(219 days)
Cobe Century Perfusion Pump (K960974)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and testing focus on traditional medical device components and standards.
Yes
The device is used "during cardiopulmonary bypass for procedures," which is a therapeutic intervention.
No
The device description and intended use indicate that the Century Perfusion System is used during cardiopulmonary bypass procedures, performing functions like pumping blood and providing safety alarms. It does not mention analyzing patient data to diagnose a condition.
No
The device description explicitly states it is a "modular system... consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces," indicating it includes significant hardware components beyond just software. The performance studies also detail testing of hardware characteristics like electromagnetic compatibility and the peristaltic pump head.
Based on the provided information, the Century Perfusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less." This describes a device used in vivo (within the living body) to support physiological functions during surgery.
- Device Description: The description mentions a "modular system, like the Stöckert S5 System, consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces." This aligns with a system designed to circulate blood and manage parameters during surgery, not to analyze samples in vitro.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or assays
- Laboratory use
The device is clearly intended for use directly on a patient during a surgical procedure, which is the definition of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DTQ
Device Description
The Century Perfusion System is a modular system, like the Stöckert S5 System, consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces.
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
Not Found
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)
Non-Clinical Tests Performed:
The Century Perfusion System has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the Stöckert S5 System. The essential critical component in both the Century Perfusion System and the Stöckert S5 System is the Stöckert peristaltic pump head. The Century Perfusion System and the Stöckert S5 System provide the same perfusion safety devices including user selected alarms for pressure, temperature, air bubble and reservoir level detectors.
Testing to the following standard was conducted by Element Materials Technology to prove the safety and effectiveness of the Century Perfusion System regarding electromagnetic disturbances:
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
Testing to the following standards was conducted by Intertek to prove the safety and effectiveness of the Century Perfusion System:
- IEC 60601-1 Edition 3.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1:2015 Medical devices – Part 1: Application of usability engineering to medical devices
- IEC 60601-1-8:2010 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: Alarms
- IEC 62304:2015 Medical device software - Software life-cycle processes.
- ISO 14971:2007 Medical devices – Application of risk management to medical devices
- EN ISO 14971:2012 Medical devices - Application of risk management to medical devices.
None of the testing demonstrated any design characteristics that violated the above requirements or resulted in any safety hazards. It was our conclusion that the Century Perfusion System met all relevant requirements of the aforementioned tests.
Clinical Tests Performed:
No clinical tests performed. Roller pumps have been used for cardiopulmonary bypass procedures since the 1950s. The use and risks have been studied extensively. Information analyzed that was reported to the FDA via the MAUDE database was found to be representative of the hazards and risks that have been addressed both in the ISO 14971 Century Perfusion System Risk Management Document and the Instructions for Use. Per the Instructions for Use, this device is to be used only when continuously attended by a properly trained perfusionist. This means any incident would happen in the presence of a person trained on how to respond in the appropriate manner. These factors minimize the risks associated with the use of the Century Perfusion System. Journal articles analyzed show that the use of cardiopulmonary bypass pumps for extracorporeal oxygenation have been studied and analyzed extensively, either as the main topic of the article / study (in the analysis of 93 previously performed studies, for example) or as an adjunct to more specific discussions related to very specific conditions or pharmaceutical agents administered during this type of surgical procedure (such as an article relating to the inflammatory response of the patient).
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.
Stöckert S5 System (K060053)
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.
Cobe Century Perfusion Pump (K960974)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 1, 2021
Century HLM, LLC % Vaibhav Rajal Official Correspondent for Century HLM, Inc. mdi Consultants,Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K202125
Trade/Device Name: Century Perfusion System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary bypass heart-lung machine console Regulatory Class: Class II Product Code: DTQ
Dear Vaibhav Rajal:
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 March 7, 2021. Specifically, FDA is updating this SE Letter to correct the typo in the title for Vaibhav Rajal, Official Correspondent for Century HLM, Inc., as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Fernando Aguel, OHT2: Office of Cardiovascular Devices, 301-796-6326, Fernando.Aguel@fda.hhs.gov.
Sincerely,
Nicole M. Gillette -S
for Fernando Aguel 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). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
March 7, 2021
Century HLM, LLC % Vaibhav Rajal Officer Correspondenr for Century HLM, Inc. mdi Consultants,Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K202125
Trade/Device Name: Century Perfusion System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTO Dated: February 2, 2021 Received: February 5, 2021
Dear Vaibhav Rajal:
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
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,
Fernando Aguel
-s
Fernando Aguel 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)
Device Name Century Perfusion System
Indications for Use (Describe)
The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
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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4
510(k) SUMMARY
| The assigned 510(k) number is: | K202125 |
|---|---|
| Submitter's Identification: | |
| Submitter's Name and Address: | Century HLM, LLC |
| 3110 N. Oakland, STE 101 | |
| Mesa, AZ 85215 | |
| USA | |
| Name of Contact Person: | Jeff Poland |
| Phone Number: | 1-314-497-5232 |
| Fax Number: | 1-314-787-1580 |
| Email: | jeff@centuryheartlung.com |
| Establishment registration # | 3001589655 |
| Date Summary Prepared: | July 29, 2020 |
| Date Summary Revised to | |
| add reference Predicate: | December 2, 2020 |
| Name of the Device: | |
| Trade Name: | Century Perfusion System |
| Common/Generic Name: | Heart Lung Machine |
| Regulation Name: | Console, Heart-Lung Machine, |
| Cardiopulmonary Bypass | |
| Regulation Number: | 21 CFR 870.4220 |
| Product Code: | DTQ |
| Regulatory Class: | Class II |
Information for the 510(k) Cleared Device (Predicate Device):
Stöckert S5 System (K060053) currently marketed by LivaNova
5
Information for the 510(k) Cleared Device (Reference Predicate Device):
Cobe Century Perfusion Pump (K960974) currently marketed by Century HLM, LLC (Submitter).
Device Description:
The Century Perfusion System is a modular system, like the Stöckert S5 System, consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces.
Indications for Use:
The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Comparison to the 510(k) Cleared Devices (Predicate Devices):
The Century Perfusion System utilizes the same Stöckert peristaltic pump head used by the Stöckert S5 System and by the Cobe Century Perfusion Pump (Century has an indefinite license for the Stöckert peristaltic pump head obtained by Cobe circa 1980). The Century Perfusion Pump (K960974) remains unchanged with the exceptions of label improvements, non RoHS compliant components exchanged to the RoHS compliant version, and electrical improvements to meet current regulations. The Century Console Base includes a UPS battery backup system and computer components to support monitors, displays, controls, and user interfaces like the Stöckert S5 System. Perfusion safety devices include user selected alarms for pressure, temperature, air and level detectors like the Stöckert S5 System.
The Century Perfusion System has been compared to the Stöckert S5 System as a predicate device for substantial equivalence and to the Cobe Century Perfusion Pump as a reference predicate device for substantial equivalence . A table comparing the Century Perfusion System to the Stöckert S5 System is provided below and a table comparing the Century Perfusion Pump to the Cobe Century Perfusion Pump follows the Century Perfusion System to the Stöckert S5 System table below:
6
| Item | Subject device: | Predicate Device: | Substantially
Equivalent (SE)
or Different (D) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Century HLM, LLC | LivaNova, PLC | |
| | Century Perfusion System | Stöckert S5 System | |
| | | K060053 | |
| Indications for use | The Century Perfusion System is
intended to be used during
cardiopulmonary bypass for procedures
lasting six (6) hours or less. | The Stöckert S5 System is intended to be
used during cardiopulmonary bypass
for procedures lasting six (6) hours or less. | SE |
| Device description | The Century Perfusion System is a
modular system consisting of a console
base with peristaltic pumps, monitors,
displays, controls, and user interfaces. | The Stöckert 55 System is a modular
system consisting of a console, various
pumps, monitors, displays, controls, and
user interfaces. | SE |
| System components | Roller pumps
Console base
Sensors
UPS and Batteries | Roller pumps
Console base
Sensors
UPS and Batteries | SE |
Roller Pump
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Diameter of pump raceway | 150 mm | 150 mm | SE |
| Diameter of occlusion
roller | 30.5 mm | 30.5 mm | SE |
| Speed range | 0 to 250 RPM
(clockwise, counterclockwise) | 0 to 250 RPM (Bi-directional)
(clockwise, counterclockwise) | SE |
| Deviation in speed
accuracy | ±2% or ±1 count (whichever is greater)
of indicated RPM. | ±1% of the terminal value 250 rpm plus
±0.5% of set value | D (1) See below |
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
| Speed deviation in the
event of a fault
(Runaway/Overspeed fault
detection)
(Detection of faulty speed
from 30 rpm) | During continuous operation:
+20% max.; 2 revolutions max. until
pump stops | During continuous operation:
+15% max.; 2 revolutions max. until pump
stops | D (2) See below |
| Direction of rotation | Clockwise/counterclockwise | Clockwise/counterclockwise | SE |
| Concentricity:
- Tubing raceway
concentricity (Concentricity
about axis of rotation of
pump head.) | 0.005 mm (0.0002 inch) | 0.03 mm (.0012 inch) | D (3) See below |
| 2. Occlusion symmetry
(Difference in distance
from the center of the
pump head to the
outermost point on each
tubing roller.) | 0.025 mm (0.0010 inch) | 0.03 mm (.0012 inch) | |
| 3. Occlusion rollers
(Total runout of roller
surface measured from
roller axis.) | 0.013 mm (0.0005 inch) | 0.015 mm (0.0006 inch) | |
| Rpm display range | 0-250 RPM | 0-250 RPM | SE |
| Resolution | 1 rpm | 1 rpm | SE |
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
| L/min display range (flow) | 1/8" ID.......0 to 0.83 L/min
3/16" ID.....0 to 1.79 L/min
1/4" ID.......0 to 3.12 L/min
5/16" ID.....0 to 4.70 L/min
3/8" ID.......0 to 6.50 L/min
1/2" ID.......0 to 11.2 L/min | 1/8" ID.......0 to 0.83 L/min
3/16" ID.....0 to 1.79 L/min
1/4" ID.......0 to 3.12 L/min
5/16" ID.....0 to 4.70 L/min
3/8" ID.......0 to 6.50 L/min
1/2" ID.......0 to 11.2 L/min | SE |
| Deviation of speed slave
pump | Max. 1 percentage point of the flow
setting | Max. 1 percentage point of the flow
setting | SE |
| Operating voltage | 115 or 230 VAC ± 10%, 50 or 60 Hz
(indicated on pump nameplate) | 24 V DC | D (4) See below |
| Power Consumption | 160 VA | 160 VA | SE |
| Operating Temperature | +10 °C to +40 °C | +10 °C to +40 °C | SE |
| Storage Temperature | 0°C to +40 °C | 0°C to +40 °C | SE |
| Relative Humidity
(Operating and Storing) | 30% to 75% | 30% to 75% | SE |
| Physical dimensions: | | | D (5) See below |
| Length | 56 cm (22.1 inches) | 48.5 cm (19.1 inches) | |
| Width | 18 cm (7.1 inches) | 18 cm (7.1 inches) | |
| Height | 33 cm (13.0 inches) | 28.5 cm (11.2 inches) | |
| Weight | 26 kg (57 lbs) | 15 kg (33.1 lbs) | |
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
| Height (to the surface of
the pump cover) | 635 mm | 640 mm | D (6) See below |
| Depth | 587 mm | 600 mm | D (6) See below |
| Width (incl. push bars)
4 position | 965 mm | 890 mm | D (6) See below |
| 5 position | 1146 mm | 1073 mm | |
| Weight
4 position | 110.3 kg | 86.3 kg | D (7) See below |
| 5 position | 115.9 kg | 89.5 kg | |
| Operating Temperature | +10 °C to +40 °C | +10 °C to +40 °C | SE |
| Storage Temperature | 0 °C to +40 °C | 0 °C to +40 °C | SE |
| Relative Humidity
(Operating and Storing) | 30% to 75% | 30% to 75% | SE |
| Telescope masts
Height (from floor)
in lowest configuration
(Century has a single
configuration) | | 1230 mm min.
1840 mm max. | D (8) See below |
| in highest configuration | 1520 mm min.
2120 mm max. | 1520 mm min.
2120 mm max. | |
| Diameter (fixed part) | Ø 31.88 mm | Ø 33 mm | |
| Item | Subject device: | Predicate Device: | Substantially
Equivalent (SE)
or Different (D) |
| | Century HLM, LLC | LivaNova, PLC | |
| | Century Perfusion System | Stöckert S5 System
K060053 | |
| Movable base mast | | | SE |
| Height (from floor) | 1520 mm min.
2120 mm max. | 1520 mm min.
2120 mm max. | |
| Diameter (fixed part) | Ø 31.88 mm | Ø 33 mm | |
| Horizontal mast | | | D (9) See below |
| Length
4 position | 907 mm | 896 mm | |
| 5 position | 1088 mm | 1081 mm | |
| Diameter | Ø 31.88 mm | Ø 25 mm | |
| Maximum total load on
mast system | 45 kg | 45 kg | SE |
| Maximum total load on a
mast | 20 kg | 20 kg | SE |
| Maximum load on the
infusion rack | 5 kg | 5 kg | SE |
| System display panel | | (S5 6 slot display panel) | D (10) See below |
| Height | 307 mm | 475 mm | |
| Width | 400 mm | 375 mm | |
| Depth (without mast
holder) | 59 mm | 94 mm | |
| Weight (without mast
holder) | 6.53 kg | 7 kg (without display modules) | |
| Operating voltage | 24 V | 24 V | |
| Power consumption | 30 W | 45 W | |
| Pixel Failure Class | Conformity with Pixel Failure Class III | Conformity with Pixel Failure Class III | |
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
| Cardioplegia volume control | | | SE |
| Setting range | 0 to 2 Liters | 0 to 2 Liters | SE |
| Accuracy of Dosage | $\pm$ 10%, min. tolerance $\pm$ 20 ml | $\pm$ 10%, min. tolerance $\pm$ 20 ml | SE |
| Timer counting range | 0-999 hours 59 min 59 sec | 0-999 min 59 sec | D (11) See below |
| Input voltages | 115 V~; 60 Hz
230 V~; 50/60 Hz | 100 V~ to240 V~; 50/60 Hz | D (12) See below |
| Permissible mains voltage
fluctuation | $\pm$ 10% | $\pm$ 10% | SE |
| Maximum power
consumption (standard
equipment) | 1000 W | 1000 W | SE |
| Mains power protection
Circuit breaker: | 10 A nominal trip current | 10 A nominal trip current | SE |
| Circuit breakers: | Circuit breaker for pumps:
2.5 A in 115 VAC Pump modules
1.5 A in 230 VAC Pump modules
Circuit breaker (for auxiliary outlets):
2.5 A @ 115 VAC
1.5 A @ 230 VAC | Circuit breaker for system slots:
F1-F12 slots (pumps & devices) 10 A each
F13 (sensor module) 10 A (automatic) | D (13) See below |
| Serial interface | | | D (14) See below |
| Baud rate | 115200 | 9600 (fixed) | |
| Word length | 8 bit | 7 bit | |
| Parity | None | None | |
| Stop bits | 1 | 1 | |
| Time grid
(interval of the data sent by
perfusion system) | 1 second | 10 seconds | |
| Item | Subject device: | Predicate Device: | Substantially
Equivalent (SE)
or Different (D) |
| Output voltage: | Century HLM, LLC
Century Perfusion System | LivaNova, PLC
Stöckert S5 System
K060053 | D (15) See below) |
| Nominal voltage | 48 V | 24 V | |
| Minimum voltage | 42.5 V | 19 V | |
| Maximum voltage | 54.8 V | 32 V | |
| Output power: | | | D (16) See below) |
| Nominal output power | 400 W | 400 W | |
| Capacity of new
batteries | 22 Ah | 17 Ah | |
| Fuse protection of
batteries | 30 A | 40 A | |
| Operating time of UPS: | | | D (17) See below) |
| At 400 W output power | 112 minutes (115 V) 116 minutes (230V) | 20 minutes | |
| At 160 W output power | 297 minutes (115 V) 273 minutes (230V) | 90 minutes | |
| Charging time | 15-18 hours | 12-15 hours | |
| Discharger: | | | D (18) See below) |
| Input voltage | Not Required | 24 V DC | |
7
8
9
Console Base
10
11
12
UPS and Batteries
13
Sensors
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
|----------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Level | | | |
| Maximum
polycarbonate wall
thickness at sensor
position | 6 mm | 3 mm | D (19) See below) |
| Tolerance for triggering
the pump action
(response of the level
sensor) | $\pm$ 5 mm | $\pm$ 10 mm | |
| Air | | | D (20) See below) |
| Alarm limit 3/8 sensor | 0.087 cm³ (Ø 5.5 mm) air volume | 0.144 cm³ (Ø 6.5 mm) air volume "Large"
0.065 cm³ (Ø 5.0 mm) air volume "Medium”
0.034 cm³ (Ø 4.0 mm) air volume "Small" | |
| Alarm limit 1/4 sensor | 0.022 cm³ (Ø 3.5 mm) air volume | 0.034 cm³ (Ø 4.0 mm) air volume | |
14
| Item | Subject device:
Century HLM, LLC
Century Perfusion System | Predicate Device:
LivaNova, PLC
Stöckert S5 System
K060053 | Substantially
Equivalent (SE)
or Different (D) |
|------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------|
| Pressure | | | D (21) See below) |
| Measurement range | -200 mmHg to +800 mmHg | -200 mmHg to +800 mmHg | |
| Resolution | 1 mmHg | 1 mmHg | |
| Accuracy | ±5 mmHg | ±5 mmHg | |
| Zero point adjustment range | ±100 mmHg | ±100 mmHg | |
| Gain adjustment range
(matching) | Not required | ±20% | |
| Input resistance | 100 kΩ | 100 kΩ | |
| Output voltage to
pressure transducer |