(17 days)
Not Found
No
The document describes a physical catheter and its functionality for measuring physiological parameters, with no mention of AI or ML algorithms for data analysis or interpretation.
Yes
The device is designed to measure physiological parameters (cardiac output, pressures), administer drugs, and sample blood, which are therapeutic interventions in critical care.
Yes
The device is designed to "measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures," which are diagnostic measurements used to assess a patient's physiological state.
No
The device description clearly details a physical catheter with lumens, a hub, and a balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device 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 provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a catheter designed for in-vivo use (within the body). Its functions include:
- Measuring pressures (cardiac output, right atrium, pulmonary artery, pulmonary capillary wedge).
- Continuously monitoring temperature.
- Sampling blood (this is a collection method, not an in-vitro test performed by the device itself).
- Administering drugs and solutions.
- Measuring cardiac output via external computers.
- No Mention of In-Vitro Testing: The description focuses on the physical characteristics of the catheter and its use within the patient's circulatory system. There is no mention of the device performing any tests on samples outside of the body.
Therefore, the Biosensors flow-directed Thermodilution catheter is an invasive medical device used for monitoring and intervention within the body, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Biosensors flow-directed Thermodilution catheter is designed for use in the critical care patients to measure right atrium, pulmonary artery and pulmonary capillary wedge pressure; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computer which interfaces with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients.
The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
Product codes (comma separated list FDA assigned to the subject device)
DOO
Device Description
Biosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of cather of 90 or 110 cm. The extensions include a proximal, a distal, a thermistor and an inflation extension, where the distal end of the inflation extension ends with a tip mounted with a balloon.
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
pediatric and adult patients
Intended User / Care Setting
critical care patients
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)
Functionality performance tests were performed on the synthetic latex balloon mounted on the Thermodilution catheter to evaluate the performance and integrity of the synthetic latex balloon. Based on the test results which are of the accepted criteria, the synthetic latex balloon is concluded to be safe and effective for its intended use.
Biocompatibility tests were performed in accordance to ISO10993-1 Part 1: Evaluation & Testing and USP 27 Biological Reactivity Tests, In Vivo and was proven that the Thermodilution catheter, with synthetic latex balloon, is biocompatible and safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Biosensors International. The logo consists of a stylized symbol above the company name. The symbol is made up of three horizontal lines that are connected by vertical lines, forming a shape that resembles the letter 'B'. The text 'BIOSENSORS INTERNATIONAL' is printed in a simple, sans-serif font below the symbol.
SPECIAL 510K
K10/669
510K SUMMARY [As required by section 807.92(c)/
JUL. - 1 2010
Amended on 24 June 2010 1. Applicant Information
| Company Address: | Biosensors International Pte Ltd |
|---|---|
| 21 Kallang Avenue #07-165/171 | |
| Singapore 339412 | |
| Registration Number: | 8043983 |
| Contact Person: | Moses Tham |
| Telephone: | (+65) 6411 0506 |
| Facsimile: | (+65) 6298 6242 |
2. Device Identification
| Trade Name: | Thermodilution Catheter and Accessories |
|---|---|
| Classification Name: | Diagnostic Intravascular Catheter |
3. Predicate Devices
Thermodilution Catheter and Accessories (K083384)
4. Device Description
Biosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of cather of 90 or 110 cm. The extensions include a proximal, a distal, a thermistor and an inflation extension, where the distal end of the inflation extension ends with a tip mounted with a balloon.
5. Intended Use
Biosensors flow-directed Thermodilution catheter is designed for use in the critical care patients to measure right atrium, pulmonary artery and pulmonary capillary wedge pressure; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computer which interfaces with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients.
The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
1
Image /page/1/Picture/2 description: The image shows the logo for Biosensors International. The logo consists of a stylized symbol above the company name. The symbol is made up of three stacked shapes that resemble the letter 'B'. The text 'BIOSENSORS INTERNATIONAL' is written in a simple, sans-serif font, with 'BIOSENSORS' on the top line and 'INTERNATIONAL' on the bottom line.
Summary of Technological Characteristics of Device in relation to Predicate 6. Devices(s)
Biosensors Thermodilution catheter product family included in 510K (K083384) is currently licensed for heparin-coated Thermodilution catheter with PVC catheter tubing and noncoated Thermodifution catheter with PU catheter tubing, mounted with natural latex balloon.
This application involves the inclusion of additional models of Thermodifution Catheter where the Thermodilution catheter is mounted with synthetic latex balloon.
Comparison is made for the above models against those that have already been licensed in K083384. The additional catheter models have the same intended use and design construction with equivalent components as the predicated catheter models which has its distal end mounted with a balloon. The safety and efficiency of the subject device models with the new balloon material type have been assessed according to the standards for preclinical testing, as listed in the below table, which are also discussed in Section 7 below.
| Standard Number | Title of Standard |
|---|---|
| ISO 594/2 | Conical Fittings with 6% (luer) taper for syringes, needles and |
| certain other medical equipments - Part 2: Lock fittings | |
| ISO10555-1 | Sterile, single-use intravascular catheters |
- Part 1: General Requirements |
| ISO10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing |
7. Assessment of Performance Data used to justify Substantial Equivalence
Test Summary, In-vitro
Models with synthetic latex balloon at distal tip
Inclusion of this category of models is to provide an alternative to physicians when handling patients who are allergic to the protein in the natural latex material.
Functionality performance tests were performed on the synthetic latex balloon mounted on the Thermodilution catheter to evaluate the performance and integrity of the synthetic latex balloon. Based on the test results which are of the accepted criteria, the synthetic latex balloon is concluded to be safe and effective for its intended use.
Test Summary, Biocompatibility
Biocompatibility tests were performed in accordance to ISO10993-1 Part 1: Evaluation & Testing and USP 27 Biological Reactivity Tests, In Vivo and was proven that the Thermodilution catheter, with synthetic latex balloon, is biocompatible and safe for its intended use.
2
| PREMARKET NOTIFICATION |
|---|
| ------------------------ |
| BIOSENSORS INTERNATIONAL |
|---|
| -------------------------- |
| THERMODILUTION CATHETER |
|---|
| ------------------------- |
| SPECIAL 510K |
|---|
| -------------- |
| Section 8 | Page 3 of 4 |
|---|---|
| ----------- | ------------- |
8. Conclusion:
The Functionality Tests and Biocompatibility tests have demonstrated that the Biosensors Thermodilution catheter that is substantially equivalent to the predicated devices is safe and effective for its intended use.
3
| PREMARKET NOTIFICATION | |
|---|---|
| BIOSENSORS INTERNATIONAL | SPECIAL 510K |
| THERMODILUTION CATHETER | |
| Section 8 | |
| Page 4 of 4 |
510K Substantial Equivalence Decision-Making Tree
Image /page/3/Figure/2 description: This image is a flowchart outlining the 510(k) "Substantial Equivalence" Decision-Making Process. The process starts with comparing a new device to a marketed device. The flowchart then asks a series of questions, such as "Does New Device Have Same Intended Use?" and "Does Descriptive or Performance Information Demonstrate Equivalence?" The process leads to a determination of either "Substantially Equivalent" or "Not Substantially Equivalent."
Questions in the decision path are evaluated as follow:
Q1. Does New Device have same intended use?
Yes. The intended use of the new range of models is the same as the models currently listed.
Q2. Does New Device have Technological Characteristics that raise new types of Safety or effectiveness questions?
No. New models are of the same design construction as the models currently listed.
Q3. Does descriptive or Performance information demonstrate equivalence?
Yes. The product description and the intended use on the Instruction for Use between the subject models and predicated models demonstrated the essential equivalence. The physical and performance characteristics evaluated in Table 2 in the Section 10 - Description of Modification to the device also showed the equivalence between the subject models and predicated models.
Conclusion:
As according to the decision path, the new models of Thermodilution Catheter can be submitted using substantial Equivalence.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUL - 1 2010
Biosensors International Pte., Ltd. c/o Mr. Moses Tham Director, Quality Assurance and Regulatory Affairs 21 Kallang Avenue #07-165/171 Singapore, SINGAPORE 339412
Re: K101669
Trade/Device Name: Thermodilution Catheter and Accessories Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DOO Dated: June 2, 2010 Received: June 14, 2010
Dear Mr. Tham:
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 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
5
Page 2 - Mr. Moses Tham
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K101669
Device Name: THERMODILUTION CATHETER AND ACCESSORIES
Indications for Use:
Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients.
The tips of the catheters are mounted with a latex balloon which, when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K101669
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