(520 days)
Not Found
Electromedics AT-1000
No
The summary describes an autotransfusion system that processes blood mechanically. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of these technologies.
Yes
The device is described as an autotransfusion system intended to process and collect blood for autologous transfusion, and to separate erythrocytes or collect plasma components. These functions are directly involved in medical treatment by processing and returning blood components to a patient, which aligns with the definition of a therapeutic device.
No
The device description indicates that the system is used to process and collect blood components for autologous transfusion or to prepare PRP/PPP. It is not described as analyzing or interpreting data to diagnose a condition or disease. The summary of performance studies mentions "test results from the following in vivo functional tests: plasma free Hgb, ADP/Collagen and pH testing, cell and platelet counting," but these appear to be internal functional tests of the device's output rather than diagnostic tests performed by the device on a patient.
No
The device description explicitly states it is composed of physical equipment including a rolling cart, IV pole, and portable vacuum pump module, indicating it is a hardware system with likely integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes processing, collecting, and separating blood components for autologous transfusion and collecting PRP/PPP from the patient's whole blood immediately preoperative to a surgical procedure. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical components of a system designed for blood processing and collection, not for analyzing samples to diagnose a condition.
- Lack of Diagnostic Language: There is no mention of analyzing blood or body fluids to identify diseases, conditions, or markers. The focus is on preparing blood for reinfusion into the same patient.
- Performance Studies: The performance studies mentioned (plasma free Hgb, ADP/Collagen and pH testing, cell and platelet counting) are related to the quality and composition of the processed blood for transfusion, not for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's purpose is to prepare blood for reinfusion, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Dideco Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologuous 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.
Product codes
74 CAC
Device Description
The Dideco Compact-A and Compact-M Autotransfusion Systems are composed of the a high-speed lightweight automatic autotransfusion system following equipment: including a rolling cart for the system with an IV pole and a portable vacuum pump module.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. .
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Electromedics AT-1000
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
K9603759
510(k) Notification
Sorin Biomedical Inc. Dideco Compact-A and Compact-M Autotransfusion Systems
FEB 20 1998
510(k) SUMMARY XIV.
Name and Address of Submitter A.
Sorin Biomedical Inc. 17600 Gillette Avenue P.O. Box 19503 Irvine, California 92713-9503
Telephone and Fax Numbers of Submitter B.
| Telephone: | (714) 250-8322 |
|---|---|
| Fax: | (714) 757-8644 |
Name of Contact Person C.
Susan Reimers Manager, Clinical and Regulatory Affairs
September 16, 1996 Date Summary was Prepared: D.
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.
1
G. Device Description
The Dideco Compact-A and Compact-M Autotransfusion Systems are composed of the a high-speed lightweight automatic autotransfusion system following equipment: 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 The Compact-A and process. shed or collect blood for autologuous transfusion. 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.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare.
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
K963759 Re: 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.
3
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sincerely yours,
Thomas J. Callahan
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/Ai
Page 1 of I
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 autologuous 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 The systems blood prior to, during and/or after a surgical procedure. 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)
ે જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ
Over-The-Counter Use_
(Optional Format 1-2-96)
lege R. Camperele
SION SION-510(k) Numb