(177 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML capabilities.
No.
The device facilitates interventional procedures by aiding in the use of catheters and guide wires, but it does not directly treat a medical condition.
No
The device is primarily used to inflate/deflate balloon catheters and monitor pressure within the balloon during interventional procedures, which is an operative function rather than a diagnostic one.
No
The device description clearly outlines physical components such as a sterile 20cc inflation device with a locking mechanism, trigger, piston, manometer, connecting tube, stopcock, Y-/Tri- Adapter, Guide Wire Insertion Tool, and Steering Handle. Performance testing also includes physical tests like lubrication break away and pressurization tests.
Based on the provided text, 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 involving catheters and guide wires. This is a direct interaction with the patient's circulatory system, not the analysis of samples taken from the body.
- Device Description: The description details mechanical components like a syringe, locking mechanism, manometer, and connecting tubes. These are tools for manipulating pressure and introducing fluids, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose. The device's function is entirely procedural.
Therefore, the Everest 20cc Inflation Device/ Survival Kit is a medical device used in interventional procedures, not an in vitro diagnostic device.
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 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.
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 30bars 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)
Performance/ Bench Testing: The following tests performance or functional tests were performed to demonstrate substantial equivalence to the predicate devices:
- Lubrication break away test
- Pressurization test
- Rubber Tip and Insert Tensile test
- Compatibility with Contrast Media, Saline or any combination.
Biocompatibility testing: 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 Inflation Devices. The test data demonstrate that the modified Everest Inflation Device is safe, effective, and performs as well or better than the predicate devices.
Clinical Data: 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile, arranged in a row. The figures are connected by flowing lines, creating a sense of unity and continuity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | 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) | |
| 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) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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ချောင်းများ မြန်မာနိုင်ငံ ရွာများ ဧရာဝတီ
3
Special 510(k) Summary
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive,
Danvers, MA 01923, USA. | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Nisarg Shah
Senior Regulatory Affairs Specialist
37A Cherry Hill Drive,
Danvers, MA 01923, USA.
Phone: (978) 739-6632
Fax: (978) 750-8204
E-mail: nisarg.g.shah@medtronic.com | |
| Date Prepared: | March 11, 2016 | |
| Device Trade Name
& 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
Class II per 21 CFR §870.1650
Product Code: MAV | |
| Predicate Device: | The following Medtronic Everest™ Inflation Devices legally
marketed currently were used as predicate devices in this
510(k) premarket notification: | |
| | 1. K942269 (Medtronic Everest™ 20 Inflation Device)
2. K960983 (Medtronic Everest™ 30 Inflation Device,
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. 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
30bars 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
Intended 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. | |
| Summary of
Technological
Characteristics: | Medtronic's EverestTM Disposable Inflation Device is a sterile
20cc inflation device designed to be used during
interventional procedures to inflate/ deflate balloon catheters
as well as monitor pressure within the balloon. Medtronic
offers the EverestTM Inflation Device with a 20 atm or 30 atm
pressure gauge. The EverestTM Inflation Device is constructed
of the following key design components: | |
| | 1. Syringe body with 20cc capacity
2. Body cap
3. Compression spring
4. Piston or lead screw
5. Half nut assembly
6. Rubber Plunger Tip
7. Plunger Insert
8. Gauge or Manometer (20 atm or 30atm)
9. High pressure tube with a male rotating adaptor
10. Trigger | |
| | The difference between the subject and predicate devices is
the change in material of the rubber plunger tip component. | |
| Summary of Non- | The device performance testing and biocompatibility testing | |
4
5
| clinical Data: | were performed in accordance to the relevant FDA guidance in order to demonstrate substantial equivalence to the legally marketed predicate devices. |
|---|---|
| Performance/ Bench Testing: 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. | |
| Biocompatibility testing: 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 | |
| Clinical Data: | No clinical investigations have been performed on the modified device. |
| Conclusion from | |
| 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. |