(209 days)
AVE SiteSeer™ Catheter, AVE Envision™ Catheter, Cordis Infiniti™ Angiographic Catheter, Cordis Vista™ Bright tip Catheter
Not Found
No
The summary describes a standard intravascular diagnostic catheter and its performance testing, with no mention of AI or ML capabilities.
No.
The intended use states that the device is a "diagnostic catheter" used to "record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels," which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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 "Device Description" also labels the 4F SiteSeer (II) catheter as an "intravascular diagnostic catheter."
No
The device description explicitly states it is an "intravascular diagnostic catheter," which is a physical hardware device. The performance studies also describe physical testing (tensile strength, bending stiffness, etc.) and biocompatibility testing, further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "intravascular diagnostic catheter" used to record pressure, sample blood, and introduce substances into the heart and vessels. This is an in vivo (within a living organism) diagnostic procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The description reinforces that it's an "intravascular diagnostic catheter for use in the cardiovascular system," again indicating in vivo use.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body, using reagents, or performing tests on biological specimens in a laboratory setting, which are hallmarks of IVD devices.
Therefore, the device described is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.
Product codes (comma separated list FDA assigned to the subject device)
74 DQO
Device Description
The 4F SiteSeer (II) catheter is an intravascular diagnostic catheter for use in the cardiovascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system / heart and vessels
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)
AVEM conducted tensile strength, bending stiffness, straight-line torque, high-pressure static leak, flow rate and natural frequency testing. The test results demonstrate that the 4F SiteSeer II catheter is substantially equivalent to the AVE SiteSeer™ catheter, the AVE Envision™ Catheter, or the Cordis Vista™ Bright tip 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 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.
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.
AVE SiteSeer™ Catheter, AVE Envision™ Catheter, Cordis Infiniti™ Angiographic Catheter, Cordis Vista™ Bright tip Catheter
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
§ 870.1200 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).
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Image /page/0/Picture/1 description: The image contains a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the number '9', then '84', '62', and ends with the number '7'. The characters and numbers are written in a handwritten style.
... ...
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) Cardiovascular |
| Angiographic Catheter | |
| Common Name: | Cardiovascular Angiographic Catheter |
| Classification Name: | Diagnostic Intravascular Catheter |
| /Percutaneous Catheter | |
| C. Predicate Device Name(s): | 1. AVE SiteSeer™ Catheter |
- AVE Envision™ Catheter
- Cordis Infiniti™ Angiographic Catheter
- Cordis Vista™ Bright tip Catheter |
| D. Device Description | The 4F SiteSeer (II) catheter is an
intravascular diagnostic catheter for use in the
cardiovascular system. |
| E. Intended Use | Intravascular diagnostic catheters are used to
record intracardiac pressures, to sample blood,
and to introduce substances into the heart and
vessels. |
| F. Technological Characteristics | The AVE 4F SiteSeer II catheter
is similar to the AVE 4F SiteSeer and
Cordis Infiniti and Vista Bright Tip
catheters regarding materials of
construction, packaging, and
sterilization. |
| | The indications for use are similar to
both the AVE Angiographic catheters
and 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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the eagle.
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
4
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 _