The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

Autotransfusion is indicated for patients who meet at least one of the following criteria:

The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
Compatible allogeneic blood is not available.
The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.

Device Description

The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™):

The provided document describes a 510(k) submission for a medical device (cardioPAT™), which is for autotransfusion. The study presented here is a comparative study to demonstrate substantial equivalence to a predicate device (OrthoPAT®), rather than a standalone clinical trial establishing new efficacy. The "acceptance criteria" are implied by the comparison to the predicate device's performance.

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

The acceptance criteria are implicitly defined by acceptable deviations from the predicate device's performance, specifically less than 2% difference in washout values and less than 3% difference in red blood cell (RBC) recovery.

Performance Metric	Acceptance Criteria (Difference vs. Predicate)	Reported cardioPAT™ Performance (Difference vs. Predicate)	Meets Criteria?
Mean Washout (Supernate Heparin)	< 2%	+0.0%	Yes
Mean Washout (Supernate Albumin)	< 2%	+0.2%	Yes
Mean Washout (Supernatant Hemoglobin)	< 2%	-1.1%	Yes
Mean Red Blood Cell Recovery	< 3%	+2.1%	Yes

Reported cardioPAT™ Performance Summary (from Table 1):

Hematocrit	Mean Washout (Supernate Heparin) (%)	Mean Washout (Supernate Albumin) (%)	Mean Washout (Supernate Hemoglobin) (%)	Mean Red Blood Cell Recovery (%)
5%	99.88	99.90	99.38	77.83
15%	99.68	99.80	98.18	88.77
40%	97.19	97.67	94.37	91.00
Mean	98.9	99.1	97.3	85.9

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

Sample Size for Test Set: The document mentions "pools of different hematocrit blood" processed. It does not specify the exact number of samples or "runs" for the cardioPAT system, but it presents mean values across these pools. For the predicate device (OrthoPAT®), it refers to "previously obtained, using similar pools of blood."
Data Provenance: The study appears to be a laboratory-based performance test ("processed under simulated use conditions"). There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense. It's a technical performance validation.

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. This is a technical performance study measuring physical properties (washout, RBC recovery) of blood, not a diagnostic or interpretative study requiring human expert ground truth.

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

Not applicable. This is a technical performance study based on direct laboratory measurements.

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/diagnostic device and does not involve human readers interpreting data or assisting in a clinical decision.

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

This refers to a "standalone" performance of the device itself in processing blood. The data presented in Table 1 represents the "standalone" performance of the cardioPAT™ system under simulated use conditions.

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

The "ground truth" in this context refers to the measured physical and chemical properties of the processed red blood cells, specifically:

Concentration of Supernate Heparin
Concentration of Supernate Albumin
Concentration of Supernatant Hemoglobin
Red Blood Cell Recovery

These are objective measurements performed in a laboratory setting.

8. The sample size for the training set

Not applicable. This device is an electromechanical system for physical processing of blood, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. See point 8.

Summary

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K043/27

Section 10: 510(k) Summary

Statement	This summary of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Submitter	Haemonetics Corporation400 Wood RoadBraintree, MA. 02184-9114
CompanyContact	Gabriel J. Muraca, Jr.RA Project ManagerHaemonetics Corporation355 Wood Rd.Braintree, MA. 02184-9114
Device Name	Proprietary Name:Cardiovascular Perioperative Autotransfusion System(cardioPATTM)Common Name: Autotransfusion apparatusClassification Name: Autotransfusion apparatus (74 CAC)

The currently marketed predicate device is the Haemonetics® Orthopedic Predicate Perioperative Autotransfusion System (OrthoPAT®). Device

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The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an Device electromechanical device and a sterile single-use disposable set, which together Description collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

The Haemonetics® Cardiovascular Perioperative Autotransfusion System Indications for (cardioPAT™) is indicated for use to salvage red blood cells from blood lost Use intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

Autotransfusion is indicated for patients who meet at least one of the following criteria:

The patient is expected to lose sufficient blood in the . perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
Religious beliefs cause the patient to refuse allogeneic . transfusion, but accept autologous transfusion.
Compatible allogeneic blood is not available. .
The patient is unable to donate sufficient quantities of . autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
The patient or physician prefers perioperative autotransfusion . rather than preoperative autologous donation or transfusion of allogeneic blood.

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The quality of salvaged red blood cells returned to the donor during autotransfusion procedures with both the current OrthoPAT and modified Performance cardioPAT systems is acceptable with respect to measured markers.

The following table is a summary of Tables 1, 2 and 3 from the test report TP-& TR-DIS-02028, Exhibit 5. It shows the mean percent washout and the mean percent red blood cell recovery for pools of different hematocrit blood that were processed under simulated use conditions by the cardioPAT system.

MeanWashout			MeanRed Blood CellRecovery
Hematocrit	SupernateHeparin(%)	SupernateAlbumin(%)	SupernateHemoglobin(%)	(%)
5%	99.88	99.90	99.38	77.83
15%	99.68	99.80	98.18	88.77
40%	97.19	97.67	94.37	91.00
Mean	98.9	99.1	97.3	85.9

Table 1: Data Summary* for cardioPAT

*From TP- & TR-DIS-02028

Table 2 compares the combined means of the cardioPAT results from Table 1 and compares them to the combined mean test results previously obtained, using similar pools of blood, which were processed on the predicate OrthoPAT system (Test Report V0007, K962475, provided in Exhibit 5).

Table 2: Combined Pool Results Comparison

	MeanWashout			MeanRed Blood CellRecovery
Data Source	SupernateHeparin(%)	SupernateAlbumin(%)	SupernatantHemoglobin(%)	(%)
OrthoPATV0007 (SW 3.0c)	98.9	98.9	98.4	83.8
cardioPATTP-DIS-02028	98.9	99.1	97.3	85.9
% Difference	+ 0.0	+ 0.2	- 1.1	+ 2.1

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This comparison shows that there is less than 2% difference in combined mean percent (%) washout values and less than 3% difference between the mean percent red blood cell recovery values. Because these percent differences are very small, they are not considered clinically significant. The cardioPAT system performance test results are within the expected operating efficiencies of the predicate OrthoPAT device, which demonstrates performance equivalence.

Substantial Equivalence

The substantial equivalence of the cardioPAT System is supported by its similarities in intended use, technological characteristics, and performance as compared to the currently marketed OrthoPAT system.

Gabriel J. Munoz Jr.

Gabriel J. Muraca, Jr. RA Project Manager Haemonetics Corporation

Date: November 10, 2004

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Image /page/4/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 symbol that resembles three abstract human figures or lines, possibly representing people or services provided by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 4 2005

Haemonetics Corporation c/o Mr. Gabriel J. Muraca, Jr. RA Project Manager 355 Wood Road Braintree, MA 02184-9114

K043127 Re:

K043127
Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM) Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: November 10, 2004 Received: November 12, 2004

Dear Mr. Muraca:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 9 ro(if) presidentially equivalent (for the indications felerenced and nave determined the are are are are are and one sparketed in interstate for use stated in the cherosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 28, 1976, the enational with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of any inst devices that have been recalismod in asses approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appt to the general controls provisions of the Act. The You may, merelore, market the device, becarements for annual registration, listing of general controls provisions of the rise labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 abor of the Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ents concerning your device in the Federal Register.

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Page 2 - Mr. Gabrie! J. Muraca, Jr.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivisation that your device complies with other requirements of the Act that I Dri has made a actives and regulations administered by other Federal agencies. You must of any reactal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the 11et 31equirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roggistions 531-542 of the Act); 21 CFR 1000-1050. product lastation oona of pro recom (2) .
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notification: "The PDF interessification 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), please rryou desire specific at (301) 594-4646. Additionally, for questions on the comact the Office of Compilance and evice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (301) 594-4057. Also, prease nets roganison way obtain. Other general information on your premarket hourseation - (2) of the abe obtained from the Division of Small Manufacturers, Itsponsional and Consumer 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,

Donna R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K043127 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM)

Indications for Use:

The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is I IIe Haemonches® Cardio resource > errells from blood lost intraoperatively and postoperatively muring cardiovascular surgical procedures, where the expected rate of processing of salvaged during cardio rasoural bargical site is less than or equal to two liters per hour.

Autotransfusion is indicated for patients who meet at least one of the following criteria:

The patient is expected to lose sufficient blood in the perioperative period, so as . to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
Religious beliefs cause the patient to refuse allogeneic transfusion, but accept ● autologous transfusion.
Compatible allogeneic blood is not available. .
The patient is unable to donate sufficient quantities of autologous blood prior to . surgery to adequately cover the anticipated transfusion requirement.
The patient or physician prefers perioperative autotransfusion rather than . preoperative autologous donation or transfusion of allogeneic blood.

and/or X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

R. bechner

(Division Sign-Off)
Division of Cardiovascular Devices

510(K) Number_KO43127

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).