Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and software changes related to blood processing and does not mention AI or ML.

Therapeutic

Yes
The device is used to process and reinfuse a patient's own blood and platelet-rich plasma, which directly contributes to the treatment and recovery of the patient.

Diagnostic

No

The device is an autotransfusion system designed for processing and reinfusing blood, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of hardware components (centrifugal separation chamber, disposable equipment, pinch valve disposable sensor detection system) in addition to the software change.

IVD (In Vitro Diagnostic)

Based on the provided information, the Haemonetics Cell Saver® Elite™ Autotransfusion System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The primary intended use is to recover, process, and reinfuse a patient's own blood shed during surgery or trauma. This is a therapeutic procedure involving the manipulation and return of blood to the same patient. While it involves processing blood, it's not for the purpose of diagnosing a disease or condition.
Device Description: The description focuses on the mechanical process of separating and washing red blood cells for reinfusion. It doesn't describe any components or functions related to analyzing blood for diagnostic purposes.
Lack of Diagnostic Language: The document does not use language typically associated with IVD devices, such as "diagnosis," "detection," "measurement of analytes," or "clinical decision making based on test results."
Performance Studies: The performance studies focus on the efficiency of the blood processing (hematocrit, washout, recovery) and the characteristics of the processed blood product for reinfusion, not on the accuracy or reliability of a diagnostic test.
Key Metrics: The key metrics are related to the quality and quantity of the processed blood product (hematocrit, washout, recovery, platelet concentration), not diagnostic performance metrics like sensitivity, specificity, PPV, or NPV.

In summary, the Haemonetics Cell Saver® Elite™ Autotransfusion System is a medical device used for blood salvage and autotransfusion, which is a therapeutic procedure, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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.

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 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.

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)

Cell Saver Elite In-house Laboratory Evaluation of Processing Efficiency and RBC Recovery

Study Intent: To characterize the performance of the Cell Salvage protocol of the CS Elite in terms of processing efficiency and product characteristics.
Acceptance Criteria: 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

Study Intent: To evaluate the Platelet Sequestration protocol of the CS Elite in terms of performance and product characteristics.
Acceptance Criteria: 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

Study Intent: 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.
Acceptance Criteria: 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%
The platelet rich plasma that is produced 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.

K101907

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

Regulation Number and Section

§ 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).

Summary

0

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.

1

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 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 | No formal acceptance criteria;
characterization of the
product. |
| | | performance and product
characteristics | 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 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 cleared
K101907) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| | 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. |
| User Interface | | Graphical User Interface with touch
screen display technology for device
interface. Integrated barcode scanner to
simplify data entry.

Table 2: Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate Cell Saver Elite System

3

·

:

·

Table 2 (cont): Comparison of the Haemonetics Cell Saver Elite System to the previously cleared predicate
Cell Saver Elite System

、

4

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

·

5

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

6

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

7

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

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