(173 days)
The inflation device is designed to inflate and deflate an angioplasty balloon or other interventional device and to monitor pressure within the balloon.
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.
The provided 510(k) summary for K012480 describes the reprocessed Vanguard Inflation Devices. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing efficacy of a novel device or an AI algorithm. Therefore, many of the requested elements for AI/algorithm performance studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in numerical terms that would be typical for an AI/algorithm performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance criteria are implicitly defined by the demonstration that the reprocessed devices perform "as intended" and are "safe and effective" and "essentially identical" to the OEM predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device is "essentially identical" to OEM devices. | "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." |
| Devices perform "as intended" and are "safe and effective." | "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use.""Sterilization and packaging validations, and functional/performance, and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm study. The testing described involves "functional/performance," "biocompatibility," "sterilization," and "packaging validations." It does not provide sample sizes for these tests, nor does it detail the provenance (country of origin, retrospective/prospective) of any data beyond stating that Vanguard "receives previously used inflation devices from healthcare facilities." This implies the devices themselves are from real-world usage, but the specific data used for testing is not detailed in terms of its origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the submission is not for an AI/algorithm that requires expert-established ground truth on diagnostic images or other clinical data. The "ground truth" here is the functional performance and safety of a medical device, evaluated through engineering and biological testing against established standards or predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. The testing described (functional, biocompatibility, sterilization, packaging) would follow standard laboratory and engineering protocols, not clinical adjudication methods used for interpreting images or clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study was not done. MRMC studies are typically for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is about a reprocessed physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the acceptable performance and safety profiles of inflation devices. This is established through:
- Predicate Device Performance: The OEM devices' known performance and safety.
- Engineering Standards: Bench testing using established methods to verify pressure generation, sealing, material compatibility, etc.
- Biological Testing: Biocompatibility tests to ensure the reprocessed materials are safe for patient contact.
- Sterilization Validation: Demonstrating that the sterilization process renders the devices sterile.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained, so no training set is involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI algorithm, and therefore no training set or ground truth for it.
In summary:
This 510(k) pertains to the substantial equivalence of reprocessed medical devices, not the performance of an AI algorithm. Therefore, the requested information related to AI study design elements (like sample sizes for test/training, expert adjudication, MRMC studies, and standalone performance) is not available or relevant in this document. The study described focuses on engineering, sterilization, packaging, and biocompatibility testing to ensure the reprocessed devices perform identically to and are as safe and effective as their original counterparts.
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510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, 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.
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510(k) Summary of Safety & Effectiveness, Continued
| DeviceDescription | An inflation device is designed to generate and monitor pressure and is usedin angioplasty or other interventional procedures. It is a sterile hand-heldmechanical device comprised of a 20 cc syringe, pressure gauge, plunger,connector tube and a male luer fitting for connection to a catheter. The devicemay be used in conjunction with other accessories such as a hemostatic valveor stopcock, guide wire introducer or torque device.Vanguard receives previously used inflation devices from healthcarefacilities; cleans, inspects, tests, repackages and sterilizes the devices; andreturns them to the healthcare facility. |
|---|---|
| TechnologicalCharacteristics | The Vanguard reprocessed inflation devices are essentially identical tothe currently marketed OEM devices. No changes are made to the currentlymarketed device's specifications and they possess the same technologicalcharacteristics. Biocompatibility and performance/functional testingdemonstrate that the devices are equivalent and continue to be safe andeffective for their intended use. |
| Test Data | Sterilization and packaging validations, and functional/performance, andbiocompatibility testing demonstrates that the reprocessed devices perform asintended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the Vanguardreprocessed inflation devices are substantially equivalent to the predicatedevices under the Federal Food, Drug and Cosmetic Act. |
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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
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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
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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.
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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
§ 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.