(226 days)
AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.
The GL-1 catheter is a guiding catheter for use in the vascular system. Guide catheters provide a pathway through which dilatation systems and other interventional devices are introduced. Similar to the Mainstay Guiding catheters, the GL-1 Guiding catheter will be available in 6 French - 8 French, and will be offered in various curve styles.
The provided text describes the 510(k) summary for the AVEM GL-1 Guiding Catheter, which is a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested details about acceptance criteria, ground truth, expert opinions, and comparative effectiveness studies are not present as this type of information is typically not included in a 510(k) summary for this class of device.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) submission, the "acceptance criteria" are implied to be the successful demonstration of substantial equivalence in various engineering and biocompatibility tests compared to legally marketed predicate devices. The "reported device performance" refers to the GL-1 Guiding Catheter meeting the performance standards of these predicate devices in those tests. Clinical performance criteria (like precision, accuracy, sensitivity, specificity) akin to those for diagnostic AI models are not applicable here.
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance | Reference to Predicate Device |
|---|---|---|---|
| Mechanical Performance | Tensile strength | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ |
| Stiffness | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Burst pressure | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Torque | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Natural frequency | Met standards | AVEM Mainstay™, ACS Guidant Viking™, Cordis Brite™ Tip, Schneider Guider™ | |
| Material/Biocompatibility | Acute intracutaneous reactivity | Biocompatible | ISO 10993 standards |
| Acute systemic toxicity | Biocompatible | ISO 10993 standards | |
| Cytotoxicity | Biocompatible | ISO 10993 standards | |
| Hemolysis | Biocompatible | ISO 10993 standards | |
| Material-mediated pyrogen | Biocompatible | ISO 10993 standards | |
| Sensitization | Biocompatible | ISO 10993 standards | |
| Shelf-Life | Device integrity | Met all performance specifications within labeled shelf-life expiration date | N/A (demonstrated for GL-1) |
| Packaging integrity | Met all performance specifications within labeled shelf-life expiration date | N/A (demonstrated for GL-1) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The studies conducted are described as "tensile, stiffness, burst, torque, and natural frequency testing," and "biocompatibility tests." These are likely bench tests and laboratory assessments rather than clinical studies with human test subjects or patient data. The specific number of devices tested for each, and the origin or retrospective/prospective nature of the data, are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts establishing ground truth for a test set) is not applicable to the studies described. The tests conducted are engineering and scientific assessments, where "ground truth" would be established by validated measurement techniques and adherence to ISO standards, performed by qualified laboratory personnel, not clinical experts for diagnostic image interpretation.
4. Adjudication Method for the Test Set
Not applicable. As the studies are engineering and biocompatibility tests, clinical adjudication methods are not relevant.
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. The AVEM GL-1 Guiding Catheter is a physical medical device, not an AI or diagnostic software. Therefore, MRMC studies and AI assistance comparisons are not relevant to its regulatory submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the engineering tests (tensile, stiffness, etc.), the "ground truth" would be established by recognized physical laws and engineering standards, and verified by calibrated instrumentation. For biocompatibility, the "ground truth" is established by adherence to ISO 10993 standards and validated laboratory test methodologies. This is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The description refers to a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
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Image /page/0/Picture/1 description: The image shows a logo for Arter Vascular Engineering (AVE) along with the date JUL 30 1999. The AVE logo is large and stylized, with the letters "AVE" prominently displayed. The words "Arter" and "cular Engineering" are written in a smaller font below the logo. The date is printed at the top of the image.
VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. Submitter Information: Name:
Address: Phone: Fax: Contact Person:
Date of Preparation:
- B. Device Name Trade Name: Common Name: Classification Name:
C. Predicate Device Name(s):
D. Device Description
- E. Intended Use
/E Massachusetts. Inc
છ ( d Road
lerica. MA 01821-0566
1: 978 667-2511
vw.avei com
AVE Massachusetts, Inc. 129 Concord Road, Billerica, MA 01821 (978) 739-3116 (978) 777-0390 Fred L. Boucher Regulatory Affairs Manager July 15, 1999
AVEM GL-1 Guiding Catheter Guiding Catheter Diagnostic Intravascular Catheter/Percutaneous Catheter
-
- AVEM Mainstay™ Guiding Catheter
-
- ACS Guidant Viking™ Guiding Catheter
-
- Cordis Brite™ Tip Guiding Catheter
- Schneider Guider™ Guiding Catheter 4.
The GL-1 catheter is a guiding catheter for use in the vascular system.
Guide catheters provide a pathway through which dilatation systems and other interventional devices are introduced.
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- F. Technological Characteristics Summary
The AVEM GL-1 Guiding Catheter is similar to the AVEM Mainstay guiding catheter regarding materials, construction, packaging and sterilization.
The indications for use are also similar to the AVEM Mainstay catheter and both the ACS Guidant Viking and the Cordis Brite Tip Giding catheters.
The proposed GL-1 indications for use are:
A VE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE guiding catheters also allow pressure monitoring and injection of contrast agents.
Similar to the Mainstay Guiding catheters, the GL-1 Guiding catheter will be available in 6 French - 8 French, and will be offered in various curve styles.
G. Performance Data
A VEM conducted tensile, stiffness, burst, torque, and natural frequency testing. The test results demonstrate that the GL-1 Guiding Catheter is substantially equivalent to the AVEM Mainstay™ Guiding Catheter, the ACS Guidant Viking™ Guiding Catheter, the Cordis Brite™ Tip Guiding Catheter and/or the Schneider Guider™ Guiding Catheter.
AVEM also conducted the following biocompatibility tests in compliance with ISO 10993: acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, hemolysis, material-mediated pyrogen and sensitization test. All tests demonstrated that the GL-1 Guiding Catheter is biocompatible.
Shelf-life testing on the GL-1 Guiding catheter and its packaging demonstrates that the device and packaging meet all performance specifications within its labeled shelf-life expiration date.
Based on the results of the above testing, AVEM concludes that the AVE GL-1 Guiding Catheter is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Fred L. Boucher Requlatory Affairs Manager AVE Massavchusetts, Inc. 129 Concord Road Billerica, MA 01821
Re : K984482 Trade Name: AVE GL-1 Guiding Catheter Regulatory Class: II Product Code: DQY Dated: July 15, 1999 Received: July 16, 1999
Dear Mr. Boucher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to
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Page 2 - Mr. Fred L. Boucher
your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE D.
AVEM GL-1 Guiding Catheter Device Name:
Indications for Use:
AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.
Contraindications:
There are no known contraindications for this product.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher-Albr for Callahan.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K994482
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).