Celerity ECG Cable Accessory Pack

K171931 · Medcomp (Medical Components, Inc.) · LJS · Oct 26, 2017 · General Hospital

Device Facts

• Record ID: K171931
• Device Name: Celerity ECG Cable Accessory Pack
• Applicant: Medcomp (Medical Components, Inc.)
• Product Code: LJS · General Hospital
• Decision Date: Oct 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Indications for Use

The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including: - 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 an additional confirmation method is necessary to confirm catheter tip location.

Device Story

Accessory pack for Celerity System; includes sterile remote cover and specialized alligator PICC clip. Device facilitates continuous ECG waveform display to guide PICC placement in right atrium. Used in clinical settings by healthcare providers. Clip conducts ECG signal from PICC stylet to Celerity remote control; remote cover provides sterile barrier for remote control cable. Output allows real-time visualization of P-wave changes, aiding clinicians in optimal catheter tip positioning. Benefits include reduced reliance on X-ray/fluoroscopy for confirmation.

Clinical Evidence

Bench testing only. Testing included accelerated aging (1 and 3 years) for alligator clips and accessory packs, equipment interaction testing, and ISTA 2A shipping tests. No clinical data provided.

Technological Characteristics

Components: nickel-plated steel alligator clip with PVC insulator; latex-free polyethylene remote cover. Principle: ECG signal conduction from PICC stylet to remote control. Sterilization: Ethylene Oxide. Connectivity: Wired accessory to Celerity System. Non-patient contacting.

Indications for Use

Indicated for PICC positioning in adult patients (18+). Provides real-time tip location via cardiac electrical activity as an alternative to chest x-ray or fluoroscopy. Not contraindicated but limited in patients with atrial fibrillation, atrial flutter, severe tachycardia, pacemaker-driven rhythms, or COPD; additional confirmation methods required for these populations.

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

• Celerity™ PICC Tip Confirmation System (K142889)

Submission Summary (Full Text)

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October 26, 2017

Medical Components, Inc. (dba Medcomp®) Colton Muraira Regulatory Affairs 1499 Delp Dr. Harleysville, Pennsylvania 19438

Re: K171931

Trade/Device Name: Celerity™ ECG Cable Accessory Pack Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: September 15, 2017 Received: September 26, 2017

Dear Colton Muraira:

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

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## Indications for Use

510(k) Number (if known)

#### K171931

#### Device Name

Celerity ECG Cable Accessory Pack

#### Indications for Use (Describe)

The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

- · 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 an additional confirmation 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## K171931 510(K) SUMMARY

| Manufacturer's Name: | Medical Components, Inc. (dba Medcomp®)<br>1499 Delp Drive<br>Harleysville, PA 19438 |
|---------------------------|--------------------------------------------------------------------------------------|
| Corresponding Official: | Colton Muraira<br>Regulatory: North America and EU |
| Telephone Number: | [phone], x 2285 |
| Email: | [e-mail] |
| Preparation Date: | October 23, 2017 |
| Trade Name: | Celerity™ ECG Cable Accessory Pack |
| Common or Usual Name: | PICC Placement Accessory |
| Regulation Name: | Percutaneous, implanted, long-term<br>intravascular catheter |
| Regulation Number: | 21 CFR 880.5970 |
| Product Code: | LJS |
| Device Class: | Class II |
| Primary Predicate Device: | K142889 - AngioDynamics Inc. Celerity™ PICC Tip Confirmation<br>System |

### Device Description:

The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip. The Celerity™ ECG Cable Accessory Pack is designed to be used in conjunction with the Celerity™ System to provide a continuous display of electrocardiograph waveforms to guide placement of peripherally-inserted central catheters in the patient's right atrium of the heart.

### Indications For Use

The Celerity™ System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

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Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

- । 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 an additional method is necessary to confirm catheter tip location.

### Substantial Equivalence Discussion

The subject device is an accessory pack to the Celerity System. The subject device accessory pack consists of a sterile remote cover and a specialized alligator PICC clip. Both devices use changes in cardiac electrical activity to provide real-time catheter tip location.

Celerity™ ECG Cable Accessory Pack has been compared to the cleared "Celerity™ PICC Tip Confirmation System" (510(k)# K142889) as a reference for substantial equivalence. A table comparing the two devices is provided as follow:

| Attribute | Subject Device – K171931:<br>Celerity ECG Cable Accessory<br>Pack | Predicate Device – K142889 :<br>Celerity PICC Tip Confirmation<br>System | Comparison | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 510(k) Holder | Medcomp, Inc | AngioDynamics | N/A | |
| Design | The Celerity ECG Cable<br>Accessory Pack is designed to be<br>used in conjunction with the<br>Celerity™ System to provide a<br>continuous display of<br>electrocardiograph [ECG]<br>waveforms to guide placement of<br>peripherally-inserted central<br>catheters [PICC] in the patient's<br>right atrium of the heart.<br><br>Sterile remote cover: covers a<br>sufficient length of the remote<br>control cable to provide a sterile<br>barrier capable of being pierced by<br>the remote control PICC<br>connector.<br><br>Sterile PICC Clip Connector: | The Celerity PICC Tip<br>Confirmation System is an<br>accessory to peripherally-inserted<br>central catheters (PICC). It aids a<br>clinician in placing PICC<br>optimally, in the superior vena<br>cava near the entrance to the right<br>atrium of the heart. | Components<br>Same | |
| | Capable of conducting an ECG<br>signal from the PICC stylet to the<br>Celerity remote control. | To provide real time tip location<br>information of a central venous<br>catheter by utilization of ECG to<br>observe P-wave changes as the tip<br>approaches the right atrium of the<br>heart via the superior vena cava. | To provide real time tip location<br>information of a central venous<br>catheter by utilization of ECG to<br>observe P-wave changes as the tip<br>approaches the right atrium of the<br>heart via the superior vena cava. | Same |
| Intended use | | | | |
| Indications for<br>use | The Celerity ECG Cable<br>Accessory Pack is indicated for the<br>positioning of Peripherally<br>Inserted Central Catheters (PICC)<br>in adult patients. It provides real-<br>time catheter tip location<br>information by using the patient's<br>cardiac electrical activity. The<br>Celerity System is indicated for<br>use as an alternative method to<br>chest x-ray or fluoroscopy<br>confirmation of PICC tip<br>placement in adult patients.<br><br>Note: In general, devices that<br>utilize ECG technique to observe<br>P-wave are limited, but not<br>contraindicated for patients where<br>cardiac rhythms may change<br>presentation of the P-wave;<br>including:<br>- Atrial fibrillation<br>- Atrial flutter<br>- Severe tachycardia<br>- Pacemaker-Driven Rhythm<br>- Chronic obstructive<br>pulmonary disease (COPD)<br><br>Such patients are easily identified<br>prior to PICC insertion. Use of an<br>additional method is necessary to<br>confirm catheter tip location. | The Celerity System is indicated<br>for the positioning of Peripherally<br>Inserted Central Catheters (PICC)<br>in adult patients. It provides real-<br>time catheter tip location<br>information by using the patient's<br>cardiac electrical activity. The<br>Celerity System is indicated for<br>use as an alternative method to<br>chest x-ray or fluoroscopy<br>confirmation of PICC tip<br>placement in adult patients.<br><br>Note: In general, devices that<br>utilize ECG technique to observe<br>P-wave are limited, but not<br>contraindicated for patients where<br>cardiac rhythms may change<br>presentation of the P-wave;<br>including:<br>- Atrial fibrillation<br>- Atrial flutter<br>- Severe tachycardia<br>- Pacemaker-Driven Rhythm<br>- Chronic obstructive<br>pulmonary disease (COPD)<br><br>Such patients are easily identified<br>prior to PICC insertion. Use of an<br>additional method is necessary to<br>confirm catheter tip location. | Same | |
| Target<br>Population | Adults (18 years or older) | Adults (18 years or older) | Same | |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Same | |
| Materials | ECG Clip Cable: nickel plated<br>steel with a white PVC insulator.<br>The audio connector consists of a<br>nylon and polyethylene insulator<br>and gold or nickel plated contacts<br>Remote Cover: latex-free<br>polyethylene | ECG Clip Cable: nickel plated<br>steel with a white PVC insulator.<br>The audio connector consists of a<br>nylon and polyethylene insulator<br>and gold or nickel plated contacts<br>Remote Cover: latex-free<br>polyethylene | Same | |

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The indications for use statement and the intended use of the subject device are identical to the predicate device. The differences between the subject device and the predicate device are:

- 1. Proposed device is an accessory pack containing separate components to be used with the predicate Celerity System, which already contains stated components.
- 2. Different manufacturer of the ECG Clip Cable and Remote Cover

Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.

# Bench/Performance/Non-Clinical Testing

The following testing was conducted to demonstrate substantial equivalence of the Celerity™ ECG Cable Accessory Pack to the predicate devices:

| Item | Test Name |
|------|---------------------------------------------------------------------------------|
| 1 | Alligator Clips – 1 year accelerated aging |
| 2 | Alligator Clips – 3 year accelerated aging |
| 3 | Equipment Interaction of Alligator Clips,<br>ECG Electrodes, and ECG Snap Leads |
| 4 | Probe Cover – 1 year accelerated aging |
| 5 | Celerity Accessory Pack – 1 year accelerated aging |
| 6 | Celerity Accessory Pack – 3 year accelerated aging |
| 7 | Celerity Accessory Packs – ISTA 2A Shipping Test |

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#### Biocompatibility

The subject device is non-patient contacting and therefore, biocompatibility testing is not applicable.

## Conclusion

The modifications to the subject device include the change of the manufacture of the ECG Clip Cable and the Remote Cover and the packaging of the ECG Clip Cable and Remote Cover as an accessory pack. The modifications do not raise new or different questions of safety and effectiveness and are supported by non-clinical testing.

The Celerity ECG Cable Accessory Pack is substantially equivalent to the Celerity PICC Tip Confirmation System cleared under K142889.