(53 days)
Not Found
No
The summary describes an electromechanical device for blood salvage and processing, with no mention of AI or ML technologies in its operation or intended use. The performance studies focus on processing efficiency and blood quality metrics, not algorithmic performance.
Yes.
The device is used to salvage and return red blood cells to patients during and after surgical procedures, which constitutes a therapeutic intervention.
No
The device description indicates it is a system for salvaging and recycling red blood cells, which is a therapeutic rather than diagnostic function. It processes blood for reinfusion, not for analysis or diagnosis.
No
The device description explicitly states that the system consists of an "electromechanical device and a sterile single-use disposable set," indicating the presence of hardware components beyond just software.
Based on the provided information, the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- cardioPAT Function: The cardioPAT system's primary function is to process blood lost during surgery and return it to the same patient. It's a blood processing and transfusion system, not a diagnostic tool that analyzes blood to provide diagnostic information.
- Intended Use: The intended use clearly states it's for "salvage red blood cells from blood lost intraoperatively and postoperatively" and for "autotransfusion." This is a therapeutic procedure, not a diagnostic one.
- Device Description: The description focuses on the mechanical process of collecting and processing blood for reinfusion.
- Performance Studies: The performance studies evaluate the efficiency of the blood processing (washout, recovery) and compare it to a predicate device with a similar function. They do not involve analyzing blood for diagnostic markers.
In summary, the cardioPAT system is a medical device used for a therapeutic procedure (autotransfusion) and does not perform in vitro diagnostic testing on patient specimens.
N/A
Intended Use / Indications for Use
The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Autotransfusion is indicated for patients who meet at least one of the following criteria:
- The patient is expected to lose sufficient blood in the perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
- Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
- Compatible allogeneic blood is not available.
- The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
- The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
Product codes
CAC
Device Description
The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
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
Operating Room, Recovery Room
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
Simulated use conditions for the cardioPAT system.
Sample size: Pools of different hematocrit blood.
Data Source: Test report TP-& TR-DIS-02028, Exhibit 5.
Annotation protocol: Not Found
Summary of Performance Studies
Study type: Performance comparison test against a predicate device.
Sample size: Pools of different hematocrit blood.
AUC: Not Found
MRMC: Not Found
Standalone performance:
The quality of salvaged red blood cells returned to the donor during autotransfusion procedures with both the current OrthoPAT and modified cardioPAT systems is acceptable with respect to measured markers.
Mean Washout:
5% Hematocrit: Supernate Heparin (%) 99.88, Supernate Albumin (%) 99.90, Supernate Hemoglobin (%) 99.38
15% Hematocrit: Supernate Heparin (%) 99.68, Supernate Albumin (%) 99.80, Supernate Hemoglobin (%) 98.18
40% Hematocrit: Supernate Heparin (%) 97.19, Supernate Albumin (%) 97.67, Supernate Hemoglobin (%) 94.37
Mean: Supernate Heparin (%) 98.9, Supernate Albumin (%) 99.1, Supernate Hemoglobin (%) 97.3
Mean Red Blood Cell Recovery (%):
5% Hematocrit: 77.83
15% Hematocrit: 88.77
40% Hematocrit: 91.00
Mean: 85.9
Key results:
Comparison between cardioPAT and OrthoPAT predicate device (Test Report V0007, K962475):
Mean Washout Supernate Heparin (%): OrthoPAT 98.9, cardioPAT 98.9, % Difference +0.0
Mean Washout Supernate Albumin (%): OrthoPAT 98.9, cardioPAT 99.1, % Difference +0.2
Mean Washout Supernatant Hemoglobin (%): OrthoPAT 98.4, cardioPAT 97.3, % Difference -1.1
Mean Red Blood Cell Recovery (%): OrthoPAT 83.8, cardioPAT 85.9, % Difference +2.1
Conclusion: Less than 2% difference in combined mean percent (%) washout values and less than 3% difference between the mean percent red blood cell recovery values. These differences are not considered clinically significant. The cardioPAT system performance test results are within the expected operating efficiencies of the predicate OrthoPAT device, demonstrating performance equivalence.
Key Metrics
Mean Washout (Supernate Heparin, Supernate Albumin, Supernate Hemoglobin), Mean Red Blood Cell Recovery.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K043/27
Section 10: 510(k) Summary
| Statement | This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Haemonetics Corporation
400 Wood Road
Braintree, MA. 02184-9114 |
| Company
Contact | Gabriel J. Muraca, Jr.
RA Project Manager
Haemonetics Corporation
355 Wood Rd.
Braintree, MA. 02184-9114 |
| Device Name | Proprietary Name:
Cardiovascular Perioperative Autotransfusion System
(cardioPATTM)
Common Name: Autotransfusion apparatus
Classification Name: Autotransfusion apparatus (74 CAC) |
The currently marketed predicate device is the Haemonetics® Orthopedic Predicate Perioperative Autotransfusion System (OrthoPAT®). Device
1
The cardioPAT system is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. The system consists of an Device electromechanical device and a sterile single-use disposable set, which together Description collect and process red blood cells (RBCs) lost during and after surgery. It is a small portable system which mounts on an IV pole. It is designed to be used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
The Haemonetics® Cardiovascular Perioperative Autotransfusion System Indications for (cardioPAT™) is indicated for use to salvage red blood cells from blood lost Use intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Autotransfusion is indicated for patients who meet at least one of the following criteria:
- The patient is expected to lose sufficient blood in the . perioperative period, so as to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
- Religious beliefs cause the patient to refuse allogeneic . transfusion, but accept autologous transfusion.
- Compatible allogeneic blood is not available. .
- The patient is unable to donate sufficient quantities of . autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
- The patient or physician prefers perioperative autotransfusion . rather than preoperative autologous donation or transfusion of allogeneic blood.
2
The quality of salvaged red blood cells returned to the donor during autotransfusion procedures with both the current OrthoPAT and modified Performance cardioPAT systems is acceptable with respect to measured markers.
The following table is a summary of Tables 1, 2 and 3 from the test report TP-& TR-DIS-02028, Exhibit 5. It shows the mean percent washout and the mean percent red blood cell recovery for pools of different hematocrit blood that were processed under simulated use conditions by the cardioPAT system.
| Mean
Washout | | | Mean
Red Blood Cell
Recovery | |
|-----------------|-----------------------------|-----------------------------|------------------------------------|-------|
| Hematocrit | Supernate
Heparin
(%) | Supernate
Albumin
(%) | Supernate
Hemoglobin
(%) | (%) |
| 5% | 99.88 | 99.90 | 99.38 | 77.83 |
| 15% | 99.68 | 99.80 | 98.18 | 88.77 |
| 40% | 97.19 | 97.67 | 94.37 | 91.00 |
| Mean | 98.9 | 99.1 | 97.3 | 85.9 |
Table 1: Data Summary* for cardioPAT
*From TP- & TR-DIS-02028
Table 2 compares the combined means of the cardioPAT results from Table 1 and compares them to the combined mean test results previously obtained, using similar pools of blood, which were processed on the predicate OrthoPAT system (Test Report V0007, K962475, provided in Exhibit 5).
Table 2: Combined Pool Results Comparison
| | Mean
Washout | | | Mean
Red Blood Cell
Recovery |
|-----------------------------|-----------------------------|-----------------------------|----------------------------------|------------------------------------|
| Data Source | Supernate
Heparin
(%) | Supernate
Albumin
(%) | Supernatant
Hemoglobin
(%) | (%) |
| OrthoPAT
V0007 (SW 3.0c) | 98.9 | 98.9 | 98.4 | 83.8 |
| cardioPAT
TP-DIS-02028 | 98.9 | 99.1 | 97.3 | 85.9 |
| % Difference | + 0.0 | + 0.2 | - 1.1 | + 2.1 |
3
This comparison shows that there is less than 2% difference in combined mean percent (%) washout values and less than 3% difference between the mean percent red blood cell recovery values. Because these percent differences are very small, they are not considered clinically significant. The cardioPAT system performance test results are within the expected operating efficiencies of the predicate OrthoPAT device, which demonstrates performance equivalence.
Substantial Equivalence
The substantial equivalence of the cardioPAT System is supported by its similarities in intended use, technological characteristics, and performance as compared to the currently marketed OrthoPAT system.
Gabriel J. Munoz Jr.
Gabriel J. Muraca, Jr. RA Project Manager Haemonetics Corporation
Date: November 10, 2004
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or lines, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 2005
Haemonetics Corporation c/o Mr. Gabriel J. Muraca, Jr. RA Project Manager 355 Wood Road Braintree, MA 02184-9114
K043127 Re:
K043127
Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM) Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: November 10, 2004 Received: November 12, 2004
Dear Mr. Muraca:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 9 ro(if) presidentially equivalent (for the indications felerenced and nave determined the are are are are are and one sparketed in interstate for use stated in the cherosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 28, 1976, the enational with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of any inst devices that have been recalismod in asses approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appt to the general controls provisions of the Act. The You may, merelore, market the device, becarements for annual registration, listing of general controls provisions of the rise labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 abor of the 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 be found in the Oous or ents concerning your device in the Federal Register.
5
Page 2 - Mr. Gabrie! J. Muraca, Jr.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivisation that your device complies with other requirements of the Act that I Dri has made a actives and regulations administered by other Federal agencies. You must of any reactal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the 11et 31equirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roggistions 531-542 of the Act); 21 CFR 1000-1050. product lastation oona of pro recom (2) .
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notification: "The PDF interessification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou desire specific at (301) 594-4646. Additionally, for questions on the comact the Office of Compilance and evice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (301) 594-4057. Also, prease nets roganison way obtain. Other general information on your premarket hourseation - (2) of the abe obtained from the Division of Small Manufacturers, Itsponsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K043127 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM)
Indications for Use:
The Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is I IIe Haemonches® Cardio resource > errells from blood lost intraoperatively and postoperatively muring cardiovascular surgical procedures, where the expected rate of processing of salvaged during cardio rasoural bargical site is less than or equal to two liters per hour.
Autotransfusion is indicated for patients who meet at least one of the following criteria:
- The patient is expected to lose sufficient blood in the perioperative period, so as . to require red blood cell transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
- Religious beliefs cause the patient to refuse allogeneic transfusion, but accept ● autologous transfusion.
- Compatible allogeneic blood is not available. .
- The patient is unable to donate sufficient quantities of autologous blood prior to . surgery to adequately cover the anticipated transfusion requirement.
- The patient or physician prefers perioperative autotransfusion rather than . preoperative autologous donation or transfusion of allogeneic blood.
and/or X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
R. bechner
(Division Sign-Off)
Division of Cardiovascular Devices
510(K) Number_KO43127