(255 days)
The Transonic COstatus system is indicated for use in patients 1 month or older with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
The proposed device is a variation of the COstatus system (K080116) which can measure the same parameters in patients 2 years and above. The COstatus system uses a peristaltic pump to circulate a small volumes blood passed the sensors rather than using a hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
This document is a 510(k) summary for the Transonic COstatus System for Infants. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It states that the device is safe and effective based on safety testing, and animal and clinical validation studies. However, this document does not contain explicit acceptance criteria tables or detailed results of specific studies with performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case study information.
The document discusses the following:
1. Table of acceptance criteria and reported device performance:
The document states that "Prior to shipment, the finished products are tested and must meet all required release specifications before distribution." and that "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications." However, it does not provide any specific acceptance criteria (e.g., accuracy thresholds, precision limits) or quantitative performance results (e.g., mean absolute error, correlation coefficients) for cardiac output measurement.
2. Sample sized used for the test set and the data provenance:
The document mentions "animal and clinical validation studies were also performed to establish equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution, etc." However, it does not specify the sample size (number of animals or patients) or the data provenance (e.g., country of origin, retrospective/prospective nature) for these studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document refers to "standard clinical methods such as thermodilution" for comparison. This implies that the ground truth would be established by these methods. However, it does not mention any "experts" in the context of establishing ground truth for the test set, nor does it specify the number or qualifications of any such experts.
4. Adjudication method:
Given that expert consensus is not explicitly mentioned for ground truth, no adjudication method is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
The COstatus system measures physiological parameters and is not an imaging device typically evaluated with MRMC studies comparing human reader performance. Therefore, no MRMC comparative effectiveness study is mentioned or implied.
6. Standalone performance:
The COstatus system is designed to directly measure physiological parameters. Its performance, as implied by "animal and clinical validation studies," would be its standalone performance against a ground truth method. The document states that "equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution" was established. This implicitly refers to standalone performance, but no quantitative results are provided.
7. Type of ground truth used:
The ground truth used was "standard clinical methods such as thermodilution."
8. Sample size for the training set:
The document makes no mention of a training set. The COstatus system is a device based on "indicator dilution techniques," which usually implies a direct measurement principle rather than a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
As no training set is mentioned, this information is not applicable or provided.
In summary, this 510(k) document provides high-level information about the safety and effectiveness of the Transonic COstatus System for Infants, but lacks the specific detailed study results and acceptance criteria typically found in more comprehensive device performance reports. The focus is on demonstrating substantial equivalence to predicate devices and adherence to safety standards.
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510(k) SUMMARY Summary of Safety & Effectiveness
SEP 7 2012
Pre-
Submitter's Name & Address: Transonic Systems Inc 34 Dutch Mill Road, Ithaca, NY 14850
Contact Person & Telephone:
Naveen Thuramalla 607-257-5300 (*326)
Date Summary Prepared:
Dec 12, 2011
monitor
Device Name:
K080116: Transonic COstatus cardiac output system (for use with 2 years and older patients)
Common/Usual Name: Cardiac output, Hemodynamic
K980906: Transonic hemodialysis monitor. Cardiac
Classification Name: Computer, Diagnostic,
programmed, Single-function, 21 CFR 870.1435. Product Class and Code: DXG and Class II
Proprietary Name: COstatus System for Infants
Classification Panel: Cardiovascular
K023960: LIDCOPLUS hemodynamic monitor svstem
Device Description:
Predicate Devices:
In accordance with section 510(k) for the Federal Food. Drug, and Cosmetic Act. Transonic Systems Inc. introduce into interstate commerce the Transonic COstatus system for use with infants and older, which is an apparatus based on indicator dilution techniques for the measurement of cardiac output; blood volumes and other associated hemodynamic parameters. The proposed device is a variation of the COstatus system (K080116) which can measure the same parameters in patients 2 years and above. The COstatus system uses a peristaltic pump to circulate a small volumes blood passed the sensors rather than using a hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. These
34 Dutch Mill Rd., Ithaca, NY 14850-9787 USA; Tel: 800-353-3569, 607-257-5300 Fax: 607-257-7256; Internet: www.transonic.com
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patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
Components:
The components of the Transonic COstatus system are made of materials, which have been tested in accordance with the ISO Standard 10993 appropriate to their patient contact and therefore suitable for the intended use of this product.
Model/Part # Description HCM101 Cardiac output monitor/meter HC2T Sensors ADT2005D Arteriovenous (AV) Loop - Tubing Set ADT2005E Arteriovenous (AV) Loop - Tubing Set ADT2006E Arteriovenous (AV) Loop - Tubing Set ADT1020 Extension Set/ Sensor Adapter Tubing HCS3011 AV Loop kit with ADT2005D AV Loop HCS3021 AV Loop kit with ADT2005E AV Loop HCS3022 AV Loop kit with ADT2006E AV Loop HCS3002 Sensor Adapter Tubing Pack with ADT1020 HCP01 AV Loop Pump HCR01 Printer HFW1000 Fluid Bag Warmer
Data Transfer Module
COstatus system consists of the following components:
Substantial Equivalence:
HCMD01
The Transonic COstatus System for use with Infants is similar in materials, form and intended use to the Transonic COstatus Cardiac Output system (K080116) and to Transonic Hemodialysis Monitor, Cardiac (K980906) which are used in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. Both these devices are marketed by Transonic Systems Inc. The device is also equivalent to the LIDCOplus hemodynamic monitoring system cleared by K023960 and marketed by LiDCO, Ltd.
The difference between COstatus system cleared by K080116 and the proposed device is that the new system would allow use of the system with infants (1 month of age and above) while the previous system was cleared for use with patients 2 years and above.
The difference between COstatus system and the HDO1 is that the COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. The system can be used on patients in other clinical
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settings such as an ICU, OR, etc. The LiDCOplus Hemodynamic Monitor also uses a small peristaltic pump, but uses lithium chloride as an indicator whereas the COstatus uses normal saline. The LiDCOplus Hemodynamic Monitor does not return withdrawn blood to the patient, but the COstatus runs as a closed loop returning all drawn blood, These differences do not raise any new issues of safety or effectiveness regarding the use of Transonic COstatus System with infants and above.
Safety and Effectiveness:
The COstatus monitoring system is deemed to be safe and effective based on the safety testing conducted in accordance with the IEC 60601-1 standard and the electromagnetic compatibility test report.
In addition to the bench testing, animal and clinical validation studies were also performed to establish equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution, etc.
Prior to shipment, the finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include. but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 7 2012
Transonic Systems, Inc. Mr. Naveen Thuramalla 34 Dutch Mill Road Ithaca, NY 14850
Re: K113821
Trade/Device Name: Transonic COstatus Cardiac Output System Regulation Number: 21 CFR 870.1435 Regulation Name: Single Function Pre-programmed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: August 16, 2012 Received: August 17, 2012
Dear Mr. Thurmalla:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. Naveen Thuramalla
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
KL
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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K113821
Pg. 1 of 1
Indications for Use Statement
510(k) Number (if known):
Device Name: Transonic Systems COstatus System for use with Infants
Indications for Use:
The Transonic COstatus system is indicated for use in patients 1 month or older with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
10 2
Division of Cardiovascular Devices
510(k) Number K113821
Page 1 of 1
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).