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

K163172 · Smiths Medical Asd, Inc. · DRS · May 24, 2017 · Cardiovascular

Device Facts

• Record ID: K163172
• 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: May 24, 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 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 Story

Closed blood sampling system; integrates with LogiCal or TranStar pressure transducers for invasive hemodynamic monitoring. Device facilitates blood withdrawal from arterial or central venous lines while maintaining closed-system integrity to prevent contamination. Includes flush device providing constant 3ml/hour fluid infusion at 300mmHg source pressure to maintain catheter patency. Used in clinical settings; operated by healthcare professionals. Output consists of blood samples for analysis and continuous pressure monitoring data. Benefits include reduced risk of infection and blood exposure during sampling; simplified sampling process.

Clinical Evidence

Bench testing only. No clinical data presented. Performance evaluated via biocompatibility (ISO 10993-1, 10993-7), packaging integrity, and device performance testing (leakage, pressure containment, cycle test, vacuum, frequency response, assembly). All testing met pre-established specifications.

Technological Characteristics

Materials: Polycarbonate reservoir housing, silicone septum housing, PVC tubing. Sensing: Invasive pressure transducer interface. Connectivity: Standalone fluid path. Sterilization: Ethylene Oxide (EtO). Standards: ISO 10993-1, ISO 10993-7, ISO 594-1/2 (Luer tapers), AAMI ANSI ISO 11737-1.

Indications for Use

Indicated for hemodynamic pressure monitoring and blood sampling from arterial or central venous lines in adult patients only.

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 Arterial Blood Sampling System (K071269)
• VAMP Venous/Arterial Blood Management Protection (K885281)

Reference Devices

• LogiCal pressure transducers (K961404)
• TranStar pressure transducers (K942377)
• K070340

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary of Safety and Effectiveness

#### Administrative Information I.

| Applicant's Name<br>and Address | Smiths Medical ASD, Inc.<br>6000 Nathan Lane North<br>Minneapolis, MN 55442<br>USA |
|---------------------------------|------------------------------------------------------------------------------------|
| Contact Person | Jim Taufen<br>Director Regulatory Affairs |
| Phone | 763-383-3174 |
| Fax | 763-383-3679 |
| Email | [e-mail] |
| Date Prepared | 23-May-2017 |

#### II. Device Information

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

#### III. Predicate Device Information

| Predicate Device Name | Predicate Device 510(k)<br>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 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.

## HemoDraw® Plus Closed Blood Sampling Set 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.

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.

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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.

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.

#### 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 | Synthetic<br>Polyisoprene | Synthetic<br>Polyisoprene |
| 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<br>- Intracutaneous Toxicity<br>- Muscle Implantation Test<br>- Cytotoxicity – MEM Elution<br>- Hemolysis – Extraction and Direct<br>- Physico-Chemical Tests<br>- Heavy Metal Analysis<br>- Pyrogen Study<br>- Sensitization<br>- Mutagenicity, Ames Test – Ethanol & Saline |
| Packaging | The existing packaging materials and processes for the<br>currently marketed devices will be used for the new<br>configurations, for details reference Section 14.3 and<br>Appendix 7 of K071269 S.E. August 1, 2007 which further<br>references K070340 S.E. March 15, 2007 Section 14.3 and<br>Appendix 8.<br>With the addition of the NP Medical sampling port testing<br>was completed for package performance after climatic stress<br>and simulated distribution. The following test was conducted<br>using a worst case packaging configuration:<br>- Visual Package Integrity |

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

Biological and Bench testing was conducted to the following Standards:

| Standards<br>Development<br>Organization | Reference<br>Number and<br>Date | Title |
|------------------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| ISO | 10993-1:2010 | Biological evaluation of medical devices Part<br>1: Evaluation and testing |
| ISO | 10993-7:2008 | Biological evaluation of medical devices --<br>Part 7: Ethylene oxide sterilization residuals |
| ISO | 594-1:1986 | Conical fittings with a 6% (Luer) taper for<br>syringes, needles and certain other medical<br>equipment - Part 1: General requirements |
| ISO | 594-2:1998 | Conical fittings with a 6% (Luer) taper for<br>syringes, needles and certain other medical<br>equipment - Part 2: Lock Fittings |
| AAMI ANSI<br>ISO | 11737-1:2006 | Sterilization of Medical Devices-<br>Microbiological methods-Part 1:<br>Determination of a population of<br>microorganisms 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.