120 is substantially equivalent to the Haemonetics Cell Saver ®.

5.0 Does Performance Data Demonstrate Equivalence?

Yes. Based on the results of the testing cited above, Fresenius has demonstrated that:

. The Fresenius ATR 120 satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device,
. Shelf-life validation studies pertinent to the Fresenius ATR 120 have determined that the biocompatibility, structural integrity, packaging integrity and sterility of the Fresenius ATR 120 will be maintained for the labeled shelf-life.
. Testing demonstrated that the blood products prepared using the Fresenius ATR 120 device are of equal quality with respect to filtration efficiency, defoaming, hemolysis, and retention of cellular components as the Haemonetics Cell Saver ®.

CONCLUSION: Based on the information and test results provided in this premarket notification, The Fresenius ATR 120 Autotransfusion Reservoir is substantially equivalent to the Haemonetics Cell Saver ® Collection Reservoir.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a bird or eagle, with three curved lines forming its body and wings, and two curved lines forming its tail.

Public Health Service

JUN 2 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Virginia Singer Manager, Regulatory Affairs Fresenius Hemotechnology, Inc. 110 Mason Circle, Suite A Concord, CA 94520-1238

K984586 Re: Fresenius ATR 40 and ATR 120 Autotransfusion Reservoirs Regulatory Class: II (Two) Product Code: DTN May 14, 1999 Dated: Received: May 17, 1999

Dear Ms. Singer:

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 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 Please note: this response to your premarket Federal Register. notification submission does not affect any obliqation 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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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. Callehan

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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Indications for Use Statement

Page 1 of 1

510(k) Number (if known);

Device Name:

Indications for Use:

K984586

Fresenius ATR 40 and ATR 120 Autotransfusion Reservoirs

The ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect, defoam, filter, and store blood prior to processing.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bethe R. Bemperele
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_k984566

Prescription Use
(Per 21 CFR 801.109)

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.