(184 days)
The Orqis Extracorporeal Blood Pumping system is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants, etc).
The Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.
The Orqis Extracorporeal Blood Pumping System consists of a pump, independent motor unit, a controller, a flow sensor, and some pump tubing. The system also has two accessories: a holster for the pump and motor, and a controller stand.
The Orqis Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet of the pump runs concentric with the axis of the rotor.
The Orqis Motor is a small, compact, reusable unit that holds the disposable blood pump and drives the rotor inside the blood pump. The Motor turns a magnet that is hermetically sealed in the pump's rotor at a speed that is set by the controller. The outer shell of the motor is built from aluminum and polycarbonate. The motor is provided non-sterile.
The Orqis Controller is a microprocessor-based device, which drives and controls the blood pump, through the motor. The Controller also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display and audible and visual alarms.
The Orqis Flow Sensor is an ultrasonic flow meter that measures fluid flow through standard 3/8" tubing.
The Orqis Pump Tubing is medical grade PVC tubing used to connect the Blood Pump to external devices. The Pump Tubing is provided sterile.
This document describes the Orqis Extracorporeal Blood Pumping System, a non-roller type blood pump intended for use in extracorporeal circulation for cardiac support for up to six hours.
1. Acceptance Criteria and Reported Device Performance
The provided text indicates that the device underwent "Functional Testing" and was deemed "as safe and effective as the predicate device for its intended use." However, specific quantitative acceptance criteria or detailed performance metrics are not provided in the excerpt. Therefore, I cannot construct a table with specific acceptance criteria and reported performance values. The summary only states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate device for safety and effectiveness | "Successfully undergone functional testing demonstrating equivalence to the predicate device" |
2. Sample Size for Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The study is described as "Functional Testing," which implies laboratory or in-vitro testing rather than a clinical study with human subjects.
3. Number of Experts and Qualifications for Ground Truth Establishment
Not applicable. The "Functional Testing" described is likely engineering or laboratory-based and would not involve experts establishing ground truth in the way a clinical image analysis study or diagnostic device study would.
4. Adjudication Method for Test Set
Not applicable. As the "Functional Testing" appears to be an engineering or laboratory assessment, a clinical adjudication method like 2+1 or 3+1 is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided text describes "Functional Testing" to demonstrate equivalence to a predicate device, focusing on the device's intrinsic operation rather than its impact on human reader performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone performance assessment was conducted. The "Functional Testing" described appears to assess the device's operational capabilities (e.g., pumping blood, controlling speed, measuring flow and pressure) independently. The conclusion states "The Orqis Extracorporeal Blood Pumping System has successfully undergone functional testing demonstrating equivalence to the predicate device," which directly indicates an assessment of the device's inherent performance.
7. Type of Ground Truth Used
The ground truth for the "Functional Testing" would likely be established based on:
- Engineering specifications and design requirements: The device's operation would be tested against pre-defined performance characteristics.
- Performance of the predicate device: The benchmark for "equivalence" would be the known and established performance of the Levitronix CentriMag® Extracorporeal Blood Pumping System (K020271), Cardiac Assist TandemHeart Escort Controller (K061369), and Olsen Medical Sales Plastron Pump Tubing (K013578).
- Standardized test methods and equipment: The "functional testing" would involve using calibrated instruments and established protocols to measure parameters like flow rate, pressure, speed, and potentially hemolysis or other blood-related effects.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical blood pumping system, not an AI/ML algorithm that requires a training set of data. The "Functional Testing" described focuses on the physical and operational performance of the device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process in that context.
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2 510(k) Summary
| Submitter: | Orqis Medical Corporation14 Orchard Road, Suite 100Lake Forest, CA 92630 |
|---|---|
| Contact Person: | Ryan KellySenior Regulatory Affairs Specialist |
| Date Prepared: | December 21, 2007 |
| Trade Name: | Orqis Extracorporeal Blood Pumping SystemOrqis Blood PumpOrqis MotorOrqis ControllerOrqis Flow SensorOrqis Pump Tubing |
| Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-roller type(21 CFR 870.4360)Control, Pump Speed, Cardiopulmonary Bypass (21 CFR 870.4380)Tubing, Pump, Cardiopulmonary Bypass (21 CFR 870.4390) |
| Predicate Devices: | Levitronix CentriMag® Extracorporeal Blood Pumping System, K020271Cardiac Assist TandemHeart Escort Controller, K061369Olsen Medical Sales Plastron Pump Tubing, K013578 |
| Device Description: | The Orqis Extracorporeal Blood Pumping System consists of a pump, independent motor unit, a controller, a flow sensor, and some pump tubing. The system also has two accessories: a holster for the pump and motor, and a controller stand.The Orqis Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet of the pump runs concentric with the axis of the rotor. |
| The Orqis Motor is a small, compact, reusable unit that holds the disposable blood pump and drives the rotor inside the blood pump. The Motor turns a magnet that is hermetically sealed in the pump's rotor at a speed that is set by the controller. The outer shell of the motor is built from aluminum and polycarbonate. The motor is provided non-sterile. | |
| The Orqis Controller is a microprocessor-based device, which drives and controls the blood pump, through the motor. The Controller also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display and audible and visual alarms. | |
| The Orqis Flow Sensor is an ultrasonic flow meter that measures fluid flow through standard 3/8" tubing. | |
| The Orqis Pump Tubing is medical grade PVC tubing used to connect the Blood Pump to external devices. The Pump Tubing is provided sterile. | |
| Intended Use: | The Orqis Extracorporeal Blood Pumping System is intended to be used as a blood pumping unit in extracorporeal circulation for cardiac support that may, or may not, require cardiopulmonary bypass (for up to six hours). |
| The Orqis Pump Tubing is intended for use in extracorporeal circuits designed for cardiac support. | |
| Comparative Analysis: | The Orqis Extracorporeal Blood Pumping System has been demonstrated to be as safe and effective as the predicate device for its intended use. |
| Functional Testing: | The Orqis Extracorporeal Blood Pumping System has successfully undergone functional testing demonstrating equivalence to the predicate device |
| Conclusion: | The Orqis Extracorporeal Blood Pumping System is substantially equivalent to the predicate devices. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in capital letters. The seal represents the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Mr. Ryan Kelly Senior Regulatory Affairs Specialist Orqis Medical Corporation 14 Orchard Road, Suite 100 Lake Forest, CA 92630
K073631 Re:
Orqis® Extracorporeal Blood Pumping System Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-roller type Regulatory Class: Class III Product Code: KFM Dated: June 11, 2008 Received: June 13, 2008
Dear Mr. Kelly:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Ryan Kelly
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a dctermination 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. Kochner
A 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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1 Indications for Use Statement
510(k) Number (if known): K073631
Device Name: Orqis® Extracorporeal Blood Pumping System
Indications for Use:
The Orqis Extracorporeal Blood Pumping system is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants, etc).
The Orqis Pump Tubing is indicated for use in extracorporeal circuits for circulatory support lasting six-hours or less.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Jachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number.
Page 1 of 1
§ 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.