(414 days)
No
The document describes a physical catheter and its intended use for measuring physiological parameters. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is designed for monitoring physiological parameters and administering treatments, which are functions of a therapeutic device in critical care settings.
Yes
The device is designed to measure several physiological parameters such as cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures, and continuously monitor pulmonary artery temperature, which are diagnostic indicators of a patient's condition.
No
The device description clearly details a physical catheter with lumens, tubing, a hub, and a balloon, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in critical care patients to measure physiological parameters (cardiac output, pressures, temperature), sample blood, and administer drugs. These are all actions performed on the patient, not on a sample of the patient's body outside of the body.
- Device Description: The description details a catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic and monitoring device used directly on the patient.
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
DQO
Device Description
Blosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of catheter is either 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
Right atrium, pulmonary artery and pulmonary capillary
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 Thermodilution Catheter models with PU catheter tubing to evaluate the performance and integrity of the catheter in accordance to ISO 1055-1. Based on the per results which are of the acceptance cifleria, the design construction of the catheter with PU tubing meets the ISO10555-1 standard.
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 themodilution catheter, with PU catheter tubing, is blocompatible and safe for its intended usa.
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
§ 870.1200 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 a 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 written in a bold, sans-serif font below the symbol.
SPECIAL 510K
Paga
510K SUMMARY [As required by section 807.92(c)]
JAN - 5 2010
Revised on 2 December 2009
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 (K911710)
4. Device Description
Blosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of catheter is either 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.
કે. Intended Use
Blosensors 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/1 description: The image shows a logo for Biosensors International. The logo consists of a stylized letter "M" stacked on top of the words "BIOSENSORS INTERNATIONAL". The letter "M" is made up of three horizontal bars connected by vertical lines. The text is in a bold, sans-serif font.
6. Summary of Technological Characteristics of Device in relation to Predicate Devices(s)
Biosensors Thermodilution catheter product family included in 510K (K911710) is currently licensed for heparin-coated them of addin and intelled in 5700 (KB11710) is currently
goolication involves the including of additions of additions to of the application involves the inclusion of additional models of Themodilution Catheler where the catheter is designed with the non-coated PU catheter tubing.
Comparison was made for the above models against those that have already been licensed in K911710. The additional cather models have the same intended use and design construction with equivalent components as the predicated catheter models which models with the new mated with a ballon. The safety and efficiency of the subject device models with the new material type have been assessed and discussed further in Section 7 below.
7. Assessment of Performance Data used to justify Substantial Equivalence
Test Summary, In-vitro
Models with non-coated PU catheter tubing
Inclusion of the category of models is to provide an alternative to physician who prefers a different tautness of the catheter tubing.
Functionality performance tests were performed on the Thermodilution Catheter models with PU catheter tubing to evaluate the performance and integrity of the catheter in accordance to ISO 1055-1. Based on the per results which are of the acceptance cifleria, the design construction of the catheter with PU tubing meets the ISO10555-1 standard.
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 themodilution catheter, with PU catheter tubing, is blocompatible and safe for its intended usa.
8. Conclusion:
The Functionality Tests and Blocompatibility tests have demonstrated that the Biosensors Themodilution catheter that is substantially equivaled the predicated devices is safe and effective for its intended use.
2
| PREMARKET NOTIFICATION | THERMODILUTION CATHETER | |||
|---|---|---|---|---|
| BIOSENSORS INTERNATIONAL | SPECIAL 510K | Page | 3 of 3 |
510K Substantial Equivalence Decision-Making Tree
Image /page/2/Figure/2 description: This image is a flowchart titled "510(k) "Substantial Equivalence" Decision-Making Process (Overview)". The flowchart outlines the steps for determining if a new device is substantially equivalent to a marketed device. The process begins with comparing the new device to a marketed device and proceeds through a series of questions about intended use, technological characteristics, and performance equivalence, ultimately leading to a determination of substantial equivalence or a need for more information.
Decision to substantial Equivalence is based on 510(k) Mamorandum #486-3. 510(k). Questions in the decision path are evaluated as follow:
Q1. Does New Device have same Intended use?
Yes. The intended use of the naw 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 is 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 to the Modification to the device also showed the equivalence subject models and predicated models.
Conclusion:
As according to the decision path, the new models of Thermodiation Catheter can be submitted using substantial Equivalence.
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The figure is abstract and appears to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 2 3 2010
Biosensors International Pte., Ltd. c/o Mr. Moses Tham Quality Assurance Manager 21 Kallang Avenue #07-165/171 Singapore, 339412
Re: K083384
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: DQO Dated: December 2, 2009 Received: December 7, 2009
Dear Mr. Tham:
This letter corrects our substantially equivalent letter of January 5, 2010.
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.
4
Page 2 - Mr. Moses Tham
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 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): J. K083384
THERMODILUTION CATHETER AND ACCESSORIES Device Name: . _ _ .
· 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)
W.M.F.
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number.
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