(255 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on a peristaltic pump and sensor technology for hemodynamic measurements.
No.
The description indicates its use for "diagnostic assessment of cardiovascular status" and measuring "hemodynamic parameters," which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the 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." This clearly indicates a diagnostic purpose.
No
The device description explicitly mentions a "peristaltic pump" and "sensors," indicating the presence of hardware components beyond just software.
Based on the provided information, the Transonic COstatus system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the Transonic COstatus system indicates it directly measures parameters in patients with arterial and venous lines by circulating a small volume of blood past sensors. This is a direct measurement within the patient's circulatory system, not an examination of a specimen outside the body.
- The intended use is for diagnostic assessment of cardiovascular status in patients. This reinforces that the device is used directly on the patient, not on a sample taken from the patient.
- The device description mentions using a peristaltic pump to circulate blood past sensors. This is a method of direct measurement within the patient's blood flow.
Therefore, the Transonic COstatus system is a medical device used for in vivo (within the living body) diagnostic assessment, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
DXG
Device Description
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 patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
1 month or older
Intended User / Care Setting
ICU, OR or other such environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Transonic Systems Inc. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "The Flow Measurement Specialists."
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
1
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
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which are arranged in a circular fashion around the emblem. The overall design is simple and conveys a sense of authority and service.
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
4
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
5
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