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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The provided document describes a Thermodilution Catheter and Accessories that has been modified to include models with a synthetic latex balloon instead of a natural latex balloon. The assessment is to demonstrate substantial equivalence to previously licensed devices (K083384).

The acceptance criteria are not explicitly detailed with numerical thresholds for performance metrics. Instead, the document states that "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." Similarly for biocompatibility, it states it "was proven that the Thermodilution catheter, with synthetic latex balloon, is biocompatible and safe for its intended use."

The document focuses on demonstrating that the new synthetic latex balloon material does not negatively impact the performance characteristics or safety of the device, maintaining equivalence to the predicate device.

Table 1: Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Functionality Performance (In-vitro)	The synthetic latex balloon, when mounted on the Thermodilution catheter, must demonstrate performance and integrity equivalent to the natural latex balloon predicate device, ensuring safe and effective use. (Implied: No degradation in balloon inflation/deflation, pressure capabilities, or resistance to damage during intended use compared to predicate).	"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." The new models "have the same intended use and design construction with equivalent components as the predicated catheter models." "The physical and performance characteristics evaluated... also showed the equivalence between the subject models and predicated models."
Biocompatibility	The Thermodilution catheter with the synthetic latex balloon must be biocompatible and safe for its intended use, conforming to established biological evaluation standards. (Implied: No adverse biological reactions, toxicity, or sensitization). Specifically, compliance with ISO10993-1 Part 1: Evaluation & Testing and USP 27 <88> Biological Reactivity Tests, In Vivo.	"Biocompatibility tests were performed in accordance to ISO10993-1 Part 1: Evaluation & Testing and USP 27 <88> Biological Reactivity Tests, In Vivo and was proven that the Thermodilution catheter, with synthetic latex balloon, is biocompatible and safe for its intended use."
Technological Characteristics	The new device models with synthetic latex balloons should not introduce new safety or effectiveness questions compared to the predicate device. (Implied: Material change should not alter critical mechanical, electrical, or chemical properties in a way that creates new risks or compromises established performance).	"No. New models are of the same design construction as the models currently listed." "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."

Study Details:

The document describes pre-clinical testing (in-vitro functionality and biocompatibility) rather than a clinical study involving human patients or a complex algorithm performance study.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "functionality performance tests" and "biocompatibility tests" being conducted on the "synthetic latex balloon mounted on the Thermodilution catheter." This implies a set of physical samples of the device and its synthetic latex balloon.
- Data Provenance: The tests are described as "In-vitro," meaning they were conducted in a laboratory setting, not from human patients. The applicant company, Biosensors International Pte Ltd, is based in Singapore, so the testing likely occurred there or at a contract lab. Whether the data is retrospective or prospective is not applicable in the context of in-vitro bench testing; it would be prospective for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable or not specified. For in-vitro functionality tests, the "ground truth" is typically objective measurements (e.g., pressure, volume, tensile strength, resistance to leakage), not expert consensus. For biocompatibility, the "ground truth" is determined by established assay protocols and test results interpreted by qualified toxicologists/biologists according to standard guidelines (ISO 10993-1 and USP 27 <88>), not a panel of clinical experts adjudicating individual cases.
- Qualifications of Experts: Not specified for performance testing. Biocompatibility testing would be performed by personnel qualified in toxicology and biological evaluations.
Adjudication method for the test set:
- Adjudication Method: Not applicable. This is not a study requiring human adjudication of results in the traditional sense (e.g., 2+1, 3+1 for imaging studies). The assessment relies on objective measurements against defined standards.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter) and does not involve AI or human "readers" interpreting output. The study demonstrates the physical and biological performance of the device itself.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for functionality testing is based on objective physical and mechanical measurements (e.g., luer taper fit, catheter dimensions, balloon inflation/deflation characteristics) against pre-defined engineering and performance specifications. The ground truth for biocompatibility is established through standardized biological assays (e.g., cytotoxicity, irritation, sensitization) that yield quantifiable results, interpreted according to global standards (ISO 10993-1, USP 27 <88>). There is no "expert consensus," "pathology," or "outcomes data" used to establish ground truth for this type of pre-clinical submission.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in this context. The study evaluates the physical device itself.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary

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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

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.

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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 andcertain 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 <88> Biological Reactivity Tests, In Vivo and was proven that the Thermodilution catheter, with synthetic latex balloon, is biocompatible and safe for its intended use.

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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.

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	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.

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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

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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

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Indications for Use

510(k) Number (if known): K101669

Device Name: THERMODILUTION CATHETER AND ACCESSORIES

Indications for Use:

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

Page 1 of 1

Regulation Number and Section

§ 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).