(256 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical and electrical components and standard performance testing.
No
The device pumps blood in an extracorporeal bypass circuit but does not directly treat a disease or condition; it facilitates a medical procedure (cardiopulmonary bypass).
No
The device is described as a "Pump Console" intended to pump blood through an extracorporeal bypass circuit. Its function is to move blood, not to provide diagnostic information about a patient's condition.
No
The device description explicitly lists multiple hardware modules (Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module) and mentions hardware testing (mechanical testing, electrical safety and electromagnetic interference and compatibility testing).
Based on the provided text, the Anivia SG1000 Pump Console is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass." This describes a device that directly interacts with the patient's blood outside the body for therapeutic support, not for diagnostic testing of samples.
- Device Description: The description reinforces this by stating it's for "pumping blood without direct contact in an extracorporeal blood circulation circuit." It's used in conjunction with components like oxygenators and cannulas, which are part of a life support system, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing blood samples, detecting analytes, or providing diagnostic information. Its function is purely mechanical pumping.
- Care Setting and User: The device is used in operating rooms, cardiac catheterization labs, and intensive care units by physicians and perfusionists for surgical and life support procedures. This is consistent with a therapeutic device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Anivia SG1000 Pump Console does not perform this function.
N/A
Intended Use / 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).
Product codes
DWA
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, Backup Battery Module, and Cart Module. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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Image /page/3/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, teal font. Below the letters, the full name of the organization, "Asia Pacific Medical Technology Development," is written in a smaller font size and the same teal color.
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 B16 |
| Wilmington, MA 01887 | |
| USA | |
| Telephone: | 1-949-623-8403 |
| Contact Information: | John Sasso |
| Director of Projects and Programs | |
| Telephone: 781-962-6274 | |
| Email: 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
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:
| 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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Image /page/5/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.
| Product Name
and Model | Anivia SG1000 Pump
Console | Bio-Console® 560
Extracorporeal Blood
Pump Console
(Predicate) | Rotaflow® Centrifugal
Pump System
(Reference Device) |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | APMTD Inc.
USA | Medtronic Inc.
USA | Getinge Maquet
Cardiopulmonary AG,
Germany |
| FDA 510(k)
number | K221491 | K131964 | K991864 |
| 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). | The Medtronic
centrifugal blood
pumping system is
intended to pump blood
through the
extracorporeal bypass
circuit for extracorporeal
support for periods
appropriate to
cardiopulmonary bypass
procedures (up to 6
hours). | The RotaFlow Centrifugal
Pump System is intended
for use in an
extracorporeal perfusion
circuit to pump blood
during short duration
cardiopulmonary bypass
procedures lasting six
hours or less. |
| FDA
Classification
Codes | Class II, CFR 870.4380,
DWA,
Cardiopulmonary
bypass pump speed
control | Class II, CFR 870.4380,
DWA
Cardiopulmonary bypass
pump speed control | Class II, CFR 870.4360,
KFM
Pump, Blood,
Cardiopulmonary Bypass,
Non-Roller Type |
| Duration of Use | Up to 6 hours (limited
by disposables, not
limited by Console
electro-mechanical
modules) | Up to 6 hours | Up to 6 hours |
| Intended Use | Pump Speed Control,
CPB Machine Console
(not including sterile,
blood-contacting
accessories) | Pump Speed Control,
CPB Machine Console
(not including sterile,
blood-contacting
accessories) | Pump Speed Control, CPB
Machine Console
(bundled with sterile,
blood-contacting
accessories, outside the
scope of this application) |
| Product Name
and Model | Anivia SG1000 Pump
Console | Bio-Console® 560
Extracorporeal Blood
Pump Console
(Predicate) | Rotaflow® Centrifugal
Pump System
(Reference Device) |
| Intended Users | Cardiopulmonary
physicians,
perfusionists, trained
physician assistants | Cardiopulmonary
physicians, perfusionists,
trained physician
assistants | Cardiopulmonary
physicians, perfusionists,
trained physician
assistants |
| Intended Use
Environment | Cardiopulmonary
procedure rooms,
intensive care units | Cardiopulmonary
procedure rooms,
intensive care units | Cardiopulmonary
procedure rooms,
intensive care units |
| Intended
Patients | As prescribed by
cardiopulmonary
specialists | As prescribed by
cardiopulmonary
specialists | As prescribed by
cardiopulmonary
specialists |
| Compatible
Disposable
Centrifugal
Pump Heads | 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) | Medtronic Bio-Pump®
or Affinity® Series
centrifugal pump heads,
including BPX-80, BP-
50 | RotaFlow® RF-32
centrifugal pump heads |
| Centrifugal
Pump Driver | Non-contact,
magnetically coupled | Non-contact,
magnetically coupled | Non-contact, magnetically
coupled |
| Control
Function | • Speed Control
• Flow Control
(Stability)
Mechanical Knob and
Touch Display | • Speed Control
• Coast Mode (low set
speed)
Mechanical Knob | • Speed Control
• Flow Control (Stability)
• Mechanical Knob |
| Product Name
and Model | Anivia SG1000 Pump
Console | Bio-Console® 560
Extracorporeal Blood
Pump Console
(Predicate) | Rotaflow® Centrifugal
Pump System
(Reference Device) |
| Components | • Pump Driver Module
• Touch screen control
and display panel
• Flow Bubble Sensor
• Backup Battery
Module
• Mobile cart with
adjustable Support
Arm (optional
accessory)
• Backup Pump Driver
Module
• Emergency Handcrank | • Bio-Console 560 Pump
Speed Controller
• Flow Transducer
• Backup battery
• 540T External Drive
(Pump) Unit
• PBS Cabinet
• Adjustable Support
Arm
• Emergency Handcrank | • Integrated flow and
bubble sensors in the
drive unit
• Integrated battery back-
up
• Rotaflow Console
• Backup battery
• Adjustable Support Arm
• Emergency Handcrank |
| Pump Speed
(RPM) | 0 – 4500 for CS-0210-
ASY-00002 (Medtronic
BPX-80 compatible
Pump Driver Module)
0 – 5000 for CS-0210-
ASY-00010 (Maquet
Rotaflow RF-32
compatible Pump Driver
Module) | 0 - 4500 | 0 - 5000 |
| | Same as predicate. | | |
| Visual and
Auditory
Alarms on
Abnormal
Conditions | Yes, preset limits:
Speed, Flow Rate, Back
Flow, Bubble, Pressure,
Temperature | Yes, preset limits:
Speed, Flow Rate, Back
Flow, Bubble, Pressure,
Temperature | Yes, preset limits |
| | Same as predicate | | |
| Blood Flow
Rate (L/min) | Dependent on external
circuit, up to 0 – 9.9
L/min | Dependent on external
circuit, up to 0 – 9.9
L/min | Dependent on external
circuit, up to 0 – 9.9
L/min |
| | Same as predicate | | |
| Interface to
Blood Flow
Sensor | Yes (Qty 1) | Yes (Qty 1) | Yes (Qty 1) |
| | Same as predicate | | |
| Air Bubble
Detector | Yes (Qty 1), integrated
with 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 | Universal
90-264 VAC/50-60 Hz
2.5A / 1.3A
up to 250 W
Same as predicate – single universal power supply, instead of different models, no effect on safety and effectiveness. | Three models:
100 VAC, 50-60 Hz, 3 amps
110-120 VAC, 50-60 Hz, 3 amps
220-240 VAC, 50-60 Hz, 1.5 amps | Factory Set
100/115/230/240 V AC
2A / 1A |
| Backup Battery | LiFePO4
Improvement 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 flow
Same as predicate | 24 VDC, capacity not listed | 24 VDC, 5 AH, 120 WH |
| Product Name
and Model | Anivia SG1000 Pump
Console | Bio-Console® 560
Extracorporeal Blood
Pump Console
(Predicate) | Rotaflow® Centrifugal
Pump System
(Reference Device) |
| Backup Pump | Yes, backup electrical
Pump Driver Module on
standby, and hand-crank
Same as predicate | Yes, hand-crank | Yes, hand-crank |
| Pump Motor
Technology | Brushless DC motor
Same as predicate | Brushless DC motor | Brushless DC motor |
| Display Screen | 31 cm (12.1")
Difference has no
impact on safety and
effectiveness | 26 cm (10.4") | None |
| Dimensions,
Display &
Control
Module | 14 cm W x 15 cm H x 9
cm D
Difference has no
impact on safety and
effectiveness | 31.88 cm (12.55 in) high
by 22.83 cm (8.99 in)
wide by 43.02 cm (16.9
in) long | 18 x 39 x 24 cm |
| Weight,
Display &
Control
Module | 3.3 kg – Display &
Control Module
4 kg – Backup Battery
Module
Difference (mostly due
to newer technology)
has no impact on safety
and effectiveness. | 17.2 kg
including backup
batteries | 14.4 kg including backup
battery |
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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).