HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)

K053000 · Haemonetics Corp. · CAC · Nov 21, 2005 · Anesthesiology

Device Facts

• Record ID: K053000
• Device Name: HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
• Applicant: Haemonetics Corp.
• Product Code: CAC · Anesthesiology
• Decision Date: Nov 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System collects and processes shed blood during/after cardiovascular surgery; utilizes electromechanical device and sterile single-use disposable set. Operates in OR or recovery room; mounted on IV pole. Processes salvaged blood/fluid at rates ≤ 2 L/hr. Recycles red blood cells for autologous transfusion; reduces/eliminates need for allogeneic blood. Healthcare providers use salvaged blood to manage patient blood loss and transfusion requirements. Benefits include reduced allogeneic transfusion risks and conservation of blood resources.

Clinical Evidence

Bench testing only. Performance evaluated via simulated use conditions using pools of blood with varying hematocrit levels (5%, 15%, 40%). Primary endpoints included mean percent washout (supernate heparin, albumin, hemoglobin) and mean percent red blood cell recovery. Results demonstrated mean washout of 98.9% (heparin), 99.1% (albumin), 97.3% (hemoglobin), and mean red blood cell recovery of 85.9%.

Technological Characteristics

Electromechanical autotransfusion apparatus; portable, IV-pole mounted. Consists of base unit and sterile single-use disposable set. Fluid path materials identical to predicate. Processing principle involves collection and washing of salvaged red blood cells.

Indications for Use

Indicated for patients undergoing cardiovascular surgery requiring red blood cell salvage intraoperatively or postoperatively, where salvage/processing rate is ≤ 2 L/hr. Applicable when patient requires transfusion, refuses allogeneic blood (religious/preference), allogeneic blood is unavailable, or preoperative autologous donation is insufficient.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Haemonetics® Cardiovascular Perioperative Autotransfusion System (cardioPATTM) (K043127)

Submission Summary (Full Text)

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## 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

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| Device<br>Description | The cardioPAT system is designed to provide perioperative autotransfusion for<br>patients undergoing cardiovascular surgery. The system consists of an<br>electromechanical device and a sterile single-use disposable set, which together<br>collect and process red blood cells lost during or after surgery. It is designed to<br>be used in the operating room to recycle blood lost during cardiovascular<br>surgical procedures and in the recovery room to recycle blood lost after surgery,<br>where the expected rate of processing of salvaged blood and fluid aspirated<br>from the surgical site is less than or equal to two liters per hour. It is a small<br>portable system which mounts on an IV pole. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Haemonetics® Cardiovascular Perioperative Autotransfusion System<br>(cardioPAT™) is indicated for use to salvage red blood cells from blood lost<br>intraoperatively and postoperatively during cardiovascular surgical<br>procedures, where the expected rate of processing of salvaged blood and fluid<br>aspirated from the surgical site is less than or equal to two liters per hour.<br>Autotransfusion is indicated for patients who meet at least one of the<br>following criteria: |
| | The patient is expected to lose sufficient blood in the<br>perioperative period, so as to require red blood cell<br>transfusion, and autotransfusion will likely reduce or<br>eliminate the need for allogeneic blood transfusion. |
| | Religious beliefs cause the patient to refuse allogeneic<br>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<br>Washout | | | Mean<br>Red Blood Cell<br>Recovery | |
|-----------------|-----------------------------|-----------------------------|------------------------------------|-------|
| Hematocrit | Supernate<br>Heparin<br>(%) | Supernate<br>Albumin<br>(%) | Supernate<br>Hemoglobin<br>(%) | (%) |
| 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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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 [phone]. 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 [phone] or [phone] 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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