(80 days)
No
The device description and performance studies focus on mechanical and analog components (syringe, pressure gauge, bourdon tube) and standard physical tests (pressure, leak). There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an accessory used for inflating and deflating balloon dilatation catheters, which are therapeutic devices themselves. The inflation device facilitates a therapeutic procedure but does not directly provide therapy.
No
This device is used to inflate and deflate balloon dilatation catheters during angioplasty procedures, which is a therapeutic intervention, not a diagnostic one. It assists in a medical procedure by controlling pressure, rather than gathering information or identifying a condition.
No
The device description clearly details physical components such as a syringe, analog pressure gauge, plunger, connecting tube, and stopcock, indicating it is a hardware device, not software-only.
Based on the provided text, the Medtronic® Everest™ 30 Inflation Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "inflation / deflation of balloon dilatation catheters" during "angioplasty procedures." This is a procedure performed in vivo (within the living body) to treat blockages in blood vessels.
- Device Description: The description details a mechanical device used to apply pressure and vacuum to a balloon catheter. It involves a syringe, pressure gauge, and connections for delivering contrast medium and inflating/deflating the balloon. This is consistent with a device used for a medical procedure on a patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples of human origin (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used for screening, diagnosis, prognosis, or monitoring of disease.
In summary, the Medtronic® Everest™ 30 Inflation Device is a medical device used during a medical procedure on a patient, not a device used to perform tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.
Product codes
Not Found
Device Description
The Medtronic® Everest™ 30 Inflation Device is a sterilized, single use device intended as an accessory to balloon dilatation catheters. The Everest™ 30 Inflation Device will be used to inflate and deflate balloon dilatation catheters during angioplasty procedures. The device contains an analog pressure gauge which will read the inflation pressure of the balloon catheter. The pressure gauge is isolated from the syringe fluid with use of a bouron tube and is graduated in 0.5 atmosphere / bar increments to a 30 atmosphere / bar maximum. The device has a twenty (20) cubic centimeter syringe to hold a contrast medium for balloon inflation. The device has a plunger engaging mechanism. When engaged, the plunger, which applies contrast medium to the syringe, is rotated in a clockwise direction by the user to slowly increase the syringe pressure or in a counter clockwise direction to slowly decrease the syringe pressure. When disengaged, the plunger can be manually retracted to rapidly apply vacuum and advanced to rapidly apply syringe pressure. The inflation device is connected to the balloon catheter manifold via a high pressure connecting tube which terminates into a male luer fitting. The inflation device also contains an accessory three way stopcock for preparation procedures.
The inflation device may also be provided as a Survival Kit. The Survival Kit includes one (1) Y -Adapter with Hemostasis Valve, one (1) Guide Wire Introducer and one (1) Guide Wire Torque 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)
Testing of the devices for safety and effectiveness included the following: Pressure Gauge Accuracy Test, Leak Test and Pressure Test.
Pressure Gauge Accuracy Test: Inflation devices were tested for their gauge accuracy. All samples were previously EtO sterilized. Each device was filled with water and connected to a calibrated pressure gauge. Each device was pressurized to three (3) settings, 4 ATM (235 psi) and 27 ATM (397 psi). Once the desired pressure was achieved, the device's gauge was compared to the calibrated gauge reading. This testing showed results comparable to other commercially available inflation devices.
Leak Test: Each device was pressurized with water at 200 psi, 350 psi and 500 psi. Each device was filled with water, then all air bubbles were removed. Each device was then connected to a calibrated high pressure gauge, and pressurized to the indicated pressure setting was held for two (2) minutes, and the device was observed for any water leakage. This testing showed results comparable to other commercially available inflation devices.
Pressure Test: Each device was filled with 10 cc of water and connected to a calibrated high pressure gauge. Each device was inflated until the calibrated high pressure gauge read 600 psi. This testing showed results comparable to other commercially available inflation devices.
Biocompatibility of Materials / Finished Devices: Biocompatibility testing was not required due to material changes not being involved with the fluid path of the device. Refer to K942269 for biocompatibility testing for the Medtronic® Everest™ Inflation 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.
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Summary of Safety and Effectiveness
2960983
- General Information I.
Device Generic Name:
Inflation Device
Device Trade Name:
Applicant's Name and Address:
Medtronic(0) Everest™ 30 Inflation Device / Survival Kit
Medtronic Interventional Vascular, Inc. 37A Cherr / Hill Drive Danvers, Massachusetts 01923
II. Description of the Diseases and Conditions for Which the Devices are Indicated
The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.
III. Device Description
The Medtronic® Everest™ 30 Inflation Device is a sterilized, single use device intended as an accessory to balloon dilatation catheters. The Everest™ 30 Inflation Device will be used to inflate and deflate balloon dilatation catheters during angioplasty procedures. The device contains an analog pressure gauge which will read the inflation pressure of the balloon catheter. The pressure gauge is isolated from the syringe fluid with use of a bouron tube and is graduated in 0.5 atmosphere / bar increments to a 30 atmosphere / bar maximum. The device has a twenty (20) cubic centimeter syringe to hold a contrast medium for balloon inflation. The device has a plunger engaging mechanism. When engaged, the plunger, which applies contrast medium to the syringe, is rotated in a clockwise direction by the user to slowly increase the syringe pressure or in a counter clockwise direction to slowly decrease the syringe pressure. When disengaged, the plunger can be manually retracted to rapidly apply vacuum and advanced to rapidly apply syringe pressure. The inflation device is connected to the balloon catheter manifold via a high pressure connecting tube which terminates into a male luer fitting. The inflation device also contains an accessory three way stopcock for preparation procedures.
The inflation device may also be provided as a Survival Kit. The Survival Kit includes one (1) Y -Adapter with Hemostasis Valve, one (1) Guide Wire Introducer and one (1) Guide Wire Torque Handle.
IV. Alternatives
Alternatives for patients requiring interventional procedures includes medical therapy and surgery. Alternatives to use of the Medtronic® Everest™ 30 Inflation Device / Survival Kit are other commercially available inflation devices.
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1
V. Potential Adverse Effects
Potential adverse effects of interventional procedures include: vessel trauma at the treatment site, vessel occlusion, localized dissection, vessel spasm or thrombosis. Total occlusion in the absence of collateral blood supply in coronary arteries could cause severe myocardial ischemia, and if not properly relieved, acute myocardial infarction and death may ensue. Other adverse effects are potentials for routine catheterizations. These include hypotension, bradycardia, reaction to contrast media, air emboli, nausea, palpitations, angina, minor atrial or ventricular rhythm disturbances and general discomfort. Local complications at the site of catheter introduction include vascular thrombosis, hematoma, other bleeding complications, infection and pain or tendemess. The Medtronic® Everest™ 30 Inflation Device / Survival Kit are used as accessories for these procedures.
VI. Summary of Studies
Testing of the devices for safety and effectiveness included the following:
Pressure Gauge Accuracy Test, Leak Test and Pressure Test.
Pressure Gauge Accuracy Test:
Inflation devices were tested for their gauge accuracy. All samples were previously EtO sterilized. Each device was filled with water and connected to a calibrated pressure gauge. Each device was pressurized to three (3) settings, 4 ATM (235 psi) and 27 ATM (397 psi). Once the desired pressure was achieved, the device's gauge was compared to the calibrated gauge reading. This testing showed results comparable to other commercially available inflation devices.
Leak Test:
Each device was pressurized with water at 200 psi, 350 psi and 500 psi. Each device was filled with water, then all air bubbles were removed. Each device was then connected to a calibrated high pressure gauge, and pressurized to the indicated pressure setting was held for two (2) minutes, and the device was observed for any water leakage. This testing showed results comparable to other commercially available inflation devices.
Pressure Test:
Each device was filled with 10 cc of water and connected to a calibrated high pressure gauge. Each device was inflated until the calibrated high pressure gauge read 600 psi. This testing showed results comparable to other commercially available inflation devices.
Biocompatibility of Materials / Finished Devices:
Biocompatibility testing was not required due to material changes not being involved with the fluid path of the device. Refer to K942269 for biocompatibility testing for the Medtronic® Everest™ Inflation Device.
030000
2
VII. Conclusion
The testing performed for the Medtronic® Everest™ 30 Inflation Device / Survival Kit provides reasonable assurance that the device will perform in a safe and effective manner when used as indicated.
I believe, to the best of my knowledge, that all data and information submitted in the 510(k) are truthful and accurate, and that no material fact has been omitted.
Joseph Q. Magliocco
Joseph O. Magliozzi RAC Sr. Regulatory Affairs Specialist