The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.

The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.

Device Description

The HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and central venous invasive pressure monitoring line. The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

The HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a closed blood Sampling System designed to allow easy and safe withdrawal of blood samples from an arterial and venous invasive pressure monitoring line. The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The TranStar® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm. This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour. The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics and acceptance criteria in the way a clinical trial might.

Therefore, many of the requested details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific efficacy or accuracy metrics, and details on training sets) are not applicable or not provided within this type of regulatory submission. The submission is primarily concerned with bench testing and validation against established engineering standards and existing regulatory guidance.

Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For the type of device (Extravascular Blood Pressure Transducer) and the nature of this 510(k) submission (design update and labeling changes), the "acceptance criteria" are primarily based on demonstrating compliance with relevant international standards and ensuring that the minor changes do not compromise the safety and effectiveness established by the predicate device. Specific quantitative performance metrics with defined acceptance thresholds (e.g., accuracy, sensitivity, specificity) for the device as a whole are not explicitly presented as they would be in a clinical study report for a diagnostic device.

The reported device performance is that "All testing met pre-established specifications."

Acceptance Criteria Category	Reported Device Performance
Luer Taper Conical Fittings	Bench Testing per ISO 594-1: 1986 (general requirements for conical fitting with a 6% (Luer) taper for syringes, needles, and certain other medical equipment). Met requirements.
Luer Lock Fittings	Bench Testing per ISO 594-2: 1998 (requirements for lock fittings for conical fitting with a 6% (Luer) taper for syringes, needles, and certain other medical equipment). Met requirements.
Sterility	Sterilization/Microbiology Validation per ISO 11135, AAMI TIR28, and ISO 11747 to ensure product sterility to the end user (SAL 10-6). Ensured product sterility.
MR Compatibility	Material Bench Testing to ensure the HemoDraw® Plus Closed Blood Sampling System device materials met MR compatibility specifications. Met MR compatibility specifications (leading to "MR Conditional" labeling).
Design Validation/Human Factors	Design Validation / Human Factors per ISO 62366 (usability engineering for medical devices). Performance acceptable for intended use.
Biocompatibility	Biocompatibility assessment per ISO 10993-1. Materials are biocompatible to the indicated patient population.
Overall Intended Performance	"All testing met pre-established specifications, and successfully demonstrated that the HemoDraw® Plus Closed Blood Sampling Set with TranStar® and LogiCal® Pressure Monitoring Systems performed as intended." The device is considered "as safe, as effective, and perform as well as or better than the predicate devices" for hemodynamic pressure monitoring and blood sampling while maintaining a closed system. The proposed changes (distal stopcock, expanded patient population, MR conditional labeling) do not raise new questions of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided document. The testing described is primarily bench testing against engineering standards for components and system integrity, not a clinical trial with a "test set" of patient data.
Data Provenance: The document refers to "Bench Testing" and "Validation" conducted by Smiths Medical. There is no mention of country of origin for patient data or retrospective/prospective data collection, as this is not a study involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable here. The "ground truth" for demonstrating substantial equivalence and meeting safety/effectiveness standards in this context comes from adherence to established international standards (e.g., ISO, AAMI) and internal company specifications, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging AI systems and is not relevant for a blood sampling and pressure monitoring system's safety and effectiveness evaluation for a 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical medical device, not an AI algorithm. "Standalone performance" in this context refers to the device's functional performance as evaluated through bench testing and validation against engineering specifications, which was indeed done.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by established international engineering standards (e.g., ISO 594-1, ISO 594-2, ISO 11135, AAMI TIR28, ISO 11747, ISO 62366, ISO 10993-1) and the manufacturer's internal specifications derived from these standards and the predicate device's performance. There is no reference to pathology, outcomes data, or expert consensus on patient cases for determining the device's fundamental safety and performance characteristics in this submission.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable (see point 8).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2017

Smiths Medical ASD, Inc. Mikael Evans Regulatory Affairs Specialist I 6000 Nathan Lane North Minneapolis, Minnesota 55442

Re: K172458

Trade/Device Name: HemoDraw® Plus Closed Blood Sampling System with LogiCal® Transducer Pressure Monitoring System HemoDraw® Plus Closed Blood Sampling System with TranStar® Transducer Pressure Monitoring System Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: August 11, 2017 Received: August 14, 2017

Dear Mikael Evans:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

{1}------------------------------------------------

801); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Wilhelm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172458

Device Name

HemoDraw® Plus Closed Blood Sampling System with LogiCal® Transducer Pressure Monitoring System HemoDraw® Plus Closed Blood Sampling System with TranStar® Transducer Pressure Monitoring System

Indications for Use (Describe)

HemoDraw® Plus Closed Blood Sampling System with LogiCal® Transducer Pressure Monitoring System:

HemoDraw® Plus Closed Blood Sampling System with TranStar® Transducer Pressure Monitoring System:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Smiths Medical. The words "smiths medical" are written in a sans-serif font, with "smiths" in a darker blue and "medical" in a lighter blue. Below the logo is the tagline "bringing technology to life" in a smaller, lighter blue font.

510(k) Summary

ADMINISTRATIVE INFORMATION
Date of Preparation:	August 11, 2017
Submitter:	Smiths Medical6000 Nathan Lane NorthMinneapolis, MN 55442USA
Establishment Registration Number:	1526863 (Dublin)
Company Contact (Primary):	Mikael EvansRegulatory Affairs Specialist IEmail: mike.evans@smiths-medical.comOffice: 763-383-3047

PURPOSE

The purpose of this Traditional 510(k) premarket notification is to obtain FDA 510(k) clearance of the HemoDraw" Plus Closed Blood Sampling System with LogiCal®/TranStar® Pressure Monitoring System for the following changes:

. Design Update
- o Add distal stopcock sampling site option
. Labeling update:
- o Removal of "This device is for adult use only"
- Add "MR conditional" o

DEVICE INFORMATION

Trade Name	Closed Blood Sampling System
Device Name	HemoDraw® Plus Closed Blood Sampling System withLogiCal® Transducer Pressure Monitoring System
	HemoDraw® Plus Closed Blood Sampling System withTranStar® Transducer Pressure Monitoring System
Device Classification	Class II
Classification Name	Transducer, Blood-Pressure, Extravascular, 21 CFR § 870.2850Product Code DRS

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Smiths Medical. The words "smiths medical" are written in a blue sans-serif font, with the word "smiths" in a darker blue than the word "medical". Below the logo is the tagline "bringing technology to life", also in blue.

PREDICATE DEVICE INFORMATION

Predicate Device Name	FDA Product Code	Predicate Device 510(k)Number
HemoDraw® Plus Closed BloodSampling Set with LogiCal®/TranStar® Transducer System	DRS21 CFR § 870.2850	K163712

DEVICE DESCRIPTION

HemoDraw® Plus Closed Blood Sampling System with LogiCal® Pressure Monitoring System

The LogiCal® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System. The LogiCal® monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm.

This set includes a flush device that is intended for use in invasive blood pressure measurements that require continuous flow to maintain catheter patency. The flush device provides a controlled and constant fluid infusion at a rate determined by the patient's blood pressure and the fluid source pressure. With a total fluid source pressure equal to 300mmHg, the flush device delivers an average flow rate of 3ml/hour.

The device is supplied with a vented cap on the zeroing stopcock; this vented cap will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the vented cap should be replaced with a nonvented cap.

This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

HemoDraw® Plus Closed Blood Sampling System with TranStar® Pressure Monitoring System

{5}------------------------------------------------

The TranStar® Pressure Transducer mounting plate is intended for uses with the HemoDraw® Closed Blood Sampling Set with TranStar® Pressure Monitoring System. The TranStar® disposable monitoring set provides isolation between the fluid path connection to the patient and the transducer diaphragm.

The device is supplied with a porous plug on the zeroing stopcock; this porous plug will allow air and saline to pass through and therefore can be kept in place when priming. To prevent the introduction of air into the system; after priming the porous plug should be replaced with a nonvented cap.

This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

INDICATIONS FOR USE

COMPARATIVE ANALYSIS

There a minor physical differences between the subject and predicate device. The physical difference is the addition of a distal, to patient, stopcock sampling site and a distal stopcock positioning label to remind the user of the proper stopcock positions for priming and flushing the device. The proposed changes include an update to the indications for use to remove the "Adult use only" phrasing. Additionally, information and symbols will be added in the labeling for MR Conditional.

{6}------------------------------------------------

TECHNOLOGICAL CHARACTERISTICS

The Smiths Medical HemoDraw® Plus Closed Blood Sampling System has the same technological characteristics as the predicate devices with the exception that the proposed version introduces a new distal, to patient, stopcock sampling site.

SectionofDevice	Device Name	SUBJECTDEVICESmiths-MedicalHemoDraw® PlusClosed BloodSampling System(single and dualsampling siteoption)	PREDICATEDEVICESmiths-MedicalHemoDraw®Plus ClosedBlood SamplingSystem (Singlein-line patientsampling site)K163172	Comparisonof Subjectto PredicateDevice forsubstantialequivalence
	Product Code	DRS	DRS	Same
Device System	ProductClassification	FDA 21 CFRClass II	FDA 21 CFRClass II	Same
	DeviceClassificationName and 21CFR	Transducer, Blood-Pressure,Extravascular, 21CFR § 870.2850	Transducer, Blood-Pressure,Extravascular, 21CFR § 870.2850	Same
	PatientPopulation	Various Populations	Adult	Similar – Thesubject deviceis expandingthe indicatedpatientpopulation.
	MR labeling	MR Conditional	MR Unsafe	Different – Thesubjectconductedadditionaltesting to label"MRconditional"
SectionofDevice	Device Name	SUBJECTDEVICESmiths-MedicalHemoDraw® PlusClosed BloodSampling System(single and dualsampling siteoption)	PREDICATEDEVICESmiths-MedicalHemo DrawⓇPlus ClosedBlood SamplingSystem (Singlein-line patientsampling site)K163172	Comparisonof Subjectto PredicateDevice forsubstantialequivalence
Device System	Intended Use	The HemoDraw®Plus Closed BloodSampling System is ahemodynamicpressure monitoringand blood samplingsystem designed toallow easywithdrawal of bloodsamples from anarterial or centralvenous pressuremonitoring linewhile maintaining acompletely closedsystem.	The HemoDraw®Plus Closed BloodSampling System is ahemodynamicpressure monitoringand blood samplingsystem designed toallow easywithdrawal of bloodsamples from anarterial or centralvenous pressuremonitoring linewhile maintaining acompletely closedsystem.	Same
	Indications forUse	The HemoDraw®Plus Closed BloodSampling Set withLogiCal®/TranStar®Pressure MonitoringSystem is ahemodynamicpressure monitoringand blood samplingsystem designed toallow easywithdrawal of bloodsamples from anarterial or centralvenous pressuremonitoring linewhile maintaining acompletely closedsystem.	The HemoDraw®Plus Closed BloodSampling Set withLogiCal®/TranStar®Pressure MonitoringSystem is ahemodynamicpressure monitoringand blood samplingsystem designed toallow easywithdrawal of bloodsamples from anarterial or centralvenous pressuremonitoring linewhile maintaining acompletely closedsystem. This deviceis for adult use only	Similar - Thesubject deviceis removingthe “Adult useonly”indication.
SectionofDevice	Device Name	SUBJECTDEVICESmiths-MedicalHemoDraw® PlusClosed BloodSampling System(single and dualsampling siteoption)	PREDICATEDEVICESmiths-MedicalHemoDraw®Plus ClosedBlood SamplingSystem (Singlein-line patientsampling site)K163172	Comparisonof Subjectto PredicateDevice forsubstantialequivalence
Device System	Transducertypes	Reusable/Disposable	Reusable/Disposable	Same
	Hospitallocation use	ICU/OR	ICU/OR	Same
	Tubing	PVC	PVC	Same
	Biocompatibility	Compatiblematerials ISO 10993-1	Compatiblematerials ISO 10993-1	Same
	Sterilization	Ethylene Oxide (EO)Sterile SAL 10-6 toend user	Ethylene Oxide (EO)Sterile SAL 10-6 toend user	Same
	PackagingMaterials	Top Web: DupontUncoated 1073BTYVEKBottom Web: Rexam48 GA. Polyester /0.0025" LDP	Top Web: DupontUncoated 1073BTYVEKBottom Web: Rexam48 GA. Polyester /0.0025" LDP	Same
	Shelf-Life	3 Years	3 Years	Same
Reservoir	Technologicalfeatures	Rigid, variablevolume reservoir	Rigid, variablevolume reservoir	Same
	Reservoir Size	5-mL/13-mL	5-mL/13-mL	Same
	Material	Polycarbonate	Polycarbonate	Same
SectionofDevice	Device Name	SUBJECTDEVICESmiths-MedicalHemoDraw® PlusClosed BloodSampling System(single and dualsampling siteoption)	PREDICATEDEVICESmiths-MedicalHemoDraw®Plus ClosedBlood SamplingSystem (Singlein-line patientsampling site)K163172	Comparisonof Subjectto PredicateDevice forsubstantialequivalence
Sampling Site(s)	Technological	In-line Split Septumand Stopcocksampling site	In-line Split Septum	Same
	Number ofSampling site(s)	2 – Distal Stopcockand Proximal in-linesampling site	1 – in-line samplingsite	Similar – Thesubject deviceas added adistal stopcocksampling site.
	SeptumHousing	Silicone	Silicone	Same
Connectors	Design by ISOStandard	ISO 594-1: 1986 andISO 594-2: 1998	ISO 594-1: 1986 andISO 594-2: 1998	Same

{7}------------------------------------------------

smiths medical bringing technology to life

Smiths Medial ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Phone: 763-383-3000 www.smiths-medical.com

{8}------------------------------------------------

smiths medical bringing technology to life

Smiths Medial ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Phone: 763-383-3000 www.smiths-medical.com

{9}------------------------------------------------

bringing technology to

Smiths Medial ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Phone: 763-383-3000 www.smiths-medical.com

SUMMARY OF PERFORMANCE TESTING

The HemoDraw® Plus Closed Blood Sampling Set with TranStar® and LogiCal® Pressure Monitoring Systems were evaluated via non-clinical performance testing to demonstrate the devices are as safe, as effective, and perform as well as or better than the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the HemoDraw® Plus Closed Blood Sampling Set with TranStar® and LogiCal® Pressure Monitoring Systems performed as intended. A summary of the evaluation is provided below:

. Bench Testing was conducted per ISO 594-1: 1986 to ensure the HemoDraw® Plus Closed Blood Sampling System device meets the general requirements for conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical equipment.
Bench Testing was conducted per ISO 594-2: 1998 to ensure the HemoDraw® Plus Closed Blood Sampling System device meets the requirements for lock fittings for conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical equipment.

{10}------------------------------------------------

. Sterilization/Microbiology Validation was conducted to ensure product sterility to the end user for ISO 11135, AAMI TIR28 and ISO 11747.
. Material Bench Testing was conducted to ensure the HemoDraw® Plus Closed Blood Sampling System device materials met MR compatibility specifications
Design Validation / Human Factors per ISO 62366 was conducted to ensure the subject device performance is acceptable for its intended use.
. Biocompatibility was assessed per ISO 10993-1 to ensure the HemoDraw® Plus Closed Blood Sampling System device materials are biocompatible to the indicated patient population

SUBSTANTIAL EQUIVALENCE CONCLUSION

Smiths Medical considers the subject device, HemoDraw® Plus Closed Blood Sampling System with LogiCal®/TranStar® Pressure Monitoring System performance to be substantially equivalent to the predicate device because, these devices are intended to be used in the same clinical manner; to monitor patient's blood pressure and allow patient blood sampling in closed system.

There are no significant difference in the intended use, mechanical and functional performance, and functional scientific technology. Smiths Medical demonstrates there are no new issues of safety and effectiveness raised due to the similarities/differences between the subject and predicate devices, as each are used to treat the same clinical condition and represent a similar design.

The subject device, HemoDraw® Plus Closed Blood Sampling System with LogiCal®/TranStar® Pressure Monitoring System, does not raise new questions of safety risks imposed on the patient or the device user.

K172458 pg. 8 of 8

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).