(28 days)
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.
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.
The document describes a 510(k) premarket notification for Medtronic's Everest™ Inflation Device and Survival Kits. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing related to packaging and shelf-life, rather than clinical efficacy. Therefore, a traditional "study" proving the device meets acceptance criteria in terms of clinical performance or an AI algorithm's performance isn't applicable here.
Instead, the document details the acceptance criteria for packaging performance and shelf-life, and the tests conducted to show the device meets these criteria. The approval is based on the device being "substantially equivalent" to an existing, legally marketed predicate device, not on demonstrating new clinical efficacy.
Here's the information requested, adapted to the context of this device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device relate to its packaging and shelf-life, ensuring it maintains sterility and integrity. The document states that "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." This implies that all tested criteria were met.
Due to the nature of the document detailing specific tests rather than numerical performance metrics for each acceptance criterion, a direct table of "performance" for each against a criterion is not provided with exact values. However, the document lists the performed tests, which serve as the acceptance criteria. The "Reported Device Performance" is broadly stated as successful.
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| I) Packaging Performance Testing | |
| 1. Visual Inspection of Seals | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 2. Labeling Legibility and Adhesion | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 3. Seal Strength | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 4. Sterile Barrier Integrity Bubble Leak | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 5. Minimum Seal Width | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 6. Peel-Open/Aseptic Presentation | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 7. IFU Legibility Test | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| II) Package Shelf-Life Testing | |
| 1. Visual Inspection of Seals | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 2. Labeling Legibility and Adhesion | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 3. Seal Strength | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 4. Sterile Barrier Integrity Bubble Leak | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 5. Minimum Seal Width | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 6. Peel-Open/Aseptic Presentation | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
| 7. IFU Legibility Test | No new safety or effectiveness issues were raised; Data demonstrated device is safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical "sample size" for the non-clinical packaging and shelf-life tests. This type of information is typically found in the full test reports, which are not included in this summary.
The "data provenance" is internal to Medtronic (manufacturer), based on testing performed on the modified Everest™ Inflation Devices. It is retrospective in the sense that the tests are performed on manufactured devices to confirm design and material changes maintain equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device submission. The tests are physical and chemical property tests on packaging and product integrity, not diagnostic or clinical assessments requiring expert human interpretation or "ground truth" establishment in the medical sense. The "ground truth" here is the physical measurement or observation of the packaging and device components against engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. Physical performance tests on a device's parts and packaging do not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes. The results are obtained directly from laboratory measurements and observations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device (inflation balloon and accessories) is a mechanical tool used in interventional procedures. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device does not involve an algorithm or AI component.
7. The Type of Ground Truth Used
For the non-clinical tests (packaging and shelf-life), the ground truth is established by engineering specifications, industry standards (e.g., ISO 15223-1 mentioned for symbols), and regulatory requirements for medical device packaging integrity and sterility. The outcome of these tests determines if the device meets these pre-defined physical and performance benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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
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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 Vascular37A Cherry Hill Drive,Danvers, MA 01923, USA. | |
|---|---|---|
| Contact Person: | Nikita Ciandra VazSenior Regulatory Affairs Specialist35 Cherry Hill Drive,Danvers, MA 01923, USA.Phone: +1 (978) 739-6632E-mail: nikitaciandra.vaz(@medtronic.com | |
| SubmissionNumber: | 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 | |
| ClassificationName: | Angiographic injector and syringeClass II per 21 CFR §870.1650Product Code: MAV | |
| Predicate Device: | The following Medtronic Everest™ InflationDevices legally marketed currently are used aspredicate devices in this 510(k) premarketnotification: | |
| K153038 (Medtronic Everest 20 DisposableInflation Device, Everest 20 Survival Kit,Everest 30 Disposable Inflation Device, Everest30 Survival Kit) | ||
| DeviceDescription: | Medtronic's Everest™ Disposable InflationDevice is a sterile 20cc inflation device with alocking mechanism that is operated via a trigger.Normally, the locking mechanism is engaged. |
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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 inintended use and technological characteristics.The testing performed to assess safety andeffectiveness demonstrated that the modifieddevice does not raise any new concerns of safetyand effectiveness. | |
|---|---|
| Summary of Non-clinical Data: | The following testing was performed to assesssafety and effectiveness of Medtronic'smodified Everest™ Inflation Devices:I) Packaging Performance Testing1) Visual Inspection of Seals2) Labeling Legibility and Adhesion3) Seal Strength4) Sterile Barrier Integrity Bubble Leak5) Minimum Seal Width6) Peel-Open/ Aseptic Presentation7) IFU Legibility TestII) Package Shelf-Life Testing1) Visual Inspection of Seals2) Labeling Legibility and Adhesion3) Seal Strength4) Sterile Barrier Integrity Bubble Leak5) Minimum Seal Width6) Peel-Open/ Aseptic Presentation7) IFU Legibility TestNo new safety or effectiveness issues wereraised during the testing. The test datademonstrated that the modified Medtronic'sEverest™ Inflation Devices is as safe andeffective as the legally marketed predicatedevice. |
| Summary of Clinical Data: | No clinical investigations have been performedon the modified device. |
| Conclusion from Data: | Medtronic Vascular has demonstrated that themodified Everest™ Inflation Devices aresubstantially equivalent to the legally marketedpredicate devices based on the intended use andtechnological characteristics. |
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§ 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.