(148 days)
Not Found
No
The description focuses on mechanical processes (centrifugation, washing), hardware updates (touch screen, barcode scanner, vacuum system), and compatibility with existing disposables. There is no mention of algorithms, data analysis for decision-making, or any features that suggest AI/ML is used in the blood processing or sequestration protocols.
Yes
The device is used to process and reinfuse a patient's own blood and blood components, directly supporting a therapeutic outcome by returning vital blood products to the patient.
No
The device is used to process and reinfuse blood during or after surgery, not to diagnose a medical condition.
No
The device description clearly outlines hardware components such as a centrifugal separation chamber (bowl), disposable sets, reservoirs, A&A lines, a graphical user interface with a touch screen display, barcode data capture capability, and an onboard vacuum system. While it mentions a modernized graphical user interface, this is part of a larger hardware system for processing blood.
Based on the provided text, the Haemonetics Cell Saver® Elite™ Autotransfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a patient's health. The Cell Saver Elite System, while processing blood, is doing so to prepare it for reinfusion into the same patient. It's a blood processing and recovery system, not a diagnostic tool that analyzes the blood to diagnose a condition or monitor health status.
- The intended use clearly states its purpose is to "recover blood shed during or subsequent to an operation or as a result of trauma, 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.
- The description focuses on the mechanical process of separating and washing red blood cells for reinfusion. There is no mention of analyzing the blood for diagnostic markers or providing information about the patient's health based on the blood's composition (beyond the separation of components).
Therefore, the Cell Saver Elite System falls under the category of a medical device used for blood processing and reinfusion, not an IVD.
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 Autotransfusion System is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery 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 centrifygal 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.
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 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 performance testing was completed in accordance with AT6:2005.
- "Cell Saver Elite In-house Laboratory Evaluation of Processing Efficiency and RBC Recovery" (TR-CLN-100177): The intent of this study was to characterize the performance of the Cell Salvage protocol of the CS Elite in terms of processing efficiency and product characteristics. Final product hematocrit of 40-60% Heparin Washout ≥95% Free Hemoglobin Washout ≥95% Red Blood Cell Recovery ≥80%. Conclusion: Data met Acceptance Criteria.
- "In-house Laboratory Validation of Platelet Sequestration Protocol Using the Cell Saver Elite" (TR-CLN-100201): The intent of this study was to evaluate the Platelet Sequestration protocol of the CS Elite in terms of performance and product characteristics. No formal acceptance criteria; characterization of the product. Conclusion: The platelet rich plasma that is produced meets the threshold of three (3) times the incoming platelet count of the whole blood.
- "In-house Laboratory Evaluation of Processing Efficiency and Product Characteristics using Pools without Lysate" (TR-CLN-100049): The intent of this study was to characterize the performance of the Cell Salvage protocol of the CS Elite in terms of processing efficiency and product characteristics of blood without Lysate; and therefore to confirm the true red cell recovery. Final product hematocrit of 40-60% Heparin Washout ≥95% Free Hemoglobin Washout ≥95% Red Blood Cell Recovery ≥80%. Conclusion: Data met Acceptance Criteria. The data above indicate the processed RBC product data from all three bowl types exceeded the acceptance criteria in terms of Hematocrit, RBC Recovery and Washout. The RBC recovery data was, on average 12% higher than the RBC Recovery derived from procedures using pools with high levels of free hemoglobin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Final product hematocrit of 40-60%
- Heparin Washout ≥95%
- Free Hemoglobin Washout ≥95%
- Red Blood Cell Recovery ≥80%
- Platelet rich plasma meets the threshold of three (3) times the incoming platelet count of the whole blood.
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).
0
Date Prepared: November 22, 2010
Submitter: Haemonetics Corporation 400 Wood Road. Braintree MA 02184
Contact: Greg Calder Regulatory Affairs Specialist 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 5 Autologous Blood Recovery 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 Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver 5 was most recently cleared via 510(k) K014083.
The Cell Saver 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 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 centrifygal 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.
DEC - 3 2010
i
:,
1
Non-clinical Testing Summary:
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 thathe evice 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 Laboratory
Evaluation of
Processing Efficiency
and RBC Recovery | TR-CLN-100177 | The intent of this study was to
characterize the performance
of the Cell Salvage protocol of
the CS Elite in terms of
processing efficiency and
product characteristics. | Final product hematocrit of
40-60% Heparin Washout ≥95% Free Hemoglobin Washout
≥95% Red Blood Cell Recovery
≥80% Conclusion:
Data met Acceptance
Criteria |
|-------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| In-house Laboratory
Validation of Platelet
Sequestration Protocol
Using the Cell Saver
Elite | TR-CLN-100201 | The intent of this study was
to evaluate the Platelet
Sequestration protocol of the
CS Elite in terms of
performance and product
characteristics | No formal acceptance criteria;
characterization of the
product.
Conclusion:
The platelet rich plasma that
is produced meets the
threshold of three (3) times
the incoming platelet count of
the whole blood. |
| In-house Laboratory
Evaluation of
Processing Efficiency
and Product
Characteristics using
Pools without Lysate | TR-CLN-100049 | The intent of this study was to
characterize the performance
of the Cell Salvage protocol of
the CS Elite in terms of
processing efficiency and
product characteristics of
blood without Lysate; and
therefore to confirm the true
red cell recovery. | Final product hematocrit of
40-60% Heparin Washout ≥95% Free Hemoglobin Washout
≥95% Red Blood Cell Recovery
≥80% Conclusion:
Data met Acceptance
Criteria
The data above indicate the
processed RBC product data
from all three bowl types
exceeded the acceptance
criteria in terms of Hematocrit,
RBC Recovery and Washout.
The RBC recovery data was,
on average 12% higher than
the RBC Recovery derived
from procedures using pools
with high levels of free
hemoglobin. |
Table 1: Summary of Performance Studies
2
Comparison to Predicate Summary:
The Cell Saver Elite system is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver 5 system was most recently cleared via 510(k) K014083. The Cell Saver Elite system is y ysyd. to perform the same types of procedures as the Cell Saver 5 system, utilizing very similar disposable sets. The Envary changes from the Cell Saver 5 to the Cell Saver Elite systems include a modernized graphical user interface with a touch screen display, barcode data capture capability to simplify data entry, and the integration of an onboard vacuum system to provide regulated vacuum to the collection reservoir.
A summary of the Cell Saver Elite system comparison to the predicate Cell Saver 5 system is presented in Table 2: Comparison of the Haemonetics Cell Saver Elite system to the predicate Cell Saver 5 system.
| Characteristic | Cell Saver Elite System
(Subject device) | Cell Saver 5 System
(Predicate most recently cleared
K014083) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Cell Saver 5 Autologous Blood
Recovery System is 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. |
| Disposable Set | Designed to utilize the Latham 225 ml
bowl, Latham 125 ml bowl, and Blow
Molded 70 ml bowl processing sets.
Designed to utilize the PRP/PPP
Sequestration disposable accessory. | Designed to utilize the Latham 225 ml
bowl, Latham 125 ml bowl, and Blow
Molded 70 ml bowl processing sets.
Designed to utilize the PRP/PPP
Sequestration disposable accessory. |
| 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. | LCD display with discrete keys for
device interface. |
| Characteristic | Cell Saver Elite System
(Subject device) | Predicate Cell Saver 5 System
(Cleared K932890, K014083) |
| Processing
Functionality | Cell Salvage protocol:
Fill
Wash
Empty
Concentrate
Return
Emergency mode (Latham processing
sets only)
Sequestration protocol:
Fill
Empty
Concentrate | Cell Salvage protocol:
Fill
Wash
Empty
Concentrate
Return
Emergency mode (Latham processing
sets only)
Sequestration protocol:
Fill
Empty
Concentrate |
| 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. | 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. |
| Pump | A three-roller occlusive pump moves
fluids into and out of the bowl. Pump
speeds are defined for each phase. | A three-roller occlusive pump moves
fluids into and out of the bowl. Pump
speeds are defined for each phase. |
| 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. | The bowl optics assembly is mounted
within the centrifuge. |
| 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. | 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. |
| 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. | Consists of three pinch valves, which are
used to direct flow of fluids through the
set and a clamped line sensor, which
monitors pressure levels in blue-striped
and red-striped lines during Empty and
Return. |
| 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. | 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. |
| Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite to the Predicate | | |
| Characteristic | Cell Saver Elite System
(Subject device) | Predicate Cell Saver 5 System
(Cleared K932890, K014083) |
| 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. | Load cell based sensor used to monitor
the amount of fluid collected in the 10 L
waste bag.
When ~ 8 L of fluid is detected, the
device displays a message that the waste
bag is almost full. When ~9 L of fluid is
detected, the device displays a message
that the waste bag is full.
For the 70 ml processing set: When ~4
L of fluid is detected, the device displays
a message that waste bag should be
emptied. When ~ 4.5 L of fluid is
detected, the device displays a message
that the waste bag is full. |
| 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. | 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. |
| Suction | Designed to work with both regulated
external suction, and onboard manual
and SmartSuction technology. | Designed to work with regulated
external suction. |
| 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. | Designed to provide a limited procedure
summary that can be viewed on the
display. |
Table 2: Comparison of the Haemonetics Cell Saver Elite System to the Predicate Cell Saver 5 System
3
Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite to the Predicate
: .
4
ﺎ ﺑﻪ ﻋ די
Grey Calder
Greg Calder
Date: 11/22/2010
Greg Calder
Regulatory Affairs Specialist
Haemonetics Corporation
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
- Haemonetics Corporation c/o Mr. Greg Calder 400 Wood Road Braintree. MA 02184-9114
DEC - 3 2010
Re: K101907
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: November 22, 2010 Received: November 29, 2010
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 t 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
6
Page 2 - Mr. Greg Calder
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 (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/CDRH/CDRHOffices/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,
D.vina R. le. Minu
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
DEC - 3 2010
510(k) Number (if known): K101907
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DWANA R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K10 \ 407
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