(173 days)
Not Found
Not Found
No
The device description and intended use describe a purely mechanical device for inflating and monitoring pressure, with no mention of AI/ML terms or functionalities. The reprocessing aspect is also described as a standard cleaning, inspection, and testing process.
No
The device is used to inflate and deflate other interventional devices (like angioplasty balloons) and monitor pressure, rather than directly treating a disease or condition itself. It's an accessory to a therapeutic procedure.
No
The device is an "inflation device" used to inflate and deflate angioplasty balloons and monitor pressure, which describes a therapeutic or procedural function rather than a diagnostic one. Its purpose is to facilitate an interventional procedure, not to identify or characterize a disease or condition.
No
The device description explicitly states it is a "sterile hand-held mechanical device comprised of a 20 cc syringe, pressure gauge, plunger, connector tube and a male luer fitting for connection to a catheter," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon." This is a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description details a mechanical device used in angioplasty and other interventional procedures, connecting to a catheter. This further supports its use in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This inflation device is used directly on a medical device within the body.
N/A
Intended Use / Indications for Use
The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon.
Product codes (comma separated list FDA assigned to the subject device)
MAV
Device Description
An inflation device is designed to generate and monitor pressure and is used in angioplasty or other interventional procedures. It is a sterile hand-held mechanical device comprised of a 20 cc syringe, pressure gauge, plunger, connector tube and a male luer fitting for connection to a catheter. The device may be used in conjunction with other accessories such as a hemostatic valve or stopcock, guide wire introducer or torque device. Vanguard receives previously used inflation devices from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
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)
Sterilization and packaging validations, and functional/performance, and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective.
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.
Respective ACS, Medtronic, Merit Medical, and SCIMED® legally marketed inflation devices under various 510(k) premarket notifications.
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
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Mike Sammon, Ph.D.
Director, Research and Development
(863) 683-8680, extension 228
(801) 327-3339 (facsimile)
mikes@safe-reuse.com |
| Date | July 27, 2001 |
| Device | Trade Names: Vanguard Reprocessed Inflation Devices ⇒ ACS Indeflator™ Inflation Devices⇒ Medtronic Everest™ 20/30 Inflation Devices⇒ Merit Medical Systems Monarch™/ IntelliSystem®25 Inflation Devices⇒ SCIMED® Encore® 26 Inflation DevicesCommon Name: Inflation device or syringeClassification: Class II - Syringe, Balloon InflationProduct Code MAV |
| Predicate Devices | Respective ACS, Medtronic, Merit Medical, and SCIMED® legally marketed inflation devices under various 510(k) premarket notifications. |
| Indications for Use | The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon. |
Continued on next pageContinued on next page
Indeflator is a trademark of Advanced Cardiovascular Systems, Inc.
Everest is a trademark of Medtronic, Inc.
Monarch and IntelliSystem are trademarks of Merit Mcdical Systems, Inc. Monarch and IntelliSystem are trademarks of Meril Wednesd bystenlific Scimed, Inc.
1
510(k) Summary of Safety & Effectiveness, Continued
| Device
Description | An inflation device is designed to generate and monitor pressure and is used
in angioplasty or other interventional procedures. It is a sterile hand-held
mechanical device comprised of a 20 cc syringe, pressure gauge, plunger,
connector tube and a male luer fitting for connection to a catheter. The device
may be used in conjunction with other accessories such as a hemostatic valve
or stopcock, guide wire introducer or torque device.
Vanguard receives previously used inflation devices from healthcare
facilities; cleans, inspects, tests, repackages and sterilizes the devices; and
returns them to the healthcare facility. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Vanguard reprocessed inflation devices are essentially identical to
the currently marketed OEM devices. No changes are made to the currently
marketed device's specifications and they possess the same technological
characteristics. Biocompatibility and performance/functional testing
demonstrate that the devices are equivalent and continue to be safe and
effective for their intended use. |
| Test Data | Sterilization and packaging validations, and functional/performance, and
biocompatibility testing demonstrates that the reprocessed devices perform as
intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that the Vanguard
reprocessed inflation devices are substantially equivalent to the predicate
devices under the Federal Food, Drug and Cosmetic Act. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Mike Sammon, Ph.D. Director, Research and Development Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, FL 33815
K012480 Re:
Vanguard Reprocessed Inflation Devices Regulation Number: 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: 74 MAV Dated: November 25, 2001 Received: November 27, 2001
Dear Dr. Sammon:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 - Mike Sammon, Ph.D.
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Deeda Tiller
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KO12480 510(k) Number:
Device Name: Vanguard Reprocessed Inflation Devices
Indications for Use:
The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number
iv