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.

The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative 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.

Device Description

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm.

The Cell Saver Elite System consists of a single use disposable set and reusable 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 centrifugal 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 using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (for Fat Washing Protocol):

Acceptance Criteria	Reported Device Performance (Reference Device - Sorin Xtra)	Reported Device Performance (Subject Device - Haemonetics Cell Saver Elite)
HCT%	≈ 50% (***)	≥ 40%
RBC Recovery	N/A (implied good hematocrit)	≥ 80%
Plasma HgB Washout	>95% (***)	≥ 95%
Heparin Washout	>95% (***)	≥ 95%
Albumin Washout	>95% (***)	≥ 95%
Fat Removal	>99% (***)	≥ 99% (*)

Note: (**) refers to data from the reference device Sorin Xtra, cited as "Fat removal during cell salvage - An optimized program in the XTRA® autotransfusion device" by Timo Seyfried, MD, Michael Gruber, MD; Lilith Haas; Emil Hansen, PhD, MD 13th ECOPEAT Vienna - Austria 2013.*
Note: () for the subject device indicates "depending on bowl size used".*

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

Sample Size: The document does not explicitly state the sample size used for the performance tests (functional testing and software validation). It lists several test reports by number (e.g., TR-SOF-100562, TR-OTH-100649), but these reports themselves are not included in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "non-clinical performance testing was submitted."

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. The testing described appears to be primarily technical and functional validation against predefined performance metrics for a medical device rather than studies requiring expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The testing described is against established performance requirements and is not a clinical study requiring adjudication of expert interpretations.

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

No MRMC comparative effectiveness study is mentioned. The submission is for a modification to an existing autotransfusion system, focused on technical performance improvements rather than reader interpretation.

6. Standalone Performance Study (Algorithm Only):

The document implies standalone performance studies were conducted for the device's functionality. Table 1 "Summary of Performance Studies" lists "Software Validation" and "Functional Testing" with corresponding report numbers and "Test Intent" that demonstrate the device (or its software components and new features like fat washing protocol and modified 70mL bowl algorithm) met performance requirements. The results are simply "Passed," indicating the algorithm's performance in achieving the specified criteria.

7. Type of Ground Truth Used:

The ground truth used for the performance studies appears to be based on objective, quantitative measurements related to blood processing parameters. For example:
- Hematocrit (HCT%)
- Red Blood Cell (RBC) Recovery
- Plasma Hemoglobin (HgB) Washout
- Heparin Washout
- Albumin Washout
- Fat Removal
These are physical and chemical properties of blood that can be measured directly by laboratory methods, establishing a clear objective ground truth for the device's performance in processing blood.

8. Sample Size for the Training Set:

The document does not provide details about a "training set" as this device is not an AI/ML algorithm that typically requires a large training dataset in the same way. The mentioned "Software Validation" and "Functional Testing" refer to verification and validation activities for the device's software and hardware, where "training" in the context of machine learning is not directly applicable.

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

As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to this type of device submission based on the provided information. The validation focuses on ensuring the device meets pre-defined performance specifications for blood processing.

Summary

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

June 23, 2016

Haemonetics Corporation Mark Anzalone Regulatory Affairs Specialist 400 Wood Road Braintree, MA 02184

Re: K160197

Trade/Device Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: May 17, 2016 Received: May 18, 2016

Dear Mr. Anzalone:

This letter corrects our substantially equivalent letter of May 24, 2016.

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 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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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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hillebrand
for

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

Enclosure

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Indications for Use

510(k) Number (if known) K160197

Device Name

Haemonetics Cell Saver Elite Autotransfusion System

Indications for Use (Describe)

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 cetther 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in a row, followed by the company name in red font. The squares are light blue, light green, gray, and red. Below the company name is the tagline "THE Blood Management Company" in a smaller, red font.

510(k) Summary

Date: March 4th, 2016

Submitter:

Haemonetics Corporation 400 Wood Road Braintree, MA 02184

Contact:

Mark Anzalone Regulatory Affairs Specialist Phone: 781-356-9912 Fax: 781-356-3558 Email: mark.anzalone@haemonetics.com

Device Information:

Trade Name:	Haemonetics Cell Saver Elite Autotransfusion System
Common Name:	Autotransfusion Device
Classification Name:	Autotransfusion Apparatus
Regulation Number:	21 CFR 868.5830
Product Code:	CAC
Device Class:	2

Device Characteristics Summary:

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm.

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Image /page/4/Picture/0 description: The image displays the logo for "Haemonetics", a blood management company. The logo features a series of four colored squares in the upper left corner, followed by the company name in a bold, red font. Below the company name, the tagline "THE Blood Management Company" is written in a smaller, red font.

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

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.

Intended Use:

Non-Clinical Testing Summary:

The following non-clinical performance testing was submitted in support of a determination of substantial equivalence between the subject and predicate device. A summary of the performance testing is presented below in Table 1. Test data demonstrates that the device met all performance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in a row, followed by the company name in red, and the tagline "THE Blood Management Company" in a smaller font size, also in red. The squares are light blue, light green, gray, and red.

Table 1: Summarv of Performance Studies

Test Name	Test Report #	Test Intent	Test Result
Software Validation	TR-SOF-100562	To validate fat washing protocol in revisionAK of the CS Elite software.	Passed
Software Validation	TR-SOF-100565	To validate revision AL of the CS Elitesoftware.	Passed
Functional Testing	TR-OTH-100649	To verify CS Elite 70 mL bowl performance	Passed
Functional Testing	TR-OTH-100647	To verify CS Elite blood washoutperformance with fat washing protocol.	Passed
Functional Testing	TR-OTH-100641A	To verify the performance of the CS Elite fatwashing protocol.	Passed
Functional Testing	TR-OTH-100646	To verify CS Elite blood washoutperformance.	Passed

Comparison to Predicate:

The Haemonetics Cell Saver Elite Autotransfusion system with fat washing protocol and modified 70mL bowl algorithm is substantially equivalent to the Cell Saver Elite Autotransufsion system cleared in K120586. The Cell Saver Elite is intended for use with the same hardware and disposables as the predicate device and in the same operating environment with the same donor/operator population. The indications for use are the same. The technological characteristics of the subject device differ from the predicate only in the addition of the fat washing feature and modifications to the 70mL bowl algorithm. These differences do not render the device non-substantially equivalent because non-clinical testing has demonstrated that the subject device is as safe and effective as the predicate and the results of verification and validation have not raised different questions of safety and effectiveness than the predicate.

Sorin XTRA PFAT program is provided as a reference device only for comparison of the fat reduction program to the subject device.

A summary comparison is presented below in Table 2.

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Image /page/6/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in light blue, green, gray, and red, respectively. Below the squares is the company name, "HAEMONETICS," in red, followed by the tagline "THE Blood Management Company" in a smaller font, also in red.

Table 2: Comparison of the Cell Saver Elite Software revision AL to the Predicate Cell Saver Elite Software Revision AD

	PredicateCell Saver Elite System (K120586)	SubjectCell Saver Elite System with software revisionAL	Reference DeviceSorin Xtra (K131553)
Manufacturer	Haemonetics Corporation	Same	N/A
Trade Name	Haemonetics Cell Saver Elite	Same	N/A
Common Name	Automated Blood Cell Separator	Same	N/A
Classification Name	Separator, Automated, Blood Cell, Diagnostic	Same	N/A
Regulation Number	21 CFR 864.9245	Same	N/A
Product Code	CAC	Same	N/A
Device Class	2	Same	N/A
Indications for Use	The Haemonetics Cell Saver® Elite™Autotransfusion System and its related accessorycomponents are intended for use to recover bloodshed during or subsequent to an operation or as aresult of trauma, processing the blood by acentrifugation and washing procedure, and pumpingthis processed red cell product to either a bag forgravity reinfusion into the patient or to the arterialline of an extracorporeal circuit for reinfusion into thepatient. The intended use of the SequestrationProtocol is to collect an autologous, preoperative,platelet rich plasma product for reinfusion to the samepatient within 6 hours of collection.	Same	N/A
Discussion	The devices have the same Indications for Use and the proposed changes to not expand the previously cleared Indications for Use.
	Predicate	Subject	Reference Device
	Cell Saver Elite System (K120586)	Cell Saver Elite System with software revision	Sorin Xtra (K131553)
		AL
Intended Use	The Cell Saver Elite System is intended to be used bytrained physicians, operating room nurses or floornurses, anesthesia technicians and autotransfusionservice providers to provide intra-operative and post-operative blood salvage for surgical procedures withmedium to high blood loss including, but not limitedto CABG, AAA, joint replacement, spinal, traumaand transplant surgeries.	Same	N/A
Discussion	Both devices have the same intended use. The addition of fat washing and the modified 70 mL bowl do not impact the intended use of the device, only improveupon existing functionality.
Disposables	There were no changes to the Cell Saver Elitedisposables associated with the changes that are thesubject of this 510(k) application.	Same	N/A
Discussion	The disposables used with the Cell Saver Elite device have not changed.
ProcessingFunctionality	Cell Salvage protocol:FillWashEmptyConcentrateReturnEmergency mode (Latham processing sets only)	Same	N/A
	Sequestration protocol:FillEmptyConcentrate	Same	N/A
	Cell Salvage protocol acceptance criteria:HCT% $≥$ 40%RBC Recovery $≥$ 80%Plasma HgB Washout $≥$ 95%Heparin Washout $≥$ 95%Albumin Washout $≥$ 95%	Same	N/A
	Predicate	Subject	Reference Device
	Cell Saver Elite System (K120586)	Cell Saver Elite System with software revision	Sorin Xtra (K131553)
		AL
	Fat Washing ProtocolN/A	Fat Washing Protocol: (New to subject device)Fill	PFAT
		Fat Wash	• Removal of fat particles
		• Return	• Excellent supernatant removal
		• Fill	• Good Hematocrit
		• Wash
		• Empty
		• Fill
		• Wash
		Empty
		Concentrate
		Return
	Fat Washing Protocol Acceptance Criteria:N/A	Fat Washing Protocol Acceptance Criteria:HCT% ≥ 40%	Fat Removal Performance:Fat Particles Removal >99% ***
		RBC Recovery ≥ 80%	HCT ≈ 50%***
		Plasma HgB Washout ≥ 95%	Heparin, Protein,
		Heparin Washout ≥ 95%	Albumin, Potassium >95% ***
		Albumin Washout ≥ 95%
		Fat Removal ≥ 99% *	*** "Fat removal during cell salvage - An optimized program in the
		*depending on bowl size used	XTRA® autotransfusion device" Timo Seyfried, MD, Michael
			Gruber, MD; Lilith Haas;Emil Hansen, PhD, MD 13th ECOPEAT Vienna - Austria 2013
Discussion	Both devices have similar processing capabilities. The Cell Saver Elite with revision AL software adds the Fat Washing protocol which will function in a similar
		manner to the existing Cell Salvage protocol as described in Section 4 - Device Description. Both the Cell Salvage protocol and the proposed Fat Washing
		protocol will both use the same technological characteristic described below to operate. The Fat Washing protocol is optimized to remove additional fat during
		the wash phase and will not introduce any new concerns for safety or effectiveness as shown through testing summarized in Table 1 above. The key device
	performance characteristics for the cell salvage protocol and the fat washing protocol remain the same when compared to the predicate device.

		The proposed Fat Washing protocol discussed through this 510(k) can be seen in other cleared devices. One such reference device is Sorin Xtra Autotransfusion
		System (K131553). The Sorin Xtra has a PFAT process which has similar performance characteristics to the proposed Fat Washing protocol.
	PredicateCell Saver Elite System (K120586)	SubjectCell Saver Elite System with software revisionAL	Reference DeviceSorin Xtra (K131553)
Graphical UserInterface	Graphical User Interface with touch screen displaytechnology for device interface. Integrated barcodescanner to simplify data entry.Beacon light on top of the display to provide generaldevice status at a glance. The status indicator andmessage area on the GUI each have a vertical colorcoded bar that corresponds to the beacon light.	Same	N/A
SoftwareCentrifuge	Software Revision 4.0 (AD)Holds the rotating portion of the Latham bowls duringa procedure. For the 70 ml Blow Molded bowl, achuck adaptor is used to hold the rotating portion ofthe bowl in the centrifuge. Centrifuge speeds aredefined for each protocol and bowl type.	Software Revision 7.0 (AL)Same	N/AN/A
Pump	A three-roller occlusive pump moves fluids into andout of the bowl. Pump speeds are defined for eachphase.	Same	N/A
Bowl Optics	The bowl optics assembly is mounted within thecentrifuge. The optics assembly possesses twooptical sensors; one for Latham bowls and one forBlow Molded bowl.	Same	N/A
Effluent Line Sensor	Monitors quality of bowl effluent (eg. wash issatisfactory), adjusts pump speed (eg. avoid red cellspillage), and advances system to next phase whenappropriate.	Same	N/A
Valve Module	Consists of three pinch valves, which are used todirect flow of fluids through the set, and a manifoldpressure sensor, which monitors pressure levels inblue-striped and red-striped lines during Empty andReturn.	Same	N/A
	PredicateCell Saver Elite System (K120586)	SubjectCell Saver Elite System with software revisionAL	Reference DeviceSorin Xtra (K131553)
Air Detector	Ultrasonic air detector monitors fluid flow in thepump tubing. In Fill, the sensor detects air whenreservoir is empty. In Concentrate, the sensor detectsair when RBC bag is empty. During Wash, it sensesair when saline bag is empty. In Empty and Return, itsenses air when bowl is empty.	Same	N/A
Waste Bag Weigher	Load cell based sensor used to monitor the amount offluid collected in the 10 L waste bag. When ~ 7.5 Lof fluid is detected, the device displays a message thatthe waste bag is almost full. When ~ 8.5 L of fluid isdetected, the device displays a message that the wastebag is full.	Same	N/A
Reservoir Weigher	Load cell based sensor used to track the amount offluid collected in the reservoir. The device initiatesFill depending upon the values set for Fill startvolume and Fill resume volume.	Same	N/A
Suction	Designed to work with both regulated externalsuction, and onboard manual and SmartSuctiontechnology.	Same	N/A
Historical ProcedureData	Designed to provide historical procedure records thatinclude procedure data and optional consumable data.Consumable data can be entered via an onboardbarcode scanner or typed directly into the record.The procedure records can be downloaded onto aUSB storage device. The device can retain data forup to 100 procedures.	Same	N/A
Discussion	All device technological characteristics remain the same between the Predicate and Subject device with the exception to the software, which has added fat washing and the modified 70 mL bowl algorithm. The technological characteristics that differ between the predicate and subject device do not raise any new concerns for safety or effectiveness.

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Image /page/7/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of the word "HAEMONETICS" in red, with the words "THE Blood Management Company" in a smaller font below it. There are four squares in the upper left corner of the logo in the colors light blue, green, gray, and red.

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Image /page/8/Picture/0 description: The image features the logo for Haemonetics, a blood management company. The logo consists of four colored squares in light blue, green, gray, and red, respectively. Below the squares is the company name, "HAEMONETICS," in large, red font, followed by the tagline "THE Blood Management Company" in a smaller font size.

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Image /page/9/Picture/0 description: The image contains the logo for Haemonetics, a blood management company. The logo consists of the word "HAEMONETICS" in red, with the tagline "THE Blood Management Company" underneath. There are four colored squares above the company name, colored light blue, green, gray, and red.

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Image /page/10/Picture/0 description: The image contains the logo for Haemonetics, a blood management company. The logo features the company name in a bold, red font, with the tagline "THE Blood Management Company" underneath. There are also four squares in the upper left corner of the logo, colored light blue, green, gray, and red.

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Image /page/11/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in blue, yellow, gray, and red, respectively. Below the squares is the company name "HAEMONETICS" in large, red, bold letters. Underneath the company name is the tagline "THE Blood Management Company" in a smaller font.

Mudr. Cpl.

Mark Anzalone Regulatory Affairs Specialist Haemonetics Corporation

4-Mar-2016

Date

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).