(147 days)
The Revolution Centrifugal Blood Pump is intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of us to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Centrifugal Blood Pump with PC Coating is intended for use only with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vained impeller design to move blood by centrifugal force. The device is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. It is indicated for use only with a LivaNova centrifugal pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for long term use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Pump consists of a rotating vained impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single -barbed, 3/8" inlet port and tangential, doublebarbed, 3/8" outlet port. The vained impeller is molded onto steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the centrifugal pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
The Revolution Centrifugal Blood Pump with PC Coating is an extracorporeal blood pump that utilizes a rotating vained impeller design to move blood by centrifugal force. The device is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. It is indicated for use only with a LivaNova centrifugal pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for long term use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Pump consists of a rotating vained impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vained impeller is molded onto steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the centrifugal pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.
This document is a 510(k) Premarket Notification from the FDA for two medical devices: the "Revolution Centrifugal Blood Pump" and the "Revolution Centrifugal Blood Pump with PC Coating." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a study with the information requested in your prompt.
Therefore, most of the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document. This is because the device approval is based on demonstrating equivalence to existing devices, not on a new, comprehensive performance study as might be conducted for an AI/ML medical device.
However, I can extract the following relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance:
This document does not provide specific acceptance criteria or quantitative performance data for the devices themselves. Instead, it asserts "No difference" in several characteristics when comparing the subject devices to the predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicates.
| Feature / Criterion | Acceptance Criteria (Implied) | Reported Device Performance | Comments from Document |
|---|---|---|---|
| Product Code | KFM | KFM | No difference. |
| Regulation # | 870.4360 | 870.4360 | No difference. |
| Class | II | II | No difference. |
| Indications for Use | Same as predicate (see below) | Same as predicate | No difference. |
| Environment of Use | Operating room | Operating room | No difference. |
| Limitations of Use / Intended Use | Same as predicate (see below) | Same as predicate | No difference. |
| Principles of Operation | Rotating, vained impeller designed to move blood by centrifugal force | Rotating, vained impeller designed to move blood by centrifugal force | No difference. |
| Main Performance Features | Deliver blood at certain flow and pressure | Deliver blood at certain flow and pressure | No difference. |
Indications for Use (Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating):
"Intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO)."
Limitations of Use / Intended Use (Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating):
"The pump can only be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO) procedures."
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states, "No clinical testing was conducted in support of the Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating, as the indications for use are equivalent to those of their respective predicates." The substantial equivalence is based on engineering evaluation and non-clinical performance data (bench testing) rather than a and clinical study with a test set of patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical performance data refers to "extensive verification and validation testing" in-house by SORIN GROUP ITALIA S.R.L. and adherence to national and international standards. This implies lab-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device, and no MRMC study was performed as the approval pathway is substantial equivalence based on engineering and non-clinical data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The document mentions "non-clinical performance data" which refers to bench testing of the physical pump, not an algorithm. "...as centrifugal blood pumps capable of delivering blood to the patient at certain reliable flow and pressure rate. The modified component... was tested to ensure that the systems as a whole can provide all the capabilities necessary to operate safely and effectively."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" would be engineering specifications and established performance standards (e.g., flow rates, pressure, durability, hemolysis, biocompatibility), measured through bench testing. No clinical ground truth from patients is established for this submission.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device and no training set is described.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device and no training set is described.
In summary, this FDA 510(k) clearance is for a physical medical device (blood pump) based on substantial equivalence to existing devices, relying on non-clinical (bench) testing and engineering justification rather than a comprehensive clinical study with a test set or training set data, which would be typical for AI/ML device submissions.
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Image /page/0/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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2019
Sorin Group Italia S.r.1. % Scott Light Senior Manager, Regulatory Affairs LivaNova USA, Inc. 14401 West 65th Way Arvada, Colorado 80004
Re: K190650
Trade/Device Name: Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Blood Pump Regulatory Class: Class II Product Code: KFM Dated: January 29, 2019 Received: March 13, 2019
Dear Scott Light:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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 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)
K190650
Device Name Revolution Centrifugal Blood Pump
Indications for Use (Describe)
The Revolution Centrifugal Blood Pump is intended to be used with a LivaNova Centrifygal Pump Console in cardiopulmonary bypass procedures for periods of us to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
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Indications for Use
510(k) Number (if known)
K190650
Device Name Revolution Centrifugal Blood Pump with PC Coating
Indications for Use (Describe)
The Revolution Centrifugal Blood Pump with PC Coating is intended to be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of us to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
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510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number: K190650
l. Applicant Information
Applicant:
SORIN GROUP ITALIA S.R.L. Via Statale 12 Nord, 86 Mirandola (MO) 41037 Italy
Contact Person:
Luigi Vecchi RA Director Tel: +39-346-391-0707 e-mail: luigi.vecchi@livanova.com
Application Correspondent:
Same as Applicant
Date Prepared: August 6, 2019
II. Devices Identification
Proprietary Name: Revolution Centrifuqal Blood Pump Common/Usual Name: Nonroller-type cardiopulmonary bypass blood pump Classification Name: Nonroller-type blood pump 21 CFR 870.4360 Regulation Number: Product Code: KFM Classification: Class II Classification Panel: Cardiovascular Proprietary Name: Revolution Centrifuqal Blood Pump with PC Coating
Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification: Classification Panel:
Nonroller-type cardiopulmonary bypass blood pump Nonroller-type blood pump 21 CFR 870.4360 KFM Class II Cardiovascular
lll. Predicate Devices
The Revolution Centrifugal Blood Pump device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:
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| 510(k) Number: | K011835 |
|---|---|
| Proprietary Name: | Revolution Centrifugal Blood Pump |
| Common/Usual Name: | Nonroller-type cardiopulmonary bypass blood pump |
| Classification Name: | Nonroller-type blood pump |
| Regulation Number: | 21 CFR 870.4360 |
| Product Code: | KFM |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
The Revolution Centrifuqal Blood Pump with PC Coating device is substantially equivalent to the following cleared predicate device. Both models have the same fundamental scientific technology and intended use:
| 510(k) Number: | K030462 |
|---|---|
| Proprietary Name: | Revolution Centrifugal Blood Pump with PCCoating |
| Common/Usual Name: | Nonroller-type cardiopulmonary bypass blood pump |
| Classification Name: | Nonroller-type blood pump |
| Regulation Number: | 21 CFR 870.4360 |
| Product Code: | KFM |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
IV. Devices Description
Revolution Centrifuqal Blood Pump
The Revolution Centrifyaal Blood Pump is an extracorporeal blood pump that utilizes a rotating vained impeller design to move blood by centrifygal force. The device is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. It is indicated for use only with a LivaNova centrifugal pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for long term use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Pump consists of a rotating vained impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single -barbed, 3/8" inlet port and tangential, doublebarbed, 3/8" outlet port. The vained impeller is molded onto steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the centrifugal pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
Revolution Centrifuqal Blood Pump with PC Coating
The Revolution Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vained impeller design to move blood by centrifugal force.
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The device is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. It is indicated for use only with a LivaNova centrifugal pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for long term use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Pump consists of a rotating vained impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vained impeller is molded onto steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the centrifugal pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.
V. Indications for Use
The Revolution Centrifugal Blood Pump is intended to be used with a LivaNova Centrifuqal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
The Revolution Centrifugal Blood Pump with PC Coating is intended for use only with a LivaNova Centrifuqal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
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VI. Summary of Technical Characteristics
Revolution Centrifuqal Blood Pump
Nonroller-type cardiopulmonary bypass blood pumps are designed to deliver blood at certain flow and pressure by use of centrifugal forces.
The device contains a multi-pole magnet that is fully enclosed within the magnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump driver unit of LivaNova centrifugal pump consoles. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
The blood flow from the Revolution Centrifugal Blood Pump responds to the resistance against which it is pumping and to the amount of fluid returned from the pump, with corresponding changes in flow and pressure. The flow is slowly accelerated from a point of relatively low tangential velocity to a maximum tangential velocity that occurs when the blood reaches the outer blade end. This unique design of the impeller vanes minimizes heat generation, hence hemolysis, while providing adequate blood flow and pressure.
These technical characteristics are identical to the predicate device, the Revolution Centrifugal Blood Pump.
Revolution Centrifuqal Blood Pump with PC Coating
Nonroller-type cardiopulmonary bypass blood pumps are designed to deliver blood at certain flow and pressure by use of centrifugal forces.
The device contains a multi-pole magnet that is fully enclosed within the maqnet housing and impeller, and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump driver unit of LivaNova centrifugal pump consoles. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
The blood flow from the Revolution Centrifugal Blood Pump with PC coating responds to the resistance against which it is pumping and to the amount of fluid returned from the pump, with corresponding changes in flow and pressure. The flow is slowly accelerated from a point of relatively low tangential velocity to a maximum tangential velocity that occurs when the blood reaches the outer blade end. This unique design of the impeller vanes minimizes heat generation, hence hemolysis, while providing adequate blood flow and pressure.
These technical characteristics are identical to the predicate device, the Revolution Centrifugal Blood Pump with PC coating.
VII. Substantial Equivalence Discussion
The following tables compare the features of the Revolution Centrifyigal Blood Pump to its predicate the Revolution Centrifugal Blood Pump cleared under K011835 and the features of the Revolution Centrifugal Blood
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Pump with PC Coating to its predicate Revolution Centrifugal Blood Pump with PC Coating cleared under K030462, with respect to indications for use, environment of use, intended use, limitations of use, principles of operation and main performance characteristics.
Both subject devices have the same fundamental scientific technology and intended use as their respective predicate devices.
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| Device Name | Subject Device:Revolution Centrifugal Blood Pump | Predicate Device:(K011835)Revolution Centrifugal Blood Pump | Significant Differences | ||
|---|---|---|---|---|---|
| Product Code | KFM | KFM | |||
| Regulation # | 870.4360 | 870.4360 | No difference. | ||
| Class | II | II | No difference. | ||
| Indicationsfor Use | The Revolution Centrifugal Blood Pump isintended to be used with a LivaNovaCentrifugal Pump Console incardiopulmonary bypass procedures forperiods of up to six hours. Refer to theconsole operator's manual for consoleoperating procedures. The pump has notbeen qualified through in vitro, in vivo, orclinical studies for long term use (i.e.,longer than six hours) as a bridge totransplant, for pending recovery of thenatural heart or extracorporeal membraneoxygenation (ECMO). | The Revolution Centrifugal Blood Pump isintended to be used with a StockertInstrumente Centrifugal Pump Console incardiopulmonary bypass procedures forperiods of up to six hours. The pump hasnot been qualified through in vitro, in vivo,or clinical studies for long term use (i.e.,longer than six hours) as a bridge totransplant, for pending recovery of thenatural heart or extracorporeal membraneoxygenation (ECMO) procedures. | No difference. | ||
| Environment | Operating room. | Operating room. | No difference. | ||
| of UseLimitations ofUse/IntendedUse | The pump can only be used with aLivaNova Centrifugal Pump Console incardiopulmonary bypass procedures forperiods of up to six hours. The pump hasnot been qualified through in vitro, in vivo, | The pump can only be used with a StockertInstrumente Centrifugal Pump Console incardiopulmonary bypass procedures forperiods of up to six hours. The pump hasnot been qualified through in vitro, in vivo, | No difference. | ||
| or clinical studies for long term use (i.e.,longer than six hours) as a bridge totransplant, for pending recovery of thenatural heart or extracorporeal membraneoxygenation (ECMO) procedures. | or clinical studies for long term use (i.e.,longer than six hours) as a bridge totransplant, for pending recovery of thenatural heart or extracorporeal membraneoxygenation (ECMO) procedures. | ||||
| Principles ofOperation | The Pump utilizes a rotating, vainedimpeller designed to move blood bycentrifugal force. | The Pump utilizes a rotating, vainedimpeller designed to move blood bycentrifugal force. | No difference. | ||
| MainPerformanceFeatures | Nonroller-type cardiopulmonary bypassblood pumps are designed to deliver bloodat certain flow and pressure. | Nonroller-type cardiopulmonary bypassblood pumps are designed to deliver bloodat certain flow and pressure. | No difference. | ||
| Device Name | Subject Device:Revolution Centrifugal Blood Pump with PC Coating | Predicate Device: (K030462)Revolution Centrifugal Blood Pump with PC Coating | Significant Differences | ||
| Product Code | KFM | KFM | No difference. | ||
| Regulation # | 870.4360 | 870.4360 | No difference. | ||
| Class | II | II | No difference. | ||
| Indicationsfor Use | The Revolution Centrifugal Blood Pump with PC Coating is intended for use only with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). | The Revolution Centrifugal Blood Pump with PC Coating is intended for use only with Stockert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). | No difference. | ||
| Environmentof Use | Operating room. | Operating room. | No difference. | ||
| Limitations ofUse/IntendedUse | The pump can only be used with a LivaNova Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has | The pump can only be used with a Stockert Instrumente Centrifugal Pump Console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has | No difference. | ||
| not been qualified through in vitro, in vivo, | not been qualified through in vitro, in vivo, | ||||
| or clinical studies for long term use (i.e., | or clinical studies for long term use (i.e., | ||||
| longer than six hours) as a bridge to | longer than six hours) as a bridge to | ||||
| transplant, for pending recovery of the | transplant, for pending recovery of the | ||||
| natural heart or extracorporeal membrane | natural heart or extracorporeal membrane | ||||
| oxygenation (ECMO) procedures. | oxygenation (ECMO) procedures. | ||||
| Principles ofOperation | The pump utilizes a rotating, vainedimpeller designed to move blood bycentrifugal force. | The pump utilizes a rotating, vainedimpeller designed to move blood bycentrifugal force. | No difference. | ||
| MainPerformanceFeatures | Nonroller-type cardiopulmonary bypassblood pumps are designed to deliver bloodat certain flow and pressure. | Nonroller-type cardiopulmonary bypassblood pumps are designed to deliver bloodat certain flow and pressure. | No difference. |
Predicate Device Comparison Table for the Revolution Centrifugal Blood Pump
Special 510(k) – Centrifugal Blood Pumps
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Predicate Device Comparison Table for the Revolution Centrifugal Blood Pump with PC Coating
Special 510(k) – Centrifugal Blood Pumps
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VIII. Non-Clinical Performance Data
SORIN GROUP ITALIA S.R.L. has conducted extensive verification and validation testing of the Revolution Centrifuqal Blood Pump and Revolution Centrifygal Blood Pump with PC Coating, as centrifygal blood pumps capable of delivering blood to the patient at certain reliable flow and pressure rate. The modified component of the Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating was tested to ensure that the systems as a whole can provide all the capabilities necessary to operate safely and effectively.
The Revolution Centrifuqal Blood Pump and Revolution Centrifyqal Blood Pump with PC Coating comply with all the applicable voluntary standards related to centrifugal blood pump systems. The devices passed all the testing in accordance with national and international standards.
IX. Clinical Performance Data
No clinical testing was conducted in support of the Revolution Centrifyugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating, as the indications for use are equivalent to those of their respective predicates. which have been on the market for many years with proven safety and efficacy of use. The non-clinical testing detailed in this submission supports the substantial equivalence of these devices with their respective predicates in relation to the change subject of this submission.
X. Statement of Substantial Equivalence
Based on identical intended use and technological characteristics, as well as on identical performance testing, the Revolution Centrifugal Blood Pump and Revolution Centrifuqal Blood Pump with PC Coating can be deemed to be substantially equivalent to their predicate devices, the Revolution Centrifuqal Blood Pump and Revolution Centrifuqal Blood Pump with PC Coating cleared under K011835 and K030462, respectively.
The Revolution Centrifugal Blood Pump and Revolution Centrifugal Blood Pump with PC Coating, as designed and manufactured, do not raise new questions regarding their safety and effectiveness as compared to their predicates devices and are determined to be substantially equivalent to the predicate devices.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.