The ABMS 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 ABMS consists of hardware and disposables. It is an enhancement of the parent device, the Dideco Compact-A. It integrates the automated autotransfusion protocols of the STAT-P as well as adding automated sequestration protocols. The main elements of the hardware include the centrifuge, blood pump, three automatic clamps, control sensors, and a user interface (control panel). The modifications to the disposables are an increase in the thickness of the base of the bowl and a change in labeling to the new product codes.

AI/ML Overview

This document describes the Dideco Autologous Blood Management System (ABMS) and its substantial equivalence to predicate devices, supported by a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison of the ABMS's automated sequestration results to those previously submitted for the manual sequestration process. The goal was to demonstrate similar performance with improved consistency.

Characteristic	Acceptance Criteria (Implied: similar to Manual Process with improved consistency)	ABMS Performance (Automated Mode)	Manual Process Performance
PRP Platelet Yield (1011) Mean	Similar to 0.75	0.79	0.75
PRP Platelet Yield (1011) SD	Lower than 0.32 (improved consistency)	0.29	0.32
PRP Platelet Collection Efficiency (%) Mean	Similar to 69.4	69.2	69.4
PRP Platelet Collection Efficiency (%) SD	Lower than 20.3 (improved consistency)	17.6	20.3

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

The document does not explicitly state the sample size used for the clinical study comparing automated and manual sequestration, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions "a clinical study was conducted."

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.

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 not a multi-reader, multi-case comparative effectiveness study. It's a device performance study comparing automated processing with manual processing for autotransfusion. There is no mention of human readers or AI assistance in this context.

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

The study described is a standalone performance study of the ABMS in its automated sequestration mode, comparing its output to a manual process. The "algorithm only" aspect applies to the automated functions of the ABMS itself, as it performs the sequestration process autonomously after initiation.

7. The Type of Ground Truth Used

The ground truth implicitly used is the measured performance characteristics of the Platelet Rich Plasma (PRP) from both the automated ABMS process and the manual sequestration process. These characteristics include PRP Platelet Yield and PRP Platelet Collection Efficiency. The manual process results served as the reference for comparison.

8. The Sample Size for the Training Set

This information is not provided in the document. The ABMS is an enhancement of a parent device and integrates automated protocols; it's not a machine learning or AI algorithm in the contemporary sense that would typically involve a separate "training set."

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

This information is not provided. As noted above, the concept of a "training set" in the context of modern machine learning algorithms doesn't directly apply here. The device's protocols were likely developed through engineering design, experimentation, and optimization, rather than by training a model on a labeled dataset. The reference to "automated autotransfusion protocols of the STAT-P" suggests that existing successful protocols were integrated and enhanced.

Summary

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DEC 16 1988

K982650

,在 ্ত

్లి ప్రజలు

APPENDIX H

2017-02-04 11:12:13

・・・

510(k) Summary

Dideco S.p.A. Abbreviated 510(k) 7/29/98 Autologous Blood Management System (ABMS)

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510(k) Summary Dideco S.p.A. Autologous Blood Management System (per 21 CFR 807.92)

SPONSOR/APPLICANT 1.

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

DEVICE NAME 2.

Proprietary Name:	Autologous Blood Management System (ABMS)
Common/Usual Name:	Autotransfusion Device
Classification Names:	Autotransfusion Apparatus

PREDICATE DEVICES 3.

• STAT-P	K884564
• Compact	K910991 (under the name Shiley Therapeutic Autotransfusion System)
• Compact-A	K940519
	K963758
	K963759
• AT-1000	K Number could not be identified

4. INTENDED USE

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DEVICE DESCRIPTION 5.

BASIS FOR DETERMINATION OF EQUIVALENCE 6.

Dideco S.p.A. makes the claim of substantial equivalence based on the intended use, indications for use, design, operational and technological characteristics, materials of construction, and principles of operation.

Bench and electrical (safety and EMI/EMC) testing presented in this 510(k) demonstrates that the ABMS is substantially equivalent to the Compact-A in these areas. In addition, a clinical study was conducted to compare the results obtained using automated sequestration (ABMS) with those previously submitted to FDA for the manual sequestration process. As shown in Table H-1 below, results for the PRP collected with the ABMS in the automatic mode were similar to those using the manual mode. The lower standard deviations for the ABMS results demonstrate more consistency and overall reproducibility in product collection than that observed with the manual sequestration process.

Characteristic	ABMS	ManualProcess
PRP Platelet Yield (1011)	Mean	0.79	0.75
	SD	0.29	0.32
PRP Platelet Collection Efficiency(%)	Mean	69.2	69.4
	SD	17.6	20.3

	Table H-1. Sequestration Results
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A side by side comparison of the characteristics of the ABMS with cited predicate devices is provided in Table H-2.

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Characteristic	ABMS	STAT-P	COMPACT	COMPACT-A	AT-1000
Separation bycentrifugation	YES	YES	YES	YES	YES
Separation chamber: bowl	YES	YES	YES	YES	YES
Available bowl sizes (ml)	55, 125,175, 225	55, 125,175, 225	55, 125,175, 225	55, 125,175, 225	125, 225, 375
Blood source for PPP/PRP	bag orpatient	NA	bag orpatient	bag orpatient	bag orpatient
Fully and semi-automaticprocessing	YES	YES	NO	YES	YES
Air detector	YES	YES	YES	YES	YES
Buffy coat detector	YES	YES	YES	YES	YES
Pre-programmable	YES	YES	NO	YES	YES
Reprogrammable	YES	YES	NO	YES	YES
Tools required for bowlinstallation	NO	YES	NO	NO	YES
Integral vacuum unit	NO	YES	NO	NO	YES
Dimensions (inches)	17 x 22 x18	34 x 20 x31	17 x 22 x18	17 x 22 x 18	17 x 31 x 48
Weight (approx. in lbs.)	73	262	73	73	265
Identical tubing diameter	YES	YES	YES	YES	YES
Blood pump speed(range in ml/min)	25-1000	25-1000	25-1000	25-1000	0-1000
Centrifuge speed (range inRPM)	1500-5600	1500-4800	1500-5600	1500-5600	2400-5600
PPP collection parameters	50 ml/min5600 RPM	NA	50 ml/min5600 RPM	50 ml/min5600 RPM	50-100 ml/min5600 RPM
PRP collection parameters	50 ml/min2400 RPM	NA	50 ml/min2400 RPM	50 ml/min2400 RPM	50-100 ml/min2400 RPM
Operating Phases
PRIME mode	YES	YES	YES	YES	YES
WASH mode	YES	YES	YES	YES	YES
EMPTY mode	YES	YES	YES	YES	YES
RETURN mode	YES	YES	YES	YES	YES
CONCentrate mode	YES	YES	YES	YES	YES
CONTinuous operation	YES	YES	YES	YES	YES
BQW (Better QualityWash feature)	YES	NO	YES	YES	YES (PulseWash Mode)

Table H-2. Comparison of the ABMS with Predicate Devices

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.

DEC 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dideco, S.P.A. c/o Ms.Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

K982650 Re : Dideco Autologous Blood Management System (ABMS) Requlatory Class: II (Two) Product Code: CAC November 11, 1998 Dated: November 12, 1998 Received:

Dear Ms. Robinson:

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 leqally 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 Requlations, 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 Requlation (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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Rosina Robinson

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 requlation (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 Other general information on your responsibilities under 807.97) . . 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/dsma/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

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K 98,265 510(k) Number (if known):

Device Name: Dideco Autologous Blood Management System (ABMS)

Indications For Use:

The ABMS is 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)

Sue L. Cooper

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 98267 510(k) Number _

Prescription Use Use Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Dideco S.p.A. Abbreviated 510(k) 7/29/98 Autologous Blood Management System (ABMS)

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).