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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Dideco Compact-A and Compact-M Autotransfusion Systems:

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Electromedics AT-1000), rather than establishing new performance criteria through extensive clinical trials. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, expert involvement, and ground truth for an AI-like device is not present in this document because it is not typically required or relevant for a substantial equivalence claim for this type of medical device.

Key takeaway: This is a traditional medical device submission, not an AI/ML device submission. The study described is for substantial equivalence to a predicate device, not for establishing new performance metrics against a defined acceptance criterion for a novel algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (substantial equivalence to a predicate device), explicit, quantifiable "acceptance criteria" and direct "reported device performance" against those criteria are not presented in a table format as one might find for a novel device or AI/ML algorithm. Instead, the submission states that substantial equivalence was based on a comparison of test results from in-vivo functional tests between the Dideco systems and the predicate Electromedics AT-1000.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (as stated in the submission)
Comparable plasma free Hgb levels	Comparable to Electromedics AT-1000
Comparable ADP/Collagen levels	Comparable to Electromedics AT-1000
Comparable pH testing results	Comparable to Electromedics AT-1000
Comparable cell counting	Comparable to Electromedics AT-1000
Comparable platelet counting	Comparable to Electromedics AT-1000
Comparable process steps, method of operation, materials, and suggested flow rates	Identical to Electromedics AT-1000

The overall "acceptance criteria" is that the Dideco systems are functionally equivalent to the Electromedics AT-1000, as demonstrated by the comparable in-vivo test results and similar technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document states "Summary of In-Vivo Tests" but does not specify the sample size used for these tests. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that these are in-vivo functional tests for a physical medical device, it is highly likely that they are prospective tests performed on biological samples (likely human or animal blood).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For a substantial equivalence claim of this type of medical device, the ground truth is typically established by laboratory measurements or clinical observations, not necessarily by expert consensus in the way it applies to image interpretation or AI diagnostics. The "ground truth" would be the actual measured values of Hgb, ADP/Collagen, pH, cell counts, and platelet counts, derived from standard analytical methods.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This concept (e.g., 2+1, 3+1) is typically relevant for studies where subjective expert review is required to establish ground truth for a diagnostic output, particularly in AI/ML performance evaluations. For functional comparisons of physical devices like autotransfusion systems, adjudication in this sense is usually not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study framework is specific to evaluating diagnostic technologies, especially in fields like radiology where multiple human readers interpret cases and their performance is compared with and without AI assistance. The Dideco Compact-A and Compact-M Autotransfusion Systems are physical devices for processing blood, not diagnostic AI algorithms. Therefore, the concept of human readers improving with AI assistance does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the Dideco systems are physical autotransfusion devices, not an AI algorithm. The performance described relates to the machine's ability to process blood and separate components, which is inherently a "standalone" machine process when considering its direct function. However, it's not an "algorithm only" performance claim in the context of AI.

7. The Type of Ground Truth Used

The ground truth used for the in-vivo functional tests (plasma free Hgb, ADP/Collagen, pH, cell and platelet counting) would be based on laboratory analytical measurements against established standards for those biological parameters. These are objective, quantifiable measurements.

8. The Sample Size for the Training Set

The document does not mention a training set. This concept (training set, validation set, test set) is fundamental to machine learning and AI development. Since this submission is for a traditional medical device demonstrating substantial equivalence, there is no AI algorithm being "trained."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set mentioned or implied in the submission.

Summary

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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.

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G. Device Description

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.

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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.

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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 (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

Regulation Number and Section

§ 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).