(236 days)
The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. 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.
This 510(k) submission (K080116) for the Transonic COstatus System surprisingly does not include any explicit acceptance criteria or a detailed study section demonstrating the device's performance against such criteria. Instead, the submission relies heavily on a claim of substantial equivalence to predicate devices (K023960 and K980906) and general statements about internal testing and manufacturing processes.
Therefore, many of the requested sections about specific study design parameters cannot be filled as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence rather than defining specific performance metrics and acceptance thresholds for the new device. | Not explicitly stated as performance against defined acceptance criteria. The document states that "All finished products are tested and must meet all required release specifications before distribution," including "physical testing" and "visual examination." It also mentions "product performance parameters conform to the product design specifications." However, what these specifications are and the results of testing against them for the COstatus System are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. No specific test set for performance evaluation is described.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable, as there's no mention of a clinical or expert-validated test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no test set requiring ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, nor does it mention evaluating human reader improvement with or without AI assistance. The device is a diagnostic computer for cardiovascular status, not an AI-assisted diagnostic imaging or interpretation tool in this context.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No specific standalone performance study comparing the algorithm's output to a ground truth with quantitative metrics is described. The device is described as an "apparatus using an indicator dilution technique" to measure fluid volumes, implying a direct measurement system rather than a complex algorithm whose standalone performance would typically be evaluated in isolation.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated or described. The document refers to "product design specifications" for performance parameters, but not how these were validated externally or against an established ground truth.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is not described as an AI/ML product that undergoes a "training" phase.
9. How Ground Truth for Training Set Was Established
- Method for Establishing Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model.
Summary of the Study:
Based on the provided text, the submission for the Transonic COstatus System does not describe a traditional clinical performance study with explicit acceptance criteria, a defined test set, or a ground truth established by experts. Instead, the entire submission hinges on demonstrating substantial equivalence to two predicate devices:
- K023960: LiDCOplus Hemodynamic Monitor
- K980906: Transonic Hemodialysis Monitor, Cardiac Output (Measurement)
The primary "study" or evidence presented for safety and effectiveness is through this comparison, highlighting:
- Similar Materials, Form, and Intended Use: The COstatus System is stated to be similar to the HD01 (K980906) in these aspects.
- Mechanism of Action: Both the COstatus and the HD01 use an indicator dilution technique. The COstatus differs from the HD01 by using a peristaltic pump instead of a hemodialysis circuit, allowing for use on any patient with arterial and venous lines.
- Comparison to LiDCOplus (K023960): The COstatus also uses a peristaltic pump like the LiDCOplus, but uses saline as an indicator instead of lithium chloride. Crucially, the COstatus runs as a closed loop, returning drawn blood to the patient, unlike the LiDCOplus which does not.
- Conclusion on Differences: The submission states that these differences "do not raise any new issues of safety or effectiveness regarding the Transonic COstatus System."
- Internal Testing: The document mentions that "All finished products are tested and must meet all required release specifications before distribution," including "physical testing" and "visual examination" to ensure performance parameters conform to "product design specifications." However, these specifications and specific results are not detailed.
In essence, the "study" proving the device meets criteria is primarily the argument for substantial equivalence based on engineering design comparison and internal product quality control, rather than a clinical trial with performance metrics.
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510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
May 17, 2008
| Transonic Systems Inc. | |
|---|---|
| 34 Dutch Mill Rd | Telephone: (607) 257-5300 |
| Ithaca, NY | Fax: (607) 257-7256 |
| Contact: | Mark S. Alsberge |
|---|---|
| ---------- | ------------------ |
Product Name: Transonic COstatus System
Classification name: Single-Function, Preprogrammable Diagnostic Computer Circulatory System Devices Panel Class II, 74 DXG 21 CFR §870.1435
SUBSTANTIAL EQUIVALENCE1 TO:
| 510 (k) Number | Name | Applicant |
|---|---|---|
| K023960 | LiDCOplus HemodynamicMonitor | LiDCO Limited |
| K980906 | Transonic HemodialysisMonitor, Cardiac Output(Measurement) | Transonic Systems Inc. |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. 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.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact the from an marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent to this product or the technology used to manufacture the product.
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Material:
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.
This COstatus system consists of the following components;
HCM101 Cardiac output meter HC2T Sensors ADT2005D AV-Loop tubing set ADT2005E AV-Loop tubing set HCS3002 Sensor Tubing Adaptor HCP01 AV-Loop Pump HFW1000 Fluid Warmer HCR01 Printer HCMD01 Data Transfer Module
Substantial equivalence:
The Transonic COstatus System is similar in materials, form and intended use to the Transonic Hemodialysis Monitor, Cardiac Output HD01 system which can measure CO during a Hemodialysis treatment currently marketed by Transonic Systems Inc. cleared by the under K980906 and the LiDCOplus Hemodynamic Monitor cleared by K023960. The difference between COstatus system and the HD01 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 settings such as an ICU. The LiDCOplus Hemodynamic Monitor also uses a small peristaltic pump, but uses lithium chloride as an indicator whereas the COstatus uses 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 Transonic COstatus System.
Safety and Effectiveness:
All 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
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with three wavy lines below them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 0 8 2008
SEP 08 2008
Rockville MD 20850
Transonic Systems, Inc. c/o Mr. Mark S. Alsberge VP Medical and Regulatory Affairs 34 Dutch Mill Road Ithaca, NY 14850-9787
Re: K080116
Trade/Device Name: Transonic COStatus System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: September 4, 2008 Received: September 4, 2008
Dear Mr. Alsberge:
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.
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
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Page 2 - Mr. Mark S. Alsberge
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 Biometrics' (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 yours.
Ondley B. Bour
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): K080116 _Transonic COSTATUS System ___________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use:
The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Prescription Use · Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The -Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Ashley Bra for BZ
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Numbe
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§ 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).