The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

Device Description

The Cell Saver Elite Autotransfusion System is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifygal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The Cell Saver Elite system is designed to perform the same types of procedures as the Cell Saver 5 system, utilizing very similar disposable sets. The primary changes from the Cell Saver 5 to the Cell Saver Elite systems include a modernized graphical user interface with a touch screen display, barcode data capture capability to simplify data entry, and the integration of an onboard vacuum system to provide regulated vacuum to the collection reservoir.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

Acceptance Criteria and Device Performance Study for Haemonetics Cell Saver Elite Autotransfusion System

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Cell Saver Elite In-house Laboratory Evaluation of Processing Efficiency and RBC Recovery(Protocol TR-CLN-100177)	- Final product hematocrit of 40-60%- Heparin Washout ≥95%- Free Hemoglobin Washout ≥95%- Red Blood Cell Recovery ≥80%	Conclusion: Data met Acceptance Criteria
In-house Laboratory Validation of Platelet Sequestration Protocol Using the Cell Saver Elite(Protocol TR-CLN-100201)	No formal acceptance criteria; characterization of the product.	Conclusion: The platelet rich plasma that is produced meets the threshold of three (3) times the incoming platelet count of the whole blood.
In-house Laboratory Evaluation of Processing Efficiency and Product Characteristics using Pools without Lysate(Protocol TR-CLN-100049)	- Final product hematocrit of 40-60%- Heparin Washout ≥95%- Free Hemoglobin Washout ≥95%- Red Blood Cell Recovery ≥80%	Conclusion: Data met Acceptance Criteria. The data above indicate the processed RBC product data from all three bowl types exceeded the acceptance criteria in terms of Hematocrit, RBC Recovery and Washout. The RBC recovery data was, on average 12% higher than the RBC Recovery derived from procedures using pools with high levels of free hemoglobin.

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

The provided document does not explicitly state the sample sizes used for the test sets in the non-clinical laboratory studies (TR-CLN-100177, TR-CLN-100201, TR-CLN-100049).

The data provenance is internal in-house laboratory evaluations. There is no information regarding the country of origin of the data beyond "in-house laboratory" or whether it was retrospective or prospective. Given it is laboratory testing for performance characterization, it would typically be prospective testing conducted for the purpose of the submission.

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

This information is not provided in the document. The studies are described as "in-house laboratory evaluations" characterizing device performance, not assessments based on expert-derived ground truth from a clinical data set. The ground truth for these tests would be the measured properties of the processed blood products (e.g., hematocrit, washout percentages), which are quantifiable laboratory values.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective expert assessment is used to establish ground truth or evaluate a device's diagnostic output. Since these are laboratory performance studies measuring objective parameters of blood processing, an adjudication method is not applicable and therefore not mentioned. The "ground truth" for these studies is the direct measurement of the physical and chemical properties of the blood components.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document describes non-clinical laboratory performance testing of the device itself and a comparison of its characteristics to a predicate device. It does not involve human readers evaluating output or comparing human performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The studies described are standalone performance studies of the device (Haemonetics Cell Saver Elite system) itself, focusing on its ability to process blood and produce a specific output (e.g., washed red blood cells, platelet-rich plasma). The device itself operates autonomously in its processing functions, so its performance is inherently "algorithm only" or "device only" in terms of its processing capabilities. There is no human interaction during the blood processing and characterization that would alter the device's fundamental performance metrics.

7. Type of Ground Truth Used

The ground truth used for these performance studies is objective, quantitative laboratory measurements of the processed blood products. This includes:

Final product hematocrit
Heparin Washout percentage
Free Hemoglobin Washout percentage
Red Blood Cell Recovery percentage
Platelet count in platelet-rich plasma

These are direct physical and chemical measurements rather than subjective expert consensus, pathology reports, or patient outcomes.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The Haemonetics Cell Saver Elite Autotransfusion System is a medical device that performs physical blood processing through centrifugation and washing. It is not an AI/ML-based diagnostic or prognostic algorithm that requires a "training set" in the computational sense. Its design and performance are established through engineering, physics, and validation testing, not machine learning training.

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

This information is not applicable. As stated above, the device does not use a training set as it is not an AI/ML system. Its "ground truth" for development and validation is based on established principles of blood processing, and performance is verified through rigorous laboratory testing against predefined specifications.

Summary

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Date Prepared: November 22, 2010

Submitter: Haemonetics Corporation 400 Wood Road. Braintree MA 02184

Contact: Greg Calder Regulatory Affairs Specialist Phone: 781-356-9538 Fax: 781-356-3558 fax Email: gcalder@haemonetics.com

Device Information: Trade Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC

Predicate Device Information: Trade Name: Haemonetics Cell Saver 5 Autologous Blood Recovery System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC

Device Characteristics Summary:

The Cell Saver Elite Autotransfusion System is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver 5 was most recently cleared via 510(k) K014083.

The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses. anesthesia technicians and autotransfusion service provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines.

The collected blood is processed through a centrifygal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient.

The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

DEC - 3 2010

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Non-clinical Testing Summary:

Non-clinical performance testing was completed in accordance with AT6:2005. A summary of the performance testing is presented below in Table 1: Summary of Performance Studies. Test data demonstrates thathe evice and resultant blood products met all clinical and performance requirements, and is as safe, as effective, and performs as well as or better than the predicate device.

Cell Saver Elite In-house LaboratoryEvaluation ofProcessing Efficiencyand RBC Recovery	TR-CLN-100177	The intent of this study was tocharacterize the performanceof the Cell Salvage protocol ofthe CS Elite in terms ofprocessing efficiency andproduct characteristics.	Final product hematocrit of40-60% Heparin Washout ≥95% Free Hemoglobin Washout≥95% Red Blood Cell Recovery≥80% Conclusion:Data met AcceptanceCriteria
In-house LaboratoryValidation of PlateletSequestration ProtocolUsing the Cell SaverElite	TR-CLN-100201	The intent of this study wasto evaluate the PlateletSequestration protocol of theCS Elite in terms ofperformance and productcharacteristics	No formal acceptance criteria;characterization of theproduct.Conclusion:The platelet rich plasma thatis produced meets thethreshold of three (3) timesthe incoming platelet count ofthe whole blood.
In-house LaboratoryEvaluation ofProcessing Efficiencyand ProductCharacteristics usingPools without Lysate	TR-CLN-100049	The intent of this study was tocharacterize the performanceof the Cell Salvage protocol ofthe CS Elite in terms ofprocessing efficiency andproduct characteristics ofblood without Lysate; andtherefore to confirm the truered cell recovery.	Final product hematocrit of40-60% Heparin Washout ≥95% Free Hemoglobin Washout≥95% Red Blood Cell Recovery≥80% Conclusion:Data met AcceptanceCriteriaThe data above indicate theprocessed RBC product datafrom all three bowl typesexceeded the acceptancecriteria in terms of Hematocrit,RBC Recovery and Washout.The RBC recovery data was,on average 12% higher thanthe RBC Recovery derivedfrom procedures using poolswith high levels of freehemoglobin.

Table 1: Summary of Performance Studies

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Comparison to Predicate Summary:

The Cell Saver Elite system is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver 5 system was most recently cleared via 510(k) K014083. The Cell Saver Elite system is y ysyd. to perform the same types of procedures as the Cell Saver 5 system, utilizing very similar disposable sets. The Envary changes from the Cell Saver 5 to the Cell Saver Elite systems include a modernized graphical user interface with a touch screen display, barcode data capture capability to simplify data entry, and the integration of an onboard vacuum system to provide regulated vacuum to the collection reservoir.

A summary of the Cell Saver Elite system comparison to the predicate Cell Saver 5 system is presented in Table 2: Comparison of the Haemonetics Cell Saver Elite system to the predicate Cell Saver 5 system.

Characteristic	Cell Saver Elite System(Subject device)	Cell Saver 5 System(Predicate most recently clearedK014083)
Indications forUse	The Haemonetics Cell Saver® Elite™Autotransfusion System and its relatedaccessory components are intended foruse to recover blood shed during orsubsequent to an operation or as a resultof trauma, processing the blood by acentrifugation and washing procedure,and pumping this processed red cellproduct to either a bag for gravityreinfusion into the patient or to thearterial line of an extracorporeal circuitfor reinfusion into the patient. Theintended use of the SequestrationProtocol is to collect an autologous,preoperative, platelet rich plasmaproduct for reinfusion to the samepatient within 6 hours of collection.	The Cell Saver 5 Autologous BloodRecovery System is intended for use torecover blood shed during or subsequentto an operation or as a result of trauma,processing the blood by a centrifugationand washing procedure, and pumpingthis processed red cell product to either abag for gravity reinfusion into thepatient or to the arterial line of anextracorporeal circuit for reinfusion intothe patient. The intended use of theSequestration Protocol is to collect anautologous, preoperative, platelet richplasma product for reinfusion to thesame patient within 6 hours ofcollection.
Disposable Set	Designed to utilize the Latham 225 mlbowl, Latham 125 ml bowl, and BlowMolded 70 ml bowl processing sets.Designed to utilize the PRP/PPPSequestration disposable accessory.	Designed to utilize the Latham 225 mlbowl, Latham 125 ml bowl, and BlowMolded 70 ml bowl processing sets.Designed to utilize the PRP/PPPSequestration disposable accessory.
User Interface	Graphical User Interface with touchscreen display technology for deviceinterface. Integrated barcode scanner tosimplify data entry.Beacon light on top of the display toprovide general device status at a glance.The status indicator and message area onthe GUI each have a vertical color codedbar that corresponds to the beacon light.	LCD display with discrete keys fordevice interface.
Characteristic	Cell Saver Elite System(Subject device)	Predicate Cell Saver 5 System(Cleared K932890, K014083)
ProcessingFunctionality	Cell Salvage protocol:FillWashEmptyConcentrateReturnEmergency mode (Latham processingsets only)Sequestration protocol:FillEmptyConcentrate	Cell Salvage protocol:FillWashEmptyConcentrateReturnEmergency mode (Latham processingsets only)Sequestration protocol:FillEmptyConcentrate
Centrifuge	Holds the rotating portion of the Lathambowls during a procedure. For the 70 mlBlow Molded bowl, a chuck adaptor isused to hold the rotating portion of thebowl in the centrifuge. Centrifugespeeds are defined for each protocol andbowl type.	Holds the rotating portion of the Lathambowls during a procedure. For the 70 mlBlow Molded bowl, a chuck adaptor isused to hold the rotating portion of thebowl in the centrifuge. Centrifugespeeds are defined for each protocol andbowl type.
Pump	A three-roller occlusive pump movesfluids into and out of the bowl. Pumpspeeds are defined for each phase.	A three-roller occlusive pump movesfluids into and out of the bowl. Pumpspeeds are defined for each phase.
Bowl Optics	The bowl optics assembly is mountedwithin the centrifuge. The opticsassembly possesses two optical sensors;one for Latham bowls and one for BlowMolded bowl.	The bowl optics assembly is mountedwithin the centrifuge.
Effluent LineSensor	Monitors quality of bowl effluent (eg.wash is satisfactory), adjusts pumpspeed (eg. avoid red cell spillage), andadvances system to next phase whenappropriate.	Monitors quality of bowl effluent (eg.wash is satisfactory), adjusts pumpspeed (eg. avoid red cell spillage), andadvances system to next phase whenappropriate.
Valve Module	Consists of three pinch valves, which areused to direct flow of fluids through theset, and a manifold pressure sensor,which monitors pressure levels in blue-striped and red-striped lines duringEmpty and Return.	Consists of three pinch valves, which areused to direct flow of fluids through theset and a clamped line sensor, whichmonitors pressure levels in blue-stripedand red-striped lines during Empty andReturn.
Air Detector	Ultrasonic air detector monitors fluidflow in the pump tubing. In Fill, thesensor detects air when reservoir isempty. In Concentrate, the sensordetects air when RBC bag is empty.During Wash, it senses air when salinebag is empty. In Empty and Return, itsenses air when bowl is empty.	Ultrasonic air detector monitors fluidflow in the pump tubing. In Fill, thesensor detects air when reservoir isempty. In Concentrate, the sensordetects air when RBC bag is empty.During Wash, it senses air when salinebag is empty. In Empty and Return, itsenses air when bowl is empty.
Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite to the Predicate
Characteristic	Cell Saver Elite System(Subject device)	Predicate Cell Saver 5 System(Cleared K932890, K014083)
Waste BagWeigher	Load cell based sensor used to monitorthe amount of fluid collected in the 10 Lwaste bag. When ~ 7.5 L of fluid isdetected, the device displays a messagethat the waste bag is almost full. When~ 8.5 L of fluid is detected, the devicedisplays a message that the waste bag isfull.	Load cell based sensor used to monitorthe amount of fluid collected in the 10 Lwaste bag.When ~ 8 L of fluid is detected, thedevice displays a message that the wastebag is almost full. When ~9 L of fluid isdetected, the device displays a messagethat the waste bag is full.For the 70 ml processing set: When ~4L of fluid is detected, the device displaysa message that waste bag should beemptied. When ~ 4.5 L of fluid isdetected, the device displays a messagethat the waste bag is full.
ReservoirWeigher	Load cell based sensor used to track theamount of fluid collected in thereservoir. The device initiates Filldepending upon the values set for Fillstart volume and Fill resume volume.	Load cell based sensor used to track theamount of fluid collected in thereservoir. The device initiates Filldepending upon the values set for Fillstart volume and Fill resume volume.
Suction	Designed to work with both regulatedexternal suction, and onboard manualand SmartSuction technology.	Designed to work with regulatedexternal suction.
HistoricalProcedure Data	Designed to provide historical procedurerecords that include procedure data andoptional consumable data. Consumabledata can be entered via an onboardbarcode scanner or typed directly intothe record.The procedure records can bedownloaded onto a USB storage device.The device can retain data for up to 100procedures.	Designed to provide a limited proceduresummary that can be viewed on thedisplay.

Table 2: Comparison of the Haemonetics Cell Saver Elite System to the Predicate Cell Saver 5 System

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Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite to the Predicate

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ﺎ ﺑﻪ ﻋ די

Grey Calder
Greg Calder

Date: 11/22/2010

Greg Calder
Regulatory Affairs Specialist
Haemonetics Corporation

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Haemonetics Corporation c/o Mr. Greg Calder 400 Wood Road Braintree. MA 02184-9114
DEC - 3 2010

Re: K101907

Trade/Device Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: II Product Code: CAC Dated: November 22, 2010 Received: November 29, 2010

Dear Mr. Calder:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean t that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Greg Calder

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

D.vina R. le. Minu

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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

DEC - 3 2010

510(k) Number (if known): K101907

Device Name: Haemonetics Cell Saver® Elite™ Autotransfusion System Indications For Use: The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DWANA R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K10 \ 407

Page 1 of 1_

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).