(251 days)
Not Found
No
The description focuses on real-time ECG waveform display and visualization of P-wave changes, which is a standard signal processing technique, not AI/ML. There is no mention of algorithms that learn from data or make predictions.
No.
The device is used to assist in the placement of a medical device (PICC) by providing real-time tip location, not to treat a disease or medical condition itself. It provides an alternative to traditional imaging for confirmation of PICC tip placement.
Yes
The device provides real-time information by displaying changes in cardiac electrical activity, specifically the P wave in the ECG waveform, to determine the position of a PICC catheter tip. This function is a form of diagnostic assessment as it interprets physiological signals to determine a medical condition (catheter tip location) and aids in confirming the correct placement of a medical device, serving as an alternative to other diagnostic imaging methods like X-ray or fluoroscopy.
No
The device description explicitly states that the system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. It also mentions wireless transmission to a tablet. This indicates the presence of hardware components (ECG leads, wireless transmitter) beyond just software running on a general-purpose computing platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- C3 Wave System Function: The C3 Wave System works by monitoring the patient's in vivo (within the body) cardiac electrical activity (ECG) to guide the placement of a catheter. It is directly interacting with the patient's physiological signals, not analyzing a sample taken from the patient.
Therefore, the C3 Wave System falls under the category of a medical device used for monitoring and guiding a procedure within the patient's body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-ime cather tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tin placement in adult patients.
Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:
-Atrial fibrillation
-Atrial flutter
- Severe tachycardia
-Pacemaker-Driven Rhythm
-Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a quide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Superior Vena Cava [SVC]
Indicated Patient Age Range
adult patients
Intended User / Care Setting
skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.
Hospital/Clinical Setting
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)
Clinical Study:
Objective: To demonstrate clinical acceptance between the MedComp C3 Wave System ECG Tip Confirmation System positioning results and traditional portable chest xray in determining proper distal tip location during a PICC procedure.
Methods: A total of 303 PICCs were to be placed at two healthcare facilities using the C3 Wave System ECG Tip Confirmation System in accordance with the instructions for use. A subsequent portable chest x-ray was to be obtained, with the patient position similar of PICC placement, to ascertain acceptable tip location of PICC. The clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related assessments and final catheter functionality questions referred to as the Bundle Protocol.
Outcome: The C3 Wave System has demonstrated a 98% success rate when the Bundle Protocol Parameters were met.
Human Factors Testing:
Participants in the study were representative of the population who place PICC lines in the clinical environment where the product is intended to be used, e.g., hospital wards, acute care centers, extended care centers, alternate care centers, and outpatient clinics. Clinicians with experience in the placement of PICC lines were recruited for the study. No critical task failures were observed in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98% success rate (Clinical Study Outcome)
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2017
Medical Components, Inc (dba Medcomp) Courtney Nix Regulatory Affairs Manager, North American and Europe 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K170934
Trade/Device Name: C3 Wave System Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: October 27, 2017 Received: November 6, 2017
Dear Courtney Nix:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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 mediation-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,
Tina Kiang -
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170934
Device Name C3 Wave System
Indications for Use (Describe)
The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-ime cather tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tin placement in adult patients.
Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:
-Atrial fibrillation
-Atrial flutter
- Severe tachycardia
-Pacemaker-Driven Rhythm
-Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary: K170934
B.
C.
A. Submitter Information:
| Submitter: | Medcomp®
1499 Delp Drive
Harleysville, PA 19438
Tel: (215) 256-4201, x 2285
Fax: (215) 256-9191 |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Registration Number: | 2518902 |
| Contact: | Courtney Nix
Cnix@Medcompnet.com
Regulatory Affairs Manager: North America and EU |
| Date Prepared: | November 28, 2017 |
| Proposed or Subject Device Information: | |
| Trade Name: | C3 Wave System |
| Device: | Catheter, intravascular, Therapeutic Long-Term
Greater Than 30 Days |
| Product Code: | LJS |
| Regulation Description: | Percutaneous, implanted, long-term intravascular
catheter |
| C.F.R. Section: | 880.5970 |
| Class: | ll |
| Regulation Medical
Specialty and Review
Panel: | General Hospital |
| Predicate Device Information: | |
| 510(k) Number: | K143238 |
| 510(k) Holder: | Medcomp® |
| Trade Name: | C3 Wave System |
| Device: | Catheter, intravascular, Therapeutic Long-Term
Greater Than 30 Days |
| Product Code: | LJS |
4
| Regulation Description: | Percutaneous, implanted, long-term intravascular
catheter |
|------------------------------------------------------|--------------------------------------------------------------|
| C.F.R. Section: | 880.5970 |
| Class: | II |
| Regulation Medical
Specialty and Review
Panel: | General Hospital |
E. Purpose for Submission:
The primary purpose of this submission is to revise the indications for use for the C3 Wave System. The indications currently included, cleared by C3 Wave System K143238, "Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.q., Chest X-Ray, Fluoroscopy)." The proposed indications will revise this statement to read "for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients."
The proposed C3 Wave System is equivalent to the cleared C3 Wave System, K143238, in device design, materials and materials. The changes to the cleared device include the hardware to the hub portion of the system, software, and the indications for use.
E. Device Description:
C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a quide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.
The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.
G. Indications for Use:
The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
5
Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave:
- -Atrial fibrillation
- -Atrial flutter
- Severe tachycardia
- -Pacemaker-Driven Rhythm
- -Chronic obstructive pulmonary disease (COPD)
Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.
H. Intended Use:
C3 Wave System is intended to provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.
l. Comparison to Predicate Device:
The C3 Wave system is substantially equivalent to the predicate device.
| Device | Proposed Device: | Predicate Device: | Substantially
Equivalent
Comparison | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The C3 Wave System | The C3 Wave System | | |
| | K170934 | (K143238) | | |
| Indications
for Use | The C3 Wave System is
indicated for use in the
positioning of Peripherally
Inserted Central Catheters
(PICC). The C3 Wave
provides real-time catheter
tip location information by
displaying changes in the
patient's cardiac electrical
activity. The C3 Wave is
indicated for use as an
alternative method to chest
X-ray or fluoroscopy
confirmation of PICC tip
placement in adult patients.
Note: Limiting, but not
contraindicated, situations
for this technique are
patients where cardiac
rhythms may change
presentation of the P-Wave:
-Atrial fibrillation
-Atrial flutter- Severe
tachycardia
-Pacemaker-Driven Rhythm | The C3 Wave System is
indicated for use as a
supplemental aid in
positioning for Peripherally
Inserted Central Catheters
(PICC) in adult patients. It
provides real-time catheter
tip location information by
using the patient's cardiac
electrical activity.
Confirmation of tip
placement should be
verified according to clinical
judgement and established
hospital protocol (e.g.,
Chest XRay, Fluoroscopy).
Note: Limiting, but not
contraindicated, situations
for this technique are
patients where cardiac
rhythms may change
presentation of the P wave:
atrial fibrillation, atrial
flutter, severe
tachycardia, pacemaker
driven rhythm, and chronic | The subject
device is
indicated as an
alternative
method to chest
x-ray or
fluoroscopy
confirmation of
PICC tip
placement in
adult patients,
subject to the
noted limitations.
The differences
between the
subject and
predicate device
indications for use
do not raise
different
questions of
safety and
effectiveness.
Performance data
was provided to
verify the design | |
| | | -Chronic obstructive
pulmonary disease (COPD)
Such patients are easily
identified prior to PICC
insertion. Use of additional
method is necessary to
confirm catheter tip
location. | obstructive pulmonary
disease (COPD).
Such patients are easily
identified prior to PICC
insertion. Use of additional
confirmation method is
necessary to confirm
catheter tip location. | and labeling
adequately
support the
revised
indications for
use. |
| User/Setting | | Prescription Use –
Hospital/Clinical Setting | Prescription Use –
Hospital/Clinical Setting | Equivalent |
| Patient/User
Interface | | iPad | iPad | Equivalent |
| System | | iPad, C3 Wave Hub, ECG
Leads, C3 Wave Remote | iPad, C3 Wave Hub, ECG
Leads, C3 Wave Remote | Equivalent |
| Sterilization
Method | | Sterile Accessory Packs – EO | Sterile Accessory Packs – EO | Equivalent |
| Energy Source | | Mains power (battery
backed) | Mains power (battery
backed) | Equivalent |
| EMC & Electrical
Safety | | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | Equivalent |
| ATTRIBUTE | | C3 Wave (Proposed Device) | | C3 Wave System (K143238) |
| Operating
Principle/Technology: | | The C3 Wave system consists
of an iPad® monitor, a C3 hub,
and remote control.
First, the hub, which can be
placed on the patient's chest,
collects the ECG signal from
the surface ECG (via ECG
chest pad electrode leads)
and the intravascular ECG
(lead connected to the
catheter stylet).
Next, the waveform is sent
wirelessly by Bluetooth™
technology from the hub to the
mobile application.
Then, the C3 mobile
application, installed on an
iPad®, displays the ECG
waveform. Hence, the
medical professional can
monitor the location of the
PICC catheter through the
ECG waveform and,
specifically, monitor the P-
wave shape and amplitude
which indicates tip position
relative to the sinoatrial node.
Further, sterility can be | | The C3 Wave system consists
of an iPad® monitor, a C3 hub,
and remote control.
First, the hub, which can be
placed on the patient's chest,
collects the ECG signal from
the surface ECG (via ECG
chest pad electrode leads) and
the intravascular ECG (lead
connected to the catheter
stylet).
Next, the waveform is sent
wirelessly by Bluetooth™
technology from the hub to the
mobile application.
Then, the C3 mobile
application, installed on an
iPad®, displays the ECG
waveform. Hence, the medical
professional can monitor the
location of the PICC catheter
through the ECG waveform
and, specifically, monitor the P-
wave shape and amplitude
which indicates tip position
relative to the sinoatrial node.
Further, sterility can be |
| | | maintained during the entire | | maintained during the entire |
510(K) Summary: Comparison Table
6
7
| | process as the C3 Wave
system is controlled using a
remote control. | system is controlled using a
remote control. |
|--|---------------------------------------------------------------------------|-------------------------------------------------|
| | | |
The proposed C3 Wave System is equivalent to the cleared C3 Wave System, K143238, in device design, materials and materials. The changes to the proposed device from the predicate are in the hardware to the hub portion of the system, software and the expanded indications for use.
Through performance bench testing, the subject device has demonstrated that it is substantially equivalent to the predicate.
J. Non-Clinical Performance Testing
| Standards | Performance
Testing |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:2006+A12:2014 Medical electrical equipment -
Part 1: General requirements for basic safety and essential
performance | IEC 60601-1 Test
Report (E468297-D1-
IT-1) |
| IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests | IEC 60601-1-2 Test
Report (R-2642P) |
| IEC 62304:2006 Medical device software — Software life cycle
processes | IEC 62304 Test Report |
| | Equipment Interaction |
| | C3 Wave Remote –
Updated Firmware |
| | C3 Wave Application
Software - Equipment
Interaction “Software
Driven Warnings” |
| | C3 Wave – Equipment
Interaction (C3 Wave
Application iPad
Software) |
| | Lextech - Medcomp
functionality checklist
VPI - Hub firmware test |
| | VPI - Remote firmware
test |
| ISTA-2A Partial simulation performance test procedure | Non-Sterile C3 Wave
Accessory Pack- ECG
Electrodes Test
Summary |
| ISTA-1A Non-simulation integrity performance test procedure | C3 Wave Navigation
System w/ iPad – ISTA-
2A Shipping Test
Summary |
| IEC 62133:2013 Secondary cells and batteries containing
alkaline or other non-acid electrolytes - Safety requirements for
portable sealed secondary cells, and for batteries made from
them, for use in portable applications | C3 Wave Hub - ISTA-
1A Shipping Test
IEC 62133 CB Test
Certificate (4307556.50) |
| 47 CFR Part 15, Subpart C Intentional Radiators | Bluetooth Low Energy
Certification Test
Report (10463456A) |
| | Bluetooth Low Energy
Certification Test
Report (10463456B) |
| | EN 300 328 V1.8.1
Certification Test
Report (14L18625-
E1)(Remote) |
| | EN 300 328 V1.8.1
Certification Test
Report (14L18625-
E2)(Hub) |
| RSS-210 License-Exempt Radio Apparatus: Category I
Equipment | Bluetooth Low Energy
Certification Test
Report (10463456A) |
| | Bluetooth Low Energy
Certification Test
Report (10463456B) |
| | EN 300 328 V1.8.1
Certification Test
Report (14L18625-E1) |
| | EN 300 328 V1.8.1
Certification Test
Report (14L18625-E2) |
| ETSI EN 300 328 V1.8.1 Electromagnetic compatibility and
Radio spectrum Matters (ERM); Wideband transmission
systems; Data transmission equipment operating in the 2,4 GHz
ISM band and using wide band modulation techniques;
Harmonized EN covering the essential requirements of article
3.2 of the R&TTE Directive | EN 300 328 V1.8.1
Certification Test
Report (14L18625-E1) |
| | EN 300 328 V1.8.1
Certification Test
Report (14L18625-E2)) |
| ETSI EN 301 489-17 V2.2.1 Electromagnetic compatibility and
Radio spectrum Matters (ERM); ElectroMagnetic Compatibility
(EMC) standard for radio equipment; Part 17: Specific
conditions for Broadband Data Transmission Systems | Bluetooth Low Energy
Certification Test
Report (10463456A) |
| | Bluetooth Low Energy
Certification Test
Report (10463456B) |
| Bluetooth 4.1 | Low Energy RF PHY
Test Specification (TS):
Test Suite Structure
(TSS) and Test
Purposes (TP) RF-
PHY.TS.4.1.0 (UL-
BQT-
RP10522414JD01A
V2.0) (Hub) |
| | Low Energy RF PHY
Test Specification (TS):
Test Suite Structure
(TSS) and Test
Purposes (TP) RF-
PHY.TS.4.1.0 UL-BQT-
RP10522414JD02A
V2.0 (Remote) |
8
9
In addition to demonstrating performance in accordance with these standards, the submission contained information recommended in FDA quidance documents for software and cybersecurity:
- Content of Premarket Submissions for Software Contained in Medical Devices. ●
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
The current released version of the C3 Wave app is 2.0.3. The current released remote firmware is version 16. The current released hub firmware is version 39.
Clinical and Human Factors Testing
Clinical and human factors studies were collected/performed to evaluate the C3 Wave System.
Clinical Study
Clinical Surveys were completed to demonstrate that various PICC line nurses of different years of experience can successfully insert the PICC Line based on their ability to read the ECG display on the iPad
- . Objective: To demonstrate clinical acceptance between the MedComp C3 Wave System ECG Tip Confirmation System positioning results and traditional portable chest xray in determining proper distal tip location during a PICC procedure.
- Methods: A total of 303 PICCs were to be placed at two healthcare facilities using the C3 Wave System ECG Tip Confirmation System in accordance with the instructions for use. A subsequent portable chest x-ray was to be obtained, with the patient position similar of PICC placement, to ascertain acceptable tip location of PICC. The clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related
10
assessments and final catheter functionality questions referred to as the Bundle Protocol.
Outcome: The C3 Wave System has demonstrated a 98% success rate when the Bundle Protocol Parameters were met.
Human Factors
Human Factors Testing has been conducted to evaluate the application of the C3 Wave System when used to confirm PICC tip position as an alternative method to chest X-ray or fluoroscopy confirmation. Participants in the study were representative of the population who place PICC lines in the clinical environment where the product is intended to be used, e.g., hospital wards, acute care centers, extended care centers, alternate care centers, and outpatient clinics. Clinicians with experience in the placement of PICC lines were recruited for the study. No critical task failures were observed in the study.
K. Summary/Conclusion of Substantial Equivalence:
In conclusion, the proposed device, C3 Wave System, is equivalent to the predicate device, C3 Wave System (K143238).