(126 days)
Not Found
No
The summary describes a blood processing system based on centrifugation and washing. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on mechanical and software control for blood processing and connectivity.
Yes
The device is used to process and reinfuse a patient's own blood and platelet-rich plasma, which directly contributes to the treatment and management of blood loss during surgery or trauma.
No
The device is an autotransfusion system designed to process and reinfuse a patient's own blood. Its function is to recover, wash, and concentrate red blood cells, and in a specific protocol, collect platelet-rich plasma, for reinfusion. It does not perform any diagnostic function such as identifying, monitoring, or predicting disease.
No
The device description explicitly states that the system consists of both a single-use disposable set and reusable equipment, including a centrifugal separation chamber (bowl). While the submission focuses on software and hardware for connectivity, the core function relies on physical components for blood processing.
Based on the provided text, the Haemonetics Cell Saver® Elite®+ Autotransfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cell Saver Elite/Elite+ system processes blood that is shed during or subsequent to an operation or trauma and then reinfuses it back into the same patient. It's a blood processing and reinfusion system, not a diagnostic tool that analyzes specimens for diagnostic purposes.
- Intended Use: The intended use clearly states the purpose is to "recover blood shed," "processing the blood," 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." This is a therapeutic/supportive function, not a diagnostic one.
- Lack of Diagnostic Information: The description doesn't mention any analysis of the blood to provide diagnostic information about the patient's condition. It focuses on separating and washing red blood cells for reinfusion.
Therefore, the Haemonetics Cell Saver® Elite®+ Autotransfusion System falls under the category of a medical device used for blood processing and reinfusion, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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)
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| Test Name | Test Report # | Test Intent | Test Result |
|---|---|---|---|
| Electromagnetic Compatibility | TR-ELE-100782 | To verify compliance with EMC requirements per IEC 60601-1-2 | Pass |
| Electrical Safety | TR-ELE-100812 | To verify compliance with electrical safety requirements per IEC 60601-1 | Pass |
| Wireless Coexistence | TR-ELE-100786 | To verify wireless coexistence of the CS Elite/Elite+ with potential interference appliances | Pass |
| Software Validation | TR-SOF-100592 | To validate version AN of the CS Elite/Elite+ Software | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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
2
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 |
|---|---|---|---|
| Electromagnetic | |||
| Compatibility | TR-ELE-100782 | To verify compliance with EMC | |
| requirements per IEC 60601-1-2 | Pass | ||
| Electrical Safety | TR-ELE-100812 | To verify compliance with electrical safety | |
| requirements per IEC 60601-1 | Pass | ||
| Wireless Coexistence | TR-ELE-100786 | To verify wireless coexistence of the CS | |
| Elite/Elite+ with potential interference | |||
| appliances | Pass | ||
| Software Validation | TR-SOF-100592 | To validate version AN of the CS | |
| 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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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 | ||
| Cell Saver Elite System (K160197) | Subject | |
| Cell Saver Elite/Elite+ System with connectivity | ||
| 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. | Same | |
| Discussion | The previously cleared device and proposed device have the same Intended Use. The addition of the connectivity | |
| feature 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 subject | ||
| 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) |
| • Fix open software anomalies | ||
| • Update software to allow communication with | ||
| an approved server application | ||
| Discussion | The proposed modifications will add new networking features to the Cell Saver Elite/Elite+ device. This new | |
| feature will allow the device to transmit data from the device to an approved server application and receive device | ||
| settings and software updates from an approved server application. The software modifications will not affect | ||
| substantial 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 user | ||
| 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 | |
| technology for device interface. Integrated barcode scanner | ||
| to simplify data entry. |
Beacon light on top of the display to provide general device
status at a glance. The status indicator and message area on
the GUI each have a vertical color coded bar that | Graphical User Interface and beacon light will remain
the same as the predicate device
User Interface hardware updated: Add wireless module Update single board computer to support
wireless module Update barcode scanner from 1D scanning to
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
allow support for the wireless module. The modified device will remain substantially equivalent to the predicate
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:
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
Cell Saver Elite System (K160197) | Subject
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 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 |
| | Predicate
Cell Saver Elite System (K160197) | Subject
Cell Saver Elite/Elite+ System with connectivity |
| Reservoir Weigher | Load cell based sensor used to track the amount of fluid
collected in the reservoir. The device initiates Fill
depending upon the values set for Fill start volume and Fill
resume volume. | Same |
| Suction | Designed to work with both regulated external suction, and
onboard manual and SmartSuction technology. | Same |
| Historical Procedure
Data | Designed to provide historical procedure records that
include procedure data and optional consumable data.
Consumable data can be entered via an onboard barcode
scanner or typed directly into the record.
The procedure records can be downloaded onto a USB
storage device. The device can retain data for up to 100
procedures. | Same |
| Discussion | The technological characteristics of the device remain the same between the Predicate and Subject device with the
exception of the modified UI hardware and the connectivity feature in software version AN. The technological
characteristics that differ as a result of the proposed modifications do not render the device not substantially
equivalent. | |
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HAEMONETICS®
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HAEMONETICS®
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Image /page/9/Picture/0 description: The image shows the logo for Haemonetics. The logo consists of four colored squares in the top left corner, followed by the company name in red, "HAEMONETICS". The squares are light blue, green, gray, and red, respectively. The registered trademark symbol is located to the right of the company name.
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HAEMONETICS®
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Image /page/11/Picture/0 description: The image shows the word "HAEMONETICS" in a red serif font. There are four colored squares above the word. The colors of the squares are blue, green, gray, and red. There is a registered trademark symbol to the right of the word.
Mud Gyl
Mark Anzalone Regulatory Affairs Specialist Haemonetics Corporation
21-Dec-2016
Date