(394 days)
The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation: Oxygenator Blood Volume and other 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 ELSA system, which is an apparatus based on transit time ultrasound indicator dilution techniques that provides clinically relevant data to healthcare providers treating patients undergoing Extracorporeal Life Support Procedures. The clinically relevant data (such as delivered flow, recirculation, oxygenator blood volume and other related hemodynamic parameters), shall indicate the efficacy of such procedures and quantify the patient's hemodynamic status. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
The provided text includes a 510(k) summary for the Transonic ELSA System, outlining its substantial equivalence to predicate devices and detailing bench testing. However, it does not contain the specific acceptance criteria or the full study details to definitively answer all parts of your request.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The ELSA system (HCE101) 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." and "Prior to shipment, the finished product will be tested and must meet all required release specifications before distribution."
- Acceptance Criteria (General): Safe and effective; compliance with IEC 60601-1 standard; electromagnetic compatibility test report; meeting all required release specifications (physical testing and visual examination).
- Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined acceptance criteria are provided in this summary. It states "These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications," but doesn't list the parameters or their achieved values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The testing mentioned is "bench testing," meaning it was likely conducted in a laboratory setting. No patient data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/not specified. The testing described is bench testing, not a clinical study involving experts establishing ground truth from patient data.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. This is typically relevant for clinical studies involving multiple readers, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study is mentioned. This device is described as a diagnostic monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The testing described is "bench testing" focusing on safety, electromagnetic compatibility, and conformity to product design specifications. This implies standalone device performance testing, but the specific metrics are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench testing, the "ground truth" would likely be instrument calibration standards, reference measurements (e.g., using established flow meters), or predefined physical standards for visual and physical examinations. No patient-derived ground truth (like expert consensus or pathology) is mentioned because this was bench testing, not a clinical study.
8. The sample size for the training set
- Sample Size: Not applicable. The document describes a medical device, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized caduceus with three human profiles incorporated into the design, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2015
Transonic Systems Inc. Naveen Thuramalla VP, Engineering & Clinical Studies 34 Dutch Mill Road Ithaca, NY 14850
Re: K134051
Trade/Device Name: Transonic ELSA System Regulation Number: 21 CFR 870.1435 Regulation Name: Computer, Diagnostic, Pre-programmed, Single-function Regulatory Class: II Product Code: DXG Dated: December 26, 2014 Received: December 29, 2014
Dear Naveen Thuramalla:
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
{1}------------------------------------------------
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
M.A. Hillebrand
for Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K134051
Device Name
ELSA (Extracorporeal Life Support Assurance) System
Indications for Use (Describe)
The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation: Oxygenator Blood Volume and other associated hemodynamic parameters.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
| Submitter's Name & Address: | Transonic Systems Inc34 Dutch Mill Road,Ithaca, NY 14850 |
|---|---|
| Contact Person & Telephone: | Naveen Thuramalla607-257-5300 (*326) |
| Date Summary Prepared: | January 28, 2015 |
| Device Name: | Classification Name: Computer, Diagnostic, Pre-programmed, Single-function, 21 CFR 870.1435.Product Class and Code: DXG and Class IIClassification Panel: CardiovascularCommon/Usual Name: Extracorporeal, DiagnosticmonitorProprietary Name: Transonic ELSA System |
| Predicate Devices: | K960817: HD01-SERIESTRANSONIC HEMODIALYSIS MONITORK113821: TRANSONIC COstatus Cardiac OutputSystem |
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 ELSA system, which is an apparatus based on transit time ultrasound indicator dilution techniques that provides clinically relevant data to healthcare providers treating patients undergoing Extracorporeal Life Support Procedures. The clinically relevant data (such as delivered flow, recirculation, oxygenator blood volume and other related hemodynamic parameters), shall indicate the efficacy of such procedures and quantify the patient's hemodynamic status. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
Components:
ELSA system consists of the following components:
{4}------------------------------------------------
| Model/Part # | Description |
|---|---|
| HCE101 | ELSA monitor/meter |
| HnFX | - Sensor pair configuration (H6FX; H7FX; H9FX.Other sizes such as H5FX are possibledepending on the size of the tubing used byclinicians with extracorporeal circuits).- Single head sensor configuration could also beused with ELSA system. |
| HFW1000 | Fluid Bag Warmer |
| HCED01 | Data Transfer Module |
Substantial Equivalence:
The Transonic ELSA System for use with patients undergoing extracorporeal life support procedures is similar to the HD01- Series Transonic Hemodialysis Monitor (K960817) which is used in the diagnostic assessment of delivered blood flow, and recirculation. Both systems use clamp-on sensors placed on standard extracorporeal circuits to obtain diagnostic measurements.
Oxygenator blood volume (OXBV) measurement by ELSA system is similar to Central blood volume (CBV) measurement by Transonic COstatus Cardiac Output System (K113821). Both represent the volume between point of injection and point of detection of the indicator. The two systems are also similar in terms of touch screen device, onscreen user instructions, and measurement trend plots on the screen.
Both HD01 and COstatus devices are manufactured and marketed by Transonic Systems Inc. All three systems (ELSA, HD01 and COstatus) are based on transit time ultrasound dilution principles.
The difference between COstatus system and the proposed ELSA system is that the ELSA system would allow use of the system with patients being treated on extracorporeal life support procedures while COstatus system could be used with patients with in-situ arterial and venous catheters. COstatus measured CBV is the volume between injection site and recording site and includes the volume of blood in the heart, lungs and large vessels. Whereas, ELSA measured OXBV is the volume between injection site and recording site and includes the volume of blood in the oxygenator and any tubing in between the sensors.
The difference between ELSA system and the HD01 is that the ELSA system would be used with patients undergoing extracorporeal life support procedures while HD01 would be used with patients undergoing dialysis procedures.
{5}------------------------------------------------
These differences do not raise any new issues of safety or effectiveness regarding the use of Transonic ELSA System.
Bench Testing:
The ELSA system (HCE101) 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, bench testing was conducted by Transonic Systems Inc. and the validation report can be found in Section 18 of this 510(k) submission. Prior to shipment, the finished product will be tested and must meet all required release specifications before distribution. The array of testing required for release includes, but are not limited to: physical testing and 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 product's 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.
Conclusion:
Based on the information provided above, we conclude that the Transonic ELSA system is substantially equivalent to the predicate devices.
§ 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).