C3 Wave System

K180567 · Medical Components, Inc. (dba MedComp) · LJS · Apr 12, 2018 · General Hospital

Device Facts

• Record ID: K180567
• Device Name: C3 Wave System
• Applicant: Medical Components, Inc. (dba MedComp)
• Product Code: LJS · General Hospital
• Decision Date: Apr 12, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

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.

Device Story

C3 Wave System assists in PICC placement by providing real-time catheter tip location. System uses three ECG leads on patient chest and a third lead generated by switching from RA to PICC stylet. ECG waveform is wirelessly transmitted to a tablet for operator viewing. As catheter approaches heart atrium, P-wave amplitude changes are visualized. Operated by skilled nurses or physicians in hospital/clinical settings. Output allows clinicians to confirm catheter tip location in lower third of Superior Vena Cava, potentially reducing need for confirmatory X-ray or fluoroscopy.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, -10), sterilization validation (ANSI/AAMI/ISO 11135-1), and packaging integrity (ASTM F1929-15, ASTM F1140/F1140M-13).

Technological Characteristics

System includes iPad, C3 Wave Hub, ECG leads, and remote. Sterile accessory packs sterilized via Ethylene Oxide (EO). Packaging validated per ASTM F1929-15 and ASTM F1140/F1140M-13. Biocompatibility per ISO 10993-1. Wireless transmission of ECG data to tablet interface.

Indications for Use

Indicated for positioning of Peripherally Inserted Central Catheters (PICC) in adult patients as an alternative to chest X-ray or fluoroscopy. Not contraindicated but limited in patients with atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythm, or COPD.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• C3 Wave System (K170934)

Submission Summary (Full Text)

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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.

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

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## 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)

| <span style="font-size:10pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:10pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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| K180567 | | 510(k) SUMMARY | Special 510K |
|---------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | A. Submitter Information: | | |
| | Submitter: | Medical Components Inc.<br>(dba Medcomp®)<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Tel: [phone] x 2285<br>Fax: [phone] | |
| | Registration Number: | 2518902 | |
| | Contact Person: | Courtney Nix<br>Regulatory Affairs Manager,<br>North America and Europe | |
| | Date of Preparation: | 03/02/2018 | |
| | B. Subject Device | | |
| | Trade Name: | C3 Wave System | |
| | Device: | Catheter, intravascular, Therapeutic Long-Term<br>Greater Than 30 Days | |
| | Product Code: | LJS | |
| | Regulation Description: | Percutaneous, implanted, long-term intravascular<br>catheter | |
| | C.F.R. Section: | 880.5970 | |
| | Class: | II | |
| | Regulation Medical<br>Specialty and Review<br>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<br>Greater Than 30 Days | |
| | Product Code: | LJS | |
| | Regulation Description: | Percutaneous, implanted, long-term intravascular<br>catheter | |
| | C.F.R. Section: | 880.5970 | |
| | Class: | II | |
| | Regulation Medical<br>Specialty and Review<br>Panel: | General Hospital | |

Medcomp®: C3 Wave System
K180567 510(k) Summary

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# 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

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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:<br>C3 Wave System<br>(MRC3RD004) | Predicate Device:<br>C3 Wave System<br>(MRC3RD000) | Substantially<br>Equivalent<br>Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Indications<br>for Use | The C3 Wave System<br>is indicated for use in<br>the positioning of<br>Peripherally Inserted<br>Central Catheters<br>(PICC). The C3 Wave<br>provides real-time<br>catheter tip location<br>information by<br>displaying changes in<br>the patient's cardiac<br>electrical activity. The<br>C3 Wave is indicated<br>for use as an<br>alternative method to<br>chest X-ray or<br>fluoroscopy<br>confirmation of PICC<br>tip placement in adult<br>patients.<br><br>Note: Limiting, but not<br>contraindicated,<br>situations for this<br>technique are patients<br>where cardiac rhythms<br>may change<br>presentation of the P-<br>Wave:<br>-Atrial fibrillation<br>-Atrial flutter- Severe<br>tachycardia<br>-Pacemaker-Driven<br>Rhythm<br>-Chronic obstructive<br>pulmonary disease<br>(COPD)<br>Such patients are | The C3 Wave System<br>is indicated for use in<br>the positioning of<br>Peripherally Inserted<br>Central Catheters<br>(PICC). The C3 Wave<br>provides real-time<br>catheter tip location<br>information by<br>displaying changes in<br>the patient's cardiac<br>electrical activity. The<br>C3 Wave is indicated<br>for use as an<br>alternative method to<br>chest X-ray or<br>fluoroscopy<br>confirmation of PICC<br>tip placement in adult<br>patients.<br><br>Note: Limiting, but not<br>contraindicated,<br>situations for this<br>technique are patients<br>where cardiac rhythms<br>may change<br>presentation of the P-<br>Wave:<br>-Atrial fibrillation<br>-Atrial flutter- Severe<br>tachycardia<br>-Pacemaker-Driven<br>Rhythm<br>-Chronic obstructive<br>pulmonary disease<br>(COPD)<br>Such patients are<br>easily identified prior | Unchanged |
| | to PICC insertion. Use<br>of additional method is<br>necessary to confirm<br>catheter tip location. | to PICC insertion. Use<br>of additional method is<br>necessary to confirm<br>catheter tip location. | |
| User/Setting | Prescription Use –<br>Hospital/Clinical<br>Setting | Prescription Use –<br>Hospital/Clinical<br>Setting | Unchanged |
| Patient/User<br>Interface | iPad | iPad | Unchanged |
| System | iPad, C3 Wave Hub,<br>ECG Leads, C3 Wave<br>Remote | iPad, C3 Wave Hub,<br>ECG Leads, C3 Wave<br>Remote | Unchanged |
| Overall<br>System<br>Components<br>(incl.<br>Accessory<br>Packs) | iPad, iPad Case,<br>Remote, Remote<br>Battery, Hub, Hub<br>Battery, Hub Power<br>Supply, Leads, Base,<br>ECG Clip Cable,<br>Remote Cover,<br>Electrodes, Skip Prep,<br>Drape | iPad, iPad Case,<br>Remote, Remote<br>Battery, Hub, Hub<br>Battery, Hub Power<br>Supply, Leads, Base,<br>ECG Clip Cable,<br>Remote Cover,<br>Electrodes, Skip Prep,<br>Drape | Equivalent; Change<br>to Dimension of<br>Drape |
| Sterile<br>Accessory<br>Pack<br>Components | ECG Clip Cable,<br>Remote Cover, and<br>Drape | ECG Clip Cable,<br>Remote Cover, and<br>Drape | Equivalent; Change<br>to Dimension of<br>Drape |
| Drape<br>Dimensions | 100" x 86" | 45" x 40" | Equivalent; Change<br>to Dimension of<br>Drape |
| Sterilization<br>Method | Sterile Accessory<br>Packs – EO | Sterile Accessory<br>Packs – EO | Unchanged |
| Packaging<br>Systems | 12.250"x18.500"<br>Tyvek Headerbag | 17.500"x10.750"<br>Tyvek Headerbag | Equivalent; Change<br>to Dimension of<br>Headerbag to<br>accommodate larger<br>drape |
| | CSR wrapped kit<br>placed inside a<br>Tyvek /LLDPE<br>headerbag and<br>shipped within a<br>corrugated shipping<br>carton | CSR wrapped kit<br>placed inside a<br>Tyvek /LLDPE<br>headerbag and<br>shipped within a<br>corrugated shipping<br>carton | |
| Testing<br>(Accessory<br>Packs) | ISTA 2A, Endotoxin,<br>EO Residuals, and<br>LAL | ISTA 2A, Endotoxin,<br>EO Residuals, and<br>LAL | Unchanged |

Table 6.1: 510(K) Summary: Design Comparison Matrix

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#### 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

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## 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).