(209 days)
An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.
The 4F SiteSeer (II) catheter is an intravascular diagnostic catheter for use in the cardiovascular system.
The provided text is a 510(k) summary for the AVE 4F SiteSeer (II) Cardiovascular Angiographic Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against specific acceptance criteria in a clinical study for an AI-powered device. Therefore, much of the requested information regarding AI device evaluation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable or present in this document.
However, I can extract information related to the device's technical performance and the studies conducted to show substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in the way an AI device might have for diagnostic accuracy. Instead, it details performance testing done to show substantial equivalence to predicate devices. The "reported device performance" are the results demonstrating this equivalence.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary of Results) |
|---|---|---|
| Mechanical Performance | Similar to predicate devices (AVE 4F SiteSeer, AVE Envision, Cordis Infiniti, Cordis Vista Bright Tip) | Demonstrated equivalence in tensile strength, bending stiffness, straight-line torque, high-pressure static leak, flow rate, and natural frequency testing to predicate devices. |
| Biocompatibility | Compliance with ISO 10993 for predicate device materials | Demonstrated biocompatibility in acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, hemolysis, material-mediated pyrogen, and sensitization tests. |
| Sterilization | Similar to predicate devices | Similar to predicate devices. |
| Packaging | Similar to predicate devices | Similar to predicate devices. |
| Materials of Construction | Similar to predicate devices | Similar to predicate devices. |
| Shelf-Life | Meets performance specifications for labeled life expiration date | Demonstrated device meets all performance specifications within its labeled life expiration date. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a traditional medical device (catheter) submission, not an AI/ML device, and no "test set" of patient data was used in the context of an AI study. The "testing" referred to are engineering and biocompatibility tests on the physical catheter.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as ground truth in the context of diagnostic accuracy is not relevant for this type of device submission. Expert judgment might have been involved in establishing test protocols or assessing results for mechanical properties, but this is not detailed as "ground truth" for a test set.
4. Adjudication Method for the Test Set
This information is not applicable. See Point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable. This is not an AI-assisted diagnostic device, so no MRMC study was conducted.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
This information is not applicable in the context of diagnostic performance. The "ground truth" for the device's performance would be the objective measurements from the engineering and biocompatibility tests compared against established standards or predicate device performance.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. See Point 8.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION VI.
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
| A. Submitter Information: | |
|---|---|
| Name: | Arterial Vascular Engineering, Massachusetts |
| Address: | 129 Concord Road, Billerica, MA 01821 |
| Phone: | (978) 739-3116 |
| Fax: | (978) 777-0390 |
| Contact Person: | Fred Boucher |
| Regulatory Affairs Manager | |
| Date of Preparation: | 6/28/99 |
| B. Device Name | |
| Trade Name: | AVE 4F SiteSeer (II) CardiovascularAngiographic Catheter |
| Common Name: | Cardiovascular Angiographic Catheter |
| Classification Name: | Diagnostic Intravascular Catheter/Percutaneous Catheter |
| C. Predicate Device Name(s): | 1. AVE SiteSeer™ Catheter2. AVE Envision™ Catheter3. Cordis Infiniti™ Angiographic Catheter4. Cordis Vista™ Bright tip Catheter |
| D. Device Description | The 4F SiteSeer (II) catheter is anintravascular diagnostic catheter for use in thecardiovascular system. |
| E. Intended Use | Intravascular diagnostic catheters are used torecord intracardiac pressures, to sample blood,and to introduce substances into the heart andvessels. |
| F. Technological Characteristics | The AVE 4F SiteSeer II catheteris similar to the AVE 4F SiteSeer andCordis Infiniti and Vista Bright Tipcatheters regarding materials ofconstruction, packaging, andsterilization. |
| The indications for use are similar toboth the AVE Angiographic cathetersand the Cordis catheters. They are all |
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indicated to deliver media or substances into the vascular system. The actual indications are listed below:
The AVE 4F SiteSeer II is indicated for use in the cardiovascular system. Their primary function is to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.
Cordis Infiniti indications are The designed to deliver radiopaque contrast media to selected sites in the vascular system. Similar to the AVE and Cordis catheters, the AVE SiteSeer II catheter will be available in various curve styles.
- AVEM conducted tensile strength, bending G. Performance Date stiffness, straight-line torque, high-pressure static leak, flow rate and natural frequency testing. The test results demonstrate that the SiteSeer II catheter is substantially 4F equivalent to the AVE SiteSeer™ catheter, the AVE Envision™ Catheter, or the Cordis Vista™ Bright tip Catheter.
also conducted the following AVEM 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 4F SiteSeer II catheter is biocompatible.
Shelf-life testing on the AVE 4F SiteSeer II catheter demonstrates that the device meets all performance specifications within its labeled life expiration date.
Based on the results of the above testing. AVEM concludes that the AVE 4F SiteSeer catheter II is substantially equivalent to the predicate devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 1999
Mr. Fred Boucher Regulatory Affairs Manager AVE Massachusetts, Inc. 129 Concord Road Billerica, MA 01821-0566
Re : K984627 4F SiteSeer™ II Cardiovascular Angiographic Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: June 18, 1999 Received: June 21, 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 You may, therefore, market the device, subject to the Act (Act). 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. Please note: 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with
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Page 2 - Mr. Fred Boucher
the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to 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 Regulations.
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 the labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christopher, Abon for.
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.
AVE 4F SiteSeer™ Cardiovascular Angiographic Catheter Device Name:
- An intravascular diagnostic catheter is a device used to Indications for Use: record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.
None Contraindications:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Chr. M. Attridge for Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K984627 510(k) Number _
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).