(38 days)
Not Found
No
The description focuses on real-time ECG waveform analysis and visualization for manual interpretation by a trained professional, with no mention of automated analysis, pattern recognition, or learning algorithms.
No
The device is indicated for guiding the positioning of PICC lines by monitoring cardiac electrical activity, not for treating a disease or condition itself.
No
The device is used for real-time catheter tip location during PICC placement, acting as an alternative to imaging for confirmation of proper placement. It aids in the procedure rather than making a diagnosis.
No
The device description explicitly states 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 the ECG waveform is wirelessly transmitted to a tablet. This indicates the system includes hardware components (ECG leads, wireless transmitter, potentially a component connected to the PICC stylet) in addition to the software on the tablet.
Based on the provided information, the C3 Wave System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the positioning of PICC catheters by displaying changes in the patient's cardiac electrical activity. This is a real-time, in-vivo measurement of a physiological signal.
- Device Description: The device works by using ECG leads placed on the patient's chest and a stylet in the catheter to generate and display an ECG waveform. This is a direct measurement of electrical activity within the patient's body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The C3 Wave System does not process or analyze any such specimens.
The C3 Wave System is a medical device used for guiding a procedure (PICC placement) by monitoring a physiological parameter (ECG). It is not performing a diagnostic test on a sample taken from the patient.
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-time catheter tip location 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 contrindicated, 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 guide 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 / 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)
Non-Clinical Testing: The following non-clinical testing was completed on the modified accessory pack (larger drape and headerbag). Testing was performed as a result of the risk assessment and design control activities based on the subject device modifications from the cleared predicate.
Biocompatibility: Performed for the device modifications per ISO 10993-1 for a skin contacting surface device, with limited exposure (i.e. less than 24 hours).
Tests included:
- CYTOTOXICITY: ISO 10993-5: 2009; Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- SENSITIZATION: ISO 10993-10; Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
- IRRITATION: ISO 10993-10; Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
Sterilization testing on the modified subject device: The sterilization cycle was developed using the Overkill Approach defined in ANSI/AAMI/ISO 11135-1: 2014, Annex B. The Microbiological Performance Qualification was performed in accordance with ANSI/AAMI/ISO 11135-1: 2014, section 9.4.2 and the Physical Performance Qualification was performed in accordance with section 9.4.3.
The residuals for C3 ECG Cable Accessory Pack (MRC3RD004) were in accordance with AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals, the maximum level is 4/mg/device.
The packaging integrity of the pouch seal was validated with a dye test per ASTM F 1929-15.
The strength of the packaging seal was validated with a compressed air burst test per ASTM F1140/F1140M-13.
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
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 12, 2018
Medical Components, Inc. (dba Medcomp) Courtney Nix Regulatory Affairs Manager, North America and EU 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K180567
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: March 12, 2018 Received: March 15, 2018
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.
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 -
s
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) K180567
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-time catheter tip location 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 contrindicated, 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| K180567 | 510(k) SUMMARY | Special 510K | |
|---|---|---|---|
| A. Submitter Information: | |||
| Submitter: | Medical Components Inc. | ||
| (dba Medcomp®) | |||
| 1499 Delp Drive | |||
| Harleysville, PA 19438 | |||
| Tel: (215) 256-4201 x 2285 | |||
| Fax: (215) 256-9191 | |||
| Registration Number: | 2518902 | ||
| Contact Person: | Courtney Nix | ||
| Regulatory Affairs Manager, | |||
| North America and Europe | |||
| Date of Preparation: | 03/02/2018 | ||
| B. Subject Device | |||
| 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: | II | ||
| Regulation Medical | |||
| Specialty and Review | |||
| Panel: | General Hospital | ||
| C. Predicate Device | |||
| 510(k) Number: | K170934 | ||
| 510(k) Holder: | Medcomp® | ||
| 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: | II | ||
| Regulation Medical | |||
| Specialty and Review | |||
| Panel: | General Hospital |
Medcomp®: C3 Wave System
K180567 510(k) Summary
4
D. Subject of Submission:
The purpose of this submission is to expand the accessory packs offerings for the C3 Wave System. The K170394 clearance includes three accessory packs. The submission is to add an accessory code that contains a large drape. As a result, the packaging system had to be revised to a larger header bag. All testing was completed and is the subject of this submission.
E. Device Description:
C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a guide 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.
F. 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
- -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.
G. Intended Use:
Medcomp®: C3 Wave System K180567 510(k) Summary
5
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.
H. Comparison to Predicate Devices:
| Device | Proposed Device:
C3 Wave System
(MRC3RD004) | Predicate Device:
C3 Wave System
(MRC3RD000) | Substantially
Equivalent
Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| 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
-Chronic obstructive
pulmonary disease
(COPD)
Such patients are | 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
-Chronic obstructive
pulmonary disease
(COPD)
Such patients are
easily identified prior | Unchanged |
| | to PICC insertion. Use
of additional method is
necessary to confirm
catheter tip location. | to PICC insertion. Use
of additional method is
necessary to confirm
catheter tip location. | |
| User/Setting | Prescription Use –
Hospital/Clinical
Setting | Prescription Use –
Hospital/Clinical
Setting | Unchanged |
| Patient/User
Interface | iPad | iPad | Unchanged |
| System | iPad, C3 Wave Hub,
ECG Leads, C3 Wave
Remote | iPad, C3 Wave Hub,
ECG Leads, C3 Wave
Remote | Unchanged |
| Overall
System
Components
(incl.
Accessory
Packs) | iPad, iPad Case,
Remote, Remote
Battery, Hub, Hub
Battery, Hub Power
Supply, Leads, Base,
ECG Clip Cable,
Remote Cover,
Electrodes, Skip Prep,
Drape | iPad, iPad Case,
Remote, Remote
Battery, Hub, Hub
Battery, Hub Power
Supply, Leads, Base,
ECG Clip Cable,
Remote Cover,
Electrodes, Skip Prep,
Drape | Equivalent; Change
to Dimension of
Drape |
| Sterile
Accessory
Pack
Components | ECG Clip Cable,
Remote Cover, and
Drape | ECG Clip Cable,
Remote Cover, and
Drape | Equivalent; Change
to Dimension of
Drape |
| Drape
Dimensions | 100" x 86" | 45" x 40" | Equivalent; Change
to Dimension of
Drape |
| Sterilization
Method | Sterile Accessory
Packs – EO | Sterile Accessory
Packs – EO | Unchanged |
| Packaging
Systems | 12.250"x18.500"
Tyvek Headerbag | 17.500"x10.750"
Tyvek Headerbag | Equivalent; Change
to Dimension of
Headerbag to
accommodate larger
drape |
| | CSR wrapped kit
placed inside a
Tyvek /LLDPE
headerbag and
shipped within a
corrugated shipping
carton | CSR wrapped kit
placed inside a
Tyvek /LLDPE
headerbag and
shipped within a
corrugated shipping
carton | |
| Testing
(Accessory
Packs) | ISTA 2A, Endotoxin,
EO Residuals, and
LAL | ISTA 2A, Endotoxin,
EO Residuals, and
LAL | Unchanged |
Table 6.1: 510(K) Summary: Design Comparison Matrix
6
Non-Clinical Testing l.
The Following non-clinical testing was completed on the modified accessory pack (larger drape and headerbag). Testing was performed as a result of the risk assessment and design control activities based on the subject device modifications from the cleared predicate.
Medcomp®: C3 Wave System K180567 510(k) Summary
7
Biocompatibility:
Biocompatibility was performed for the device modifications per ISO 10993-1 for a skin contacting surface device, with limited exposure (i.e. less than 24 hours).
CYTOTOXICITY:
ISO 10993-5: 2009; Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
SENSITIZATION:
ISO 10993-10; Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
IRRITATION:
ISO 10993-10; Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
Sterilization testing on the modified subject device:
The sterilization cycle was developed using the Overkill Approach defined in ANSI/AAMI/ISO 11135-1: 2014, Annex B. The Microbiological Performance Qualification was performed in accordance with ANSI/AAMI/ISO 11135-1: 2014, section 9.4.2 and the Physical Performance Qualification was performed in accordance with section 9.4.3.
The residuals for C3 ECG Cable Accessory Pack (MRC3RD004) were in accordance with AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals, the maximum level is 4/mg/device.
The packaging integrity of the pouch seal was validated with a dye test per ASTM F 1929-15.
The strength of the packaging seal was validated with a compressed air burst test per ASTM F1140/F1140M-13.
J. Summary of Substantial Equivalence:
Based on the indications for use, design, and performance testing results, the modified subject device raises no new questions of safety or effectiveness compared to the predicate device and is substantially equivalent to the predicate device, C3 Wave System (K170934).