(87 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, fluid dynamics, and sterility, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as a "hemodynamic pressure monitoring and blood sampling system" which is used for withdrawing blood samples and monitoring pressure, not for providing therapy.
No
The device is designed for blood sampling and pressure monitoring, not for diagnosing medical conditions. It facilitates the collection of samples and measurement of physiological parameters for analysis, but does not itself provide a diagnosis.
No
The device description explicitly details physical components such as a closed blood sampling system, pressure transducers, mounting plates, flush devices, stopcocks, and caps. The performance studies also focus on bench testing of physical properties and material compatibility. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system." This describes a system for collecting a sample, not for testing or analyzing the sample itself.
- Device Description: The description focuses on the mechanics of the blood sampling and pressure monitoring system, including flush devices, stopcocks, and maintaining a closed system. It does not mention any components or processes related to analyzing blood components or characteristics.
- Performance Studies: The performance studies listed are related to the physical and functional aspects of the device (luer fittings, sterilization, biocompatibility, human factors), not to the accuracy or performance of any diagnostic test.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostic devices that perform tests on biological samples.
The device is designed to facilitate the collection of a blood sample, which can then be used for in vitro diagnostic testing elsewhere, but the device itself does not perform the diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DRS
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial or central venous pressure monitoring line
Indicated Patient Age Range
Various Populations
Intended User / Care Setting
ICU/OR
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- . 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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:
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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510(k) Summary
| ADMINISTRATIVE INFORMATION | |
|---|---|
| Date of Preparation: | August 11, 2017 |
| Submitter: | Smiths Medical |
| 6000 Nathan Lane North | |
| Minneapolis, MN 55442 | |
| USA | |
| Establishment Registration Number: | 1526863 (Dublin) |
| Company Contact (Primary): | Mikael Evans |
| Regulatory Affairs Specialist I | |
| Email: mike.evans@smiths-medical.com | |
| 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 |
| LogiCal® Transducer Pressure Monitoring System | |
| HemoDraw® Plus Closed Blood Sampling System with | |
| TranStar® Transducer Pressure Monitoring System | |
| Device Classification | Class II |
| Classification Name | Transducer, Blood-Pressure, Extravascular, 21 CFR § 870.2850 |
| Product Code DRS |
4
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PREDICATE DEVICE INFORMATION
| Predicate Device Name | FDA Product Code | Predicate Device 510(k)
Number |
|-------------------------------------------------------------------------------------------|--------------------------|-----------------------------------|
| HemoDraw® Plus Closed Blood
Sampling Set with LogiCal®/
TranStar® Transducer System | DRS
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.
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.
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.
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.
| Section
of
Device | Device Name | SUBJECT
DEVICE
Smiths-Medical
HemoDraw® Plus
Closed Blood
Sampling System
(single and dual
sampling site
option) | PREDICATE
DEVICE
Smiths-Medical
HemoDraw®
Plus Closed
Blood Sampling
System (Single
in-line patient
sampling site)
K163172 | Comparison
of Subject
to Predicate
Device for
substantial
equivalence |
|-------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | Product Code | DRS | DRS | Same |
| Device System | Product
Classification | FDA 21 CFR
Class II | FDA 21 CFR
Class II | Same |
| | Device
Classification
Name and 21
CFR | Transducer, Blood-
Pressure,
Extravascular, 21
CFR § 870.2850 | Transducer, Blood-
Pressure,
Extravascular, 21
CFR § 870.2850 | Same |
| | Patient
Population | Various Populations | Adult | Similar – The
subject device
is expanding
the indicated
patient
population. |
| | MR labeling | MR Conditional | MR Unsafe | Different – The
subject
conducted
additional
testing to label
"MR
conditional" |
| Section
of
Device | Device Name | SUBJECT
DEVICE
Smiths-Medical
HemoDraw® Plus
Closed Blood
Sampling System
(single and dual
sampling site
option) | PREDICATE
DEVICE
Smiths-Medical
Hemo DrawⓇ
Plus Closed
Blood Sampling
System (Single
in-line patient
sampling site)
K163172 | Comparison
of Subject
to Predicate
Device for
substantial
equivalence |
| Device System | Intended Use | The HemoDraw®
Plus Closed Blood
Sampling 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 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. | Same |
| | Indications for
Use | The HemoDraw®
Plus Closed Blood
Sampling Set with
LogiCal®/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. | The HemoDraw®
Plus Closed Blood
Sampling Set with
LogiCal®/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 adult use only | Similar - The
subject device
is removing
the “Adult use
only”
indication. |
| Section
of
Device | Device Name | SUBJECT
DEVICE
Smiths-Medical
HemoDraw® Plus
Closed Blood
Sampling System
(single and dual
sampling site
option) | PREDICATE
DEVICE
Smiths-Medical
HemoDraw®
Plus Closed
Blood Sampling
System (Single
in-line patient
sampling site)
K163172 | Comparison
of Subject
to Predicate
Device for
substantial
equivalence |
| Device System | Transducer
types | Reusable/Disposable | Reusable/Disposable | Same |
| | Hospital
location use | ICU/OR | ICU/OR | Same |
| | Tubing | PVC | PVC | Same |
| | Biocompatibility | Compatible
materials ISO 10993-
1 | Compatible
materials ISO 10993-
1 | Same |
| | Sterilization | Ethylene Oxide (EO)
Sterile SAL 10-6 to
end user | Ethylene Oxide (EO)
Sterile SAL 10-6 to
end user | Same |
| | Packaging
Materials | Top Web: Dupont
Uncoated 1073B
TYVEK
Bottom Web: Rexam
48 GA. Polyester /
0.0025" LDP | Top Web: Dupont
Uncoated 1073B
TYVEK
Bottom Web: Rexam
48 GA. Polyester /
0.0025" LDP | Same |
| | Shelf-Life | 3 Years | 3 Years | Same |
| Reservoir | Technological
features | Rigid, variable
volume reservoir | Rigid, variable
volume reservoir | Same |
| | Reservoir Size | 5-mL/13-mL | 5-mL/13-mL | Same |
| | Material | Polycarbonate | Polycarbonate | Same |
| Section
of
Device | Device Name | SUBJECT
DEVICE
Smiths-Medical
HemoDraw® Plus
Closed Blood
Sampling System
(single and dual
sampling site
option) | PREDICATE
DEVICE
Smiths-Medical
HemoDraw®
Plus Closed
Blood Sampling
System (Single
in-line patient
sampling site)
K163172 | Comparison
of Subject
to Predicate
Device for
substantial
equivalence |
| Sampling Site(s) | Technological | In-line Split Septum
and Stopcock
sampling site | In-line Split Septum | Same |
| | Number of
Sampling site(s) | 2 – Distal Stopcock
and Proximal in-line
sampling site | 1 – in-line sampling
site | Similar – The
subject device
as added a
distal stopcock
sampling site. |
| | Septum
Housing | Silicone | Silicone | Same |
| Connectors | Design by ISO
Standard | ISO 594-1: 1986 and
ISO 594-2: 1998 | ISO 594-1: 1986 and
ISO 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