(27 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Mean) |
|---|---|---|
| Supernate Heparin Washout (%) | Not explicitly stated | 98.9% |
| Supernate Albumin Washout (%) | Not explicitly stated | 99.1% |
| Supernate Hemoglobin Washout (%) | Not explicitly stated | 97.3% |
| Red Blood Cell Recovery (%) | Not explicitly stated | 85.9% |
Note: The document states, "The quality of salvaged red blood cells returned to the donor during autotransfusion procedures with both the current cardioPAT and modified cardioPAT system is acceptable with respect to measured markers." While specific numeric acceptance criteria are not explicitly given, the presentation of these mean values, with the accompanying statement of acceptability, implies these are the performance targets or within acceptable ranges determined by the manufacturer.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of samples or "pools of different hematocrit blood" tested. It lists results for 5%, 15%, and 40% hematocrit levels, implying at least three distinct test conditions.
- Data Provenance: The study was conducted under "simulated use conditions." There is no information regarding the country of origin of the data or whether it was retrospective or prospective. The reference "From TP- & TR-DIS-02028" suggests an internal company test report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The study appears to be a laboratory performance test measuring objective criteria (washout percentages, recovery percentage) rather than requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided, as the study involves objective measurements rather than subjective expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is an autotransfusion system, not a diagnostic AI system that would assist human readers in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is an electromechanical autotransfusion system, not an algorithm, and its performance relies on its mechanical and operational function, not an algorithm's interpretation.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on objective laboratory measurements of:
- Supernatant concentrations of Heparin, Albumin, and Hemoglobin (used to calculate washout percentages).
- Red blood cell recovery percentage.
These are direct measurements of the physical properties and efficacy of the device's processing function.
8. The Sample Size for the Training Set
This information is not applicable as the device is an electromechanical system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
{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.
ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
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}------------------------------------------------
| DeviceDescription | The cardioPAT system is designed to provide perioperative autotransfusion forpatients undergoing cardiovascular surgery. The system consists of anelectromechanical device and a sterile single-use disposable set, which togethercollect and process red blood cells lost during or after surgery. It is designed tobe used in the operating room to recycle blood lost during cardiovascularsurgical procedures and in the recovery room to recycle blood lost after surgery,where the expected rate of processing of salvaged blood and fluid aspiratedfrom the surgical site is less than or equal to two liters per hour. It is a smallportable system which mounts on an IV pole. |
|---|---|
| Indicationsfor Use | The Haemonetics® Cardiovascular Perioperative Autotransfusion System(cardioPAT™) is indicated for use to salvage red blood cells from blood lostintraoperatively and postoperatively during cardiovascular surgicalprocedures, where the expected rate of processing of salvaged blood and fluidaspirated 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 thefollowing criteria: |
| The patient is expected to lose sufficient blood in theperioperative period, so as to require red blood celltransfusion, and autotransfusion will likely reduce oreliminate the need for allogeneic blood transfusion. | |
| Religious beliefs cause the patient to refuse allogeneictransfusion, but accept autologous transfusion. | |
| Compatible allogeneic blood is not available. | |
| The patient is unable to donate sufficient quantities of |
{2}------------------------------------------------
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.
| MeanWashout | MeanRed Blood CellRecovery | |||
|---|---|---|---|---|
| Hematocrit | SupernateHeparin(%) | SupernateAlbumin(%) | SupernateHemoglobin(%) | (%) |
| 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
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
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)
Page 1 of 1
్లాల్లో
సాహిత్యం
Duna R. Vuchner
(Division Sign-Off)
Division of Cardiovascular Devices
(K) Number KC53600
5
§ 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).