Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

K170488 · Surge Cardiovascular · DWF · Aug 10, 2017 · Cardiovascular

Device Facts

• Record ID: K170488
• Device Name: Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
• Applicant: Surge Cardiovascular
• Product Code: DWF · Cardiovascular
• Decision Date: Aug 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is nation of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

Device Story

Single-lumen PVC cannula used for venting left ventricle during cardiopulmonary bypass; duration up to 6 hours. Device features open-ended distal tip with side holes to facilitate fluid flow; includes malleable PVC introducer with stainless steel wire core for positioning. Physician inserts cannula via right superior pulmonary vein through mitral valve; connects to vacuum source via 1/4" tubing connector. Device facilitates blood removal from left ventricle; prevents distension; improves surgical field visibility; supports cardiac decompression during bypass.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 for external communicating, circulating blood, limited duration devices (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, hemocompatibility, genotoxicity). Performance testing included simulated use, flow, pressure, vacuum, bond strength, kink resistance, and packaging integrity.

Technological Characteristics

Single-lumen PVC cannula; 16 Fr, 18 Fr, and 20 Fr sizes; 36cm length. Includes malleable PVC introducer with stainless steel wire core. Features open-ended distal tip with side holes and 1/4" slip connector. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring left ventricular venting for up to 6 hours. Entrance via right superior pulmonary vein through the mitral valve.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Curved Left Heart Vent Catheter (K096419)
• DLP Left Heart Vent Catheter (K834352)
• Malleable Vent Catheter (K981601)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 10, 2017

Surge Cardiovascular % Korina Akhondzadeh Regulatory Consultant to Surge Cardiovascular KARA & Associates 6965 El Camino Real, Suite 105-428 Carlsbad, California 92009

Re: K170488

Trade/Device Name: Peak Left Ventricular Vent Cannula, 20 Fr .; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 15, 2017 Received: June 19, 2017

Dear Korina Akhondzadeh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K170488

### Device Name

Peak Left Ventricular Vent Cannula

# Indications for Use (Describe)

The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is nation of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

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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FORM FDA 3881 (8/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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# 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### l. SUBMITTER

Surge Cardiovascular 2680 Walker Ave NW, Suite C Walker, MI 49544

269-629-0300 Phone: Contact at Surge Cardiovascular: Rick Shorey

# Official Correspondent

Korina A. Akhondzadeh KARA & Associates - Regulatory Consultant to Surge Cardiovascular 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009

760-798-9642 Phone: Fax: [phone]

Date Prepared:

June 15, 2017

#### ll. DEVICE

| Device Name: | Peak Left Ventricular Vent Cannula |
|----------------------|-------------------------------------------------------------------------------------|
| Common/Usual Name: | Left Ventricular Vent |
| Classification Name: | Catheter, Cannula and Tubing, Vascular,<br>Cardiopulmonary Bypass (21 CFR 870.4210) |
| Product Code: | DWF |
| Class: | II |

#### III. PREDICATE DEVICE

Primary Predicate Device Curved Left Heart Vent Catheter, K0964194

Secondary Predicate Devices DLP Left Heart Vent Catheter, K834352 Malleable Vent Catheter, K981601

This predicate devices have not been subject to a recall.

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#### DEVICE DESCRIPTION IV

The Peak Left Ventricular Vent Cannula is a single lumen. PVC cannula intended for use in venting the left ventricle during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

The 36cm Cannula has an open end at the distal tip and a series of side holes at the distal end of the cannula to allow for venting when inserted into the left ventricle. The device is designed with an open-ended smooth, tapered tip to minimize trauma to the tissues. The cannula body slip connector allows for connection to ¼" tubing for venting by the physician.

The device is supplied with a malleable PVC Introducer which has a length of stainless steel wire enclosed within the Introducer sheath. The Introducer has a smooth rounded tip at the distal end. When the Introducer is inserted into the cannula body, the luer hub fits into the internal diameter of the slip connector. When the luer hub is seated in the cannula slip connector, the smooth rounded end of the introducer extends beyond the open tip of the Cannula.

The device is provided sterile and is intended for single-use.

#### V. INDICATIONS FOR USE

The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the Peak Left Ventricular Vent Cannula and the predicate devices are tubing sets with similar inlets and outlets for connection to source containers and vials or final medication containers. Both the subject and predicate devices are based upon the same technological elements:

The Peak Left Ventricular Vent Cannula and its predicate devices have similar technological characteristics:

- Device materials Both subject and predicate devices have PVC cannula bodies .
- . Introducer design - The subject device and the California Medical Laboratories Malleable Vent Catheter have PVC Sheath over a malleable Stainless Steel core.
- . Tip design – The subject device and the California Medical Laboratories Malleable Vent Catheter have an open ended cannula with open ended tip integrated with the catheter body.
- Depth markings - All devices have depth markings.
- . Canula Sizes OD - Both Left Ventricular Vent Cannula and the Chase predicate device are availabel in 20 Fr The subject device and the Medtronic DLP device are avaialbe in 16 Fr and 18 Fr.

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- Side Openings The subject device and predicate devices have holes at the distal end to allow for fluid flow through the cannula body.
- . Cannula Length - Both the subject device and the Chase and DLP predicate devices are 15" long.
- . Connector - All devices include a ¼" connector to allow for connection to a vacuum source.

#### VII. PERFORMANCE DATA

# Biocompatibility Testing

The biocompatibility evaluation for the Peak Left Ventricular Vent Cannula device was conducted in accordance with FDA Guidance for Industry and FDA Staff - "Use of International Standard ISO 10993-1, "biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" June 16, 2016. Biocompatibility testing as required for External Communicating Devices, Circulating Blood, Limited Duration was conducted in accordance with cited guidances and standards.

The battery of testing included the following tests:

- Cytotoxicity
- . Sensitization
- Intracutaneous reactivity
- . Acute systemic toxicity
- Material-mediated pyrogenicity
- . Hemocompatibility- Hemolysis Indirect and Hemolysis Direct
- . Hemocompaiblity - Thrombogenicity
- . Hemocompatiblity – Complement Activation
- . Genototixicty - Reverse Mutation Assay (Ames Test)
- Genotoxicity – Chromosomal Abberration

# Performance Testing

- Testing of Introducer Assembly of Device
- . Simulated Bend/Removal of Introducer
- . Flow and Simulated Use Flow Testing
- . Simulated Pressure Testing
- Simulated Vacuum Testing
- Limit Testing for Connector Bond
- Limit Testing for Introducer Bond
- . Limit Testing for Kink Resistance – Empty
- . Limit Testing for Kink Resistance - Full
- Ink Adherence Testing
- . Shipping/Disribution Studies for Packaging Integrity

#### VIII. CONCLUSIONS

The testing conducted supports the substantial equivalence of the Peak Left Ventricular Vent Cannula to the predicate devices and demonstrates the Peak Left Ventricular Vent

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Cannula performs as intended. The performance testing conducted demonstrates that the Peak Left Ventricular Vent Cannula performs substantially equivalent to the predicate devices. Both the Peak Left Ventricular Vent Cannula and the predicate devices have the same intended use and technological characteristics.