(154 days)
No
The description focuses on manual control options and standard blood processing techniques (centrifugation and washing). There is no mention of AI/ML terms, image processing, or data-driven decision-making algorithms.
Yes.
The device is intended to recover, process, and reinfuse a patient's own blood and plasma, which directly involves treatment by returning a therapeutic product (red blood cells and plasma) to the patient.
No
The device is an autotransfusion system designed to process and reinfuse a patient's own blood shed during or after surgery/trauma. It performs a physical process of blood recovery and washing, not a diagnostic function.
No
The device description explicitly states that the system consists of a single-use disposable set and reusable equipment, indicating the presence of hardware components beyond just software. The 510(k) is for a software update, but the overall device is a system with both hardware and software.
Based on the provided text, the Haemonetics® Cell Saver® Elite®+ Autotransfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to recover, process (centrifugation and washing), and reinfuse the patient's own blood shed during surgery or trauma. This is a process performed on the patient's blood outside the body, but the purpose is to return it to the patient, not to diagnose a condition or provide information about a patient's health status.
- Device Description: The description focuses on the mechanical process of separating and washing red blood cells. It doesn't mention any components or functions related to analyzing blood for diagnostic purposes.
- Lack of Diagnostic Indicators: The text does not mention any measurements, analyses, or outputs that would be used for diagnosis.
- Performance Studies: The performance studies focus on software verification, functional testing (washout performance), and usability, which are relevant to the device's mechanical and operational function, not its diagnostic accuracy.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Cell Saver Elite/Elite+ System's purpose is to process and return blood to the patient, which falls under the category of a therapeutic or supportive device rather than a diagnostic one.
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 the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume.
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 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+ 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
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 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.
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)
Non-Clinical Testing Summary:
The following non-clinical performance testing was submitted in support of a determination of substantial equivalence between the subject and predicate device. A summary of the performance testing is presented below in Table 1. Test data demonstrates that the device met all performance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device.
Test Name: Software Verification, Test Report #: TR-SOF-100792, Test Intent: To verify the AQ revision of the Cell Saver Elite/Elite+ software, Test Result: Passed
Test Name: Software Verification, Test Report #: TR-SOF-100769, Test Intent: To verify the AQ revision of the Cell Saver Elite/Elite+ software, Test Result: Passed
Test Name: Functional Testing, Test Report #: TR-OTH-101003, Test Intent: To validate Cell Saver Elite/Elite+ washout performance, Test Result: Passed
Test Name: Usability Testing, Test Report #: TR-OTH-101010, Test Intent: To validate the operational needs and usability of the Cell Saver Elite/Elite+, Test Result: Passed
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.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2022
Haemonetics Corporation Ergang Alexis Director Regulatory Affairs 125 Summer Street Boston, Massachusetts 02110
Re: K221722
Trade/Device Name: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: Class II Product Code: CAC Dated: October 14, 2022 Received: October 14, 2022
Dear Ergang Alexis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221722
Device Name
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
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 the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.
| 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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3
510(k) Summarv
Date: November 15, 2022
Submitter:
Haemonetics Corporation 125 Summer Street Boston, MA 02110
Contact:
Alexis Ergang Director, Regulatory Affairs Phone: 224-244-2850 Email: alexis.ergang@haemonetics.com
Device Information:
Trade Name: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) Common Name: Autotransfusion Device Classification Name: Autotransfusion Apparatus Regulation Number: 21 CFR 868.5830 Product Code: CAC Device Class: 2
Predicate Device Information:
| Trade Name: | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) |
|---|---|
| Common Name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Device Class: | 2 |
| 510k Number: | K162423 |
Reference Device Information:
| Trade Name: | Medtronic autoLog IQ Autotransfusion System |
|---|---|
| Common Name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
4
| Product Code: | CAC |
|---|---|
| Device Class: | 2 |
| 510k Number: | K181954 |
| Trade Name: | Xtra Autotransfusion System |
| Common Name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Device Class: | 2 |
| 510k Number: | K131553 |
Device Characteristics Summary:
The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume.
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 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+ 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 the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within the recommended time guidelines of the
Page 2 of 8 K221722
5
American Association of Blood Banks (AABB), 9th Edition.
Non-Clinical Testing Summary:
The following non-clinical performance testing was submitted in support of a determination of substantial equivalence between the subject and predicate device. A summary of the performance testing is presented below in Table 1. Test data demonstrates that the device met all performance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device.
| Test Name | Test Report # | Test Intent | Test Result |
|---|---|---|---|
| Software | |||
| Verification | TR-SOF-100792 | To verify the AQ revision of the Cell Saver | |
| Elite/Elite+ software | Passed | ||
| Software | |||
| Verification | TR-SOF-100769 | To verify the AQ revision of the Cell Saver | |
| Elite/Elite+ software | Passed | ||
| Functional Testing | TR-OTH-101003 | To validate Cell Saver Elite/Elite+ washout | |
| performance | Passed | ||
| Usability Testing | TR-OTH-101010 | To validate the operational needs and | |
| usability of the Cell Saver Elite/Elite+ | Passed |
Comparison to Predicate:
The Haemonetics Cell Saver Elite/Elite+ Autotransfusion system with 7.3 (AQ) software is substantially equivalent to the Cell Saver Elite/Elite+ Autotransufsion system cleared in K162423. 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 have been clarified for the Cell Saver Elite/Elite+. The proposed modifications to the Indications for Use and the proposed software changes do not expand or change the safety profile from the previous cleared Indication for Use. The Intended Use for the Cell Saver Elite/Elite+ is the same between the subject and predicate device. The technological characteristics of the subject device differ from the predicate only in the new embedded software, which includes new features for manual control of the cell salvage procedure. These differences do not impact the clinical functionality of the device and do not render the device non-substantially equivalent. The non-clinical and clinical testing has demonstrated the subject device is as safe and effective as the predicate device. The results of the testing have not raised different questions of safety and efficacy from the predicate.
A summary comparison is presented below in Table 2.
6
Table 2: Comparison of the Cell Saver Elite/Elite+ Software with 7.3 (AQ) Software to the Predicate Cell Saver Elite/Elite+ Software version 7.1 (AN)
| Predicate | Subject | |
|---|---|---|
| Cell Saver Elite/Elite+ System (K162423) | Cell Saver Elite/Elite+ System with 7.3 Software | |
| Manufacturer | Haemonetics Corporation | Same |
| Trade Name | Haemonetics Cell Saver Elite/Elite+ | Same |
| 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™ 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 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 the processed red blood cells to a product bag. |
The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within the recommended time guidelines of the American Association of Blood Banks (AABB), 9th Edition. |
7
| Predicate | Subject | |
|---|---|---|
| Cell Saver Elite/Elite+ System (K162423) | Cell Saver Elite/Elite+ System with 7.3 Software | |
| 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 | |
| Disposables | There were no changes to the Cell Saver Elite disposables | |
| associated with the changes that are the subject of this | ||
| 510(k) application. | Same | |
| Software | Software Revision 7/0 (AN) | Software Revision 7.3 (AQ) |
| 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 | ||
| corresponds to the beacon light. | Same, with updates to help and on screen information |
8
| Predicate | Subject | |
|---|---|---|
| Cell Saver Elite/Elite+ System (K162423) | Cell Saver Elite/Elite+ System with 7.3 Software | |
| Processing | ||
| Functionality | Cell Salvage protocol: | |
| Fill | ||
| Wash | ||
| Empty | ||
| Concentrate | ||
| Return | ||
| Emergency mode (Latham processing sets only) |
Sequestration protocol:
Fill
Empty
Concentrate
Fat Washing Protocol:
Fill
Fat Wash
ReturnFillWashEmptyFillWashEmpty
Concentrate
Return | Same, with the addition of manual mode, quick
transfer, and modification of the range selection for
minimum wash volume. These modifications provide
the users to manually control the cell salvage
procedure. |
| 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 | Same |
9
| Predicate | Subject | |
|---|---|---|
| Cell Saver Elite/Elite+ System (K162423) | Cell Saver Elite/Elite+ System with 7.3 Software | |
| the centrifuge. Centrifuge speeds are defined for each protocol and bowl type. | ||
| 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 |
| Reservoir Weigher | Load cell based sensor used to track the amount of fluid collected in the reservoir. The device initiates Fill | Same |
Page 7 of 8
10
| Predicate | Subject | |
|---|---|---|
| Cell Saver Elite/Elite+ System (K162423) | Cell Saver Elite/Elite+ System with 7.3 Software | |
| depending upon the values set for Fill start volume and Fill resume volume. | ||
| 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 |
Conclusion:
The summary of the data, included in this submission, is sufficient to show that the Hite/Elite- Autotransfusion System is substantially equivalent to the legally marketed predicate device, the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System.