(27 days)
No
The summary describes an electromechanical device for blood salvage and processing, with no mention of AI or ML capabilities.
Yes
The device is used to process and return a patient's own red blood cells lost during surgery, which directly contributes to maintaining the patient's physiological state and reducing the need for external blood transfusions, thus aiding in their recovery and well-being.
No
The device is described as an autotransfusion system designed to salvage and process red blood cells for reinfusion, a therapeutic function, not a diagnostic one.
No
The device description explicitly states the system consists of an "electromechanical device and a sterile single-use disposable set," indicating it includes hardware components beyond just software.
Based on the provided information, the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPAT™) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- CardioPAT Function: The cardioPAT system is designed to collect, process, and return a patient's own blood lost during surgery. It is a blood processing system, not a diagnostic test performed on a sample to gain information about a patient's health status.
- Intended Use: The intended use clearly states it's for "salvage red blood cells from blood lost intraoperatively and postoperatively" and "autotransfusion." This is a therapeutic procedure, not a diagnostic one.
- Device Description: The description focuses on the electromechanical device and disposable set used for collecting and processing blood, not for analyzing it for diagnostic purposes.
Therefore, the cardioPAT system falls under the category of a medical device used for blood processing and autotransfusion, not an In Vitro Diagnostic device.
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 lost during or after surgery. 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. It is a small portable system which mounts on an IV pole.
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
Not Found
Summary of Performance Studies
The quality of salvaged red blood cells returned to the donor during Performance autotransfusion procedures with both the current cardioPAT and modified cardioPAT system is acceptable with respect to measured markers.
The following table is a summary from testing that 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.
Key Metrics
Mean Washout: Supernate Heparin (%) 98.9, Supernate Albumin (%) 99.1, Supernate Hemoglobin (%) 97.3.
Mean Red Blood Cell Recovery (%): 85.9.
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
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted Statement in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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Haemonetics Corporation Submitter 400 Wood Road Braintree, MA. 02184-9114
| Company | Gabriel J. Muraca, Jr. |
|---|---|
| Contact | RA Project Manager |
| Haemonetics Corporation | |
| 400 Wood Road. | |
| Braintree, MA. 02184-9114 | |
| 781-356-9553 |
Device Name Proprietary Name: Cardiovascular Perioperative Autotransfusion System (cardioPATTM) Common Name: Autotransfusion apparatus Classification Name: Autotransfusion apparatus (CAC)
Predicate The predicate device is the Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM), previously cleared in K043127. Device
1
| 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 lost during or after surgery. 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. It is a small
portable system which mounts on an IV pole. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
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The quality of salvaged red blood cells returned to the donor during Performance autotransfusion procedures with both the current cardioPAT and modified cardioPAT system is acceptable with respect to measured markers.
The following table is a summary from testing that 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
Substantial Equivalence The substantial equivalence of the cardioPAT System is substantiated by its similarities in intended use, technological characteristics, and performance to the previously marketed cardioPAT system. Fluid path materials and components in the modified and currently available disposable sets are identical.
Gabriel J. Munoz Jr.
Gabriel J. Muraca, Jr. Regulatory Affairs Project Manager HAEMONETICS CORPORATION
Date 10/24/05
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The symbol is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
NOV 2 ] 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Haemonetics Corporation c/o Mr. Gabriel J. Muraca Jr. Regulatory Affairs Project Manager 400 Wood Road Braintree, MA 02184-9114
Re: K053000
Cardiovascular Perioperative Autotransfusion System (cardioPATTM) Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (Two) Product Code: CAC Dated: October 24, 2005 Received: October 25, 2005
Dear Mr. Muraca:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Gabriel J. Muraca Jr.
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dman R. Vuchner
Image /page/4/Picture/5 description: The image contains a close-up of a signature or symbol next to the letters "Br" and "Di". The signature or symbol is a circular shape with a line going through it. The letters "Br" and "Di" are in a simple, sans-serif font and are positioned to the right of the signature.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K0530CO
Device Name:
Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM)
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ and/or -(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)
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్లాల్లో
సాహిత్యం
Duna R. Vuchner
(Division Sign-Off)
Division of Cardiovascular Devices
(K) Number KC53600
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