(85 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 Autotransfusion System is an evolution of the previously cleared Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The changes from the previously cleared Cell Saver Elite to the subject Cell Saver Elite system include a software change and a mechanical change to the pinch valve disposable sensor detection system.
The Haemonetics Cell Saver Elite Autotransfusion System is an autotransfusion apparatus. The data provided includes non-clinical performance testing which focuses on processing efficiency and product characteristics of blood products.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Final product hematocrit | 40-60% | Data met Acceptance Criteria |
| Heparin Washout | ≥95% | Data met Acceptance Criteria |
| Free Hemoglobin Washout | ≥95% | Data met Acceptance Criteria |
| Red Blood Cell Recovery | ≥80% | Data met Acceptance Criteria |
| Platelet Rich Plasma (PRP) product | N/A (characterization only) | Meets threshold of 3x incoming platelet count |
| RBC recovery (without Lysate) | ≥80% | Exceeded acceptance criteria, ~12% higher than procedures with high free hemoglobin |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of tests or units of blood) used for each in-house laboratory evaluation. It states "Test data demonstrates that the device and resultant blood products met all clinical and performance requirements". The data provenance is "In-house Laboratory Evaluation," implying the data was generated within Haemonetics Corporation and is retrospective for the purpose of this 510(k) submission, as it refers to testing submitted with a previous 510(k) in 2010.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the non-clinical performance studies described. The ground truth for these studies relies on instrumental measurements and validated laboratory protocols for determining blood product characteristics (e.g., hematocrit, concentration of substances, cell recovery). There is no mention of human expert evaluation for establishing ground truth in these technical performance tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on laboratory measurements and established performance criteria, not on expert consensus or 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
Not applicable. This device is an autotransfusion system, a medical device that processes blood. It is not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance studies described ("In-house Laboratory Evaluation") are essentially standalone performance evaluations of the device's ability to process blood and achieve specific product characteristics. The device operates automatically based on programmed protocols.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established through:
- Laboratory Measurements: Quantifiable parameters like hematocrit, heparin concentration, free hemoglobin concentration, and red blood cell recovery.
- Established Performance Criteria/Thresholds: Pre-defined numerical targets or ranges (e.g., hematocrit 40-60%, washout ≥95%) that the device's output should achieve.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical device (autotransfusion system) rather than an algorithm or AI model that requires a training set in the conventional sense. Its performance is based on engineering design and validated physical/chemical processes.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device. The "ground truth" for its operation is the set of physical and biochemical principles it utilizes for blood processing.
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510(k) Summary
Date Prepared: April 25, 2012
Submitter: Haemonetics Corporation 400 Wood Road. Braintree MA 02184
Contact: Greg Calder Regulatory Affairs Manager Phone: 781-356-9538 Fax: 781-356-3558 fax Email: gcalder@haemonetics.com
Device Information: Trade Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC
Predicate Device Information: Trade Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC
Device Characteristics Summary:
The Cell Saver Elite Autotransfusion System is an evolution of the previously cleared Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite was most recently cleared via 510(k) K 101907 on December 03, 2010.
The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or fior nurses, anesthesia technicians and autotransfusion service provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.
The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines.
The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient.
The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.
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Non-clinical Testing Summary:
The following non-clinical performance testing was submitted in K101907. The data remains applicable to the system under review. 1
Non-clinical performance testing was completed in accordance with AT6:2005. A summary of the performance testing is presented below in Table 1: Summary of Performance Studies. Test data demonstrates that the device and resultant blood products met all clinical and performance requirements, and is as safe, as effective, and performs as well as or better than the predicate device.
| Cell Saver Elite In-house LaboratoryEvaluation ofProcessing Efficiencyand RBC Recovery | TR-CLN-100177 | The intent of this study was tocharacterize the performanceof the Cell Salvage protocol ofthe CS Elite in terms ofprocessing efficiency andproduct characteristics. | • Final product hematocrit of40-60%• Heparin Washout ≥95%• Free Hemoglobin Washout≥95%• Red Blood Cell Recovery≥80% |
|---|---|---|---|
| Conclusion:Data met AcceptanceCriteria | |||
| In-house LaboratoryValidation of PlateletSequestration ProtocolUsing the Cell SaverElite | TR-CLN-100201 | The intent of this study wasto evaluate the PlateletSequestration protocol of theCS Elite in terms of | No formal acceptance criteria;characterization of theproduct. |
| performance and productcharacteristics | Conclusion:The platelet rich plasma thatis produced meets thethreshold of three (3) timesthe incoming platelet count ofthe whole blood. | ||
| In-house LaboratoryEvaluation ofProcessing Efficiencyand ProductCharacteristics usingPools without Lysate | TR-CLN-100049 | The intent of this study was tocharacterize the performanceof the Cell Salvage protocol ofthe CS Elite in terms ofprocessing efficiency andproduct characteristics ofblood without Lysate; andtherefore to confirm the truered cell recovery. | • Final product hematocrit of40-60%• Heparin Washout ≥95%• Free Hemoglobin Washout≥95%• Red Blood Cell Recovery≥80%Conclusion:Data met AcceptanceCriteriaThe data above indicate theprocessed RBC product datafrom all three bowl typesexceeded the acceptancecriteria in terms of Hematocrit,RBC Recovery and Washout.The RBC recovery data was,on average 12% higher thanthe RBC Recovery derivedfrom procedures using poolswith high levels of freehemoglobin. |
Table 1: Summary of Performance Studies
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Comparison to Predicate Summary:
The Cell Saver Elite system is an evolution of the Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite system was most recently cleared via 510(k) K101907 on December 03, 2010. The Cell Flite system is designed to perform the same types of procedures as the previously cleared Cell Saver Elite system, utilizing identical disposable sets. The changes from the previously cleared Cell Saver Elite to the subject Cell Saver Elite system include a software change and a mechanical change to the pinch valve disposable sensor detection system.
A summary of the Cell Saver Elite system comparison to the predicate Ccll Saver Elite system is presented in Table 2: Comparison of the Haemonetics Cell Saver Elite system to the system to the system in 1 abit system.
| Characteristic | Cell Saver Elite System(Subject device) | Cell Saver Elite System(Predicate most recently clearedK101907) |
|---|---|---|
| Indications forUse | The Haemonetics Cell Saver® Elite™Autotransfusion System and its relatedaccessory components are intended foruse to recover blood shed during orsubsequent to an operation or as a resultof trauma, processing the blood by acentrifugation and washing procedure,and pumping this processed red cellproduct to either a bag for gravityreinfusion into the patient or to thearterial line of an extracorporeal circuitfor reinfusion into the patient. Theintended use of the SequestrationProtocol is to collect an autologous,preoperative, platelet rich plasmaproduct for reinfusion to the samepatient within 6 hours of collection. | Same |
| Disposable Set | Designed to utilize the Latham 225 mlbowl, Latham 125 ml bowl, and BlowMolded 70 ml bowl processing sets.Designed to utilize the PRP/PPPSequestration disposable accessory. | |
| User Interface | Graphical User Interface with touchscreen display technology for deviceinterface. Integrated barcode scanner tosimplify data entry.Beacon light on top of the display toprovide general device status at a glance.The status indicator and message area onthe GUI each have a vertical color codedbar that corresponds to the beacon light | |
| Characteristic | Cell Saver Elite System | |
| (Subject device) | (Predicate most recently cleared | |
| K101907) | ||
| Processing | Cell Salvage protocol: | Same |
| Functionality | Fill | |
| Wash | ||
| Empty | ||
| Concentrate | ||
| Return | ||
| Emergency mode (Latham processing | ||
| sets only) | ||
| Sequestration protocol: | ||
| Fill | ||
| Empty | ||
| Concentrate | ||
| Centrifuge | Holds the rotating portion of the Latham | Same |
| bowls during a procedure. For the 70 ml | ||
| Blow Molded bowl, a chuck adaptor is | ||
| used to hold the rotating portion of the | ||
| bowl in the centrifuge. Centrifuge | ||
| speeds are defined for each protocol and | ||
| bowl type. | ||
| Pump | A three-roller occlusive pump moves | |
| Same | ||
| fluids into and out of the bowl. Pump | ||
| Bowl Optics | speeds are defined for each phase. | |
| The bowl optics assembly is mounted | Same | |
| within the centrifuge. The optics | ||
| assembly possesses two optical sensors; | ||
| one for Latham bowls and one for BlowMolded bowl. | ||
| Effluent Line | ||
| Sensor | Monitors quality of bowl effluent (eg. | Same |
| wash is satisfactory), adjusts pump | ||
| speed (eg. avoid red cell spillage), and | ||
| advances system to next phase when | ||
| appropriate. | ||
| Valve Module | Consists of three pinch valves, which areused to direct flow of fluids through the | Same |
| set, and a manifold pressure sensor, | ||
| which monitors pressure levels in blue- | ||
| striped and red-striped lines during | ||
| Air Detector | Empty and Return.Ultrasonic air detector monitors fluid | |
| flow in the pump tubing. In Fill, the | Same | |
| sensor detects air when reservoir is | ||
| empty. In Concentrate, the sensor | ||
| detects air when RBC bag is empty. | ||
| During Wash, it senses air when saline | ||
| bag is empty. In Empty and Return, it | ||
| senses air when bowl is empty. | ||
| Characteristic | Cell Saver Elite System(Subject device) | Cell Saver Elite System(Predicate most recently clearedK101907) |
| Waste BagWeigher | Load cell based sensor used to monitorthe amount of fluid collected in the 10 Lwaste bag. When ~ 7.5 L of fluid isdetected, the device displays a messagethat the waste bag is almost full. When~ 8.5 L of fluid is detected, the devicedisplays a message that the waste bag isfull. | Same |
| ReservoirWeigher | Load cell based sensor used to track theamount of fluid collected in thereservoir. The device initiates Filldepending upon the values set for Fillstart volume and Fill resume volume. | Same |
| Suction | Designed to work with both regulatedexternal suction, and onboard manualand SmartSuction technology. | Same |
| HistoricalProcedure Data | Designed to provide historical procedurerecords that include procedure data andoptional consumable data. Consumabledata can be entered via an onboardbarcode scanner or typed directly intothe record.The procedure records can bedownloaded onto a USB storage device.The device can retain data for up to 100procedures. | Same |
Table 2: Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate Cell Saver Elite System
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Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate
Cell Saver Elite System
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Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate Cell Saver Elite System
Greg Calder
Greg Calder Regulatory Affairs Manager
Haemonetics Corporation
Date: 04/25/2012
·
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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 2 2012
Haemonetics Corporation c/o Mr. Greg Calder 400 Wood Road Braintree. MA 02184-9114
Re: K120586
Trade/Device Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: II Product Code: CAC Dated: February 24, 2012 Received: February 27, 2012
Dear Mr. Calder:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 – Mr. Greg Calder
device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M. L. Miller
C. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K120586 510(k) Number (if known):
Device Name: Haemonetics Cell Saver® Elite® Autotransfusion System
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
ce of CDRH, Office of Device Evaluation (ODE) of Cardiovascular Devices
K 120586
510(k) Number
Page 1 of 1
§ 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).