FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

K170029 · International Biophysics Corporation · KFM · Dec 15, 2017 · Cardiovascular

Device Facts

• Record ID: K170029
• Device Name: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
• Applicant: International Biophysics Corporation
• Product Code: KFM · Cardiovascular
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FloPump 32mL Centrifugal Pump is a 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.

Device Story

Single-use disposable centrifugal pump; provides extracorporeal blood circulation. Device draws blood via inlet; internal impeller, driven by magnetic coupling with external console (Maquet RotaFlow), imparts rotary motion; blood directed through spiral housing to outflow port. Used in clinical settings (OR) by perfusionists/surgeons during open heart/vascular surgery. Non-occlusive design; maintains blood flow through extracorporeal circuit (including oxygenator) for <6 hours. Benefits patient by enabling surgical access to heart/vessels while maintaining systemic perfusion.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing including flow curves, heat generation, prime volume, air handling, hemolysis, reliability, biocompatibility, and packaging/shelf-life validation.

Technological Characteristics

Centrifugal pump; polycarbonate housing/rotor/connector, HDPE bearing cup, alumina spherical bearing, neodymium magnet. Non-occlusive; magnetic drive coupling. Flow rate 0-7 L/min; max pressure 750 mmHg. Priming volume 32 mL. Sterile (SAL 10^-6). Standalone disposable component for use with external console.

Indications for Use

Indicated for patients undergoing open surgical procedures on the heart, great vessels, aorta, or vena cava requiring full or partial cardiopulmonary bypass or temporary circulatory bypass for <6 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Maquet (Jostra) RotaFlow Centrifugal Pump (K991864)
• IBC FloPump Centrifugal Pump (K983272)

Submission Summary (Full Text)

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December 15, 2017

International Biophysics Corporation Geoff Marcek Director, Engineering and Quality 2101 E. St. Elmo Road Austin, Texas 78744

Re: K170029

Trade/Device Name: FloPump 32mL Centrifugal Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: Class II Product Code: KFM Dated: November 6, 2017 Received: November 7, 2017

Dear Mr. Marcek:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K170029

Device Name FloPump 32mL Centrifugal Pump

Indications for Use (Describe)

The FloPump 32mL Centrifugal Pump is a 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

Date: November 06, 2017

Manufacturer: International Biophysics Corporation 2101 E. St. Elmo Road Austin, TX 78744

Contact Person: Geoff Marcek VP, Engineering and Quality Phone: [phone] Email: [e-mail]

| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|-------------------------------|----------------|---------------|--------------|--------------------------------------------------------------------------|
| FloPump 32mL Centrifugal Pump | Class II | KFM | KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type per 21 CFR 870.4360 |

## Description:

The FloPump 32mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.

## Specifications:

| Model Numbers | 6400S (Sterile), 6400N (Non-Sterile) |
|---------------------------|--------------------------------------|
| Priming Volume | Approx. 32 mL |
| Inlet/Outlet I.D. | 9.5mm (3/8") |
| Max. rated pressure | 750 mmHg |
| Flow rates | 0 - 7 L/min |
| Materials | |
| Housing, rotor, connector | Polycarbonate |
| Bearing Cup | HDPE |
| Spherical Bearing | Alumina |
| Magnet | Neodymium |

## Indications for Use:

The FloPump 32mL Centrifugal Pump is a 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.

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#### Predicate Devices: Maquet (Jostra) RotaFlow Centrifugal Pump - K991864 IBC FloPump Centrifugal Pump – K983272

Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, design features, specifications, manufacturing methods, raw materials, intended use, packaging, labeling and sterilization.

Key Differences in Subject Device to Predicate: There are no key differences between the subject device and the predicate. The subject device has been designed and constructed to the predicate.

## Non-Clinical Testing:

The following non-clinical testing was performed to determine substantial equivalence:

| Testing | Results Summary |
|----------------------|-----------------------------------------------------------------|
| Flow curves | Substantially equivalent to predicates |
| Heat generation | Substantially equivalent to predicates |
| Prime volume | Substantially equivalent to predicates |
| Air handling | Substantially equivalent to predicates |
| Hemolysis | Substantially equivalent to predicates |
| Reliability | Substantially equivalent to predicates |
| Biocompatibility | Substantially equivalent to predicates |
| Sterilization | The sterilization process results in an SAL of 10-6 |
| Packaging durability | No signs of damage and functioned as intended following testing |
| Shelf-life | No signs of damage and functioned as intended following testing |

Clinical Testing: Clinical testing was not required