(219 days)
The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
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.
The provided text describes a 510(k) premarket notification for the Century Perfusion System, demonstrating its substantial equivalence to predicate devices (Stöckert S5 System and COBE Century Perfusion Pump). The document primarily focuses on engineering specifications, comparisons, and adherence to various medical device standards. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML-driven medical devices, as the Century Perfusion System is a mechanical pump and not an AI/ML device.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
- Stand-alone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The document states: "No clinical tests performed." and details non-clinical tests to prove safety and effectiveness through compliance with standards like IEC 60601-1, IEC 62366-1, ISO 14971, etc. It also discusses software validation for the device's control system, but this is for a general software safety classification (Class C) and not for AI/ML performance.
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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
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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
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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
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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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510(k) SUMMARY
| The assigned 510(k) number is: | K202125 |
|---|---|
| Submitter's Identification: | |
| Submitter's Name and Address: | Century HLM, LLC3110 N. Oakland, STE 101Mesa, AZ 85215USA |
| 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 toadd 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
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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:
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| Item | Subject device: | Predicate Device: | SubstantiallyEquivalent (SE)or Different (D) |
|---|---|---|---|
| Century HLM, LLC | LivaNova, PLC | ||
| Century Perfusion System | Stöckert S5 System | ||
| K060053 | |||
| Indications for use | The Century Perfusion System isintended to be used duringcardiopulmonary bypass for procedureslasting six (6) hours or less. | The Stöckert S5 System is intended to beused during cardiopulmonary bypassfor procedures lasting six (6) hours or less. | SE |
| Device description | The Century Perfusion System is amodular system consisting of a consolebase with peristaltic pumps, monitors,displays, controls, and user interfaces. | The Stöckert 55 System is a modularsystem consisting of a console, variouspumps, monitors, displays, controls, anduser interfaces. | SE |
| System components | Roller pumpsConsole baseSensorsUPS and Batteries | Roller pumpsConsole baseSensorsUPS and Batteries | SE |
Roller Pump
| Item | Subject device:Century HLM, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (SE)or Different (D) |
|---|---|---|---|
| Diameter of pump raceway | 150 mm | 150 mm | SE |
| Diameter of occlusionroller | 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 speedaccuracy | ±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, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (SE)or Different (D) |
| Speed deviation in theevent of a fault(Runaway/Overspeed faultdetection)(Detection of faulty speedfrom 30 rpm) | During continuous operation:+20% max.; 2 revolutions max. untilpump stops | During continuous operation:+15% max.; 2 revolutions max. until pumpstops | D (2) See below |
| Direction of rotation | Clockwise/counterclockwise | Clockwise/counterclockwise | SE |
| Concentricity:1. Tubing racewayconcentricity (Concentricityabout axis of rotation ofpump head.) | 0.005 mm (0.0002 inch) | 0.03 mm (.0012 inch) | D (3) See below |
| 2. Occlusion symmetry(Difference in distancefrom the center of thepump head to theoutermost point on eachtubing roller.) | 0.025 mm (0.0010 inch) | 0.03 mm (.0012 inch) | |
| 3. Occlusion rollers(Total runout of rollersurface measured fromroller 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, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (SE)or Different (D) |
| L/min display range (flow) | 1/8" ID.......0 to 0.83 L/min3/16" ID.....0 to 1.79 L/min1/4" ID.......0 to 3.12 L/min5/16" ID.....0 to 4.70 L/min3/8" ID.......0 to 6.50 L/min1/2" ID.......0 to 11.2 L/min | 1/8" ID.......0 to 0.83 L/min3/16" ID.....0 to 1.79 L/min1/4" ID.......0 to 3.12 L/min5/16" ID.....0 to 4.70 L/min3/8" ID.......0 to 6.50 L/min1/2" ID.......0 to 11.2 L/min | SE |
| Deviation of speed slavepump | Max. 1 percentage point of the flowsetting | Max. 1 percentage point of the flowsetting | 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, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (SE)or Different (D) |
| Height (to the surface ofthe 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 | |
| Weight4 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 mastsHeight (from floor)in lowest configuration(Century has a singleconfiguration) | 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: | SubstantiallyEquivalent (SE)or Different (D) |
| Century HLM, LLC | LivaNova, PLC | ||
| Century Perfusion System | Stöckert S5 SystemK060053 | ||
| 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 | ||
| Length4 position | 907 mm | 896 mm | |
| 5 position | 1088 mm | 1081 mm | |
| Diameter | Ø 31.88 mm | Ø 25 mm | |
| Maximum total load onmast system | 45 kg | 45 kg | SE |
| Maximum total load on amast | 20 kg | 20 kg | SE |
| Maximum load on theinfusion 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 mastholder) | 59 mm | 94 mm | |
| Weight (without mastholder) | 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, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (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 Hz230 V~; 50/60 Hz | 100 V~ to240 V~; 50/60 Hz | D (12) See below |
| Permissible mains voltagefluctuation | $\pm$ 10% | $\pm$ 10% | SE |
| Maximum powerconsumption (standardequipment) | 1000 W | 1000 W | SE |
| Mains power protectionCircuit 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 modules1.5 A in 230 VAC Pump modulesCircuit breaker (for auxiliary outlets):2.5 A @ 115 VAC1.5 A @ 230 VAC | Circuit breaker for system slots:F1-F12 slots (pumps & devices) 10 A eachF13 (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 byperfusion system) | 1 second | 10 seconds | |
| Item | Subject device: | Predicate Device: | SubstantiallyEquivalent (SE)or Different (D) |
| Output voltage: | Century HLM, LLCCentury Perfusion System | LivaNova, PLCStöckert S5 SystemK060053 | 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 newbatteries | 22 Ah | 17 Ah | |
| Fuse protection ofbatteries | 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 |
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Console Base
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UPS and Batteries
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Sensors
| Item | Subject device:Century HLM, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (SE)or Different (D) |
|---|---|---|---|
| Level | |||
| Maximumpolycarbonate wallthickness at sensorposition | 6 mm | 3 mm | D (19) See below) |
| Tolerance for triggeringthe pump action(response of the levelsensor) | $\pm$ 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 |
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| Item | Subject device:Century HLM, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (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 topressure 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 (withoutsensors) | 0.0 °C - 25 °C ± 0.2 °C25.0 °C - 45 °C ± 0.1 °C45.0 °C - 50.0 °C ± 0.2 °C | 0.0 °C - 25 °C ± 0.2 °C25.0 °C - 45 °C ± 0.1 °C45.0 °C - 50.0 °C ± 0.2 °C |
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Classifications
| Item | Subject device:Century HLM, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 | SubstantiallyEquivalent (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 ofwater or particulate matter | IPX1 | IPX1 | SE |
| Method of Sterilization or Disinfection | Not Applicable | Not Applicable | SE |
| Degree of Safety in the Presence of FlammableAnesthetic Mixtures | Not suitable for use in thepresence of a flammableanesthetic mixtures | Must not be used in thepresence of explosivesubstances | SE |
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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 pump, a range of the most common settings used in cardiopulmonary bypass were compared. The most common settings for the most critical roller pump (arterial) are between 4 and 5 LPM and the tubing used in an arterial roller pump is most often 1/2 inch ID but may also be 3/8 inch ID. The most common settings for the second most critical roller pump (cardioplegia) are between 0.2 LPM and 0.3 LPM and the tubing most often used is a combination of 1/4 inch ID and 1/8 inch ID tubing to produce a 4:1 ratio of cardioplegia solution. The most common settings for less critical Vent and Suction roller pumps are 50 RPM to 100 RPM and the tubing most often used is 1/4 inch ID tubing. The comparison table below illustrates a slightly better deviation in speed accuracy range for the subject device Century Perfusion System roller pump below 187 RPM and a slightly better deviation in speed accuracy range for the predicate device Stöckert S5 System roller pump above 187 RPM. The deviation in speed accuracy range difference does not affect the subject device's safety, effectiveness, or performance.
1/2" ID tubing
4 LPM = approx. 90 RPM 5 LPM = approx. 113 RPM
3/8″ ID tubing 4 LPM = approx. 152 RPM
5 LPM = approx. 187 RPM
1/4" and 1/8" ID tubing 0.1 LPM = approx. 13 RPM 0.2 LPM = approx. 20 RPM
1/4" ID tubing (Vents and Suctions) 50 RPM 100RPM
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| Item | Subject device:Century HLM, LLCCentury Perfusion System | Predicate Device:LivaNova, PLCStöckert S5 SystemK060053 |
|---|---|---|
| Deviation inspeed accuracyat: | ±2% or ±1 count (whicheveris greater) of indicatedRPM. | ±1% of the terminal value250 rpm plus ±0.5% of setvalue |
| 90 RPM | 88.2 to 91.8 | 87.05 to 92.95 |
| 113 RPM | 110.74 to 115.26 | 109.94 to 116.07 |
| 152 RPM | 148.96 to 155.04 | 148.74 to 155.26 |
| 187 RPM | 183.26 to 190.74 | 183.57 to 190.44 |
| 13 RPM | 12 to 14 | 10.44 to 15.57 |
| 20 RPM | 19 to 21 | 17.4 to 22.6 |
| 50 RPM | 49 to 51 | 47.25 to 52.75 |
| 100 RPM | 98 to 102 | 97 to 103 |
Deviation in Speed Accuracy Table Using Most Common Settings
2. Speed deviation in the event of a fault
Also referred to as "Runaway Fault" in LivaNova/Sorin S5 manuals and "Overspeed Detection" in Century manuals, this detection and mitigation was developed to address the phenomenon commonly known as "Runaway pump". Runaway pump is characterized by a rapid acceleration to the maximum pump speed with complete loss of speed control over the affected roller pump. Rapid starting or stopping of the roller pump without tubing in the pump head may trigger a false Runaway pump fault. Manually turning the roller head during loading of tubing in the roller pump head may also trigger a false Runaway pump fault. Runaway pump detection and mitigation occurs at a 15% increase over the displayed RPM in the predicate device Stöckert S5 System roller pump and at a 20% increase over the displayed RPM in the subject device Century Perfusion System roller pump. The Century Perfusion System roller pump Overspeed Detection at a 20% increase over the displayed RPM lessens the occurrence of false or unintended Runaway pump triggers without affecting its ability to detect a rapid acceleration to the maximum pump speed. This difference does not affect the subject device's safety, effectiveness, or performance.
3. Concentricity
The subject device Century Perfusion System roller pump demonstrates a slight improvement in concentricity compared to the predicate device Stöckert S5 System roller pump. The improved concentricity specifications of the subject device Century Perfusion System roller pump does not affect the subject device's safety or effectiveness and may improve performance.
4. Operating voltage (roller pump)
The subject device Century Perfusion System roller pump requires a 115 or 230 VAC ± 10%, 50 or 60 Hz electrical supply input and each Century module contains its own
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internal power supply and transformer to convert the AC input to 24 V DC, whereas the predicate device Stöckert S5 System roller pump requires 24 V DC from a power supply and transformer in the Stöckert S5 System Console base. The subject device roller pump is capable of operating independently of its Century Perfusion System Console base in emergency situations due to failures in the Console base whereas the predicate device Stöckert S5 System roller pump is incapable of operating independently of its Stöckert S5 System Console base as it requires 24 V DC from a power supply and transformer in the Stöckert S5 System Console. This difference does not affect the subject device's performance or effectiveness and may increase the subject device's safety in Console base failure situations.
5. Physical dimensions (roller pump)
The subject device Century Perfusion System modular roller pump physical dimensions are larger than the predicate device Stöckert S5 System modular roller pump physical dimensions to accommodate the subject device's inclusion of a dedicated power supply and transformer as discussed in difference number 4 above. This does not affect the subject device's safety, effectiveness, or performance.
6. Physical dimensions (Console Base)
The subject device Century Perfusion System Console Base physical dimensions are slightly different than the predicate device Stöckert S5 System. The slight differences are attributed to design differences. The slight differences in physical dimensions does not affect the subject device's safety, effectiveness, or performance.
7. Weight (Console Base)
The subject device Century Perfusion System's 4 position Console Base weight is 24Kg heavier than the predicate device Stöckert S5 System's 4 position Console Base and the subject device Century Perfusion System's 5 position Console Base weight is 26.4Kg heavier than the predicate device Stöckert S5 System's 5 position Console Base due to the increased battery backup weight that provides increased emergency UPS battery backup capacity. This difference does not affect the subject device's performance or effectiveness and may increase the subject device's safety during facility power failures.
8. Physical dimensions (Console Base Telescope masts)
The subject device Century Perfusion System's Telescope masts have one configuration for the height from floor whereas the predicate device Stöckert S5 System's Telescope masts have two configurations for the height from floor. The subject device Century Perfusion System's Telescope masts diameter is 1.11 millimeter less than the diameter of the predicate device Stöckert S5 System's Telescope masts. These differences do not affect the subject device's safety, effectiveness, or performance.
9. Horizontal mast (Console Base)
The subject device Century Perfusion System's Horizontal mast lengths are substantially equivalent to the predicate device Stöckert S5 System's Horizontal mast lengths. The
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subject device Century Perfusion System's Horizontal mast diameter is 6.89 mm larger than the predicate device Stöckert S5 System's Horizontal mast diameter. This does not affect the subject device's safety, effectiveness, or performance.
10. System display panel (Console Base)
The subject device Century Perfusion System provides a single display panel interface for control and monitoring of timers, pumps, cardioplegia functions, pressures, temperatures, UPS, air detectors and level detectors whereas the predicate device Stöckert S5 System provides a variety of system display panels with 3 to 6 slots to accommodate control and monitoring of timers, pumps, cardioplegia functions, pressures, temperatures, UPS, air detectors and level detectors dependent on which modules are purchased by the user. The subject device Century Perfusion System's single display panel interface is compared to the predicate device Stöckert S5 System's 6 position display panel interface as the 6 position display panel interface is capable of displaying control and monitoring functions substantially equivalent to the Century Perfusion System's single display panel interface. The subject device Century Perfusion System's single display panel interface is smaller in size, weight, and power consumption compared to the functionally substantially equivalent predicate device Stöckert S5 System's 6 position display panel interface. The difference in size, weight, and power consumption does not affect the subject device's safety, effectiveness, or performance.
11. Timer counting range
The subject device Century Perfusion System's timer counting range is significantly higher but functionally equivalent to the predicate device Stöckert S5 System's timer counting range. This difference does not affect the subject device's safety, effectiveness, or performance.
12. Input voltages
The subject device Century Perfusion System uses two models to accommodate the most common global input voltages; 115 V~; 60 Hz and 230 V~; 50/60 Hz whereas the predicate device Stöckert S5 System uses one model to accommodate global input voltages 100 V~ to 240 V~; 50/60 Hz. This difference does not affect the subject device's safety, effectiveness, or performance.
13. Mains Power Protection and Circuit Breaker Protection
The subject device Century Perfusion System modular design is different than the predicate device Stöckert S5 System. The subject device Century Perfusion System's modules are designed to be able to operate independently. Each module includes its own transformer, power supply, and circuit breaker for safe operation independently in the event of a failure in the Century Console Base or in another Century module. The predicate device Stöckert S5 System modules are electrically integrated with the S5 Console Base and the circuit breaker for system slots reflect that. The power protection and circuit breaker design for each device is different but appropriate for each design. This does not affect the subject device's safety, effectiveness, or performance.
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14. Serial interface
The subject device Century Perfusion System improves serial interface parameters over the predicate device Stöckert S5 System to allow more data to transfer more frequently. This does not affect the subject device's safety and improves effectiveness and performance of the serial interface.
15. Output voltage (UPS and Batteries)
The subject device Century Perfusion System's UPS battery backup utilizes batteries operating at 48V whereas the predicate device Stöckert S5 System's UPS battery backup utilizes batteries operating at 24V. The subject device Century Perfusion System's UPS battery backup capacity is increased compared to the predicate device Stöckert S5 System's UPS battery backup capacity by operating the UPS battery backup at a nominal voltage of 48VDC compared to the predicate device Stöckert S5 System's UPS battery backup operating at a nominal voltage of 24VDC. This does not affect the subject device's safety, effectiveness, or performance.
16. Output Power (UPS and Batteries)
The subject device Century Perfusion System's fuse protection of UPS batteries is 30 A whereas the predicate device Stöckert S5 System's fuse protection of UPS batteries is 40 A. The subject device Century Perfusion System's UPS battery backup capacity is increased compared to the predicate device Stöckert S5 System's UPS battery backup capacity by operating the UPS battery backup at a nominal voltage of 48VDC compared to the predicate device Stöckert S5 System's UPS battery backup operating at a nominal voltage of 24VDC. The increased operating voltage of the Century Perfusion System UPS battery backup allows for lower UPS battery backup operating current while providing similar operating power. Therefore, the Century Perfusion System UPS battery backup can limit the fault current to a lower level than that of the Stöckert S5 System's UPS battery backup. This does not affect the subject device's safety, effectiveness, or performance.
17. Operating time (UPS and Batteries)
The subject device Century Perfusion System's UPS battery backup operating time is increased compared to the predicate device Stöckert S5 System's UPS battery backup. The subject device Century Perfusion System's UPS battery backup charging time has a wider range compared to the predicate device Stöckert S5 System's UPS battery backup charging time to accommodate the higher capacity of the subject device Century Perfusion System's UPS battery backup. The differences in UPS battery backup operating times and charging times does not affect the subject device's performance or effectiveness and may increase safety in facility power failure situations.
18. Discharger (UPS and Batteries)
The subject device Century Perfusion System's UPS battery backup utilizes a color-coded battery icon that will decrease in length and change color as the UPS battery charge is
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depleted whereas the predicate device Stöckert S5 System's UPS battery backup utilizes a percentage of battery backup capacity that decreases as the UPS battery charge is depleted. In order to calibrate the percentage display of battery life remaining the predicate device Stöckert S5 System requires a discharge test utilizing a Discharger on a regular basis. The subject device Century Perfusion System's UPS battery backup colorcoded battery icon is based on decreasing battery voltage that does not require a discharge test.
19. Tolerance for triggering the pump action (Level sensor)
The subject device Century Perfusion System's level sensor maximum polycarbonate wall thickness tolerance at the sensor position is 6 mm whereas the predicate device Stöckert S5 System's level sensor maximum polycarbonate wall thickness tolerance at the sensor position is 3 mm. The subject device Century Perfusion System's level sensor tolerance for triggering the pump action (response of the level sensor) is ±5 mm whereas the predicate device Stöckert S5 System's level sensor tolerance for triggering the pump action (response of the level sensor) is ±10 mm. The subject device's maximum polycarbonate wall thickness increased tolerance enables it to work with a wider variety of disposable products and the decreased level sensor triggering tolerance improves triggering accuracy. This does not affect the subject device's safety and improves the subject device's effectiveness and performance.
20. Alarm limit (Air Sensor)
The subject device Century Perfusion System air sensor alarm limit for 3/8″ tubing is 0.087 cm3 (Ø 5.5 mm) of air volume whereas the predicate device Stöckert S5 System has three user selectable air sensor alarm limits: 0.144 cm³ (Ø 6.5 mm) of air volume for "Large", 0.065 cm³ (Ø 5.0 mm) of air volume for "Medium", and 0.034 cm³ (Ø 4.0 mm) of air volume for "Small". The subject device Century Perfusion System air sensor alarm limit for 3/8″ tubing is substantially equivalent to the predicate device Stöckert S5 System air sensor "Medium" alarm limit for 3/8″ tubing. The subject device Century Perfusion System air sensor alarm limit for 1/4″ tubing of 0.022 cm³ (Ø 3.5 mm) air volume is substantially equivalent to the predicate device Stöckert S5 System air sensor alarm limit for 1/4″ tubing of 0.034 cm³ (Ø 4.0 mm) air volume. The subject device Century Perfusion System air sensor's function to detect air as part of the protection system against harmful air delivery is substantially equivalent to the predicate device Stöckert S5 System.
21. Gain adjustment range (Pressure sensor)
The subject device Century Perfusion System does not require a user adjustable gain for the pressure sensor whereas the predicate device Stöckert S5 System does require a user adjustable gain for the pressure sensor. To determine that no user adjustable gain for the pressure sensor is required for the subject device Century Perfusion System to meet substantial equivalence to the predicate device Stöckert S5 System, 32 combinations of pressure sensors and pressure channels on the Century Perfusion System device were tested. These pressure measurements were taken across six
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different pressures ( -200, 100, 200, 400, 600 and 800 mmHg) across the range of acceptable pressures as noted in the Century Perfusion System documentation. The pressure was individually verified with a calibrated pressure meter, Model HDM97 BOH, SN3628310103002225, in addition to being read by the device with the result recorded. A two-sided K-factor with 90% confidence for 90% of the population was calculated to determine the upper and lower bound for each pressure setting. The resulting bounds were shown to be within the ± 5mmHg accuracy set forth by the predicate device Stöckert S5 System. This difference does not affect the subject device's safety, effectiveness, or performance.
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| Item | Subject device:Century HLM, LLCCentury Perfusion Pump | Predicate Device:Century HLM, LLCCOBE Century Perfusion PumpK960974 | SubstantiallyEquivalent (SE)or Different (D) |
|---|---|---|---|
| Indications for use | The Century Perfusion Pump isintended to be used duringcardiopulmonary bypass for procedureslasting six (6) hours or less. | The COBE Century Perfusion Pump isintended for use in cardiopulmonarysurgical procedures requiring pumping offluids in an extracorporeal circuit forperiods up to 6 hours. | SE |
| Device description | The Century Perfusion Pump is theprinciple component of the CenturyPerfusion System. It is a peristaltic-typeroller pump that functions by tube-occluding rollers that move along apiece of tubing. As the pump headrotates, the rollers draw fluid throughthe tubing. Pumped fluids arecontained within the tubing and haveno contact with the pump. The pumphas positive displacement over a widerange of flow rates and deliverypressures. | The COBE Century Perfusion Pump is theprinciple component of the COBE CenturyPerfusion System. It is a peristaltic-typeroller pump that functions by tube-occluding rollers that move along a pieceof tubing. As the pump head rotates, therollers draw fluid through the tubing.Pumped fluids are contained within thetubing and have no contact with thepump. The pump has positivedisplacement over a wide range of flowrates and delivery pressures. | SE |
| Pump components | A front panel containing displays andoperational switches.A pump head with the roller pumpmechanism and shields.A chassis containing control cards, apower supply, and connectors forexternal devices. | A front panel containing displays andoperational switches.A pump head with the roller pumpmechanism and shields.A chassis containing control cards, apower supply, and connectors for externaldevices. | SE |
| ltem | Subject device:Century HLM, LLCCentury Perfusion Pump | Predicate Device:Century HLM, LLCCOBE Century Perfusion PumpK960974 | SubstantiallyEquivalent (SE)or Different (D) |
| Diameter of pump raceway | 150 mm | 150 mm | SE |
| Diameter of occlusionroller | 30.5 mm | 30.5 mm | SE |
| Speed range | 0 to 250 RPM(clockwise, counterclockwise) | 0 to 250 RPM(clockwise, counterclockwise) | SE |
| Deviation in speedaccuracy | ±2% or ±1 count (whichever is greater)of indicated RPM. | ±2% or ±1 count (whichever is greater) ofindicated RPM. | SE |
| Speed deviation in theevent of a fault(Runaway/Overspeed faultdetection)(Detection of faulty speedfrom 30 rpm) | During continuous operation:+20% max.; 2 revolutions max. untilpump stops | During continuous operation:+20% max.; 2 revolutions max. untilpump stops | SE |
| Direction of rotation | Clockwise/counterclockwise | Clockwise/counterclockwise | SE |
| Item | Subject device:Century HLM, LLC | Predicate Device:Century HLM, LLC | SubstantiallyEquivalent (SE) |
| Century Perfusion Pump | COBE Century Perfusion PumpK960974 | or Different (D) | |
| Concentricity: | D (1) See below | ||
| 1. Tubing racewayconcentricity (Concentricityabout axis of rotation ofpump head.) | 0.005 mm (0.0002 inch) | 0.095 mm (0.0037 inch) | |
| 2. Occlusion symmetry(Difference in distancefrom the center of thepump head to theoutermost point on eachtubing roller.) | 0.025 mm (0.0010 inch) | 0.05 mm (0.0020 inch) | |
| 3. Occlusion rollers(Total runout of rollersurface measured fromroller 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 |
| L/min display range (flow) | 1/8" ID.......0 to 0.83 L/min3/16" ID.....0 to 1.79 L/min1/4" ID.......0 to 3.12 L/min5/16" ID.....0 to 4.70 L/min3/8" ID.......0 to 6.50 L/min1/2" ID.......0 to 11.2 L/min | 1/8" ID.......0 to 0.83 L/min3/16" ID.....0 to 1.79 L/min1/4" ID.......0 to 3.12 L/min5/16" ID.....0 to 4.70 L/min3/8" ID.......0 to 6.50 L/min1/2" ID.......0 to 11.2 L/min | SE |
| Item | Subject device:Century HLM, LLCCentury Perfusion Pump | Predicate Device:Century HLM, LLCCOBE Century Perfusion PumpK960974 | SubstantiallyEquivalent (SE)or Different (D) |
| Deviation of speed slavepump | Max. 1 percentage point of the flowsetting | Max. 1 percentage point of the flowsetting | SE |
| Operating voltage | 115 or 230 VAC ± 10%, 50 or 60 Hz(indicated on pump nameplate) | 115 or 230 VAC ± 10%, 50 or 60 Hz(indicated on pump nameplate) | SE |
| Power Consumption | 160 VA | 150 VA (nominal) | D (2) See below |
| Operating Temperature | +10 °C to +40 °C | +16 °C to +38 °C | D (3) See below |
| Storage Temperature | 0°C to +40 °C | -18 °C to 55 °C | D (4) See below |
| Relative Humidity(Operating and Storing) | 30% to 75% | 0 to 95% Noncondensing | D (5) See below |
| Physical dimensions: | SE | ||
| Length | 56 cm (22.1 inches) | 56 cm (22.1 inches) | |
| Width | 18 cm (7.1 inches) | 18 cm (7.1 inches) | |
| Height | 33 cm (13.0 inches) | 33 cm (13.0 inches) | |
| Weight | 26 kg (57 lbs) | 26 kg (57 lbs) |
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Roller Pump
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There are no major differences between the subject device Century Perfusion Pump and the predicate device COBE Century Perfusion Pump K960974. The Century Perfusion Pump remains largely unchanged with the exceptions of increased electrical grounding improvements to meet updated ESD regulations, non RoHS compliant components exchanged to the RoHS compliant version from the same manufacturer, and label improvements.
The Indications for Use statement of the subject device is substantially equivalent to the predicate device. Other differences between the devices are:
1. Concentricity
The subject device Century Perfusion Pump demonstrates improvement in concentricity compared to the predicate device COBE Century Perfusion Pump (K960974). The improved concentricity specifications of the subject device Century Perfusion Pump does not affect the subject device's safety or effectiveness and may improve performance.
2. Power Consumption
Power consumption varies by pump speed. The increased nominal power consumption calculated for the subject device Century Perfusion Pump does not affect the subject device's safety, effectiveness, or performance.
3. Operating Temperature
Operating temperature testing parameters for the subject device Century Perfusion Pump were chosen based on operating temperature parameters of the primary predicate device Stöckert S5 System. The wider operating temperature range of the subject device Century Perfusion Pump does not affect the subject device's safety, effectiveness, or performance.
4. Storage Temperature
Storage temperature testing parameters for the subject device Century Perfusion Pump were chosen based on storage temperature parameters of the primary predicate device Stöckert S5 System. The narrower storage temperature range of the subject device Century Perfusion Pump does not affect the subject device's safety, effectiveness, or performance.
5. Relative Humidity
Relative humidity testing parameters for the subject device Century Perfusion Pump were chosen based on relative humidity parameters of the primary predicate device Stöckert S5 System. The narrower relative humidity range of the subject device Century Perfusion Pump does not affect the subject device's safety, effectiveness, or performance.
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Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
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
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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).
Biocompatibility Testing
The Century Perfusion System does not come into contact with the patient. Therefore biocompatibility testing is not included as part of this premarket notification.
Software information:
In line with current FDA policy, and the 11/05 FDA "Guidance for the Content of Premarket Submissions for Software Contained in the Medical Devices", Century is submitting software validation documentation covering a "major level of software concern" for the Century HLM System software. In addition to the required sections of the FDA Guidance, the software development has followed the processes set for in the latest version of IEC 62304 with a Software Safety Classification of C. A third party has also conducted an independent summative usability study as further evidence that the system meets the user needs.
Our device utilizes two dedicated tools for the development of the software. The IDEC display has its own development tool for creation of the Graphical User Interface portion. This tool does not require any additional libraries or binaries in order to generate the output file that is downloaded to the IDEC display. The
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Panasonic PLC also has its own development tool for the creation of ladder logic 'code' that runs the system controls for air detect sensors, level sensors, pressure sensors, temperature sensors, automatic pump speed reduction, and cardioplegia delivery. This ladder logic does not directly control the pump speeds as they are manually set by the user via knobs on the front of each pump device. In conclusion, the system does not require the use of off-the-shelf software in the traditional sense.
Conclusions:
Based on the indications for use, technological characteristics, results of nonclinical testing, and comparison to the predicate device, the Century Perfusion System has been shown to be substantially equivalent to the legally marketed predicate devices.
§ 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).