Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

K153038 · Medtronic, Inc. · MAV · Apr 13, 2016 · Cardiovascular

Device Facts

• Record ID: K153038
• Device Name: Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
• Applicant: Medtronic, Inc.
• Product Code: MAV · Cardiovascular
• Decision Date: Apr 13, 2016
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Indications for Use

The Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Device Story

Sterile 20cc disposable inflation device; used in interventional procedures to inflate/deflate balloon catheters and monitor pressure. Features trigger-operated locking mechanism; allows manual piston manipulation when released. Includes manometer (20 or 30 bar/atm), high-pressure connecting tube, 3-way stopcock. Survival Kit versions include Y/Tri-Adapter with hemostasis valve, guide wire insertion tool, and steering handle. Operated by clinicians in clinical settings. Provides pressure monitoring and fluid introduction ports; assists in guide wire placement and manipulation. Benefits patient by enabling controlled balloon catheterization and reducing backbleeding during procedures.

Clinical Evidence

No clinical investigations performed. Substantial equivalence supported by bench performance testing (lubrication break away, pressurization, tensile tests, media compatibility) and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Sterile 20cc manual inflation syringe. Components: syringe body, cap, compression spring, piston/lead screw, half nut assembly, rubber plunger tip, plunger insert, manometer (20/30 atm), high-pressure tube, trigger. Mechanical operation. No software or electronic components.

Indications for Use

Indicated for use in interventional procedures to facilitate catheter and guide wire placement, inflate/deflate balloon catheters, monitor balloon pressure, control backbleeding, and manipulate guide wires.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Medtronic Everest 20 Inflation Device (K942269)
• Medtronic Everest 30 Inflation Device, Survival Kit (K960983)

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

April 13, 2016

Medtronic, Inc. Nisarg Shah Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923

Re: K153038

Trade/Device Name: Everest 20 Disposable Inflation Device. Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: MAV Dated: March 11, 2016 Received: March 14, 2016

Dear Nisarg Shah:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 (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 yours,

## Kenneth J. Cavanaugh -S

for

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 | |
| <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: January 31, 2017 |
| | See PRA Statement below. |
| 510(k) Number (if known) | |
| K153038 | |
| Device Name | |
| Medtronic's Everest ^TM Inflation Devices | |
| Indications for Use (Describe) | |
| The Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire. | |
| Type of Use (Select one or both, as applicable) | |
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## Special 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive,<br>Danvers, MA 01923, USA. | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Nisarg Shah<br>Senior Regulatory Affairs Specialist<br>37A Cherry Hill Drive,<br>Danvers, MA 01923, USA.<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Date Prepared: | March 11, 2016 | |
| Device Trade Name<br>& Model Numbers: | Trade Name | Model Number |
| | Everest™ 20 Inflation Device | AC2200 |
| | Everest™ 20 Survival Kit | AC2205P |
| | Everest™ 30 Inflation Device | AC3200 |
| | Everest™ 30 Survival Kit | AC3205P |
| Common Name: | Syringe, Balloon Inflation | |
| Classification Name: | Angiographic injector and syringe<br>Class II per 21 CFR §870.1650<br>Product Code: MAV | |
| Predicate Device: | The following Medtronic Everest™ Inflation Devices legally<br>marketed currently were used as predicate devices in this<br>510(k) premarket notification: | |
| | 1. K942269 (Medtronic Everest™ 20 Inflation Device)<br>2. K960983 (Medtronic Everest™ 30 Inflation Device,<br>Survival Kit) | |
| Device<br>Description: | Medtronic's Everest™ Disposable Inflation Device is a sterile<br>20cc inflation device with a locking mechanism that is<br>operated via a trigger. Normally, the locking mechanism is<br>engaged. Once the trigger is pulled back, the locking<br>mechanism is released and the piston can be manually<br>manipulated. | |
| | The Everest™ 20 Device is outfitted with a manometer with<br>measuring pressures ranging from vacuum to 20 bars in 0.5bar<br>increments. The Everest™ 30 Device is outfitted with a | |
| | manometer with measuring pressure reading from vacuum to<br>30bars in 1 bar increments. A high pressure connecting tube<br>with a male rotating adapter and a disposable 3-way stopcock<br>are also included to aid in preparation of the device. When<br>purchased as a “Survival Kit", the package includes a Y-/ Tri-<br>Adapter with hemostasis valve, a Guide Wire Insertion Tool<br>and a Steering Handle. | |
| Statement of<br>Intended Use: | The Everest 20cc Inflation Device/ Survival Kit is to be used<br>to facilitate the use of catheters and guide wires during<br>interventional procedures. The Everest 20cc Inflation Device<br>is designed to be used to inflate/ deflate balloon catheters as<br>well as to monitor pressure within the balloon. The Y/Tri-<br>Adaptor with Hemostasis Valve is designed to be used on a<br>guiding catheter or dilatation catheter to control backbleeding<br>and to provide a port for introduction of fluids into the<br>interventional system. The Guide Wire Insertion Tool is<br>designed to facilitate placement of a guide wire tip through<br>the Y/Tri-Adapter and into the wire lumen of an<br>interventional catheter. The Guide Wire Steering Handle is<br>designed to hold a small diameter guide wire and provide a<br>handle for manipulating the wire. | |
| Summary of<br>Technological<br>Characteristics: | Medtronic's EverestTM Disposable Inflation Device is a sterile<br>20cc inflation device designed to be used during<br>interventional procedures to inflate/ deflate balloon catheters<br>as well as monitor pressure within the balloon. Medtronic<br>offers the EverestTM Inflation Device with a 20 atm or 30 atm<br>pressure gauge. The EverestTM Inflation Device is constructed<br>of the following key design components: | |
| | 1. Syringe body with 20cc capacity<br>2. Body cap<br>3. Compression spring<br>4. Piston or lead screw<br>5. Half nut assembly<br>6. Rubber Plunger Tip<br>7. Plunger Insert<br>8. Gauge or Manometer (20 atm or 30atm)<br>9. High pressure tube with a male rotating adaptor<br>10. Trigger | |
| | The difference between the subject and predicate devices is<br>the change in material of the rubber plunger tip component. | |
| Summary of Non- | The device performance testing and biocompatibility testing | |

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| clinical Data: | were performed in accordance to the relevant FDA guidance in order to demonstrate substantial equivalence to the legally marketed predicate devices. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <b>Performance/ Bench Testing:</b> The following tests performance or functional tests were performed to demonstrate substantial equivalence to the predicate devices: |
| | 1. Lubrication break away test |
| | 2. Pressurization test |
| | 3. Rubber Tip and Insert Tensile test |
| | 4. Compatibility with Contrast Media, Saline or any combination. |
| | <b>Biocompatibility testing:</b> The Biocompatibility testing was performed pursuant to the requirements of ISO 10993-1: Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process. |
| | Based on the results of the Performance testing and Biocompatibility testing, no new concerns of safety and effectiveness were raised for Medtronic's Everest ^TM Inflation Devices. The test data demonstrate that the modified Everest ^TM Inflation Device is safe, effective, and performs as well or better than the predicate devices. |
| Summary of<br>Clinical Data: | No clinical investigations have been performed on the modified device. |
| Conclusion from<br>Data: | Medtronic Vascular has demonstrated that the modified Everest ^TM Inflation Devices are substantially equivalent to the legally marketed predicate devices based on the intended use and technological characteristics. |