(36 days)
Not Found
No
The document describes a blood pump console with standard components and testing, with no mention of AI or ML capabilities.
Yes
The device is used to pump blood through an extracorporeal bypass circuit for extracorporeal support, which is a therapeutic intervention for patients undergoing cardiopulmonary bypass procedures.
No.
The Anivia SG1000 Pump Console is intended for pumping blood, not for diagnosing conditions or diseases. It is a therapeutic device used during cardiopulmonary bypass procedures.
No
The device description explicitly lists multiple hardware modules (Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, Backup Battery Module, and Cart Module) and mentions mechanical and electrical testing, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, 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 used on the patient's blood outside the body during a medical procedure, not a device used to test or analyze biological samples to diagnose a condition.
- Device Description: The description details a pump console used in an extracorporeal blood circulation circuit. It mentions pumping blood without direct contact and being used in conjunction with other devices like oxygenators and pump heads. This aligns with a medical device used for circulatory support during surgery, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information. The device's function is purely mechanical – pumping blood.
Therefore, the Anivia SG1000 Pump Console is a medical device used for therapeutic support during cardiopulmonary bypass, not an in vitro diagnostic device.
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).
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.
Product codes (comma separated list FDA assigned to the subject device)
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:
Modules
Display & Control Module
Pump Driver Module
Flow Bubble Sensor Module
Backup Battery Module
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2023
APMTD Inc. John Sasso Director of Projects and Programs 226 Lowell Street, Unit B16 Wilmington, Massachusetts 01887
Re: K230698
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
Dear John Sasso:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated on April 18, 2023. Specifically, FDA is updating this SE Letter with correct spelling of the company name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Alejandra Cambonchi, OHT2: Office of Cardiovascular Devices, 301-796-0552, Alejandra.Cambonchi@fda.hhs.gov.
Sincerely,
Kathleen M. Grunder - S
for 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
1
Image /page/1/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 and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 18, 2023
AMPTD Inc. John Sasso Director of Projects and Programs 226 Lowell Street, Unit B16 Wilmington, Massachusetts 01887
Re: K230698
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: March 7, 2023 Received: March 13, 2023
Dear John Sasso:
We have reviewed vour 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
2
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 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,
Kathleen M. Grunder -S
for 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
3
Indications for Use
510(k) Number (if known) K230698
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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 teal-colored circle with a white abstract design inside, followed by the letters "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, lighter teal font.
APMTD, Inc., 226 Lowell Street, Unit B16 Wilmington, MA 01887 USA T: 1-949-623-8403
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: | March 7, 2023 |
| 2. 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: | Anivia SG1000 Pump Console, K221941, APMTD, 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 | |
| Anivia SG1000-PCM-003 | CS-0210-ASY-00015 | |
| Anivia SG1000-PCM-004 | CS-0210-ASY-00025 |
5
Image /page/5/Picture/0 description: The image shows the logo for APMTD, which stands for Asia Pacific Medical Technology Development. The logo consists of a teal-colored circular graphic on the left, followed by the text "APMTD" in a bold, teal font. Below the acronym, the full name of the organization, "Asia Pacific Medical Technology Development," is written in a smaller, lighter font.
APMTD, Inc., 226 Lowell Street. Unit B16 Wilmington, MA 01887 USA T: 1-949-623-8403
| Flow Bubble Sensor Module | Anivia SG1000-FBS-001 | CS-0410-ASY-00001 |
|---|---|---|
| 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/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" on the right. Below the text is the phrase "Asia Pacific Medical Technology Development".
| Product Name
| and Model | Anivia SG1000 Pump Console | Anivia SG1000 Pump Console |
|---|---|---|
| Manufacturer | APMTD Inc. | |
| USA | APMTD Inc. | |
| USA | ||
| FDA 510(k) | ||
| number | Pending | K221491 |
| 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 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). | ||
| 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 | ||
| Duration of Use | Up to 6 hours (limited by disposables, | |
| not limited by Console electro- | ||
| mechanical modules) | Up to 6 hours (limited by disposables, | |
| not limited by Console electro- | ||
| mechanical modules) | ||
| 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) | ||
| Intended Users | 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 | ||
| Intended | ||
| Patients | 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 Affinity CPAP40,
BBAP40, centrifugal pump heads
(w/Pump Driver Module SG1000-
PDM-002) | 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) |
| Product Name
and Model | Anivia SG1000 Pump Console
LivaNova Revolution® Catalog No.
050300700, 050300000 centrifugal
pump heads (w/Pump Driver Module
SG1000-PDM-004) | |
| Centrifugal
Pump Driver | Non-contact, magnetically coupled | Non-contact, magnetically coupled |
| Control
Function | • Speed Control
• Flow Control (Stability)
Mechanical Knob and Touch Display | • Speed Control
• Flow Control (Stability)
Mechanical Knob and Touch Display |
| 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 | • 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 |
| 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 - 4000 for CS-0210-ASY-00015
(Medtronic Affinity CP compatible
Pump Driver Module)
0 - 3500 for CS-0210-ASY-00025
(LivaNova Revolution® compatible
Pump Driver Module) | 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) |
| 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 |
| Product Name
and Model | Anivia SG1000 Pump Console | Anivia SG1000 Pump Console |
| 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 |
| Interface to
Blood Flow
Sensor | Yes (Qty 1) | Yes (Qty 1) |
| Air Bubble
Detector | Yes (Qty 1), integrated with Blood
Flow Sensor | Yes (Qty 1), integrated with Blood
Flow Sensor |
| Blood Flow and
Bubble Detector
Sensor
Technology | Non-contact, ultrasound
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 |
| 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 |
| 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. | 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. |
| Backup Battery | LiFePO4 | LiFePO4 |
| Backup Battery
Capacity | 25.6 VDC, 12 AH, 307 WH,
minimum 1 hour, up to 3 hours
depending on speed and flow | 25.6 VDC, 12 AH, 307 WH,
minimum 1 hour, up to 3 hours
depending on speed and flow |
| Backup Pump | Yes, backup electrical Pump Driver
Module on standby, and hand-crank | Yes, backup electrical Pump Driver
Module on standby, and hand-crank |
| Product Name
and Model | Anivia SG1000 Pump Console | Anivia SG1000 Pump Console |
| Pump Motor
Technology | Brushless DC motor | Brushless DC motor |
| Display Screen | 31 cm (12.1") | 31 cm (12.1") |
| Dimensions,
Display &
Control Module | 14 cm W x 15 cm H x 9 cm D | 14 cm W x 15 cm H x 9 cm D |
| Dimensions,
Pump Driver
Module | Maximum Diameter: 113 mm,
Height: 170 mm | Maximum Diameter: 113 mm,
Height: 170 mm |
| Weight | 3.3 kg - Display & Control Module
4 kg – Pump Driver Module
4 kg - Backup Battery Module | 3.3 kg - Display & Control Module
4 kg – Pump Driver Module
4 kg - Backup Battery Module |
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Image /page/7/Picture/0 description: The image contains 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 large, bold letters on the right. Below the letters is the full name of the organization, "Asia Pacific Medical Technology Development", in smaller letters. The logo is teal in 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 teal-colored circle with a white abstract design inside, followed by the letters APMTD in a larger, teal font. Below the letters is the full name of the organization, "Asia Pacific Medical Technology Development", in a smaller font.
9
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 and the text "APMTD Asia Pacific Medical Technology Development" on the right. The graphic is a teal circle with a white design inside. The text is also teal, with "APMTD" in a larger font than "Asia Pacific Medical Technology Development".
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.
- A. Pump Driver Module is based on a brushless DC motor, motor control electronics, and a contactless magnetic coupler driving a detachable one-time use centrifugal pump.
- B. Display & Control Module is based on a video display, a touch screen, a rotary knob, control 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 ultrasonic 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 Special 510(k) application are the following accessories:
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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 teal-colored abstract circular shape on the left, followed by the letters "APMTD" in a larger, teal-colored serif font. Below the letters, the full name of the organization, "Asia Pacific Medical Technology Development," is written in a smaller, sans-serif font, also in teal.
- 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:
- . 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.
11
Image /page/11/Picture/0 description: The image shows the logo for APMTD Asia Pacific Medical Technology Development. The logo consists of a teal circle with a white abstract design inside, followed by the text "APMTD" in a larger, teal font. Below the text "APMTD" is the text "Asia Pacific Medical Technology Development" in a smaller, teal font.
APMTD, Inc., 226 Lowell Street, Unit B16 Wilmington, MA 01887 USA T: 1-949-623-8403
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.
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 Anivia SG1000 Pump Console (K221491).