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. This device is for use in adults only.

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. This device is for use in adults only.

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® 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 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 LogiCal® 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

The provided document is a 510(k) summary for the HemoDraw® Plus Closed Blood Sampling Set with LogiCal®/TranStar® Transducer System. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. This type of document generally focuses on engineering and bench testing rather than clinical study data involving human interpretation of medical images or data. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that "All testing met pre-established specifications," but it does not detail the specific quantitative acceptance criteria or the exact reported performance values for each test. It only lists the categories of evaluations performed.

Category	Acceptance Criteria (Not explicitly stated, but implied as "met pre-established specifications")	Reported Device Performance (Implied as "met" criteria)
Biocompatibility	Compliance with ISO 10993 standards (e.g., passing tests for systemic toxicity, cytotoxicity, etc.)	Met
Packaging	Package integrity after climatic stress and simulated distribution	Met
Device Performance	No leakage, proper pressure containment, cycle test performance, vacuum performance, frequency response, correct assembly	Met

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each non-clinical test. It states "a worst case packaging configuration" for packaging tests, implying at least one configuration was tested. The data provenance is internal testing by Smiths Medical ASD, Inc. (the applicant), based on the context of a 510(k) submission. These are non-clinical bench and lab tests, not clinical data with provenance like country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The evaluations described are non-clinical engineering and biological tests (e.g., leakage, pressure containment, cytotoxicity), not expert-interpreted medical images or data. Ground truth is established by objective measurements against engineering specifications and standard biological testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 are used for human expert interpretation in clinical studies, typically for creating a consensus ground truth. The tests performed are objective bench and lab tests.

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

This is not applicable. MRMC studies are clinical trials used to compare the performance of human readers, often with and without AI assistance, on medical cases. The provided document details non-clinical bench and lab testing of a blood sampling and pressure monitoring system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device (closed blood sampling set and pressure transducer system), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests described is established by:

Engineering Specifications: For device performance tests like leakage, pressure containment, cycle test, vacuum, frequency response, and assembly, the device's performance is measured against pre-defined engineering design specifications.
Standardized Biological Testing: For biocompatibility tests, the ground truth is determined by the results of tests performed according to ISO 10993 standards, which dictate acceptable levels of toxicity, sensitization, etc.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI or machine learning system that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles facing right. The profiles are rendered in a dark color, creating a silhouette effect. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 24, 2017

Smiths Medical ASD, Inc. James Taufen Director, Regulatory Affairs 6000 Nathan Lane North Minneapolis, Minnesota 55442

Re: K163172

Trade/Device Name: HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Transducer System; HemoDraw® Plus Closed Blood Sampling Set with TranStar® Transducer System Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: April 21, 2017 Received: April 24, 2017

Dear Bruce Backlund:

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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

M.A. Hillebrand

for 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) K163172

Device Name

HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Transducer System HemoDraw® Plus Closed Blood Sampling Set with TranStar® Transducer System

Indications for Use (Describe)

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)

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510(k) Summary of Safety and Effectiveness

Administrative Information I.

Applicant's Nameand Address	Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442USA
Contact Person	Jim TaufenDirector Regulatory Affairs
Phone	763-383-3174
Fax	763-383-3679
Email	James.Taufen@smiths-medical.com
Date Prepared	23-May-2017

II. Device Information

Trade Name	HemoDraw® Plus Closed Blood Sampling Set with LogiCal®Transducer SystemHemoDraw® Plus Closed Blood Sampling Set with TranStar®Transducer System
Common Name	Closed Blood Sampling System
Classification Name	Extravascular Blood Pressure Transducer, 21 CFR § 870.2850Product Code DRS

III. Predicate Device Information

Predicate Device Name	Predicate Device 510(k)Number
HemoDraw Arterial Blood Sampling System	K071269
VAMP Venous/Arterial Blood Management Protection	K885281

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Device Description IV.

The HemoDraw® Arterial Blood Sampling System was cleared (K071269 S.E. August 1, 2007) to be used with Logical® and TranStar® pressure transducers that had been previously cleared K961404 S.E. June 27, 1996 and K942377 S.E. August 16, 1994, respectively. Their descriptions are as follows:

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

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

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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.

V. Indications for Use

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. This device is for use in adults only.

Comparative Analysis VI.

There are minor physical differences between the subject and predicate devices. The physical differences are a material change to the HemoDraw syringe tip and a new needless sample port. The proposed changes to the predicate device further include an update to the indications of the HemoDraw Arterial Blood Sampling System to include blood sample withdrawal from the central venous pressure monitoring line.

Technological Characteristics VII.

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 needleless sampling port to the existing legally marketed predicate devices.

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Factors	HemoDraw® Plus CBSS with TranStar® or LogiCal® Pressure Monitoring System	HemoDraw® Arterial Blood Sampling Set	Edwards Lifesciences VAMP
Intended Use and Claims
Same intended use	Similar	Similar	Similar
Same target population	Yes	Yes	Yes
Sharps prevention device	Yes	Yes	Yes
Sequence of Operation	Yes	Yes	Yes
Technological Features
Same technological features	Yes	Yes	Yes
Materials
Reservoir Housing	Polycarbonate	Polycarbonate	Unknown
Septum Housing	Silicone	SyntheticPolyisoprene	SyntheticPolyisoprene
Tubing	PVC	PVC	PVC
Specifications
EtO Sterilized	Yes	Yes	Yes
Sterile, single use	Yes	Yes	Yes

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VIII. Summary of Non-Clinical 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.

Category	Evaluation
Biocompatibility	- Acute Systemic Toxicity- Intracutaneous Toxicity- Muscle Implantation Test- Cytotoxicity – MEM Elution- Hemolysis – Extraction and Direct- Physico-Chemical Tests- Heavy Metal Analysis- Pyrogen Study- Sensitization- Mutagenicity, Ames Test – Ethanol & Saline
Packaging	The existing packaging materials and processes for thecurrently marketed devices will be used for the newconfigurations, for details reference Section 14.3 andAppendix 7 of K071269 S.E. August 1, 2007 which furtherreferences K070340 S.E. March 15, 2007 Section 14.3 andAppendix 8.With the addition of the NP Medical sampling port testingwas completed for package performance after climatic stressand simulated distribution. The following test was conductedusing a worst case packaging configuration:- Visual Package Integrity

Category	Evaluation
Device Performance	- Leakage
	- Pressure Containment
	- Cycle Test
	- Vacuum
	- Frequency Response
	- Assembly

StandardsDevelopmentOrganization	ReferenceNumber andDate	Title
ISO	10993-1:2010	Biological evaluation of medical devices Part1: Evaluation and testing
ISO	10993-7:2008	Biological evaluation of medical devices --Part 7: Ethylene oxide sterilization residuals
ISO	594-1:1986	Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medicalequipment - Part 1: General requirements
ISO	594-2:1998	Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medicalequipment - Part 2: Lock Fittings
AAMI ANSIISO	11737-1:2006	Sterilization of Medical Devices-Microbiological methods-Part 1:Determination of a population ofmicroorganisms on products, 2ed

IX. Substantial Equivalence Conclusion

The proposed Smiths Medical HemoDraw® Plus Closed Blood Sampling Set with TranStar® and LogiCal® Pressure Monitoring Systems are substantially equivalent to the predicate devices based on comparisons of the device classifications, intended use, and technological characteristics.

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).