(118 days)
No
The document describes a mechanical blood processing system with specific protocols and algorithms for centrifugation and washing, but there is no mention of AI or ML in the intended use, device description, or performance studies. The "algorithm" mentioned refers to a procedural set of steps for the device's operation, not an AI/ML model.
Yes
The device is intended to recover, process, and reinfuse a patient's own blood and plasma, which directly contributes to their treatment and recovery.
No
The device is an autotransfusion system designed to recover, process, and reinfuse a patient's own blood. It functions as a therapeutic device for blood salvage, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of both a single-use disposable set and reusable equipment, indicating it is a hardware-based system with software components.
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, and reinfuse blood shed during surgery or trauma. This is a therapeutic procedure involving the patient's own blood, not a diagnostic test performed on a sample outside the body to diagnose a condition or monitor a disease.
- Device Description: The device processes blood through centrifugation and washing to prepare it for reinfusion. This is a blood processing system, not a system for analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing blood components for diagnostic information (e.g., measuring analytes, identifying pathogens, etc.).
- Performance Metrics: The performance metrics listed (HCT%, RBC Recovery, Washout percentages, Fat Removal) are related to the efficiency and quality of the blood processing for reinfusion, not diagnostic accuracy.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. The Cell Saver Elite System's purpose is to prepare blood for reinfusion, which is a therapeutic intervention.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
The Cell Saver 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 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 System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative 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.
Table 1: Summary of Performance Studies
| Test Name | Test Report # | Test Intent | Test Result |
|---|---|---|---|
| Software Validation | TR-SOF-100562 | To validate fat washing protocol in revision AK of the CS Elite software. | Passed |
| Software Validation | TR-SOF-100565 | To validate revision AL of the CS Elite software. | Passed |
| Functional Testing | TR-OTH-100649 | To verify CS Elite 70 mL bowl performance | Passed |
| Functional Testing | TR-OTH-100647 | To verify CS Elite blood washout performance with fat washing protocol. | Passed |
| Functional Testing | TR-OTH-100641A | To verify the performance of the CS Elite fat washing protocol. | Passed |
| Functional Testing | TR-OTH-100646 | To verify CS Elite blood washout performance. | Passed |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cell Salvage protocol acceptance criteria:
HCT% ≥ 40%
RBC Recovery ≥ 80%
Plasma HgB Washout ≥ 95%
Heparin Washout ≥ 95%
Albumin Washout ≥ 95%
Fat Washing Protocol Acceptance Criteria:
HCT% ≥ 40%
RBC Recovery ≥ 80%
Plasma HgB Washout ≥ 95%
Heparin Washout ≥ 95%
Albumin Washout ≥ 95%
Fat Removal ≥ 99% *
*depending on bowl size used
Reference Device (Sorin Xtra K131553) Key Metrics:
Fat Removal Performance: Fat Particles Removal >99% ***
HCT ≈ 50%***
Heparin, Protein, Albumin, Potassium >95% ***
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
Haemonetics Corporation Mark Anzalone Regulatory Affairs Specialist 400 Wood Road Braintree, MA 02184
Re: K160197
Trade/Device Name: Haemonetics Cell Saver Elite Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: May 17, 2016 Received: May 18, 2016
Dear Mr. Anzalone:
This letter corrects our substantially equivalent letter of May 24, 2016.
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
1
CFR Part 807); labeling (21 CFR part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 Zuckerman, MD 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) K160197
Device Name
Haemonetics Cell Saver 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 cetther 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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Image /page/3/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in a row, followed by the company name in red font. The squares are light blue, light green, gray, and red. Below the company name is the tagline "THE Blood Management Company" in a smaller, red font.
510(k) Summary
Date: March 4th, 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 Autotransfusion System |
|---|---|
| Common Name: | Autotransfusion Device |
| Classification Name: | Autotransfusion Apparatus |
| Regulation Number: | 21 CFR 868.5830 |
| Product Code: | CAC |
| Device Class: | 2 |
Device Characteristics Summary:
The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm.
The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative 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 set and reusable 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.
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Image /page/4/Picture/0 description: The image displays the logo for "Haemonetics", a blood management company. The logo features a series of four colored squares in the upper left corner, followed by the company name in a bold, red font. Below the company name, the tagline "THE Blood Management Company" is written in a smaller, red font.
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™ 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 System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative 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.
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.
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Image /page/5/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in a row, followed by the company name in red, and the tagline "THE Blood Management Company" in a smaller font size, also in red. The squares are light blue, light green, gray, and red.
Table 1: Summarv of Performance Studies
| Test Name | Test Report # | Test Intent | Test Result |
|---|---|---|---|
| Software Validation | TR-SOF-100562 | To validate fat washing protocol in revision | |
| AK of the CS Elite software. | Passed | ||
| Software Validation | TR-SOF-100565 | To validate revision AL of the CS Elite | |
| software. | Passed | ||
| Functional Testing | TR-OTH-100649 | To verify CS Elite 70 mL bowl performance | Passed |
| Functional Testing | TR-OTH-100647 | To verify CS Elite blood washout | |
| performance with fat washing protocol. | Passed | ||
| Functional Testing | TR-OTH-100641A | To verify the performance of the CS Elite fat | |
| washing protocol. | Passed | ||
| Functional Testing | TR-OTH-100646 | To verify CS Elite blood washout | |
| performance. | Passed |
Comparison to Predicate:
The Haemonetics Cell Saver Elite Autotransfusion system with fat washing protocol and modified 70mL bowl algorithm is substantially equivalent to the Cell Saver Elite Autotransufsion system cleared in K120586. The Cell Saver 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 fat washing feature and modifications to the 70mL bowl algorithm. These differences do not render the device non-substantially equivalent because non-clinical testing has demonstrated that the subject device is as safe and effective as the predicate and the results of verification and validation have not raised different questions of safety and effectiveness than the predicate.
Sorin XTRA PFAT program is provided as a reference device only for comparison of the fat reduction program to the subject device.
A summary comparison is presented below in Table 2.
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Image /page/6/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in light blue, green, gray, and red, respectively. Below the squares is the company name, "HAEMONETICS," in red, followed by the tagline "THE Blood Management Company" in a smaller font, also in red.
Table 2: Comparison of the Cell Saver Elite Software revision AL to the Predicate Cell Saver Elite Software Revision AD
| | Predicate
Cell Saver Elite System (K120586) | Subject
Cell Saver Elite System with software revision
AL | Reference Device
Sorin Xtra (K131553) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Manufacturer | Haemonetics Corporation | Same | N/A |
| Trade Name | Haemonetics Cell Saver Elite | Same | N/A |
| Common Name | Automated Blood Cell Separator | Same | N/A |
| Classification Name | Separator, Automated, Blood Cell, Diagnostic | Same | N/A |
| Regulation Number | 21 CFR 864.9245 | Same | N/A |
| Product Code | CAC | Same | N/A |
| Device Class | 2 | Same | N/A |
| 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. | Same | N/A |
| Discussion | The devices have the same Indications for Use and the proposed changes to not expand the previously cleared Indications for Use. | | |
| | Predicate | Subject | Reference Device |
| | Cell Saver Elite System (K120586) | Cell Saver Elite System with software revision | Sorin Xtra (K131553) |
| | | AL | |
| Intended Use | The Cell Saver 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 | N/A |
| Discussion | Both devices have the same intended use. The addition of fat washing and the modified 70 mL bowl do not impact the intended use of the device, only improve
upon existing functionality. | | |
| 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 | N/A |
| Discussion | The disposables used with the Cell Saver Elite device have not changed. | | |
| Processing
Functionality | Cell Salvage protocol:
Fill
Wash
Empty
Concentrate
Return
Emergency mode (Latham processing sets only) | Same | N/A |
| | Sequestration protocol:
Fill
Empty
Concentrate | Same | N/A |
| | Cell Salvage protocol acceptance criteria:
HCT% $≥$ 40%
RBC Recovery $≥$ 80%
Plasma HgB Washout $≥$ 95%
Heparin Washout $≥$ 95%
Albumin Washout $≥$ 95% | Same | N/A |
| | Predicate | Subject | Reference Device |
| | Cell Saver Elite System (K120586) | Cell Saver Elite System with software revision | Sorin Xtra (K131553) |
| | | AL | |
| | Fat Washing Protocol
N/A | Fat Washing Protocol: (New to subject device)
Fill | PFAT |
| | | Fat Wash | • Removal of fat particles |
| | | • Return | • Excellent supernatant removal |
| | | • Fill | • Good Hematocrit |
| | | • Wash | |
| | | • Empty | |
| | | • Fill | |
| | | • Wash | |
| | | Empty | |
| | | Concentrate | |
| | | Return | |
| | Fat Washing Protocol Acceptance Criteria:
N/A | Fat Washing Protocol Acceptance Criteria:
HCT% ≥ 40% | Fat Removal Performance:
Fat Particles Removal >99% *** |
| | | RBC Recovery ≥ 80% | HCT ≈ 50%*** |
| | | Plasma HgB Washout ≥ 95% | Heparin, Protein, |
| | | Heparin Washout ≥ 95% | Albumin, Potassium >95% *** |
| | | Albumin Washout ≥ 95% | |
| | | Fat Removal ≥ 99% * | *** "Fat removal during cell salvage - An optimized program in the |
| | | *depending on bowl size used | XTRA® autotransfusion device" Timo Seyfried, MD, Michael |
| | | | Gruber, MD; Lilith Haas;
Emil Hansen, PhD, MD 13th ECOPEAT Vienna - Austria 2013 |
| Discussion | Both devices have similar processing capabilities. The Cell Saver Elite with revision AL software adds the Fat Washing protocol which will function in a similar | | |
| | | manner to the existing Cell Salvage protocol as described in Section 4 - Device Description. Both the Cell Salvage protocol and the proposed Fat Washing | |
| | | protocol will both use the same technological characteristic described below to operate. The Fat Washing protocol is optimized to remove additional fat during | |
| | | the wash phase and will not introduce any new concerns for safety or effectiveness as shown through testing summarized in Table 1 above. The key device | |
| | performance characteristics for the cell salvage protocol and the fat washing protocol remain the same when compared to the predicate device. | | |
| | | | |
| | | The proposed Fat Washing protocol discussed through this 510(k) can be seen in other cleared devices. One such reference device is Sorin Xtra Autotransfusion | |
| | | System (K131553). The Sorin Xtra has a PFAT process which has similar performance characteristics to the proposed Fat Washing protocol. | |
| | Predicate
Cell Saver Elite System (K120586) | Subject
Cell Saver Elite System with software revision
AL | Reference Device
Sorin Xtra (K131553) |
| Graphical 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 | N/A |
| Software
Centrifuge | Software Revision 4.0 (AD)
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. | Software Revision 7.0 (AL)
Same | N/A
N/A |
| Pump | A three-roller occlusive pump moves fluids into and
out of the bowl. Pump speeds are defined for each
phase. | Same | N/A |
| 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 | N/A |
| 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 | N/A |
| 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 | N/A |
| | Predicate
Cell Saver Elite System (K120586) | Subject
Cell Saver Elite System with software revision
AL | Reference Device
Sorin Xtra (K131553) |
| 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 | N/A |
| 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 | N/A |
| 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 | N/A |
| Suction | Designed to work with both regulated external
suction, and onboard manual and SmartSuction
technology. | Same | N/A |
| 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 | N/A |
| Discussion | All device technological characteristics remain the same between the Predicate and Subject device with the exception to the software, which has added fat washing and the modified 70 mL bowl algorithm. The technological characteristics that differ between the predicate and subject device do not raise any new concerns for safety or effectiveness. | | |
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Image /page/7/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of the word "HAEMONETICS" in red, with the words "THE Blood Management Company" in a smaller font below it. There are four squares in the upper left corner of the logo in the colors light blue, green, gray, and red.
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Image /page/8/Picture/0 description: The image features the logo for Haemonetics, a blood management company. The logo consists of four colored squares in light blue, green, gray, and red, respectively. Below the squares is the company name, "HAEMONETICS," in large, red font, followed by the tagline "THE Blood Management Company" in a smaller font size.
9
Image /page/9/Picture/0 description: The image contains the logo for Haemonetics, a blood management company. The logo consists of the word "HAEMONETICS" in red, with the tagline "THE Blood Management Company" underneath. There are four colored squares above the company name, colored light blue, green, gray, and red.
10
Image /page/10/Picture/0 description: The image contains the logo for Haemonetics, a blood management company. The logo features the company name in a bold, red font, with the tagline "THE Blood Management Company" underneath. There are also four squares in the upper left corner of the logo, colored light blue, green, gray, and red.
11
Image /page/11/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in blue, yellow, gray, and red, respectively. Below the squares is the company name "HAEMONETICS" in large, red, bold letters. Underneath the company name is the tagline "THE Blood Management Company" in a smaller font.
Mudr. Cpl.
Mark Anzalone Regulatory Affairs Specialist Haemonetics Corporation
4-Mar-2016
Date