Who is the manufacturer of Century Perfusion System?

Century Hlm, LLC filed the 510(k) submission for Century Perfusion System (K202125).

What is the FDA product code for Century Perfusion System?

DTQ. It is classified under 21 CFR 870.4220 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Century Perfusion System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Century Perfusion System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Century Perfusion System

K202125 · Century Hlm, LLC · DTQ · Mar 7, 2021 · Cardiovascular

Device Facts

Record ID	K202125
Device Name	Century Perfusion System
Applicant	Century Hlm, LLC
Product Code	DTQ · Cardiovascular
Decision Date	Mar 7, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4220
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Device Story

Century Perfusion System is a modular heart-lung machine console used in clinical settings by perfusionists during cardiopulmonary bypass. It consists of a console base with peristaltic roller pumps, monitors, displays, controls, and user interfaces. The system processes inputs from pressure, temperature, air, and level sensors to provide real-time monitoring and user-selected alarms. The device transforms manual user inputs (pump speed knobs) and sensor data into system control outputs, including cardioplegia volume control and automated safety responses (e.g., pump speed reduction upon fault detection). The system includes a UPS battery backup for emergency power. Healthcare providers use the display panel to monitor perfusion parameters and adjust settings during surgery. The device benefits patients by maintaining extracorporeal circulation during cardiac procedures. It is designed for procedures lasting up to 6 hours.

Clinical Evidence

No clinical tests performed. Bench testing only. Safety and effectiveness supported by compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62304, and ISO 14971 standards. Literature review of cardiopulmonary bypass pump usage and MAUDE database analysis were used to assess hazards.

Technological Characteristics

Modular console base with peristaltic roller pumps. Materials: polycarbonate (sensors). Energy: 115/230 VAC input, 24V DC internal distribution, 48V UPS battery backup. Connectivity: Serial interface. Sterilization: Not applicable (device does not contact patient). Software: Class C (IEC 62304).

Indications for Use

Indicated for use during cardiopulmonary bypass procedures lasting 6 hours or less.

Regulatory Classification

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.

Predicate Devices

Stöckert S5 System (K060053)

Reference Devices

Cobe Century Perfusion Pump (K960974)

Related Devices

K060053 — STOCKERT S5 SYSTEM · Sorin Group Deutschland GmbH · Jun 2, 2006
K052555 — MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB · Rand S.R.L. · Mar 15, 2006
K221373 — Essenz HLM · Livanova Deutschland, GmbH · Mar 9, 2023
K131041 — ADVANCED PERFUSION SYSTEM 1 · Terumo Cardiovascular Systems Corp. · Feb 20, 2014
K173834 — Quantum Pump Console · Spectrum Medical , Ltd. · May 25, 2018

Submission Summary (Full Text)

{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) K202125 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995, #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: 1. 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 | <10 V | <10 V | | | Temperature | | | SE | | Measurement range | 0 °C to 50 °C | 0 °C to 50 °C | | | Resolution | 0.1 °C | 0.1 °C | | | Accuracy (without sensors) | 0.0 °C - 25 °C ± 0.2 °C 25.0 °C - 45 °C ± 0.1 °C 45.0 °C - 50.0 °C ± 0.2 °C | 0.0 °C - 25 °C ± 0.2 °C 25.0 °C - 45 °C ± 0.1 °C 45.0 °C - 50.0 °C ± 0.2 °C | | {15}------------------------------------------------ ## Classifications | Item | Subject device: Century HLM, LLC Century Perfusion System | Predicate Device: LivaNova, PLC Stöckert S5 System K060053 | Substantially Equivalent (SE) or Different (D) | |--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------| | Type of Electric Shock Protection | Class 1 | Class 1 | SE | | Degree of Electric Shock Protection to applied parts | Type B | Type B | SE | | Degree of Protection Against Harmful Ingress of water or particulate matter | IPX1 | IPX1 | SE | | Method of Sterilization or Disinfection | Not Applicable | Not Applicable | SE | | Degree of Safety in the Presence of Flammable Anesthetic Mixtures | Not suitable for use in the presence of a flammable anesthetic mixtures | Must not be used in the presence of explosive substances | SE | {16}------------------------------------------------ The major difference between the subject device Century Perfusion System and the predicate device Stöckert S5 System is the ability of the subject device Century Perfusion System's modular Century Perfusion Pump (roller pump) to operate independently of the Century Perfusion System Console Base. A significant difference between the subject device Century Perfusion System and the predicate device Stöckert S5 System is the subject device Century Perfusion System's increased UPS battery backup capacity. The Indications for Use statement of the subject device is identical to the predicate device. Other differences between the devices are: #### 1. Deviation in speed accuracy To compare "deviation in speed accuracy" between the subject device Century Perfusion System roller pump and the predicate device Stöckert S5 System roller pum…