Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

K162423 · Haemonetics Corporation · CAC · Jan 3, 2017 · Anesthesiology

Device Facts

• Record ID: K162423
• Device Name: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
• Applicant: Haemonetics Corporation
• Product Code: CAC · Anesthesiology
• Decision Date: Jan 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Autotransfusion system for intra-operative/post-operative blood salvage; used in OR/clinical settings by trained medical staff. Device processes shed blood via centrifugal separation (bowl) and washing to remove hemolized cells, anticoagulant, and irrigating fluids. System consists of reusable equipment and single-use disposable sets. New connectivity features allow data transmission to/from approved server applications and software updates. Healthcare providers use GUI to monitor status and manage procedures. Benefits include autologous blood availability for patients undergoing medium-to-high blood loss surgeries (e.g., CABG, trauma, transplant).

Clinical Evidence

Bench testing only. Testing included electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), wireless coexistence, and software validation (version AN). All tests passed.

Technological Characteristics

Centrifugal blood processing system; three-roller occlusive pump; bowl optics assembly; pinch valve module; ultrasonic air detector; load cell-based weighers. Connectivity via wireless module and RJ45 Ethernet port. Software version AN. UI includes touchscreen and barcode scanner.

Indications for Use

Indicated for recovery of blood shed during or subsequent to operation or trauma, processing via centrifugation and washing, and pumping processed red cells for reinfusion. 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

• Haemonetics Cell Saver Elite Autotransfusion System (K160197)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Public Health Service

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

January 03, 2017

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

Re: K162423

Trade/Device Name: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: December 2, 2016 Received: December 5, 2016

Dear Mark Anzalone:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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" (21 CFR 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 D. Zuckerman, M.D.
Director 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) K162423

Device Name

Haemonetics Cell Saver Elite/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 ceither 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> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Haemonetics. The logo consists of four colored blocks in light blue, green, gray, and red. Below the blocks is the company name "HAEMONETICS" in red font with a registered trademark symbol.

#### 510(k) Summary

Date: December 21st, 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/Elite+ Autotransfusion System |
|----------------------|------------------------------------------------------------|
| Common Name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Device Class: | 2 |

#### Primary Predicate:

| Trade Name: | Haemonetics Cell Saver Elite Autotransfusion System |
|----------------------|-----------------------------------------------------|
| Common Name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus |
| Clearance Number: | K160197 |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Device Class: | 2 |

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# HAEMONB

#### Device Characteristics Summary:

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System software and hardware to enable use of wired and wireless connectivity.

The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to 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/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/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/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/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/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high

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Image /page/5/Picture/0 description: The image shows the logo for Haemonetics. The logo consists of four colored rectangles in a row, with the colors being light blue, light green, gray, and red. Below the rectangles is the word "HAEMONETICS" in red font, with a registered trademark symbol next to the "S".

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 substantially equivalent to the predicate device.

| Test Name | Test Report # | Test Intent | Test Result |
|----------------------------------|---------------|----------------------------------------------------------------------------------------------------|-------------|
| Electromagnetic<br>Compatibility | TR-ELE-100782 | To verify compliance with EMC<br>requirements per IEC 60601-1-2 | Pass |
| Electrical Safety | TR-ELE-100812 | To verify compliance with electrical safety<br>requirements per IEC 60601-1 | Pass |
| Wireless Coexistence | TR-ELE-100786 | To verify wireless coexistence of the CS<br>Elite/Elite+ with potential interference<br>appliances | Pass |
| Software Validation | TR-SOF-100592 | To validate version AN of the CS<br>Elite/Elite+ Software | Pass |

#### Table 1: Summary of Performance Studies

#### Comparison to Predicate:

The Haemonetics Cell Saver Elite/Elite+ Autotransfusion system with wireless connectivity is substantially equivalent to the Cell Saver Elite/Elite+ Autotransufsion system cleared in K 160197. The Cell Saver Elite/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 connectivity feature through software and modified User Interface (UI) hardware. These differences do not render the device non-substantially equivalent because non-clinical testing has demonstrated that the device met all performance requirements, and that the subject device is substantially equivalent to the predicate 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. The logo consists of four colored rectangles in a row, with the colors being light blue, light green, gray, and red. Below the rectangles is the word "HAEMONETICS" in red, with a registered trademark symbol to the right of the word.

### Table 2: Comparison of the Cell Saver Elite/Elite+ with connectivity to the Predicate Cell Saver Elite Software version AL

| | Predicate | Subject |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cell Saver Elite System (K160197) | Cell Saver Elite/Elite+ System with connectivity |
| Manufacturer | Haemonetics Corporation | Same |
| Trade Name | Haemonetics Cell Saver Elite | Add Haemonetics Cell Saver Elite+ |
| Common Name | Automated Blood Cell Separator | Same |
| Classification Name | Separator, Automated, Blood Cell, Diagnostic | Same |
| Regulation Number | 21 CFR 864.9245 | Same |
| Product Code | CAC | Same |
| Device Class | 2 | Same |
| Indications for Use | The Haemonetics Cell Saver® Elite/Elite+® | Same |
| | 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. | |
| Discussion | The previously cleared device and proposed device have the same Indications for Use and the proposed changes do | |
| | not expand the previous cleared Indication for Use. | |
| | Predicate<br>Cell Saver Elite System (K160197) | Subject<br>Cell Saver Elite/Elite+ System with connectivity |
| Intended Use | The Cell Saver Elite/Elite+ System is intended to be used<br>by trained physicians, operating room nurses or floor<br>nurses, anesthesia technicians and autotransfusion service<br>providers to provide intra-operative and post-operative<br>blood salvage for surgical procedures with medium to high<br>blood loss including, but not limited to CABG, AAA, joint<br>replacement, spinal, trauma and transplant surgeries. | Same |
| Discussion | The previously cleared device and proposed device have the same Intended Use. The addition of the connectivity<br>feature does not impact the intended use of the device. | |
| Disposables | There were no changes to the Cell Saver Elite/Elite+<br>disposables associated with the changes that are the subject<br>of this 510(k) application. | Same |
| Discussion | The proposed modifications do not impact the disposables used with the Cell Saver Elite/Elite+ device. | |
| Software | Software Version 7.0 (AL) | Software Version 7.1 (AN)<br>• Fix open software anomalies<br>• Update software to allow communication with<br>an approved server application |
| Discussion | The proposed modifications will add new networking features to the Cell Saver Elite/Elite+ device. This new<br>feature will allow the device to transmit data from the device to an approved server application and receive device<br>settings and software updates from an approved server application. The software modifications will not affect<br>substantial equivalence to the predicate device since performance requirements will not be affected. Additionally,<br>data can already be exported via a USB stick on the predicate device, the proposed modification will allow the user<br>additional convenience for exporting existing data. | |
| | Predicate | Subject |
| | Cell Saver Elite System (K160197) | Cell Saver Elite/Elite+ System with connectivity |
| User Interface | Graphical User Interface with touch screen display<br>technology for device interface. Integrated barcode scanner<br>to simplify data entry.<br><br>Beacon light on top of the display to provide general device<br>status at a glance. The status indicator and message area on<br>the GUI each have a vertical color coded bar that | Graphical User Interface and beacon light will remain<br>the same as the predicate device<br><br>User Interface hardware updated: Add wireless module Update single board computer to support<br>wireless module Update barcode scanner from 1D scanning to<br>2D scanning Modify housing to support RJ45 Ethernet port |
| | corresponds to the beacon light. | |
| Discussion | The proposed modifications to the User Interface hardware is a more modern single board computer, which will<br>allow support for the wireless module. The modified device will remain substantially equivalent to the predicate<br>device since the device will continue to meet existing performance requirements. | |
| | Predicate | Subject |
| | Cell Saver Elite System (K160197) | Cell Saver Elite/Elite+ System with connectivity |
| Processing | Cell Salvage protocol: | Same |
| Functionality | Fill | |
| | Wash | |
| | Empty | |
| | Concentrate | |
| | Return | |
| | Emergency mode (Latham processing sets only) | |
| | Sequestration protocol:<br>Fill | |
| | Empty | |
| | Concentrate | |
| | | |
| | Fat Washing Protocol: | |
| | Fill | |
| | Fat Wash | |
| | ● Return | |
| | ● Fill | |
| | ● Wash | |
| | ● Empty | |
| | ● Fill | |
| | ● Wash | |
| | Empty | |
| | Concentrate | |
| | Return | |
| Discussion | The processing capabilities will remain the same between the proposed device and predicate device. | |
| | Predicate<br>Cell Saver Elite System (K160197) | Subject<br>Cell Saver Elite/Elite+ System with connectivity |
| Centrifuge | Holds the rotating portion of the Latham 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. | Same |
| Pump | A three-roller occlusive pump moves fluids into and out of the bowl. Pump speeds are defined for each phase. | Same |
| Bowl Optics | The bowl optics assembly is mounted within the centrifuge. The optics assembly possesses two optical sensors; one for Latham bowls and one for Blow Molded bowl. | Same |
| Effluent Line Sensor | Monitors quality of bowl effluent (eg. wash is satisfactory), adjusts pump speed (eg. avoid red cell spillage), and advances system to next phase when appropriate. | Same |
| Valve Module | Consists of three pinch valves, which are used to direct…