The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

Device Description

The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.

AI/ML Overview

The provided text describes the Anivia SG1000 Pump Console, a device intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures (up to 6 hours). The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Medtronic Bio-console® 560 Extracorporeal Blood Pumping Console, K131964).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Anivia SG1000 Pump Console. Instead, it broadly states that "All testing met predetermined acceptance criteria." The performance characteristics are described in comparison to the predicate and reference devices in the "Technological Characteristics" table, implying that the acceptance criteria for these characteristics are met by being "Same as predicate" or by having differences that "do not raise different questions of safety and effectiveness."

Here's a breakdown of the performance characteristics provided, and where the device's performance aligns with or is considered equivalent to the predicate:

Acceptance Criteria (Implied from Predicate/Reference)	Reported Device Performance (Anivia SG1000 Pump Console)
Indications for Use: Pump blood through extracorporeal bypass circuit for up to 6 hours.	Met: Intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours). (Same as predicate)
Duration of Use: Up to 6 hours.	Met: Up to 6 hours (limited by disposables, not limited by Console electro-mechanical modules). (Same as predicate)
Intended Use: Pump Speed Control, CPB Machine Console.	Met: Pump Speed Control, CPB Machine Console (not including sterile, blood-contacting accessories). (Same as predicate)
Intended Users: Cardiopulmonary physicians, perfusionists, trained physician assistants.	Met: Cardiopulmonary physicians, perfusionists, trained physician assistants. (Same as predicate)
Intended Use Environment: Cardiopulmonary procedure rooms, intensive care units.	Met: Cardiopulmonary procedure rooms, intensive care units. (Same as predicate)
Intended Patients: As prescribed by cardiopulmonary specialists.	Met: As prescribed by cardiopulmonary specialists. (Same as predicate)
Compatible Disposable Centrifugal Pump Heads: Medtronic BPX-80, BP-50, RotaFlow® RF-32.	Met: Medtronic BPX-80, BP-50 centrifugal pump heads (w/ Pump Driver Module SG1000-PDM-001); RotaFlow® RF-32 centrifugal pump heads (w/ Pump Driver Module SG1000-PDM-002). (Matches/expands on predicate and reference)
Centrifugal Pump Driver: Non-contact, magnetically coupled.	Met: Non-contact, magnetically coupled. (Same as predicate)
Control Function: Speed Control.	Met: Speed Control, Flow Control (Stability), Mechanical Knob and Touch Display. (Similar to predicate's speed control, adds flow control and touch display, considered not to raise new safety/effectiveness questions).
Pump Speed (RPM): 0 – 4500 (predicate), 0 – 5000 (reference).	Met: 0 – 4500 for CS-0210-ASY-00002 (Medtronic BPX-80 compatible); 0 – 5000 for CS-0210-ASY-00010 (Maquet Rotaflow RF-32 compatible). (Matches/exceeds predicate)
Visual and Auditory Alarms on Abnormal Conditions: Yes, preset limits for Speed, Flow Rate, Back Flow, Bubble, Pressure, Temperature.	Met: Yes, preset limits: Speed, Flow Rate, Back Flow, Bubble, Pressure, Temperature. (Same as predicate)
Blood Flow Rate (L/min): Up to 0 – 9.9 L/min.	Met: Dependent on external circuit, up to 0 – 9.9 L/min. (Same as predicate)
Interface to Blood Flow Sensor: Yes (Qty 1).	Met: Yes (Qty 1). (Same as predicate)
Air Bubble Detector: Yes (Qty 1), integrated with Blood Flow Sensor.	Met: Yes (Qty 1), integrated with Blood Flow Sensor. (Integrated with BFS, which is implicitly similar to predicate's separate detector for safety/effectiveness)
Blood Flow and Bubble Detector Sensor Technology: Non-contact, various methods.	Met: Non-contact, ultrasound Clamp-On around blood tube. (Different technology than predicate's electrical conductivity, but implicitly determined not to raise new safety/effectiveness questions, aligning with reference device technology).
Pressure Sensors: Yes (Qty 2, external), previously 510(k)-cleared.	Met: Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties. (Same as predicate)
Temperature Sensors: Yes (Qty 2, external), previously 510(k)-cleared.	Met: Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties. (Same as predicate)
Power Input: Universal 90-264 VAC/50-60 Hz, 2.5A / 1.3A, up to 250 W.	Met: Universal 90-264 VAC/50-60 Hz, 2.5A / 1.3A, up to 250 W. (Stated as "Same as predicate – single universal power supply, instead of different models, no effect on safety and effectiveness.")
Backup Battery: Lead acid (predicate), NiCad (reference).	Met: LiFePO4. (Improvement in technology stated to "not raise question on safety and effectiveness.")
Backup Battery Capacity: 24 VDC (predicate), 24 VDC, 5 AH, 120 WH (reference).	Met: 25.6 VDC, 12 AH, 307 WH, minimum 1 hour, up to 3 hours depending on speed and flow. (Stated as "Same as predicate" in terms of function, despite numerical differences, indicating functional equivalence for backup power duration).
Backup Pump: Hand-crank.	Met: Yes, backup electrical Pump Driver Module on standby, and hand-crank. (Improvement over predicate by adding an electrical backup, stated as "Same as predicate" for safety/effectiveness).
Pump Motor Technology: Brushless DC motor.	Met: Brushless DC motor. (Same as predicate)
Display Screen Size: 26 cm (10.4") (predicate).	Met: 31 cm (12.1"). (Difference stated to have "no impact on safety and effectiveness.")
Dimensions/Weight: Varied.	Met: Dimensional and weight differences in Display & Control Module (smaller/lighter than predicate) are stated to have "no impact on safety and effectiveness" due to newer technology.
Non-Clinical Tests: Software verification, functional design, electrical safety, EMI/EMC, interoperability, reliability, simulated use, cleaning validation, packaging, shipping.	Met: All listed tests were conducted and "All testing met predetermined acceptance criteria." Compliance with numerous consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, IEC 62366, UL 2054, etc.) was also achieved.

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance, as this device does not involve AI or machine learning that would typically use such a test set. The non-clinical tests involved "system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing." The sample size for these engineering and performance tests is not quantified (e.g., number of devices tested, number of test runs).

Data provenance is not applicable since no clinical data or patient data was used to assess the device's performance in this 510(k) submission. All tests mentioned are non-clinical, benchtop, or simulated use.

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

Not applicable. This device does not involve a "ground truth" derived from expert review or clinical annotations for an algorithm. The evaluation relies on engineering tests and compliance with recognized standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there is no "test set" in the context of human-reviewed data where adjudication would be necessary.

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

Not applicable. This device is a cardiopulmonary bypass pump console, not an AI/ML-driven diagnostic or interpretative tool that would involve human readers or an MRMC study.

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

Not applicable. This device is electro-mechanical hardware with software controls, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of medical device (a pump console), "ground truth" is established through engineering specifications, validated test methods (e.g., measuring pump speed, flow rate, alarm accuracy), and compliance with international consensus standards. There is no biological or imaging "ground truth" involved.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The software embedded in the device undergoes traditional software verification and validation.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 3, 2023

APMTD, Inc. John Sasso Director Of Projects and Programs 226 Lowell Street, Unit B16 Wilmington, Massachusetts 01887

Re: K221491

Trade/Device Name: Anivia SG1000 Pump Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA Dated: January 3, 2023 Received: January 5, 2023

Dear John Sasso:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221491

Device Name Anivia SG1000 Pump Console

Indications for Use (Describe)

The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

Contraindications:

The Anivia SG1000 Pump Console is contraindicated as a cardiotomy suction device.

It is the responsibility of the physician to determine whether any physical impairment of the patient or associated equipment would contraindicate the use of this device.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based

1. 510(k) Owner's Information

510(k) Owner's Name:	APMTD Inc.
Address:	226 Lowell Street, Unit B16Wilmington, MA 01887USA
Telephone:	1-949-623-8403
Contact Information:	John SassoDirector of Projects and ProgramsTelephone: 781-962-6274Email: jsasso@apmtd.us
Date Prepared:	December 23, 2022
Device Name
Trade Name:	Anivia SG1000 Pump Console
Common Name:	Pump Console, Cardiopulmonary Bypass, Heart-Lung Machine
Classification:	870.4380, Class II Cardiopulmonary bypass pump speed control
Product Code:	DWA

3. Predicate Device:

A. Bio-console® 560 Extracorporeal Blood Pumping Console, K131964, Medtronic, Inc. (DWA)

4. Device Description

Modules	Catalog Reference Number	Part Number
Display & Control Module	Anivia SG1000-DCM-001	CS-0510-ASY-00001
Pump Driver Module	Anivia SG1000-PCM-001	CS-0210-ASY-00002
	Anivia SG1000-PCM-002	CS-0210-ASY-00010
Flow Bubble Sensor Module	Anivia SG1000-FBS-001	CS-0410-ASY-00001

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Image /page/4/Picture/0 description: The image shows the logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left and the text "APMTD Asia Pacific Medical Technology Development" on the right. The graphic is a teal-colored circle with a white design inside. The text is also teal, with "APMTD" in a larger font than "Asia Pacific Medical Technology Development."

	Anivia SG1000-FBS-002	CS-0410-ASY-00002
Backup Battery Module	Anivia SG1000-BBM-001	CS-0710-ASY-00001
Cart Module	Anivia SG1000-CRT-001	CS-0810-ASY-00001

The Anivia SG1000 Pump Console is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.

5. Indications for Use

The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

Contraindications:

The Anivia SG1000 Pump Console is contraindicated as a cardiotomy suction device.

It is the responsibility of the physician to determine whether any physical impairment of the patient or associated equipment would contraindicate the use of this device.

6. Intended Users

The Anivia SG1000 Pump Console is designed for use by licensed physicians and specialists to perform cardiopulmonary bypass procedures. Trained perfusionists, surgical nurses and physician assistants may assist in the setup of the equipment and preparation of patients.

7. Intended Patient Population and Intended Part of Body

The device is intended to be used for patients needing cardiopulmonary bypass. Suitability of the device for specific patients is determined by licensed and trained physicians and specialists.

8. Intended Use Environment

The Anivia SG1000 Pump Console is intended to be used in an operating room, a cardiac catheterization laboratory, in an intensive care unit, and placed outside a sterile field.

The device is supplied non-sterile.

9. Technological Characteristics

The intended use and technological characteristics are compared with one predicate, legally marketed device and one reference device in the table below.

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Product Nameand Model	Anivia SG1000 PumpConsole	Bio-Console® 560Extracorporeal BloodPump Console(Predicate)	Rotaflow® CentrifugalPump System(Reference Device)
Manufacturer	APMTD Inc.USA	Medtronic Inc.USA	Getinge MaquetCardiopulmonary AG,Germany
FDA 510(k)number	K221491	K131964	K991864
Indications forUse	The Anivia SG1000Pump Console isintended to pump bloodthrough theextracorporeal bypasscircuit for extracorporealsupport for periodsappropriate tocardiopulmonary bypass(up to 6 hours).	The Medtroniccentrifugal bloodpumping system isintended to pump bloodthrough theextracorporeal bypasscircuit for extracorporealsupport for periodsappropriate tocardiopulmonary bypassprocedures (up to 6hours).	The RotaFlow CentrifugalPump System is intendedfor use in anextracorporeal perfusioncircuit to pump bloodduring short durationcardiopulmonary bypassprocedures lasting sixhours or less.
FDAClassificationCodes	Class II, CFR 870.4380,DWA,Cardiopulmonarybypass pump speedcontrol	Class II, CFR 870.4380,DWACardiopulmonary bypasspump speed control	Class II, CFR 870.4360,KFMPump, Blood,Cardiopulmonary Bypass,Non-Roller Type
Duration of Use	Up to 6 hours (limitedby disposables, notlimited by Consoleelectro-mechanicalmodules)	Up to 6 hours	Up to 6 hours
Intended Use	Pump Speed Control,CPB Machine Console(not including sterile,blood-contactingaccessories)	Pump Speed Control,CPB Machine Console(not including sterile,blood-contactingaccessories)	Pump Speed Control, CPBMachine Console(bundled with sterile,blood-contactingaccessories, outside thescope of this application)
Product Nameand Model	Anivia SG1000 PumpConsole	Bio-Console® 560Extracorporeal BloodPump Console(Predicate)	Rotaflow® CentrifugalPump System(Reference Device)
Intended Users	Cardiopulmonaryphysicians,perfusionists, trainedphysician assistants	Cardiopulmonaryphysicians, perfusionists,trained physicianassistants	Cardiopulmonaryphysicians, perfusionists,trained physicianassistants
Intended UseEnvironment	Cardiopulmonaryprocedure rooms,intensive care units	Cardiopulmonaryprocedure rooms,intensive care units	Cardiopulmonaryprocedure rooms,intensive care units
IntendedPatients	As prescribed bycardiopulmonaryspecialists	As prescribed bycardiopulmonaryspecialists	As prescribed bycardiopulmonaryspecialists
CompatibleDisposableCentrifugalPump Heads	Medtronic BPX-80, BP-50 centrifugal pumpheads (w/ Pump DriverModule SG1000-PDM-001)RotaFlow® RF-32centrifugal pump heads(w/ Pump DriverModule SG1000-PDM-002)	Medtronic Bio-Pump®or Affinity® Seriescentrifugal pump heads,including BPX-80, BP-50	RotaFlow® RF-32centrifugal pump heads
CentrifugalPump Driver	Non-contact,magnetically coupled	Non-contact,magnetically coupled	Non-contact, magneticallycoupled
ControlFunction	• Speed Control• Flow Control(Stability)Mechanical Knob andTouch Display	• Speed Control• Coast Mode (low setspeed)Mechanical Knob	• Speed Control• Flow Control (Stability)• Mechanical Knob
Product Nameand Model	Anivia SG1000 PumpConsole	Bio-Console® 560Extracorporeal BloodPump Console(Predicate)	Rotaflow® CentrifugalPump System(Reference Device)
Components	• Pump Driver Module• Touch screen controland display panel• Flow Bubble Sensor• Backup BatteryModule• Mobile cart withadjustable SupportArm (optionalaccessory)• Backup Pump DriverModule• Emergency Handcrank	• Bio-Console 560 PumpSpeed Controller• Flow Transducer• Backup battery• 540T External Drive(Pump) Unit• PBS Cabinet• Adjustable SupportArm• Emergency Handcrank	• Integrated flow andbubble sensors in thedrive unit• Integrated battery back-up• Rotaflow Console• Backup battery• Adjustable Support Arm• Emergency Handcrank
Pump Speed(RPM)	0 – 4500 for CS-0210-ASY-00002 (MedtronicBPX-80 compatiblePump Driver Module)0 – 5000 for CS-0210-ASY-00010 (MaquetRotaflow RF-32compatible Pump DriverModule)	0 - 4500	0 - 5000
	Same as predicate.
Visual andAuditoryAlarms onAbnormalConditions	Yes, preset limits:Speed, Flow Rate, BackFlow, Bubble, Pressure,Temperature	Yes, preset limits:Speed, Flow Rate, BackFlow, Bubble, Pressure,Temperature	Yes, preset limits
	Same as predicate
Blood FlowRate (L/min)	Dependent on externalcircuit, up to 0 – 9.9L/min	Dependent on externalcircuit, up to 0 – 9.9L/min	Dependent on externalcircuit, up to 0 – 9.9L/min
	Same as predicate
Interface toBlood FlowSensor	Yes (Qty 1)	Yes (Qty 1)	Yes (Qty 1)
	Same as predicate
Air BubbleDetector	Yes (Qty 1), integratedwith Blood Flow Sensor	Yes (Qty 1)	Yes (Qty 1)
	Same as predicate
Product Name and Model	Anivia SG1000 Pump Console	Bio-Console® 560 Extracorporeal Blood Pump Console (Predicate)	Rotaflow® Centrifugal Pump System (Reference Device)
Blood Flow and Bubble Detector Sensor Technology	Non-contact, ultrasound Clamp-On around blood tube	Non-contact, electrical conductivity, Clamp-On around blood tube	Non-contact, ultrasound Clamp-On around blood tube
Pressure Sensors	Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties	Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties	N/A
Temperature Sensors	Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties	Yes (Qty 2, external), previously 510(k) cleared accessories manufactured by third parties	N/A
Power Input	Universal90-264 VAC/50-60 Hz2.5A / 1.3Aup to 250 WSame as predicate – single universal power supply, instead of different models, no effect on safety and effectiveness.	Three models:100 VAC, 50-60 Hz, 3 amps110-120 VAC, 50-60 Hz, 3 amps220-240 VAC, 50-60 Hz, 1.5 amps	Factory Set100/115/230/240 V AC2A / 1A
Backup Battery	LiFePO4Improvement in technology does not raise question on safety and effectiveness.	Lead acid	NiCad
Backup Battery Capacity	25.6 VDC, 12 AH, 307 WH,minimum 1 hour, up to 3 hours depending on speed and flowSame as predicate	24 VDC, capacity not listed	24 VDC, 5 AH, 120 WH
Product Nameand Model	Anivia SG1000 PumpConsole	Bio-Console® 560Extracorporeal BloodPump Console(Predicate)	Rotaflow® CentrifugalPump System(Reference Device)
Backup Pump	Yes, backup electricalPump Driver Module onstandby, and hand-crankSame as predicate	Yes, hand-crank	Yes, hand-crank
Pump MotorTechnology	Brushless DC motorSame as predicate	Brushless DC motor	Brushless DC motor
Display Screen	31 cm (12.1")Difference has noimpact on safety andeffectiveness	26 cm (10.4")	None
Dimensions,Display &ControlModule	14 cm W x 15 cm H x 9cm DDifference has noimpact on safety andeffectiveness	31.88 cm (12.55 in) highby 22.83 cm (8.99 in)wide by 43.02 cm (16.9in) long	18 x 39 x 24 cm
Weight,Display &ControlModule	3.3 kg – Display &Control Module4 kg – Backup BatteryModuleDifference (mostly dueto newer technology)has no impact on safetyand effectiveness.	17.2 kgincluding backupbatteries	14.4 kg including backupbattery

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Image /page/6/Picture/0 description: The image shows the logo for APMTD Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left and the text "APMTD Asia Pacific Medical Technology Development" on the right. The graphic is a stylized representation of a medical symbol. The text is in a dark teal color.

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Image /page/7/Picture/0 description: The image shows the logo for APMTD Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left and the text "APMTD Asia Pacific Medical Technology Development" on the right. The graphic is a stylized representation of a medical symbol. The text is in a dark teal color.

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Image /page/8/Picture/0 description: The image shows the logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left and the text "APMTD" in a bold, sans-serif font on the right. Below the text "APMTD" is the full name of the organization, "Asia Pacific Medical Technology Development", in a smaller font. The circular graphic is a stylized representation of interconnected shapes, possibly symbolizing collaboration or innovation.

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Image /page/9/Picture/0 description: The image shows the logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left, followed by the text "APMTD" in a large, bold font. Below the text "APMTD" is the full name of the organization, "Asia Pacific Medical Technology Development", in a smaller font. The logo is teal in color.

The technological characteristics of the Anivia SG1000 Pump Console device are substantially the same as predicate device and where there are minor differences they do not raise different questions of safety and effectiveness.

The geometry and design parameters are consistent with the device's intended use as an electromechanical pump driver and controller in cardiopulmonary bypass procedures.

Pump Driver Module is based on a brushless DC motor control electronics, and a A. contactless magnetic coupler driving a detachable one-time use centrifugal pump.

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Image /page/10/Picture/0 description: The image shows the logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left, followed by the text "APMTD" in a large, bold font. Below the text "APMTD" is the full name of the organization, "Asia Pacific Medical Technology Development", in a smaller font. The circular graphic is a stylized design, possibly representing a medical or technological concept.

Display & Control Module is based on a video display, a touch screen, a rotary knob, control B. electronics, isolated electronic signal interface for external sensors (accessories), and a medical grade AC-to-DC power supply.
C. Blood Flow Bubble Sensor Module is clamp-on non-contact flow meter, compatible with commonly used plastic blood tubes of specified diameters and material.
D. Backup Battery Module is based on lithium iron phosphate (LiFePO4) chemistry that can provide at least 60 minutes of backup power in case of brief power outage of the AC power line, or for supporting transport within a hospital.

Not included in this 510(k) application are the following accessories:

Cart Module (optional, supplied by Company, Product Code BZN, Class I, 510(K) Exempt) E. is a hand cart for mounting the Display & Control Module, the Pump Driver Module, the Flow Bubble Sensor Module, and the Backup Battery Module. The cart also provides a simple work surface, a storage bin, two IV poles, a holder for a gas cylinder, and locking caster wheels.
F. The Anivia SG1000 Pump Console may be used with the following previously 510(k) cleared devices, supplied by hospital users:
- Blood pressure sensors, supplied sterile, resistive bridge type that complies with a. ANSI/AAMI BP-22, 1994 and IEC 60601-2-34:Ed.3.0 standards, as listed in the Instructions for Use
- b. Temperature Sensors, supplied sterile, that meets YSI-400 and ISO 80601-2-56:2017 standards, as listed in the Instructions for Use
- One time use centrifugal pump heads, supplied sterile, as listed in the Instructions for Use c.

9.1. Biocompatibility

Not applicable. The Anivia SG1000 Pump Console does not contain any blood contacting or patient contacting devices.

9.2. Sterility and Shelf-Life

Not applicable. The Anivia SG1000 Pump Console and accessories are provided non-sterile and have been tested with sterile, one-time use accessories specified in the Instructions for Use.

9.3. Non-Clinical Tests

The Anivia SG1000 Pump Console performance characteristics were demonstrated through system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing.

The following performance tests were conducted on the Anivia SG1000 Pump Console System to support the determination of substantial equivalence:

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Image /page/11/Picture/0 description: The image shows the logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left, followed by the text "APMTD" in a bold, serif font. Below the text "APMTD" is the full name of the organization, "Asia Pacific Medical Technology Development", in a smaller font size. The logo is teal in color.

Software verification and validation testing .
. Functional design verification and validation testing
. Electrical safety, electromagnetic interference and compatibility (EMI/EMC) testing
. Interoperability evaluation with specified accessories
. Reliability testing
. Simulated use testing
. Cleaning validation
Packaging and ship testing

All testing met predetermined acceptance criteria.

The Anivia SG1000 Pump Console was also tested and certified by accredited third party laboratories to meet the following consensus standards:

IEC 60601-1:2005/AMD1:2012 ●
IEC 60601-1-2:2014 ●
IEC 60601-1-6:2010/AMD1:2013 ●
IEC 60601-1-8:2006/AMD1:2012 ●
ISO 80601-2-56:2017/AMD1:2018 ●
IEC 60601-2-34:2011
IEC 80601-2-49:2018 ●
ISO 14971:2019
IEC 62304:2006/AMD 1: 2015 ●
IEC 62366:2015
UL 2054:2004 R9.11
IEC 62133-2:2017/AMD1:2021 ●
UN38.3, Seventh Edition ●
ASTM D4169:2022, DC13, Level I ●
ISO 17664-2:2021 ●

9.4. Clinical Tests

Not Applicable

9.5. Labeling

The labeling includes instructions on circuit setup, explanation of the hardware and software user interface, visual and auditory alarms, maintenance during a procedure, precautions and warnings, trouble shooting guide, and performance characteristics relevant to compatibility among different devices and accessories in the circuit.

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Image /page/12/Picture/0 description: The image is a logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a circular graphic on the left and the text "APMTD" in large, bold letters on the right. Below the letters is the full name of the organization in smaller letters. The graphic is a stylized representation of a medical symbol.

10. Conclusions

Based on the above comparisons of intended use, intended users, use environment, indications for use, operating principles, technological characteristics, performance test data, and compliance with the listed consensus standards, the Anivia SG1000 Pump Console is as safe and effective as the predicate device, the Medtronic BioConsole (K131964).

Regulation Number and Section

§ 870.4380 Cardiopulmonary bypass pump speed control.

(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).