Haemonetics Cell Saver Elite Autotransfusion System

K160197 · Haemonetics Corporation · CAC · May 24, 2016 · Anesthesiology

Device Facts

• Record ID: K160197
• Device Name: Haemonetics Cell Saver Elite Autotransfusion System
• Applicant: Haemonetics Corporation
• Product Code: CAC · Anesthesiology
• Decision Date: May 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The Haemonetics Cell Saver Elite is an autotransfusion system used in ORs or clinical settings by trained medical staff (physicians, nurses, technicians) to salvage shed blood. The system uses a centrifugal separation chamber (bowl) to concentrate and wash red blood cells (RBCs), removing hemolyzed cells, anticoagulants, and irrigation fluids. The processed RBC product is returned to the patient via gravity bag or extracorporeal circuit. The system includes a disposable set and reusable equipment with a touchscreen GUI, barcode scanner, and status beacon. It features a fat washing protocol and a modified 70mL bowl algorithm to improve fat particle removal. The device monitors fluid quality, pump speed, and pressure via optical and load-cell sensors. By providing autologous blood, the system reduces the need for allogeneic transfusions, potentially benefiting patients by minimizing transfusion-related risks.

Clinical Evidence

Bench testing only. Performance studies verified the fat washing protocol and modified 70mL bowl algorithm. Testing confirmed RBC recovery ≥ 80%, hematocrit ≥ 40%, and washout efficiency (plasma hemoglobin, heparin, albumin) ≥ 95%. Fat removal performance for the fat washing protocol was ≥ 99%.

Technological Characteristics

Centrifugal blood processing system; 70mL bowl; three-roller occlusive pump; optical sensors for bowl effluent and air detection; load-cell sensors for waste/reservoir weighing; touchscreen GUI with barcode scanner; software-controlled processing phases (Fill, Wash, Empty, Concentrate, Return).

Indications for Use

Indicated for intraoperative and post-operative blood salvage in patients undergoing surgical procedures with medium to high blood loss, including CABG, AAA, joint replacement, spinal, trauma, and transplant surgeries. Sequestration protocol indicated for collection of autologous, preoperative, platelet-rich plasma for reinfusion within 6 hours.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Cell Saver Elite Autotransfusion System (K120586)

Reference Devices

• Sorin Xtra Autotransfusion System (K131553)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><b></b></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;"></div> 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: [phone] Fax: [phone] Email: [e-mail]

#### 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.

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.

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.

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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 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.

#### 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:

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.

# 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 revision<br>AK of the CS Elite software. | Passed |
| Software Validation | TR-SOF-100565 | To validate revision AL of the CS Elite<br>software. | 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 washout<br>performance with fat washing protocol. | Passed |
| Functional Testing | TR-OTH-100641A | To verify the performance of the CS Elite fat<br>washing protocol. | Passed |
| Functional Testing | TR-OTH-100646 | To verify CS Elite blood washout<br>performance. | 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

| | Predicate<br>Cell Saver Elite System (K120586) | Subject<br>Cell Saver Elite System with software revision<br>AL | Reference Device<br>Sorin 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™<br>Autotransfusion System and its related accessory<br>components are intended for use to recover blood<br>shed during or subsequent to an operation or as a<br>result of trauma, processing the blood by a<br>centrifugation and washing procedure, and pumping<br>this processed red cell product to either a bag for<br>gravity reinfusion into the patient or to the arterial<br>line of an extracorporeal circuit for reinfusion into the<br>patient. The intended use of the Sequestration<br>Protocol is to collect an autologous, preoperative,<br>platelet rich plasma product for reinfusion to the same<br>patient 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 by<br>trained physicians, operating room nurses or floor<br>nurses, anesthesia technicians and autotransfusion<br>service providers to provide intra-operative and post-<br>operative blood salvage for surgical procedures with<br>medium to high blood loss including, but not limited<br>to CABG, AAA, joint replacement, spinal, trauma<br>and 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 improve<br>upon existing functionality. | | |
| Disposables | There were no changes to the Cell Saver Elite<br>disposables associated with the changes that are the<br>subject of this 510(k) application. | Same | N/A |
| Discussion | The disposables used with the Cell Saver Elite device have not changed. | | |
| Processing<br>Functionality | Cell Salvage protocol:<br>Fill<br>Wash<br>Empty<br>Concentrate<br>Return<br>Emergency mode (Latham processing sets only) | Same | N/A |
| | Sequestration protocol:<br>Fill<br>Empty<br>Concentrate | Same | N/A |
| | Cell Salvage protocol acceptance criteria:<br>HCT% $≥$ 40%<br>RBC Recovery $≥$ 80%<br>Plasma HgB Washout $≥$ 95%<br>Heparin Washout $≥$ 95%<br>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 Protocol<br>N/A | Fat Washing Protocol: (New to subject device)<br>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:<br>N/A | Fat Washing Protocol Acceptance Criteria:<br>HCT% ≥ 40% | Fat Removal Performance:<br>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;<br>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. | |
| | Predicate<br>Cell Saver Elite System (K120586) | Subject<br>Cell Saver Elite System with software revision<br>AL | Reference Device<br>Sorin Xtra (K131553) |
| Graphical User<br>Interface | Graphical User Interface with touch screen display<br>technology for device interface. Integrated barcode<br>scanner to simplify data entry.<br><br>Beacon light on top of the display to provide general<br>device status at a glance. The status indicator and<br>message area on the GUI each have a vertical color<br>coded bar that corresponds to the beacon light. | Same | N/A |
| Software<br>Centrifuge | Software Revision 4.0 (AD)<br><br>Holds the rotating portion of the Latham bowls during<br>a procedure. For the 70 ml Blow Molded bowl, a<br>chuck adaptor is used to hold the rotating portion of<br>the bowl in the centrifuge. Centrifuge speeds are<br>defined for each protocol and bowl type. | Software Revision 7.0 (AL)<br>Same | N/A<br>N/A |
| Pump | A three-roller occlusive pump moves fluids into and<br>out of the bowl. Pump speeds are defined for each<br>phase. | Same | N/A |
| Bowl Optics | The bowl optics assembly is mounted within the<br>centrifuge. The optics assembly possesses two<br>optical sensors; one for Latham bowls and one for<br>Blow Molded bowl. | Same | N/A |
| Effluent Line Sensor | Monitors quality of bowl effluent (eg. wash is<br>satisfactory), adjusts pump speed (eg. avoid red cell<br>spillage), and advances system to next phase when<br>appropriate. | Same | N/A |
| Valve Module | Consists of three pinch valves, which are used to<br>direct flow of fluids through the set, and a manifold<br>pressure sensor, which monitors pressure levels in<br>blue-striped and red-striped lines during Empty and<br>Return. | Same | N/A |
| | Predicate<br>Cell Saver Elite System (K120586) | Subject<br>Cell Saver Elite System with software revision<br>AL | Reference Device<br>Sorin Xtra (K131553) |
| Air Detector | Ultrasonic air detector monitors fluid flow in the<br>pump tubing. In Fill, the sensor detects air when<br>reservoir is empty. In Concentrate, the sensor detects<br>air when RBC bag is empty. During Wash, it senses<br>air when saline bag is empty. In Empty and Return, it<br>senses air when bowl is empty. | Same | N/A |
| Waste Bag Weigher | Load cell based sensor used to monitor the amount of<br>fluid collected in the 10 L waste bag. When ~ 7.5 L<br>of fluid is detected, the device displays a message that<br>the waste bag is almost full. When ~ 8.5 L of fluid is<br>detected, the device displays a message that the waste<br>bag is full. | Same | N/A |
| Reservoir Weigher | Load cell based sensor used to track the amount of<br>fluid collected in the reservoir. The device initiates<br>Fill depending upon the values set for Fill start<br>volume and Fill resume volume. | Same | N/A |
| Suction | Designed to work with both regulated external<br>suction, and onboard manual and SmartSuction<br>technology. | Same | N/A |
| Historical Procedure<br>Data | Designed to provide historical procedure records that<br>include procedure data and optional consumable data.<br>Consumable data can be entered via an onboard<br>barcode scanner or typed directly into the record.<br>The procedure records can be downloaded onto a<br>USB storage device. The device can retain data for<br>up 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