DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

K963759 · Sorin Biomedical, Inc. · CAC · Feb 20, 1998 · Anesthesiology

Device Facts

• Record ID: K963759
• Device Name: DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
• Applicant: Sorin Biomedical, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Feb 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dideco Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologous transfusion. The Compact-A and Compact-M Autotransfusion Systems are to be used with disposables for the collection of shed blood and aspirated body fluids, and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The Systems are also recommended to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient’s whole blood immediately preoperative or intraoperative to a surgical procedure.

Device Story

The Dideco Compact-A and Compact-M are high-speed, lightweight automatic autotransfusion systems. The system includes a rolling cart, IV pole, and portable vacuum pump module. It functions by collecting shed blood and aspirated body fluids during or after surgery, or whole blood preoperatively/intraoperatively. The device processes these inputs to separate erythrocytes from other blood components or to isolate PRP/PPP. Used in clinical surgical settings, the system is operated by trained medical personnel. The output is processed autologous blood products returned to the patient, which reduces the need for donor blood transfusions and benefits the patient by minimizing transfusion-related risks.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was established via bench and in vivo functional testing, including plasma free hemoglobin, ADP/collagen, pH testing, and cell/platelet counting to verify performance against the predicate device.

Technological Characteristics

High-speed automatic autotransfusion system; includes portable vacuum pump module, rolling cart, and IV pole. Operates via mechanical separation of blood components. Materials and flow rates are identical to the predicate Electromedics AT-1000. System is designed for use with disposables.

Indications for Use

Indicated for patients undergoing surgical procedures requiring autologous blood transfusion, including collection of shed blood, aspirated body fluids, and separation of erythrocytes. Also indicated for preoperative or intraoperative collection of platelet-rich plasma (PRP) and platelet-poor plasma (PPP) from whole blood.

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

• Electromedics AT-1000

Submission Summary (Full Text)

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K963759
510(k) Notification
FEB 20 1998

Sorin Biomedical Inc.
Dideco Compact-A and Compact-M Autotransfusion Systems

XIV. 510(k) SUMMARY

A. Name and Address of Submitter
Sorin Biomedical Inc.
17600 Gillette Avenue
P.O. Box 19503
Irvine, California 92713-9503

B. Telephone and Fax Numbers of Submitter
Telephone: [phone]
Fax: [phone]

C. Name of Contact Person
Susan Reimers
Manager, Clinical and Regulatory Affairs

D. Date Summary was Prepared: September 16, 1996

E. Device Name
Trade or Proprietary Name:
Dideco Compact-A and Compact-M Autotransfusion Systems
Common Name:
Autotransfusion Apparatus
Classification Name:
Autotransfusion Devices

F. Summary of Substantial Equivalence
The Dideco Compact-A and Compact-M Autotransfusion Systems are substantially equivalent in intended use, materials, design, and performance characteristics to the Electromedics AT-1000.

SORIN BIOMEDICAL INC. CONFIDENTIAL
22

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Sorin Biomedical Inc.
510(k) Notification
Dideco Compact-A and Compact-M Autotransfusion Systems

## G. Device Description

The Dideco Compact-A and Compact-M Autotransfusion Systems are composed of the following equipment: a high-speed lightweight automatic autotransfusion system including a rolling cart for the system with an IV pole and a portable vacuum pump module.

## H. Device Intended Use

The Dideco Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologous transfusion. The Compact-A and Compact-M Autotransfusion Systems are to be used with disposables for the collection of shed blood and aspirated body fluids, and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The Systems are also recommended to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient’s whole blood immediately preoperative or intraoperative to a surgical procedure.

## I. Summary of Comparison of Technological Characteristics

The technological characteristics of the Dideco Compact-A and Compact-M Autotransfusion Systems are similar to the Electromedics AT-1000 System. All three (3) systems are identical in respect to their process steps, method of operation, materials, and suggested flow rates. All three (3) are indicated for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from the patient.

## J. Summary of In-Vivo Tests

Substantial equivalence was based on a comparison of test results from the following in vivo functional tests:

- plasma free Hgb, ADP/Collagen and pH testing
- cell and platelet counting.

## K. Conclusions

Based upon the above information, Sorin Biomedical Inc. concludes that both the Dideco Compact-A and Compact-M Autotransfusion Systems and predicate Electromedics AT-1000 Autotransfusion System have comparable and acceptable performance for the indication of the collection of shed blood and aspirated body fluids, and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The systems are also indicated for use to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient’s whole blood immediately preoperative or intraoperative to a surgical procedure.

SORIN BIOMEDICAL INC. CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 20 1998

Ms. Sharon Thompson
Director, Regulatory Affairs/Quality
Sorin Biomedical, Inc.
17600 Gillette Avenue
P.O. Box 19503
Irvine, CA 92713-9503

Re: K963759
Dideco Compact and Compact A Autotransfusion Systems
Regulatory Class: II (two)
Product Code: 74 CAC
Dated: January 30, 1998
Received: February 4, 1998

Dear Ms. Thompson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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K963759/A

Page 1 of 1

510(k) Number (if known): K963759

Device Name: DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS

Indications For Use:

The Dideco Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologous transfusion. The Compact-A and Compact-M autotransfusion systems are to be used with disposables for the collection of shed blood and aspirated body fluids, and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The systems are also recommended to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient's whole blood immediately preoperative to a surgical procedure.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K963759