HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

K172458 · Smiths Medical Asd, Inc. · DRS · Nov 9, 2017 · Cardiovascular

Device Facts

• Record ID: K172458
• Device Name: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
• Applicant: Smiths Medical Asd, Inc.
• Product Code: DRS · Cardiovascular
• Decision Date: Nov 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

Intended Use

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 Story

Closed blood sampling system for arterial/central venous lines; integrates with LogiCal® or TranStar® pressure transducers. Device maintains closed system during blood withdrawal to reduce infection risk. Includes flush device for continuous infusion (3ml/hour at 300mmHg) to maintain catheter patency. Used in ICU/OR by clinicians. Features distal stopcock sampling site and proximal in-line split septum. Single-use, sterile, MR conditional. Provides hemodynamic pressure monitoring and safe blood sampling; aids clinical decision-making via continuous pressure data and blood analysis.

Clinical Evidence

Bench testing only. Testing included ISO 594-1/594-2 for Luer taper fittings, sterilization/microbiology validation (ISO 11135, AAMI TIR28, ISO 11747), MR compatibility testing, design validation/human factors (ISO 62366), and biocompatibility (ISO 10993-1).

Technological Characteristics

Materials: PVC tubing, polycarbonate reservoir, silicone septum. Conical fittings per ISO 594-1:1986 and ISO 594-2:1998. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Form factor: Closed system with flush device and dual sampling sites (distal stopcock and proximal in-line). MR Conditional.

Indications for Use

Indicated for hemodynamic pressure monitoring and blood sampling from arterial or central venous pressure monitoring lines in various patient populations.

Regulatory Classification

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.

Predicate Devices

• HemoDraw® Plus Closed Blood Sampling Set with LogiCal®/TranStar® Transducer System (K163712)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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:

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.

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

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

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| ADMINISTRATIVE INFORMATION | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | August 11, 2017 |
| Submitter: | Smiths Medical<br>6000 Nathan Lane North<br>Minneapolis, MN 55442<br>USA |
| Establishment Registration Number: | 1526863 (Dublin) |
| Company Contact (Primary): | Mikael Evans<br>Regulatory Affairs Specialist I<br>Email: [e-mail]<br>Office: 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 with<br>LogiCal® Transducer Pressure Monitoring System |
| | HemoDraw® Plus Closed Blood Sampling System with<br>TranStar® Transducer Pressure Monitoring System |
| Device Classification | Class II |
| Classification Name | Transducer, Blood-Pressure, Extravascular, 21 CFR § 870.2850<br>Product Code DRS |

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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)<br>Number |
|-------------------------------------------------------------------------------------------|--------------------------|-----------------------------------|
| HemoDraw® Plus Closed Blood<br>Sampling Set with LogiCal®/<br>TranStar® Transducer System | DRS<br>21 CFR § 870.2850 | K163712 |

#### DEVICE DESCRIPTION

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

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.

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

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.

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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.

#### INDICATIONS FOR USE

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.

#### 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.

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## 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.

| Section<br>of<br>Device | Device Name | SUBJECT<br>DEVICE<br>Smiths-Medical<br>HemoDraw® Plus<br>Closed Blood<br>Sampling System<br>(single and dual<br>sampling site<br>option) | PREDICATE<br>DEVICE<br>Smiths-Medical<br>HemoDraw®<br>Plus Closed<br>Blood Sampling<br>System (Single<br>in-line patient<br>sampling site)<br>K163172 | Comparison<br>of Subject<br>to Predicate<br>Device for<br>substantial<br>equivalence |
|-------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | Product Code | DRS | DRS | Same |
| Device System | Product<br>Classification | FDA 21 CFR<br>Class II | FDA 21 CFR<br>Class II | Same |
| | Device<br>Classification<br>Name and 21<br>CFR | Transducer, Blood-<br>Pressure,<br>Extravascular, 21<br>CFR § 870.2850 | Transducer, Blood-<br>Pressure,<br>Extravascular, 21<br>CFR § 870.2850 | Same |
| | Patient<br>Population | Various Populations | Adult | Similar – The<br>subject device<br>is expanding<br>the indicated<br>patient<br>population. |
| | MR labeling | MR Conditional | MR Unsafe | Different – The<br>subject<br>conducted<br>additional<br>testing to label<br>"MR<br>conditional" |
| Section<br>of<br>Device | Device Name | SUBJECT<br>DEVICE<br>Smiths-Medical<br>HemoDraw® Plus<br>Closed Blood<br>Sampling System<br>(single and dual<br>sampling site<br>option) | PREDICATE<br>DEVICE<br>Smiths-Medical<br>Hemo DrawⓇ<br>Plus Closed<br>Blood Sampling<br>System (Single<br>in-line patient<br>sampling site)<br>K163172 | Comparison<br>of Subject<br>to Predicate<br>Device for<br>substantial<br>equivalence |
| Device System | Intended Use | The HemoDraw®<br>Plus Closed Blood<br>Sampling System is a<br>hemodynamic<br>pressure monitoring<br>and blood sampling<br>system designed to<br>allow easy<br>withdrawal of blood<br>samples from an<br>arterial or central<br>venous pressure<br>monitoring line<br>while maintaining a<br>completely closed<br>system. | The HemoDraw®<br>Plus Closed Blood<br>Sampling System is a<br>hemodynamic<br>pressure monitoring<br>and blood sampling<br>system designed to<br>allow easy<br>withdrawal of blood<br>samples from an<br>arterial or central<br>venous pressure<br>monitoring line<br>while maintaining a<br>completely closed<br>system. | Same |
| | Indications for<br>Use | The HemoDraw®<br>Plus Closed Blood<br>Sampling Set with<br>LogiCal®/TranStar®<br>Pressure Monitoring<br>System is a<br>hemodynamic<br>pressure monitoring<br>and blood sampling<br>system designed to<br>allow easy<br>withdrawal of blood<br>samples from an<br>arterial or central<br>venous pressure<br>monitoring line<br>while maintaining a<br>completely closed<br>system. | The HemoDraw®<br>Plus Closed Blood<br>Sampling Set with<br>LogiCal®/TranStar®<br>Pressure Monitoring<br>System is a<br>hemodynamic<br>pressure monitoring<br>and blood sampling<br>system designed to<br>allow easy<br>withdrawal of blood<br>samples from an<br>arterial or central<br>venous pressure<br>monitoring line<br>while maintaining a<br>completely closed<br>system. This device<br>is for adult use only | Similar - The<br>subject device<br>is removing<br>the “Adult use<br>only”<br>indication. |
| Section<br>of<br>Device | Device Name | SUBJECT<br>DEVICE<br>Smiths-Medical<br>HemoDraw® Plus<br>Closed Blood<br>Sampling System<br>(single and dual<br>sampling site<br>option) | PREDICATE<br>DEVICE<br>Smiths-Medical<br>HemoDraw®<br>Plus Closed<br>Blood Sampling<br>System (Single<br>in-line patient<br>sampling site)<br>K163172 | Comparison<br>of Subject<br>to Predicate<br>Device for<br>substantial<br>equivalence |
| Device System | Transducer<br>types | Reusable/Disposable | Reusable/Disposable | Same |
| | Hospital<br>location use | ICU/OR | ICU/OR | Same |
| | Tubing | PVC | PVC | Same |
| | Biocompatibility | Compatible<br>materials ISO 10993-<br>1 | Compatible<br>materials ISO 10993-<br>1 | Same |
| | Sterilization | Ethylene Oxide (EO)<br>Sterile SAL 10-6 to<br>end user | Ethylene Oxide (EO)<br>Sterile SAL 10-6 to<br>end user | Same |
| | Packaging<br>Materials | Top Web: Dupont<br>Uncoated 1073B<br>TYVEK<br>Bottom Web: Rexam<br>48 GA. Polyester /<br>0.0025" LDP | Top Web: Dupont<br>Uncoated 1073B<br>TYVEK<br>Bottom Web: Rexam<br>48 GA. Polyester /<br>0.0025" LDP | Same |
| | Shelf-Life | 3 Years | 3 Years | Same |
| Reservoir | Technological<br>features | Rigid, variable<br>volume reservoir | Rigid, variable<br>volume reservoir | Same |
| | Reservoir Size | 5-mL/13-mL | 5-mL/13-mL | Same |
| | Material | Polycarbonate | Polycarbonate | Same |
| Section<br>of<br>Device | Device Name | SUBJECT<br>DEVICE<br>Smiths-Medical<br>HemoDraw® Plus<br>Closed Blood<br>Sampling System<br>(single and dual<br>sampling site<br>option) | PREDICATE<br>DEVICE<br>Smiths-Medical<br>HemoDraw®<br>Plus Closed<br>Blood Sampling<br>System (Single<br>in-line patient<br>sampling site)<br>K163172 | Comparison<br>of Subject<br>to Predicate<br>Device for<br>substantial<br>equivalence |
| Sampling Site(s) | Technological | In-line Split Septum<br>and Stopcock<br>sampling site | In-line Split Septum | Same |
| | Number of<br>Sampling site(s) | 2 – Distal Stopcock<br>and Proximal in-line<br>sampling site | 1 – in-line sampling<br>site | Similar – The<br>subject device<br>as added a<br>distal stopcock<br>sampling site. |
| | Septum<br>Housing | Silicone | Silicone | Same |
| Connectors | Design by ISO<br>Standard | ISO 594-1: 1986 and<br>ISO 594-2: 1998 | ISO 594-1: 1986 and<br>ISO 594-2: 1998 | Same |

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# smiths medical bringing technology to life

Smiths Medial ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Phone: [phone] www.smiths-medical.com

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# smiths medical bringing technology to life

Smiths Medial ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Phone: [phone] www.smiths-medical.com

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# bringing technology to

Smiths Medial ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 Phone: [phone] 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.

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- . 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