The Giotto Monza is intended as an automated blood component separator used for blood components separation and preparation.
Device Story
Giotto Monza is an automated blood component separator used in blood banks to replace manual extraction processes. It accepts centrifuged whole blood bags as input. The device utilizes a microprocessor-controlled motorized main press to squeeze the blood bag, while a network of clamps with integrated sealing heads controls flow into satellite bags. Four integrated scales weigh components, and an optical sensor array (10 LED sensors) detects component positions to guide the separation process. The device is operated by blood bank personnel via a touch-screen interface. It automates the extraction and transfer of blood components, ensuring accurate recovery yields and purity. The system stores separation results and programs, with data transmission capabilities via Ethernet or USB. By automating the separation, the device improves consistency and efficiency in blood component preparation compared to manual methods.
Clinical Evidence
Bench testing only. A comparative study (GIOMZ_FITPR_Rev.1.2) evaluated blood component recovery yield and purity between the Giotto Monza and the predicate device. Results confirmed equivalence within a 10% admitted deviation for mean values. No device malfunctions, alarms, or operational issues were reported during testing. Safety testing confirmed compliance with IEC 60601-1 and IEC 60601-1-2 standards.
Technological Characteristics
Microprocessor-controlled automated separator. Materials: Polyurethane shells, steel/aluminum mechanical frame and press plates. Sensing: 10-LED optical sensor array, 4 integrated scales (accuracy ±3g for 0-300g). Actuation: Stepper motor-driven main and lateral presses. Connectivity: Ethernet, USB 2.0, optional RFID. Power: 100-240 VAC, 50-60 Hz. Interface: 4.3-inch color graphic LCD touch screen. Sterilization: Not specified. Software: Microprocessor-based control of clamps, sensors, and motors.
Indications for Use
Indicated for automated separation and preparation of blood components from centrifuged whole blood.
Regulatory Classification
Identification
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
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# 510(k) Giotto Monza
## 510(k) Summary
The purpose of this 510(k)-summary document is to provide an understanding of the basis for a determination of substantial equivalence according to 21 CFR 807.92 content and format prescriptions.
| **Contact Details** | |
| --- | --- |
| Applicant Name | Delcon S.r.l. |
| Applicant Address | via Zanica 19 F/I 24050 Grassobbio (BG) Italy |
| Applicant Contact Name | Fabio Belletti |
| Applicant Contact Telephone | Mobile (b) (6); Office +39 035 4522336 |
| Applicant Contact E-mail | fabio.belletti@delcon.it; regulatory@delcon.it |
| **Device Name** | |
| --- | --- |
| Application Number | BK 231039 |
| Device Trade Name | Giotto Monza |
| Common Name | Blood Component Separator |
| Classification Name | Supplies, Blood Bank |
| Regulation Number | 864.9050 |
| Product Code(s) | KSS |
| **Legally Marketed Predicate Device** | |
| --- | --- |
| 510(k) Number | BK 180306 |
| Device Trade Name | Macopress Smart Smarter |
| Common Name | Blood Component Separator |
| Classification Name | Supplies, Blood Bank |
| Regulation Number | 864.9050 |
| Product Code(s) | KSS |
### Device Description Summary
The Giotto Monza is an automated blood component separator. The device is designed to replace the manual press, traditionally used to extract blood components from centrifuged whole blood, with a motorized press and clamps controlled by a microprocessor. Giotto Monza automatically and accurately extracts and transfers blood components from the main bag to the satellite bags by means of the controlled movement of its press (main press), used to squeeze the bag of centrifuged whole blood, a network of clamps fitted with sealing heads, used to control the flow
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# 510(k) Giotto Monza
in the satellite bags, four scales, used to weight the blood components, and a series of optical sensors, used to detect the components position.
### Device Intended Use
The Giotto Monza is intended as an automated blood component separator used for blood components separation and preparation.
The Giotto Monza device has the same indication for use of the Macopress Smart Smarter predicate device. They share the same system architecture and technology and are based on the same operation principles in order to squeeze the centrifuged whole blood bag and extract in an automated way the blood component in satellite bags.
### Subject and Predicate Device Technological Comparison
The Giotto Monza device is derived from the Macopress Smart Smarter device and consequently it shares with the predicate device the indication for use, the technology, the system architecture, the principle of operation and the functional diagram.
Here is a summary of the technology main items comparison between subject and predicate device (extract from the Substantial Equivalence discussion file attached to eSTAR file):
| Model | MacoPress Smart Smarter Predicate Device | Giotto Monza Subject Device |
| --- | --- | --- |
| **Principle of Operation** | Processor based electronic device with motorized press for automated blood cells separation | Same |
| **Device architecture** | Based on a control board managing touch screen (user interface) and communication and a cpu board controlling press, clamps, sensors and separation process | Same |
| **Electronics** | Microprocessor based electronic boards, power supply, sensors motors and cables | Same |
| **Power Source** | Mains powered | Same |
| **Power Supply** | 100 - 240 VAV, 50 – 60 Hz | Same |
| **Battery** | No | Same |
| **Control panel (display & keyboard)** | 4.3' color graphic LCD with touch screen | Same |
| **Front press** | Moved by processor controlled electronic stepper motor | Same |
| **Front press door** | Aluminum door white painted | Aluminum door nickel color painted (2) |
| **Front press sensor** | Optical. 12 x LED sensors | Optical. 10 x LED sensors (1) |
| **Lateral plasma press for air removal** | Moved by processor controlled electronic stepper motor | Same |
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# **510(k) Giotto Monza**
**510(k) Summary**
| *Model* | *MacoPress Smart Smarter Predicate Device* | *Giotto Monza Subject Device* |
| --- | --- | --- |
| **Bag fixation on lateral press** | 1x fork holder | 2x suspension pins (3) |
| **Tube clamps** | 5x tube clamps | Same |
| **Tube detection** | Correct tube positioning optical sensors in all clamps | Same |
| **Tube position indicator** | Red/green LED in all clamps | Same |
| **Body shells** | Polyurethane. White cover and front panel, BLUE lateral panels | Polyurethane. White cover and front panel, RED lateral panels (2) |
| **Mechanical structure and other parts** | Mechanical parts are steel or aluminum made including frame, press plates, press door, movement parts. | Same |
| **Integrated scales** | 4 x scales | Same |
| **Scales weighting accuracy** | 0÷300 g accuracy ± 3 g (0÷0,66 lbs accuracy ± 0,007 lbs) 351g- full scale ≤ ±1% (0,77 lbs full scale ≤ ± 1%) | Same |
| **Separation process time T&T** | 45' to 2'30' average extraction duration | Same |
| **Sealing tube at the end of separation** | 5 x clamps with RF sealing function | Same |
| **User Interface** | Colored touch icons on white background style | White touch icons with colored marks on black background style (2) |
| **Blood Bags Suitability** | All blood bags | Same |
| **USB Ports** | 1 USB port (USB2.0) available to user | Same |
| **LAN Modem** | Integrated Ethernet modem, up to 256 devices | Same |
| **Wireless Modem** | Predisposed to external USB Wi-Fi adapter | Same |
| **Data Storage** | Up to 100 programs and more than 1000 separation results | Same |
| **Transmission of Data** | Stored data transmitted to external software if connected | Same |
| **Service Life** | 10 years | Same |
| **Dimensions** | 325W x 422D x 420H mm (12,8W x 16,6D x 16,5H inches) | Same |
| **Weight** | 38 Kg without packaging | Same |
| **Standards Compliance** | Safety: IEC 60601-1 EMC: IEC 60601-1-2 IEC 61010 | Same |
| **RFID read/write** | Integrated as optional | Same |
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# 510(k) Giotto Monza
510(k) Summary
The relevant changes implemented in Giotto Monza respect the Macopress Smarter predicate device are limited to:
1) The front press optical sensor is featuring 10 levels (LEDs) instead of 12, with the same separation accuracy and reliability in components separation (same optical diodes, electronics and control algorithm) and a subset of the programming options. Widely discussed through additional testing and information requested.
2) Aesthetic differences in user experience style (black background for Giotto Monza) and in some external parts: plastic shell color, metallic parts color.
3) The fixation of plasma bag on lateral has a different shape: 2 pins for Giotto Monza vs fork holder for Macopress. Minor detail: different solutions for the same purpose and effectiveness.
# Non-Clinical Tests Summary and Conclusions
Two documents have been provided, through an amendment to the eSTAR submission file, to support the determination of the substantial equivalence:
1) The analysis of the substantial equivalence of OPT2 optical sensors, following an additional data request included in a Technical Screening Hold letter.
2) The report of a study finalized to determine if the blood component separators, Giotto Monza and MacoPress Smarter, are substantially equivalent in terms of blood components processing (GIOMZ_FITPR_Rev.1.2). This following an Additional Information Requested letter.
The technical analysis evidenced the accuracy equivalence between the two OPT2 optical sensors, in addition to the consideration that the predicated and subject devices are based on the same hardware and software architecture.
Regarding the primary end point of the study, the difference calculated among the mean values obtained on the two devices regarding the blood components recovery yield and purity has been successfully verified within the 10% admitted deviation. Therefore, no adverse events, such as discomfort or inconvenient hypotension or any reaction, and no device malfunctions, alarms, or operational issues have been evidenced during and after the procedure.
All the necessary safety tests were performed and documented. The results demonstrate that the subject device complies with applicable international standards and it is safe as the predicate devices. All the necessary performance tests in support of substantial equivalence determination were conducted. The tests demonstrate that the subject device is effective and performs as well as the predicate devices. The minor differences between the devices do not raise any new issues of safety or efficacy.
# Conclusion
The submitted and the predicate device have the same indications for use and technological characteristics. The test results and comparison results show that the proposed device is substantially equivalent to the predicate devices in performance. Consequently, the proposed Giotto Monza device is considered to be substantially equivalent to the predicate device.
Date: March 12, 2025
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