(120 days)
The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. The 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 support systems (for periods up to six hours) not requiring complete unloading of the ventricle during surgery of the vena cava or aorta, liver transplants etc).
The Levitronix CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in calculations and alarms. An alphanumeric screen is used to display monitored data. The CentriMag Back-Up Console uses single phase AC power and is capable of a flow rate of up to one of eld replaceable internal battery. In addition, each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power.
Here's an analysis of the provided text regarding the Levitronix CentriMag Back-Up Console, focusing on the requested aspects of acceptance criteria and study details.
Important Note: The provided text is a 510(k) summary for a medical device. These summaries are designed to establish "substantial equivalence" to a predicate device, not necessarily to provide detailed clinical trial data. Therefore, many of the requested data points (like specific sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, effect sizes, and detailed ground truth establishment for training) are not present in this type of document. The focus here is on demonstrating that the device performs similarly to a previously cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device in terms of functional characteristics. The "reported device performance" is a general statement of equivalency rather than specific metrics.
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance & Safety | The device must be "substantially equivalent" to the predicate device (Levitronix CentriMag Console, K020271) regarding indications for use, materials, design features, and functional characteristics. It should raise no new safety or effectiveness issues. | "The Levitronix CentriMag Back-Up Console has indications for use which are substantially equivalent to the predicate device, is composed of the same or equivalent materials as the predicate device, has equivalent design features as the predicate device, and has functional characteristics which are the same or equivalent to those of the predicate device. Due to the equivalency... the device raises no new safety or effectiveness issues." |
| Functional Characteristics | Must have functional characteristics "the same or equivalent to those of the predicate device." Differences are limited to flow and pressure capabilities and associated alarm schemes but ultimately must not impact substantial equivalence. (Implied: The back-up console's motor control, sensor monitoring, display outputs, and alarm functions perform as expected). | "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with the commercially available predicate device." (No specific metrics provided, but implies satisfactory comparison). |
| Power & Battery Functionality | Must use single phase AC power and capable of a flow rate of up to one [unit not specified, likely referring to flow through the system] - though this seems to be a typo for "flow rate up to a certain maximum." Must also contain a non-rechargeable, field-replaceable internal battery capable of maintaining functionality upon loss of AC power. | "The CentriMag Back-Up Console uses single phase AC power... Console contains a non-rechargeable, field-replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power." |
| Technological Characteristics | Must have technological characteristics similar to the predicate device, with differences limited to "flow and pressure capabilities and associated alarm scheme" that do not impact substantial equivalence. | "The Levitronix CentriMag Back-Up Console has technological characteristics similar to the predicate device. The differences between the proposed capabilities and associated alarm scheme are limited to flow and pressure capabilities and associated alarm scheme." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The summary only states that "The performance characteristics... were tested and compared with the... predicate device."
- Data Provenance: Not explicitly stated. Given it's a 510(k) for a device like a pump console, testing would typically involve bench testing and possibly animal or in-vitro models to compare performance characteristics. Clinical human data is not generally required for a 510(k) unless there are significant differences that raise new safety or effectiveness concerns. The summary does not mention any human or clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the 510(k) summary. For device performance testing of this nature (comparing functional characteristics), "ground truth" would likely refer to established engineering specifications, performance standards for the predicate device, or measurements obtained from gold-standard testing equipment, rather than expert consensus on interpretive data.
4. Adjudication Method for the Test Set
- This information is not provided as the type of study described (comparison of device performance characteristics) does not typically involve expert adjudication in the way medical imaging or diagnosis studies do.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., radiology images). The Levitronix CentriMag Back-Up Console is a cardiopulmonary bypass pump console, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in spirit, standalone performance was assessed. The testing described is intrinsic device performance ("performance characteristics... were tested and compared"). While the device assists human clinicians, its core function is automated (microprocessor control, sensor monitoring, alarm generation). The "standalone" testing here refers to the device operating according to its design specifications, not necessarily an AI algorithm. There is no mention of a human-in-the-loop study to evaluate its effectiveness.
7. The Type of Ground Truth Used
- Engineering Specifications / Established Performance of Predicate Device: The ground truth for this type of device comparison would be the independently verified performance specifications of the predicate device and the engineering requirements established for the new device. For example, if the predicate device has a specified flow rate accuracy, the new device would be tested against that established accuracy. The summary states, "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with the commercially available predicate device." This implies the predicate's performance serves as the "ground truth" or benchmark.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The device described is a hardware medical device with microprocessor control, not a machine learning or AI-driven system that would typically have a "training set" in the computational sense. Its functionality is based on programmed logic and physics, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reasons as #8.
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K 051209
SEP = 8 2005
510(k) Summary Attachment 4.
510(k) Summary for Levitronix CentriMag Back-Up Console
This summary of 510(k) safety and effectiveness information is being submitted
in the submitted of the Madinal Devices Act (SMDA) of 1990 and Title 21 of This summary of 510(c) salely and enections of 1990 and Title 21 of
in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of
the Safe Medical Province B in accordance with the Sale Medical Devices 7.0. (1.1.1.1.)
the Code of Federal Regulations, Part 807, and in particular §807.92.
Application Information: A.
| Date Prepared: | May 10, 2005 |
|---|---|
| Submitter's Name & Address: | Levitronix LLC45 First AvenueWaltham, MA 02451 |
| Contact Person: | Farzad ParsaieV.P., RA/QAPh: (781) 622-5075Fax: (781) 622-5090e-mail: fparsaie@levitronix.com |
Device Information: B.
| Trade or Proprietary Name: | Levitronix CentriMag® Back-Up Console |
|---|---|
| Common or Usual Name: | Cardiopulmonary Bypass PumpConsole |
| Classification Name: | Class II, DWA, 21 CFR - 870.4380Control, Pump Speed, CardiopulmonaryBypass |
| Performance Standard: | Performance standards do not currentlyexist for these devices. Noneestablished under section 514 of theFood, Drug and Cosmetic Act. |
C. Predicate Device:
Levitronix CentriMag Console (K020271)
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Device Description D.
The Levitronix CentriMag Back-Up Console is a microprocessor-based The Levitronix CentriMag Back-op Sonerates the primary Motor control signal, device. The microprocessor generates the pinhaly outputs, and provides
monitors system sensors, generates front display outputs, and provides monitors system sensors, generates the sensor data for use in
alarm functions. The microprocessor acquires the sensor data for used alarm functions. The fillcroprocessor acquires the summeric screen is used is to display monitored data.
The CentriMag Back-Up Console uses single phase AC power and is
care and is a mate of a c o a RM In addition, each Back-Up The CentriMag Back-Op Console associate in addition, each Back-Up capable of a liow Tate of up to one of eld replaceable internal battery Console contains a non-rechargeable, field vepass
that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power.
Intended Use ய்
The Levitronix CentriMag Back-Up Console is indicated for use with the The Levitronix CentriMag Back-Op Sonosia System and as a
Levitronix CentriMag Extracorporeal Blood Pumping System and as a Levitronix CentriMag Extracorporcur Drived Console. The Levitronix CentriMag back-up To the Centrilian Thinary Sononic ted to pump blood through Extracorporeal Blood Fulliping Oystem is instructeal circulatory support for the extracorporeal bypass cirodicter on existent more). It is also periods approphate to cardiopalmonaly by provinsystems (for periods indicated for use in extracorporound cardiopulmonary bypass (e.g., up to six frours) not requiring comport during mitral valve reoperation, surgery valvaloplacty, on or aorta, liver transplants etc).
Technological Characteristics г.
Levitronix CentriMag Back-Up Console has technological The The Levitronix - Ochanniag - Daily of Chicate device. The differences between Characteristics similar to the processes are limited to flow and pressure the proposed capabilities and associated alarm scheme.
The Levitronix CentriMag Back-Up Console is a microprocessor-based The Levillonix Ochthilag Back of generates the primary Motor control signal, device. The microprocessor gonerates front display outputs, and provides monitors system schools, gonerator from the sensor data for use in alami functions. The millions and alams. An alphanumeric screen is used to display monitored data.
The CentriMag Back-Up Console uses single phase AC power and is The CentriMag Backeop Consele association, each Back-Up Capable of a llow falls of up co on- field replaceable internal battery Console contains a non-roonary-k-Jp Console functionality in the event of a loss of AC Power.
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Comparison to Predicate Device G.
The Levitronix CentriMag Back-Up Console has indications for use which The Levitronix Centriviag Back-Op Console device, is composed of the is substantially equivalent to the predicate device, has equivalent same of equivalent materials as the produces functional characteristics
design features as the predicate device, and has functional characteristics. design features as the predicate ucvio, and neadicate device. Due to
which are the same or equivalent to those of the predicate design which are the same of equivalence to use, materials of composition, design the equivalency of indications for use, materials in the evice raises no new safety or effectiveness issues.
Summary of Performance Data H.
The performance characteristics of the Levitronix CentriMag Back-Up The performance characterisates of the Levith Levith Levith performance Console were lested and computed with the commercially available predicate device.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2005
Levitronix LLC c/o Mr. Farzad Parsaie VP, RA/QA 45 First Avenue Waltham, MA 02451
Re: K051209
CentriMag® Extracorporeal Blood Pumping System Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: KFM Dated: August 2, 2005 Received: August 3, 2005
Dear Mr. Parsaie:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premated is substantially equivalent (for the indications
referenced above and have determined the device is substant also in interstate referenced above and have decembed the arrived medicate devices marketed in interstate for use stated in the enclosue) to the enactment de of the Medical Device Amendments, or to commerce prior to May 28, 1970, the chacultence with the provisions of the Federal Food. Drug, devices that have been reciassince in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . The and Cosmetic Act (Act) that do not require approvate experal controls provisions of the Act. The You may, therefore, market the device, seejeer to the .
general controls provisions of the Act include requirements for annual registration and general controls provisions of the Fectiners required in against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (See above) this existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlis. Existing in and Register be found in the Code of Pouchal Regarines with the Federal Register.
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Page 2 - Mr. Farzad Parsaie
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a doterminations administered by other Federal agencies. You must of any I callared and regarantents, including, but not limited to: registration and listing (21 Comply with an the Hot STequirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 3500110 (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of provisions (sketing your device as described in your Section 510(k) This letter will anow you to organization of substantial equivalence of your device to a legally promatice notification: "The Dr. Interessification 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 If you desire spocific acries ion your 240) 276-0120. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uma R. lochner
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):
Device Name:
CentriMag® Back-Up Console
Indications For Use:
The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix The Levitronix Ochthing Back op Sping System and as a back-up to the CentriMag CentriMag Extracorpored. Blood Pamping of Extracorporeal Blood Pumping System is Frinary Gollson. The Ectirents Son.net contracorporeal bypass circuit for extracorporeal indicated to pump blood through the to cardiopulmonary bypass (up to six hours). circulatory support for ponous appropreal circulatory support systems (for periods up It is also indicated for ase in extraosme cardiopulmonary bypass (e.g., valvuloplasty, to 'six' nours', not 'requiring 'ochiple' outdiving surgery of the vena cava or aorta, liver transplants etc).
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Donna R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Kost 209
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.