The Dideco electa is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

Device Description

The Dideco electa consists of hardware and disposables. It is the next generation of the Dideco autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and a user interface (display panel and keyboard). The modifications to the disposables are the addition of a bar code to the addition of a tubing cassette to simplify disposables installation.

AI/ML Overview

The provided submission for the Dideco electa autotransfusion device is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics through detailed studies against acceptance criteria. Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a multi-reader multi-case (MRMC) study.

The submission primarily relies on a side-by-side comparison of features and intended uses to establish equivalence.

Here's a breakdown of what the document does state in relation to your request, and where it falls short:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of quantitative acceptance criteria for the electa's performance (e.g., specific hematocrit recovery rates, wash efficiency, or red blood cell viability). Instead, it provides a "Side-by-Side Comparison of the electa and Predicate Devices" (Table I-1 in section 6 and continued in section 7). This table compares various characteristics such as:

Intended Use: Identical to predicate devices (Pre-operative Sequestration, Intraoperative/Postoperative recovery, PPP, PRP, etc.)
Typical Clinical Applications: Mostly identical, with some predicates "not specified" for certain surgical specialties where the electa is indicated.
Operating Modes: All devices (electa and predicates) have Automatic, Semi-automatic, and Manual modes, and are pre-programmed and reprogrammable.
Processing Phases: All devices perform Prime (Fill), Wash, Empty, Return, and Concentrate.
Disposables: electa uses 55, 125, 175, and 225 mL bowl sizes, similar to Dideco ABMS, but different from COBE BRAT II (135, 250 mL). All are sterile, single-use, and disposable.
Features: The electa has additional features compared to its direct predicate (Dideco ABMS) and some features not present in COBE BRAT II (e.g., Cardiotomy weighing system, Hematocrit sensor, Free hemoglobin sensor, Pressure occlusion sensor, Blood loss sensor, Bar code reader, Level sensor, Smart card, Continuous operation capability). It also shares features like Air bubble sensor, Buffy coat sensor, and Vacuum pump with some predicates.
Operating Parameters:
- Centrifuge speeds (RPM): electa (1500-5600) is identical to Dideco ABMS, and wider than COBE BRAT II (4400).
- Pump speeds (mL/min): electa (25-1000) is identical to Dideco ABMS, and within the range of COBE BRAT II (25-1300).
- Blood source for PPP/PRP: All devices can use Patient or bag.
- PPP collection parameters: Similar to Dideco ABMS and COBE BRAT II (50 mL/min, 5600 RPM or 4400 RPM for COBE).
- PRP collection parameters: Similar to Dideco ABMS and COBE BRAT II (50 mL/min, 2400 RPM or 4400 RPM for COBE).
- Vacuum level: electa (0 to 300 mmHg) is comparable to COBE BRAT II (50-300 mmHg).

The document states, "Dideco S.p.A. believes that the electa is substantially equivalent to the Dideco ABMS, COBE Brat II, and other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness."

2. Sample size used for the test set and the data provenance:

The document mentions "performance testing that demonstrate compliance with performance specifications" (Section 7). However, it does not provide any specific sample sizes for this testing, nor does it detail the nature of the "test set" (e.g., patient samples, simulated blood, etc.).
There is no information on data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. As performance data itself is not presented in detail, the method of establishing ground truth for such data (if any was used for comparison) is absent.

4. Adjudication method for the test set:

This information is not provided in the document.

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 is an autotransfusion device, not an AI diagnostic imaging or analysis tool. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are not applicable to this type of device and are not mentioned in the submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

As above, this is an autotransfusion device, not an AI algorithm. The concept of "standalone algorithm performance" is not applicable and not mentioned. The device's performance would be evaluated in the context of its function in processing blood, typically by comparing output parameters (like hematocrit) to established standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not specify the type of ground truth used for any performance testing. For an autotransfusion device, ground truth would typically refer to gold standard measurements of blood components (e.g., laboratory analysis of hematocrit, red blood cell count, hemolysis) of the processed blood, and possibly clinical outcomes related to re-infusion. This level of detail is absent.

8. The sample size for the training set:

As this is not an AI/ML device, the concept of a "training set" in that context is not applicable. The device's operation is based on established engineering principles and pre-programmed parameters, not a learned model from a training set.

9. How the ground truth for the training set was established:

Again, not applicable as it's not an AI/ML device with a training set.

In summary:

The provided 510(k) summary for the Dideco electa focuses on demonstrating substantial equivalence to predicate devices based on design characteristics and intended use, rather than presenting detailed performance study results against specific acceptance criteria. Consequently, most of the specific questions about study design, sample sizes, ground truth, and expert involvement for a performance study are not addressed in this document. The "testing" section (Section 7) is very brief, stating only that electrical testing, electromagnetic compatibility testing, and performance testing were supplied to demonstrate compliance with performance specifications, without providing specifics of those tests or their results.

Summary

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K020647

510(k) Summary Dideco S.p.A. electa (per 21 CFR 807.92)

1. SPONSOR/APPLICANT

Contact:	Mr. Luigi Vecchi
Dideco, S.p.A.
via Statale 12 Nord, 86
I-41037 Mirandola (MO)
Italy
Telephone:	011 39 535 298 11
Facsimile:	011 39 535 252 29

2. DEVICE NAME

Proprietary Name:	electa
Common/Usual Name:	Autotransfusion Device
Classification Names:	Autotransfusion Apparatus

3. PREDICATE DEVICES

Cobe Brat II K991986 �

4. INTENDED USE

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5. DEVICE DESCRIPTION

BASIS FOR DETERMINATION OF EQUIVALENCE 6.

Dideco makes the claim of substantial equivalence to cited predicates based on intended use, Indications for Use, technological characteristics, and operational characteristics. A side-by-side comparison of the Dideco electa with cited predicates is provided in Table I-1 below.

Characteristic	electa	Dideco ABMSK982650	COBE BRAT IIwith CRIT-LINEK991986
Intended Use
Pre-operative Sequestration	Yes	Yes	Yes
Intraoperative recovery of shed blood	Yes	Yes	Yes
Postoperative collection of shed blood	Yes	Yes	Yes
PPP	Yes	Yes	Yes
PRP	Yes	Yes	Yes
Bag processing for PRP	Yes	Yes	Yes
Direct Draw processing for PRP	Yes	Yes	Yes
Typical Clinical Applications
Cardiovascular Surgery	Yes	Yes	Yes
Orthopedic Surgery	Yes	Yes	Not specified
Thoracic Surgery	Yes	Yes	Not specified
Transplant Surgery	Yes	Yes	Not specified
Emergency (Trauma)	Yes	Yes	Yes
Neurosurgery	Yes	Yes	Not specified
Obstetrics and Gynecologic Surgery	Yes	Yes	Not specified
Urologic Surgery	Yes	Yes	Not specified


		Dideco ABMS	COBE BRAT IIwith CRIT-LINE
Characteristic	electa	K982650	K991986
Operating Modes
Automatic	Yes	Yes	Yes
Semi-automatic	Yes	Yes	Yes
Manual	Yes	Yes	Yes
Pre-programmed and reprogrammable	Yes	Yes	Yes
Processing Phases
Prime (Fill)	Yes	Yes	Yes
Wash	Yes	Yes	Yes
Empty	Yes	Yes	Yes
Return	Yes	Yes	Yes
Concentrate	Yes	Yes	Yes
Disposables
Bowl sizes	55, 125, 175,and 225	55, 125, 175, and225	135, 250
Sterile, single use, and disposable	X	X	X
Features
Cardiotomy weighing system	Yes	No	No
Hematocrit sensor	Yes	No	Yes
Air bubble sensor	Yes	Yes	Yes
Free hemoglobin sensor	Yes	No	No
Pressure occlusion sensor	Yes	No	No
Blood loss sensor	Yes	No	No
Buffy coat sensor	Yes	Yes	Yes
Bar code reader	Yes	No	No
Level sensor	Yes	No	No
Vacuum pump	Yes	No	Yes
Smart card	Yes	No	RS232 Option
Printer	Yes	No	Yes
Continuous operation capability	Yes	No	Up to three cycles
Better quality wash option	Yes	Yes	No
Emergency wash option	Yes	Yes	No
Characteristic	electa	Dideco ABMSK982650	COBE BRAT IIwith CRIT-LINEK991986
Operating Parameters
Centrifuge speeds (RPM)	1500-5600	1500-5600	4400
Pump speeds (mL/min)	25-1000	25-1000	25-1300
Blood source for PPP/PRP	Patient or bag	Patient or bag	Patient or bag
PPP collection parameters	50 mL/min5600 RPM	50 mL/min5600 RPM	50 mL4400 RPM
PRP collection parameters	50 mL/min2400 RPM	50 mL/min2400 RPM	50 mL4400 RPM
Vacuum level	0 to 300mmHg	NA	50 – 300 mmHg

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Table I-1. Side-by-Side Comparison of the electa and Predicate Devices (Continued)

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Table I-1. Side-by-Side Comparison of the electa and Predicate Devices (Continued)

Dideco S.p.A. believes that the electa is substantially equivalent to the Dideco ABMS, COBE Brat II, and other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness.

7. TESTING

Testing supplied in the 510(k) premarket notification for the Dideco electa includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three parallel lines that curve and merge to form a shape suggestive of a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Dideco S.p.A. electa Ms. Rosina Robinson c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K020647

Dideco electa Regulation Number: 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: June 24, 2002 Received: June 25, 2002

Dear Ms. Robinson:

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 - Ms. Rosina Robinson

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 vour device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

ickerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Dideco electa

Indications for Use:

The Dideco electais indicated for intraoperative recovery of blood, washing of blood collected in the post-operative period, and pre-operative sequestration ( with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:

Cardiovascular
Orthopedics
Thoracic
Transplant Surgery
Emergency (Trauma)
Neurosurgery
Obstetrics and gynecology
Urology

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Carliovascular & Respiratory Devices
510(k) Number K020647

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __

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).