The B. Braun Combitrans Monitoring Sets are intended for the extravascular measurement of venous, arterial, or pulmonary arterial blood pressure by converting hemodynamic waveforms into electrical signals.

The Combitrans flush device provides a continuous flush rate from approximately 3 ml/hr and allows a switch to approximately 300 ml/hr. When using the Combitrans device in neonates, infants or small children. A syringe pump should be used to control the flow rate, which should not exceed 3 ml/hr.

Device Description

The Combitrans Monitoring Set is a pre-calibrated blood pressure transducer designed to transform physiological pressure waveforms into electrical signals using a piezoresistive sensor. The set is supplied in 6 configurations:

Combitrans Monitoring Set, Venous (blue striped tubing).
Combitrans Monitoring Set, Arterial (red striped tubing).
Combitrans Monitoring Set, Pulmonary-Arterial (yellow striped tubing).
Exadyn Combitrans Monitoring Set (blue and red striped tubing with additional stopcock for the measurement of venous and arterial blood pressure with one transducer).
Combitrans Add-On Set (consists only of the transducer, flush device, three-way stopcock and pressure tubing for customized set design and extension.
Combitrans Fixation Tape (includes a hook and loop band/Velcro fixation tape used to fix the Combitrans transducer to the patient forearm or a stand).

Each set has the same basic intended use and transducer components, but varies according to the features indicated above. With each of the sets, a fluid (saline) filled pressure transmitting catheter can be connected to a venous, arterial or pulmonary-arterial patient catheter that is in indirect contact with the patient's bloodstream.

Each of the six Combitrans Monitoring Sets listed above are composed of the following components: a disposable extra-vascular blood pressure transducer, a sensor that converts hemodynamic pressure waveforms into electrical signals, a transducer cable which is connected to a pressure transmitting catheter system, a flush device and a three-way stopcock. The Combitrans transducer and the sensor function together such that physiologic waveforms are transmitted from a fluid filled cavity inside the transducer housing onto the sensor via a silicone gel cushion.

The Combitrans Monitoring Set finger-activated flush device provides a continuous flush from approximately 3 mL/hr and allows a switch to approximately 300 ml/hr. The Combitrans Monitoring Set interfaces with a standard infusion set and a transducer cable, which transmits electrical signals onto a monitor or into a computer for further processing, graphic presentation or storage. When using the Combitrans device in neonates, infants or small children, the standard gravity infusion set is not used but is exchanged for a syringe pump to control the flow rate. which should not exceed 3 ml/hr.

Combitrans disposable transducers, as well as catheters and infusion systems, are indirectly in contact with the blood stream. They are supplied sterile, individually packaged and for single use only.

Accessories available for use with the Combitrans Monitoring Sets include attachment plates for the attachment of the transducer to an infusion stand. A wide range of interface cables using different plug design and configurations are also available to facilitate storage or visualization of blood pressure measurements on patient monitors.

AI/ML Overview

The provided text describes the Combitrans Monitoring Set, a blood pressure transducer, and its 510(k) premarket notification (K102033). It outlines the device's intended use, components, and confirms its substantial equivalence to a predicate device.

The acceptance criteria and study information provided mainly focus on the device's compliance with established standards for performance, electromagnetic compatibility, and biocompatibility, rather than a clinical study establishing specific accuracy metrics against a ground truth.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance Standard: ANSI/AAMI BP22-1994/(R)2006: "Blood pressure transducers"	Performance Met: "Results of performance testing demonstrate that the Combitrans Monitoring Sets meet all requirements of the standard."
Electromagnetic Compatibility (EMC) Standard: IEC 60601-2-34 (2000-10) "Medical Electrical Equipment Part 2-34: Particular Requirements for the Safety, including Essential performance, of Invasive Blood Pressure Monitoring Equipment."	EMC Met: "The Combitrans Monitoring Set fulfills all requirements for electromagnetic compatibility as defined by this standard."
Conical Fittings Standard: ISO 594-2:1998 "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings."	Fittings Met: "All conical fittings of the Combitrans Monitoring Sets were tested in accordance with the requirements identified in ISO 594-2:1998... The Combitrans Monitoring Set fulfilled all requirements for conical luers as defined by this standard."
Biocompatibility Standard: ISO 10993-1:2003 (Biological evaluation of medical devices according to applicable patient contact categories)	Biocompatibility Met: "All materials used for the Combitrans disposable pressure transducer sets met requirements for the biological evaluation of medical devices according to the applicable patient contact categories identified in ISO 10993-1:2003."
Flush Rate (intended use): Continuous flush from approx. 3 mL/hr, switch to approx. 300 ml/hr. For neonates/infants/small children, syringe pump to control flow rate not exceeding 3 ml/hr.	(This is an intended functional specification, and the document states the device provides this functionality as part of its description and intended use, implying it meets this functionality but does not present specific test results demonstrating the precision of these flow rates in a performance summary. It's assumed to be met as part of the overall design and performance.) "The Combitrans Monitoring Set finger-activated flush device provides a continuous flush from approximately 3 mL/hr and allows a switch to approximately 300 ml/hr." and "The Combitrans flush device provides a continuous flush rate from approximately 3 ml/hr and allows a switch to approximately 300 ml/hr. When using the Combitrans device in neonates, infants or small children a syringe pump should be used to control the flow rate, as the flow rate should not exceed 3 ml/hr."

2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the performance testing. The provenance of the data is implicit: it's from internal testing performed by B. Braun Melsungen AG to support their 510(k) application. There is no indication of country of origin for the data or whether it was retrospective or prospective. The studies mentioned are engineering and laboratory tests against standards, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. The "ground truth" for these tests are the requirements and specifications defined by the referenced international and national standards (e.g., ANSI/AAMI BP22, IEC 60601-2-34, ISO 594-2, ISO 10993-1). Compliance is determined by the device's physical and functional performance against these objective standards, not through expert consensus on medical data.

4. Adjudication method for the test set
Not applicable. Testing performed was against established engineering and performance standards, not against a human-interpreted ground truth requiring adjudication.

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
Not applicable. This is a blood pressure transducer, a medical device for measuring physiological parameters. It does not involve "readers," "cases," or Artificial Intelligence (AI) in the context of diagnostic interpretation, therefore no MRMC or AI effectiveness study was performed or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no "algorithm" in the sense of AI or image analysis involved with this device. It is a physical transducer that converts pressure into electrical signals. Its performance is inherent to its design and manufacturing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is compliance with the objective requirements outlined in consensus standards such as ANSI/AAMI BP22-1994/(R)2006 (for blood pressure transducers), IEC 60601-2-34 (for electromagnetic compatibility), ISO 594-2:1998 (for conical fittings), and ISO 10993-1:2003 (for biocompatibility). These standards define measurable parameters and acceptable ranges.

8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established
Not applicable, as no training set was used.

Summary

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Combitrains Blood Pressure Monitoring Sets SIO(k) Premarket Notification

K102033

July 7, 2010

APR - 7 2011

5. 510(k) SUMMARY

SUBMITTER:

B. Braun Melsungen AG Vascular Systems Sieversufer 8 12359 Berlin Germany

Contact: Lisa Giaquinto, Sr. Analyst, Regulatory Affairs Phone: (610) 596-2354 Fax: (610) 266-4962 E-mail: lisa.giaquinto@bbraun.com

DEVICE NAME:

Combitrans Monitoring Set

COMMON OR USUAL NAME:

Transducer, Blood Pressure, Extravascular

DEVICE Class 11, Product Code DRS 21 CFR 870.2850 CLASSIFICATION:

PREDICATE DEVICES:

Accutrans® Disposable Pressure Monitoring System, Biosensors International. K070710, Class II, DRS. 870.2850

DESCRIPTION:

Combitrans Monitoring Set, Venous (blue striped tubing).
Combitrans Monitoring Set, Arterial (red striped tubing).
Combitrans Monitoring Set, Pulmonary-Arterial (yellow striped tubing).
Exadyn Combitrans Monitoring Set (blue and red striped tubing with additional stopcock for the measurement of venous and arterial blood pressure with one transducer).
Combitrans Add-On Set (consists only of the transducer, flush device, three-way stopcock and pressure tubing for customized set design and extension.
Combitrans Fixation Tape (includes a hook and loop band/Velcro fixation tape used to fix the Combitrans transducer to the patient forearm or a stand).

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Combitrans Blood Pressure Monitoring Sets 510(k) Premarker Notification

Each set has the same basic intended use and transducer components, but varies according to the features indicated above. With each of the sets, a fluid (saline) filled pressure transmitting catheter can be connected to a venous, arterial or pulmonary-arterial patient catheter that is in indirect contact with the patient's bloodstream.

Each of the six Combitrans Monitoring Sets listed above are composed of the following components: a disposable extra-vascular blood pressure transducer, a sensor that converts hemodynamic pressure waveforms into electrical signals, a transducer cable which is connected to a pressure transmitting catheter system, a flush device and a three-way stopcock. The Combitrans transducer and the sensor function together such that physiologic waveforms are transmitted from a fluid filled cavity inside the transducer housing onto the sensor via a silicone gel cushion.

The Combitrans Monitoring Set finger-activated flush device provides a continuous flush from approximately 3 mL/hr and allows a switch to approximately 300 ml/hr. The Combitrans Monitoring Set interfaces with a standard infusion set and a transducer cable, which transmits electrical signals onto a monitor or into a computer for further processing, graphic presentation or storage. When using the Combitrans device in neonates, infants or small children, the standard gravity infusion set is not used but is exchanged for a syringe pump to control the flow rate. which should not exceed 3 ml/hr.

Combitrans disposable transducers, as well as catheters and infusion systems, are indirectly in contact with the blood stream. They are supplied sterile, individually packaged and for single use only.

Accessories available for use with the Combitrans Monitoring Sets include attachment plates for the attachment of the transducer to an infusion stand. A wide range of interface cables using different plug design and configurations are also available to facilitate storage or visualization of blood pressure measurements on patient monitors.

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INTENDED USE:

July 7. 2010

SUBSTANTIAL EQUIVALENCE:

The B. Braun Combitrans Monitoring Sets have the same for use, utilize similar technological indications characteristics and incorporate components similar to the Disposable Pressure Accutrans Monitoring System (K070710). All of the proposed Combitrans Monitoring Sets and the predicate device use an integrated sensor element for the transformation of the physiological waveforms into Both sets utilize non-metallic, electrical signals. biocompatible materials in the housing, flush device, transmitting components and stopcocks.

Electromagnetic Compatibility

The electromagnetic compatibility of the Combitrans disposable pressure transducer set was evaluated in accordance with the requirements of IEC 60601-2-34 (2000-10) Medical Electrical Equipment Part 2-34: Particular Requirements for the Safety, including Essential performance, of Invasive Blood Pressure Monitoring Equipment."

The Combitrans Monitoring Set fulfills all requirements for electromagnetic compatibility as defined by this standard.

Performance

Performance testing was completed to evaluate the safety and effectiveness of the Combitrans sets, in accordance with the requirements identified in FDA recognized consensus standard ANSI/AAMI BP22-1994/(R)2006: "Blood pressure transducers." Results of performance

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testing demonstrate that the Combitrans Monitoring Sets meet all requirements of the standard.

All conical fittings of the Combitrans Monitoring Sets were tested in accordance with the requirements identified in ISO 594-2:1998 "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings." The Combitrans Monitoring Set fulfilled all requirements for conical luers as defined by this standard.

Biocompatibility

All materials used for the Combitrans disposable pressure transducer sets met requirements for the biological evaluation of medical devices according to the applicable patient contact categories identified in ISO 10993-1:2003.

Conclusions

Test results for electromagnetic compatibility, performance and biocompatibility demonstrate that the Combitrans Monitoring sets are safe and effective for their intended use. Like the Accutrans Disposable Pressure Monitoring System, the Combitrans Monitoring set meets performance requirements of ANSI/AAMI BP22-1994/(R)2006: "Blood transducers" pressure and a the biocompatibility requirements identified in ISO 10993-1.

It is concluded that the Combitrans Monitoring Sets are substantially equivalent, and raise no new issues of safety or effectiveness when compared to the predicate device.

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

B. Braun Melsungen AG c/o Ms. Lisa Giaquinto, RAC Sr. Analyst, Regulatory Affairs B. Braun Medical, Inc. 901 Marcon Blvd. Allentown, PA 18109

APR - 7 2011

Re: K102033

Trade/Device Name: Combitrans Monitoring Set with 6 models:

Combitrans Monitoring Set, Venous;
Combitrans Monitoring Set, Arterial;
Combitrans Monitoring Set, Pulmonary-Arterial;
Exadyn Combitrans Monitoring Set;
Combitrans Add-On Set; and
Combitrans Fixation Tape

Regulatory Number: 21 CFR 870.2850

Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (Two) Product Code: DRS Dated: March 17, 2011

Received: March 22, 2011

Dear Ms. Giaquinto:

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.

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Page 2 - Ms. Lisa Giaquinto. RAC

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/Resourcesfor You/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

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4. INDICATIONS FOR USE STATEMENT

Page	1 of 1
510(k) Number (if known):	K102033

Device Names:

Combitrans Monitoring Sets

Indications For Use:

The B. Braun Combitrans Monitoring Set is intended for the extravascular measurement of venous, arterial, or pulmonary arterial blood pressure by converting hemodynamic waveforms into electrical signals.

The Combitrans flush device provides a continuous flush rate from approximately 3 ml/hr and allows a switch to approximately 300 ml/hr. When using the Combitrans device in neonates, infants or small children a syringe pump should be used to control the flow rate, as the flow rate should not exceed 3 ml/hr.

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

· OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian-Off) for Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 870.2850 Extravascular blood pressure transducer.

(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).