(126 days)
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/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 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.
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.
This document describes the regulatory approval (K162423) for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System with added wired and wireless connectivity features. The approval is based on demonstrating substantial equivalence to a predicate device (K160197).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on the safety and performance of the added connectivity features and modifications to the user interface hardware. The acceptance criteria essentially revolve around demonstrating that these changes do not compromise the existing performance requirements of the autotransfusion system and comply with relevant standards.
| Acceptance Criteria (What was measured/verified) | Reported Device Performance (Result) |
|---|---|
| Electromagnetic Compatibility (EMC) compliance (per IEC 60601-1-2) | Pass |
| Electrical Safety compliance (per IEC 60601-1) | Pass |
| Wireless Coexistence of the Cell Saver Elite/Elite+ with potential interference appliances | Pass |
| Software Validation of Version AN of the CS Elite/Elite+ Software to ensure correct functionality and communication capabilities | Pass |
| Maintenance of previous performance requirements despite UI hardware and software changes (implied) | Subject device met all performance requirements, demonstrating substantial equivalence to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of number of devices or number of test cases run for each test. The non-clinical testing summary simply lists the tests conducted.
The data provenance is from non-clinical testing performed by the manufacturer, Haemonetics Corporation, as part of their 510(k) submission. This is internal testing, not patient data, and is thus prospective in the sense that it was performed specifically for this submission. The country of origin for the data generation would be where Haemonetics conducted their internal R&D and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission for device modifications. No "ground truth" based on expert medical opinion (like clinical diagnosis) was established or used for the technical performance tests (EMC, electrical safety, wireless coexistence, software validation). These tests rely on engineering standards and functional verification.
4. Adjudication Method for the Test Set
This is not applicable. The tests performed (EMC, electrical safety, wireless coexistence, software validation) are objective engineering and software verification tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission is for modifications to an autotransfusion system, a medical device that processes blood. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or making diagnostic decisions, which is typically where MRMC studies are conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an autotransfusion system, not an algorithm performing a standalone diagnostic or interpretive function. The "software validation" was for the embedded software controlling the device's functionality and connectivity, which operates as part of the overall system with human operators.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was based on engineering specifications, regulatory standards (e.g., IEC 60601-1-2, IEC 60601-1), and the defined functional requirements of the device. For example, for EMC, the ground truth is compliance with the specified limits in the standard. For wireless coexistence, the ground truth is the device operating without unacceptable interference. For software, the ground truth is the software performing as designed according to its requirements.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/ML system that undergoes a "training phase" with a training set of data in the typical sense (e.g., for image recognition or predictive models). The software validation refers to the testing of the developed software against its requirements.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. The device's software is developed through standard software engineering practices and validated against pre-defined functional and performance requirements.
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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 (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" (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 (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 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date: December 21st, 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/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 |
|---|---|---|---|
| ElectromagneticCompatibility | TR-ELE-100782 | To verify compliance with EMCrequirements per IEC 60601-1-2 | Pass |
| Electrical Safety | TR-ELE-100812 | To verify compliance with electrical safetyrequirements per IEC 60601-1 | Pass |
| Wireless Coexistence | TR-ELE-100786 | To verify wireless coexistence of the CSElite/Elite+ with potential interferenceappliances | Pass |
| Software Validation | TR-SOF-100592 | To validate version AN of the CSElite/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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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. | ||
| PredicateCell Saver Elite System (K160197) | SubjectCell Saver Elite/Elite+ System with connectivity | |
| Intended Use | The Cell Saver Elite/Elite+ System is intended to be usedby trained physicians, operating room nurses or floornurses, anesthesia technicians and autotransfusion serviceproviders to provide intra-operative and post-operativeblood salvage for surgical procedures with medium to highblood loss including, but not limited to CABG, AAA, jointreplacement, spinal, trauma and transplant surgeries. | Same |
| Discussion | The previously cleared device and proposed device have the same Intended Use. The addition of the connectivityfeature does not impact the intended use of the device. | |
| Disposables | There were no changes to the Cell Saver Elite/Elite+disposables associated with the changes that are the subjectof 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)• Fix open software anomalies• Update software to allow communication withan approved server application |
| Discussion | The proposed modifications will add new networking features to the Cell Saver Elite/Elite+ device. This newfeature will allow the device to transmit data from the device to an approved server application and receive devicesettings and software updates from an approved server application. The software modifications will not affectsubstantial equivalence to the predicate device since performance requirements will not be affected. Additionally,data can already be exported via a USB stick on the predicate device, the proposed modification will allow the useradditional 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 displaytechnology for device interface. Integrated barcode scannerto simplify data entry.Beacon light on top of the display to provide general devicestatus at a glance. The status indicator and message area onthe GUI each have a vertical color coded bar that | Graphical User Interface and beacon light will remainthe same as the predicate deviceUser Interface hardware updated: Add wireless module Update single board computer to supportwireless module Update barcode scanner from 1D scanning to2D 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 willallow support for the wireless module. The modified device will remain substantially equivalent to the predicatedevice 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: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. | |
| PredicateCell Saver Elite System (K160197) | SubjectCell 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 flow of fluids through the set, and a manifold pressure sensor, which monitors pressure levels in blue-striped and red-striped lines during Empty and Return. | Same |
| Air Detector | Ultrasonic air detector monitors fluid flow in the pump tubing. In Fill, the 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. | Same |
| Waste Bag Weigher | Load cell based sensor used to monitor the amount of fluid collected in the 10 L waste bag. When ~ 7.5 L of fluid is detected, the device displays a message that the waste bag is almost full. When ~ 8.5 L of fluid is detected, the device displays a message that the waste bag is full. | Same |
| PredicateCell Saver Elite System (K160197) | SubjectCell Saver Elite/Elite+ System with connectivity | |
| Reservoir Weigher | Load cell based sensor used to track the amount of fluidcollected in the reservoir. The device initiates Filldepending upon the values set for Fill start volume and Fillresume volume. | Same |
| Suction | Designed to work with both regulated external suction, andonboard manual and SmartSuction technology. | Same |
| Historical ProcedureData | Designed to provide historical procedure records thatinclude procedure data and optional consumable data.Consumable data can be entered via an onboard barcodescanner or typed directly into the record.The procedure records can be downloaded onto a USBstorage device. The device can retain data for up to 100procedures. | Same |
| Discussion | The technological characteristics of the device remain the same between the Predicate and Subject device with theexception of the modified UI hardware and the connectivity feature in software version AN. The technologicalcharacteristics that differ as a result of the proposed modifications do not render the device not substantiallyequivalent. |
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HAEMONETICS®
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HAEMONETICS®
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HAEMONETICS®
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Mud Gyl
Mark Anzalone Regulatory Affairs Specialist Haemonetics Corporation
21-Dec-2016
Date
§ 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).