(49 days)
Not Found
No
The description focuses on thermal-dilution principles and a catheter-based sensor for blood flow measurement, with no mention of AI or ML.
No
The device is described as a "meter and catheter" for "measurement of blood flow" and uses "thermal-dilution principles to calculate blood flow," indicating a diagnostic rather than therapeutic function. Its purpose is to verify flow "before, during, and after treatment," not to deliver treatment itself.
Yes
The device is described as measuring blood flow within a vascular bed to verify flow during angioplasty procedures. The measurement of physiological parameters for verification purposes is a diagnostic function.
No
The device description explicitly mentions both a "Transonic Angio Flow Meter" and a "catheter," indicating the presence of hardware components beyond just software.
Based on the provided information, the Transonic AngioFlow meter and catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device function: The Transonic AngioFlow meter and catheter is used to measure blood flow within a vascular bed during angioplasty procedures. This is an in vivo measurement, meaning it is performed inside the living body.
- Method of operation: The system uses a catheter-based sensor and thermal-dilution principles to calculate blood flow directly within the blood vessel. This is not a test performed on a sample taken from the body.
Therefore, the device's intended use and method of operation clearly place it outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Transonic AngioFlow meter and catheter are indicated for use during angioplasty procedures to verify the flow before, during, and after treatment. The system is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.
Product codes
DPW
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate Cosmetic Act, Transonic Angio Flow Meter and Catheter which is intended Commerce the Transonio Anglo wwwithin a vascular bed utilizing a catheterfor the measuremont of brosses thermal changes included by a based sensor. This consor of e and thermal-dilution principles to calculate blood flow in hemodialysis grafts. The patient contacting materials have been the same type as the pre with the EN Standard 30993 and/or USP class VI and are suitable for the intended use of this product. Biocompatibility is not applicable to the meter component of the system. The Diocompatibility is not dipindano to inolicable electrical safety requirements in accordance with the IEC 601 series of standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular bed
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
DEC 1 1 2003
510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
October 22, 2003
Transonic Systems Inc. 34 Dutch Mill Road Ithaca, NY 14850 Telephone Number: (607) 257-5300 Fax: (607) 257-7256 Contact: Mark S. Alsberge
Establishment Registration Number: 1319030
Transonic Anglo Flow Meter and Catheter Product Name: Thermodilution meter and catheter Trade Name: Classification name: Cardiovascular Blood Flowmeter Cardiovascular Class II, 74 DPW 21 CRF §870.2100
SUBSTANTIAL EQUIVALENCE TO:
| 11 11 11 11 11 12 12 11 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
| 510 (k) Number | Name | Applicant |
|---|---|---|
| K010253 | Transonic Anglo | |
| Flow Meter and | Transonic Systems Inc. | |
| Catheter |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate Cosmetic Act, Transonic Angio Flow Meter and Catheter which is intended Commerce the Transonio Anglo wwwithin a vascular bed utilizing a catheterfor the measuremont of brosses thermal changes included by a based sensor. This consor of e and thermal-dilution principles to calculate blood flow in hemodialysis grafts.
Indications for Use:
The Transonic Angio Flow Meter and Catheter indicated for use during angioplasty procedures to verify the flow before, during and after treatment. anglopasty prooodaroo to the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal bed utilizing a outherer base injection of normal saline and thermal-dilution principles to calculate blood flow.
1
KD 3342+
The Transonic Angio Flow Catheter is composed of materials that are the The Transonio Anglo Flow Sation. The patient contacting materials have been Samo type as the pro with the EN Standard 30993 and/or USP class VI and are suitable for the intended use of this product.
Biocompatibility is not applicable to the meter component of the system. The Diocompatibility is not dipindano to inolicable electrical safety requirements in accordance with the IEC 601 series of standards.
Substantial equivalence:
The Transonic Angio Flow Meter and catheters are similar in materials, form The Transonio Anglo he previous version of the Angio Flow meter and and intendod are no new issues of safety or effectiveness raised by the modifications to the Transonic Angio Flow Meter and Catheter.
Safety And Effectiveness:
All finished products are tested and must meet all required release specifications All firmshod products are rray of testing required for release includes, but is not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. The prysiour tooling to usines and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are rne testing instruction rocerce to d revised in accordance with document control cGMP's.
2
Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The text is in uppercase letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 11 2003
Transonic Systems, Inc. c/o Mr. Mark S. Alsberge VP Medical and Regulatory Affairs 34 Dutch Mill Road Ithaca. NY 14850
Re: K033424
Trade Name: Thermodilution Meter and Catheter Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: October 22, 2003 Received: November 12, 2003
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.
3
Page 2 - Mr. Mark S. Alsberge
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Elisa D. Harry for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1_
510(k) Number (if known): _ K0 33424
Device Name: _____Transonic AngioFlow Meter and Catheter
Indications for Use:
Prescription Use
The Transonic AngioFlow meter and catheter are indicated for use during angioplasty The Transons Tington for Hector and Juring, and after treatment. The system is intended procedures to verry the now ocrore, ating ,
for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tion of Cardiovascular Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K-033424
(Optional Format 3-10-98)