(189 days)
Not Found
Not Found
No
The device description focuses on the physical construction and intended use of a catheter for delivering contrast medium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended to deliver contrast medium, which is a diagnostic function, not a therapeutic one.
No
Explanation: This device is an angiographic catheter used to deliver contrast medium. Its function is to facilitate imaging, not to independently diagnose conditions.
No
The device description clearly details a physical catheter made of plastic and stainless steel, intended for delivering contrast medium, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Acist 4 French Angiographic Catheter is used to deliver a substance (radiopaque contrast medium) directly into the patient's vascular system. This is an in vivo procedure (within the living body).
- Intended Use: The intended use clearly states "to deliver radiopaque contrast medium to selected sites in the vasculature." This is a therapeutic or diagnostic procedure performed on the patient, not a test performed on a specimen.
The device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Acist 4 French Angiographic Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system.
Product codes
DQO
Device Description
The Acist 4 French Angiographic Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system.
It is a single-lumen catheter manufactured primarily from a radiopaque plastic tube that has an encapsulated stainless steel wire braid to provide strength for injection pressures up to 1200 psi / 8275 kPa. The proximal end of the device incorporates a strain relief with a female plastic Luer hub for injection to the injection source. The stem and tip sections are radiopague and are permanently formed to a variety of shapes to facilitate use in various parts of the patient's vasculature. The non-tapered soft distal tip has end and angled multiple side-holes to balance the injection force and stabilize tip position.
The device is packaged in a Tyvek-to-poly pouch, sterilized by a validated Ethylene Oxide sterilization cycle, and sold for single use only within a 24-month shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cordis Infinity Sones Angiographic Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
SECTION 13 - 510(k) SUMMARY
Date of Application:
August 31, 2000
Applicant's Name and Address:
Acist Medical Systems, Inc. 7450 Flying Cloud Drive Suite 150 Eden Prairie, MN 55344
Name of Contact Person:
Carl M. Beaurline Vice President, Quality Assurance / Regulatory Affairs
Telephone and Fax Numbers:
Telephone - (612) 995-9319 Fax - (612) 941-4648
Proprietary Name: Acist 4 French Angiographic Catheter
Angiographic Catheter Common Name:
Diagnostic Intravascular Catheter Classification Name:
DQO
Classification Number: 870.1200
II Class:
Classification Panel: Cardiovascular
Product Code:
Cordis Infinity Sones Angiographic Catheter Predicate Device:
1
Device Description:
The Acist 4 French Angiographic Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system.
It is a single-lumen catheter manufactured primarily from a radiopaque plastic tube that has an encapsulated stainless steel wire braid to provide strength for injection pressures up to 1200 psi / 8275 kPa. The proximal end of the device incorporates a strain relief with a female plastic Luer hub for injection to the injection source. The stem and tip sections are radiopague and are permanently formed to a variety of shapes to facilitate use in various parts of the patient's vasculature. The non-tapered soft distal tip has end and angled multiple side-holes to balance the injection force and stabilize tip position.
The device is packaged in a Tyvek-to-poly pouch, sterilized by a validated Ethylene Oxide sterilization cycle, and sold for single use only within a 24-month shelf life.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2002
Mr. Carl M. Beaurline Vice President, Quality Assurance/Regulatory Affairs Acist Medical Systems, Inc. 7450 Flying Cloud Drive, Suite 150 Eden Prairie, MN 55344
K012983 Re:
Acist 4 French Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter. Regulatory Class: Class II Product Code: DQO Dated: December 31, 2001 Received: January 14, 2002
Dear Mr. Beaurline:
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 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.
3
Page 2 - Mr. Carl M. Beaurline
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,
N. O'Dell
ram D. 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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SECTION 6 - STATEMENT OF INDICATIONS FOR USE / LABELING
PART A - INDICATIONS FOR USE FORM
Page of of
| 510(k) Number: | K012983 |
|---|---|
| ---------------- | --------- |
Acist 4 French Angiographic Catheter Device Name:
Indications for Use:
The Acist 4 French Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012985
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)