(28 days)
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or functionalities.
No.
The device facilitates the use of other tools (catheters and guide wires) and monitors pressure but does not directly treat a medical condition or disease.
No
This device is designed to facilitate medical procedures involving catheters and guide wires (e.g., inflating/deflating balloon catheters, controlling fluid introduction). While it monitors pressure, this monitoring is functional to the procedure itself, not for diagnosing a patient's condition.
No
The device description clearly details physical components like an inflation device, manometer, connecting tube, stopcock, Y/Tri-Adapter, Guide Wire Insertion Tool, and Steering Handle. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in facilitating interventional procedures by inflating/deflating balloon catheters, monitoring pressure, controlling backbleeding, and aiding in guide wire placement. These are all actions performed on or within the patient's body during a medical procedure.
- Device Description: The description details a mechanical device (inflation device, manometer, connecting tube, stopcock, adapters, tools) used for manipulating catheters and guide wires.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
The device described is a medical device used in vivo (within the body) during interventional procedures, not an IVD.
N/A
Intended Use / 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 inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter 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.
Product codes (comma separated list FDA assigned to the subject device)
MAV
Device Description
Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following testing was performed to assess safety and effectiveness of Medtronic's modified Everest™ Inflation Devices:
I) Packaging Performance Testing
- Visual Inspection of Seals
- Labeling Legibility and Adhesion
- Seal Strength
- Sterile Barrier Integrity Bubble Leak
- Minimum Seal Width
- Peel-Open/ Aseptic Presentation
- IFU Legibility Test
II) Package Shelf-Life Testing
- Visual Inspection of Seals
- Labeling Legibility and Adhesion
- Seal Strength
- Sterile Barrier Integrity Bubble Leak
- Minimum Seal Width
- Peel-Open/ Aseptic Presentation
- IFU Legibility Test
No new safety or effectiveness issues were raised during the testing. The test data demonstrated that the modified Medtronic's Everest™ Inflation Devices is as safe and effective as the legally marketed predicate device.
No clinical investigations have been performed on the modified device.
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
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2022
Medtronic Vascular Nikita Ciandra Vaz Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923
Re: K220773
Trade/Device Name: Everest 20 Inflation Device: Everest 30 Inflation Device; Everest 20 Survival Kit; 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 15, 2022 Received: March 16, 2022
Dear Nikita Ciandra Vaz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220773
Device Name
Everest™ 20 Inflation Device; Everest™ 20 Survival Kit Everest™ 30 Inflation Device; Everest™ 30 Survival Kit
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 inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter 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-Adanter 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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Special 510(k) Summary
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive,
Danvers, MA 01923, USA. | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Nikita Ciandra Vaz
Senior Regulatory Affairs Specialist
35 Cherry Hill Drive,
Danvers, MA 01923, USA.
Phone: +1 (978) 739-6632
E-mail: nikitaciandra.vaz(@medtronic.com | |
| Submission
Number: | K220773 | |
| Date Prepared: | March 15, 2022 | |
| Device Trade Name | Trade Name | Model Number |
| & Model Numbers: | 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
Class II per 21 CFR §870.1650
Product Code: MAV | |
| Predicate Device: | The following Medtronic Everest™ Inflation
Devices legally marketed currently are used as
predicate devices in this 510(k) premarket
notification: | |
| | K153038 (Medtronic Everest 20 Disposable
Inflation Device, Everest 20 Survival Kit,
Everest 30 Disposable Inflation Device, Everest
30 Survival Kit) | |
| Device
Description: | Medtronic's Everest™ Disposable Inflation
Device is a sterile 20cc inflation device with a
locking mechanism that is operated via a trigger.
Normally, the locking mechanism is engaged. | |
4
Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle. Statement of The Everest 20cc Inflation Device/Survival Kit Intended Use: 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-Adapter 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 svstem. 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. Medtronic's Everest™ Disposable Inflation Summary of Technological Device is a sterile 20cc inflation device designed Characteristics: to be used during interventional procedures to inflate/ deflate balloon catheters as well as monitor pressure within the balloon. Medtronic offers the Everest™ Inflation Device with a 20 atm or 30 atm pressure gauge. The Everest™ Inflation Device is constructed of the following key design components:
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-
- Syringe body with 20cc capacity
-
- Body cap
-
- Compression spring
-
- Piston or lead screw
-
- Half nut assembly
-
- Rubber Plunger Tip
-
- Plunger Insert
-
- Gauge (20 atm or 30 atm)
-
- High pressure tube with a male rotating adaptor
-
- Trigger
The subject device (Everest™ Disposable Inflation Device) has the same technological characteristics as that of the predicate device, including the same design, material, chemical composition, principle of operation, and performance specifications.
Comparison to the The following information outlines the predicate device: differences and similarities between the subject device and the predicate device:
- Similar Intended Use/ Indication for Use ●
- Similar Technological characteristics
- Similar Device design, materials, principle of operation
- Similar packaging
- Similar sterilization technology/ method ●
- Different labeling ●
The differences in labeling include the following:
- Addition of a symbol that implies . 'Single sterile barrier system with protective packaging outside' (per ISO 15223-1 standard).
- Updated the Instructions for Use (IFU) . document to describe the symbol mentioned above.
- . Addition of a yellow label on the outer bag, providing clarity to the end user about the single sterile barrier packaging configuration.
Medtronic's modified Everest™ Disposable Inflation Device is substantially equivalent to
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| the predicate device based on similarities in
intended use and technological characteristics.
The testing performed to assess safety and
effectiveness demonstrated that the modified
device does not raise any new concerns of safety
| and effectiveness. | |
|---|---|
| Summary of Non-clinical Data: | The following testing was performed to assess |
| safety and effectiveness of Medtronic's | |
| modified Everest™ Inflation Devices: |
I) Packaging Performance Testing
- Visual Inspection of Seals
- Labeling Legibility and Adhesion
- Seal Strength
- Sterile Barrier Integrity Bubble Leak
- Minimum Seal Width
- Peel-Open/ Aseptic Presentation
- IFU Legibility Test
II) Package Shelf-Life Testing
- Visual Inspection of Seals
- Labeling Legibility and Adhesion
- Seal Strength
- Sterile Barrier Integrity Bubble Leak
- Minimum Seal Width
- Peel-Open/ Aseptic Presentation
- IFU Legibility Test
No new safety or effectiveness issues were
raised during the testing. The test data
demonstrated that the modified Medtronic's
Everest™ Inflation Devices is as safe and
effective as the legally marketed predicate
device. |
| Summary of Clinical Data: | No clinical investigations have been performed
on the modified device. |
| Conclusion from Data: | Medtronic Vascular has demonstrated that the
modified Everest™ Inflation Devices are
substantially equivalent to the legally marketed
predicate devices based on the intended use and
technological characteristics. |
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