CELL SAVER ELITE

K120586 · Haemonetics Corp. · CAC · May 22, 2012 · Anesthesiology

Device Facts

• Record ID: K120586
• Device Name: CELL SAVER ELITE
• Applicant: Haemonetics Corp.
• Product Code: CAC · Anesthesiology
• Decision Date: May 22, 2012
• 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

Cell Saver Elite is an autotransfusion system for intra-operative/post-operative blood salvage and platelet sequestration. System processes shed blood via centrifugal separation (bowl) to concentrate and wash RBCs, removing hemolized cells, anticoagulant, and irrigating fluids. Input: shed blood from surgical site; Output: washed RBC product for reinfusion or platelet-rich plasma. Operated by trained clinicians in OR/clinical settings. Features include three-roller occlusive pump, bowl optics for effluent monitoring, pinch valve module, and ultrasonic air detector. System uses disposable bowl kits and reservoirs. Healthcare providers use GUI with touch screen and barcode scanner for data entry/tracking. Benefits include autologous blood recovery, reducing need for allogeneic transfusion.

Clinical Evidence

Bench testing only. Studies (TR-CLN-100177, TR-CLN-100201, TR-CLN-100049) evaluated processing efficiency, RBC recovery, and platelet sequestration. Results: final product hematocrit 40-60%, heparin/free hemoglobin washout ≥95%, RBC recovery ≥80%. Platelet sequestration met threshold of 3x incoming platelet count.

Technological Characteristics

Centrifugal separation system using Latham 225ml/125ml or 70ml blow-molded bowls. Features: three-roller occlusive pump, ultrasonic air detector, load-cell based waste/reservoir weighers, and optical sensors for effluent quality. Software-controlled pinch valves and centrifuge speeds. Connectivity via USB for data export. Sterilization: single-use disposable sets.

Indications for Use

Indicated for intra-operative and post-operative blood salvage in surgical procedures with medium to high blood loss (e.g., CABG, AAA, joint replacement, spinal, trauma, transplant) and for preoperative platelet-rich plasma collection. For use by trained physicians, OR nurses, perfusionists, anesthesia technicians, and autotransfusion service providers.

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

• Haemonetics Cell Saver Elite Autotransfusion System (K101907)

Submission Summary (Full Text)

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#### 510(k) Summary

Date Prepared: April 25, 2012

Submitter: Haemonetics Corporation 400 Wood Road. Braintree MA 02184

Contact: Greg Calder Regulatory Affairs Manager Phone: [phone] Fax: [phone] fax Email: [e-mail]

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 Elite Autotransfusion 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 previously cleared Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite was most recently cleared via 510(k) K 101907 on December 03, 2010.

The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or fior 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 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 disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

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# Non-clinical Testing Summary:

The following non-clinical performance testing was submitted in K101907. The data remains applicable to the system under review. 1

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 that the device 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-<br>house Laboratory<br>Evaluation of<br>Processing Efficiency<br>and RBC Recovery | TR-CLN-100177 | The intent of this study was to<br>characterize the performance<br>of the Cell Salvage protocol of<br>the CS Elite in terms of<br>processing efficiency and<br>product characteristics. | • Final product hematocrit of<br>40-60%<br>• Heparin Washout ≥95%<br>• Free Hemoglobin Washout<br>≥95%<br>• Red Blood Cell Recovery<br>≥80% |
|-------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Conclusion:<br>Data met Acceptance<br>Criteria |
| In-house Laboratory<br>Validation of Platelet<br>Sequestration Protocol<br>Using the Cell Saver<br>Elite | TR-CLN-100201 | The intent of this study was<br>to evaluate the Platelet<br>Sequestration protocol of the<br>CS Elite in terms of | No formal acceptance criteria;<br>characterization of the<br>product. |
| | | performance and product<br>characteristics | Conclusion:<br>The platelet rich plasma that<br>is produced meets the<br>threshold of three (3) times<br>the incoming platelet count of<br>the whole blood. |
| In-house Laboratory<br>Evaluation of<br>Processing Efficiency<br>and Product<br>Characteristics using<br>Pools without Lysate | TR-CLN-100049 | The intent of this study was to<br>characterize the performance<br>of the Cell Salvage protocol of<br>the CS Elite in terms of<br>processing efficiency and<br>product characteristics of<br>blood without Lysate; and<br>therefore to confirm the true<br>red cell recovery. | • Final product hematocrit of<br>40-60%<br>• Heparin Washout ≥95%<br>• Free Hemoglobin Washout<br>≥95%<br>• Red Blood Cell Recovery<br>≥80%<br>Conclusion:<br>Data met Acceptance<br>Criteria<br>The data above indicate the<br>processed RBC product data<br>from all three bowl types<br>exceeded the acceptance<br>criteria in terms of Hematocrit,<br>RBC Recovery and Washout.<br>The RBC recovery data was,<br>on average 12% higher than<br>the RBC Recovery derived<br>from procedures using pools<br>with high levels of free<br>hemoglobin. |

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 Elite Autotransfusion System. The Cell Saver Elite system was most recently cleared via 510(k) K101907 on December 03, 2010. The Cell Flite system is designed to perform the same types of procedures as the previously cleared Cell Saver Elite system, utilizing identical disposable sets. The changes from the previously cleared Cell Saver Elite to the subject Cell Saver Elite system include a software change and a mechanical change to the pinch valve disposable sensor detection system.

A summary of the Cell Saver Elite system comparison to the predicate Ccll Saver Elite system is presented in Table 2: Comparison of the Haemonetics Cell Saver Elite system to the system to the system in 1 abit system.

| Characteristic | Cell Saver Elite System<br>(Subject device) | Cell Saver Elite System<br>(Predicate most recently cleared<br>K101907) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Haemonetics Cell Saver® Elite™<br>Autotransfusion System and its related<br>accessory components are intended for<br>use to recover blood shed during or<br>subsequent to an operation or as a result<br>of trauma, processing the blood by a<br>centrifugation and washing procedure,<br>and pumping this processed red cell<br>product to either a bag for gravity<br>reinfusion into the patient or to the<br>arterial line of an extracorporeal circuit<br>for reinfusion into the patient. The<br>intended use of the Sequestration<br>Protocol is to collect an autologous,<br>preoperative, platelet rich plasma<br>product for reinfusion to the same<br>patient within 6 hours of collection. | Same |
| | Disposable Set | Designed to utilize the Latham 225 ml<br>bowl, Latham 125 ml bowl, and Blow<br>Molded 70 ml bowl processing sets.<br><br>Designed to utilize the PRP/PPP<br>Sequestration disposable accessory. |
| User Interface | | Graphical User Interface with touch<br>screen display technology for device<br>interface. Integrated barcode scanner to<br>simplify data entry.<br><br>Beacon light on top of the display to<br>provide general device status at a glance.<br>The status indicator and message area on<br>the GUI each have a vertical color coded<br>bar that corresponds to the beacon light |
| | Characteristic | Cell Saver Elite System |
| | (Subject device) | (Predicate most recently cleared |
| | | K101907) |
| Processing | Cell Salvage protocol: | Same |
| Functionality | Fill | |
| | Wash | |
| | Empty | |
| | Concentrate | |
| | Return | |
| | Emergency mode (Latham processing | |
| | sets only) | |
| | | |
| | Sequestration protocol: | |
| | Fill | |
| | Empty | |
| | Concentrate | |
| Centrifuge | Holds the rotating portion of the Latham | Same |
| | bowls during a procedure. For the 70 ml | |
| | Blow Molded bowl, a chuck adaptor is | |
| | used to hold the rotating portion of the | |
| | bowl in the centrifuge. Centrifuge | |
| | speeds are defined for each protocol and | |
| | bowl type. | |
| Pump | A three-roller occlusive pump moves | |
| | | Same |
| | fluids into and out of the bowl. Pump | |
| Bowl Optics | speeds are defined for each phase. | |
| | The bowl optics assembly is mounted | Same |
| | within the centrifuge. The optics | |
| | assembly possesses two optical sensors; | |
| | one for Latham bowls and one for Blow<br>Molded bowl. | |
| Effluent Line | | |
| Sensor | Monitors quality of bowl effluent (eg. | Same |
| | wash is satisfactory), adjusts pump | |
| | speed (eg. avoid red cell spillage), and | |
| | advances system to next phase when | |
| | appropriate. | |
| Valve Module | Consists of three pinch valves, which are<br>used to direct flow of fluids through the | Same |
| | set, and a manifold pressure sensor, | |
| | which monitors pressure levels in blue- | |
| | striped and red-striped lines during | |
| | | |
| Air Detector | Empty and Return.<br>Ultrasonic air detector monitors fluid | |
| | flow in the pump tubing. In Fill, the | Same |
| | sensor detects air when reservoir is | |
| | empty. In Concentrate, the sensor | |
| | detects air when RBC bag is empty. | |
| | | |
| | During Wash, it senses air when saline | |
| | bag is empty. In Empty and Return, it | |
| | senses air when bowl is empty. | |
| Characteristic | Cell Saver Elite System<br>(Subject device) | Cell Saver Elite System<br>(Predicate most recently cleared<br>K101907) |
| Waste Bag<br>Weigher | Load cell based sensor used to monitor<br>the amount of fluid collected in the 10 L<br>waste bag. When ~ 7.5 L of fluid is<br>detected, the device displays a message<br>that the waste bag is almost full. When<br>~ 8.5 L of fluid is detected, the device<br>displays a message that the waste bag is<br>full. | Same |
| Reservoir<br>Weigher | Load cell based sensor used to track the<br>amount of fluid collected in the<br>reservoir. The device initiates Fill<br>depending upon the values set for Fill<br>start volume and Fill resume volume. | Same |
| Suction | Designed to work with both regulated<br>external suction, and onboard manual<br>and SmartSuction technology. | Same |
| Historical<br>Procedure Data | Designed to provide historical procedure<br>records that include procedure data and<br>optional consumable data. Consumable<br>data can be entered via an onboard<br>barcode scanner or typed directly into<br>the record.<br>The procedure records can be<br>downloaded onto a USB storage device.<br>The device can retain data for up to 100<br>procedures. | Same |

Table 2: Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate Cell Saver Elite System

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Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate
Cell Saver Elite System

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Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate Cell Saver Elite System

Greg Calder

Greg Calder Regulatory Affairs Manager
Haemonetics Corporation

Date: 04/25/2012

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAY 2 2 2012

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

Re: K120586

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: February 24, 2012 Received: February 27, 2012

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 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 – Mr. Greg Calder

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/CDRH0ffices/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 Biom…