(164 days)
Not Found
No
The device description and intended use focus on the mechanical function of a balloon catheter for temporary blood flow inhibition and medication delivery. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device description states it is for "short-term therapeutic use" and allows the physician to "inject medication through the central lumen of the catheter for patient treatment." The primary function of enabling medication delivery for treatment classifies it as therapeutic.
No
The device description clearly states its purpose is to "temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications," indicating a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical catheter with a balloon, lumens, and Luer-lock adapters, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body (in vitro).
- KAVS Catheter Function: The KAVS Catheter is an invasive medical device that is introduced into the patient's body (in vivo). Its purpose is to temporarily block blood flow in a vein to facilitate the delivery of medication directly into that vein. It does not perform any diagnostic testing on a sample taken from the body.
The description clearly states it's an "intravascular catheter" used for "short-term therapeutic use" by a physician to "inject physician prescribed medications." This is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The KAVS catheter is an intravascular catheter that is introduced into the patient's vein for short-term therapeutic use. The catheter has a balloon at the distal end, that when expanded, will temporarily block the blood flow in that segment of the vein. This allows the physician to inject medication through the central lumen of the catheter for patient treatment. Once the treatment is complete the physician can then remove the medication, prior to removing the catheter.
Procedure: The catheter is advanced through a phlebotomy (incision in the vein under observation) or through an introducer sheath under ultrasound control, into the vein. The ultrasound control and radio-opaque catheter allow the physician to guide the catheter until the tip is positioned at the vascular area of interest. Once this position is verified, under ultrasound, the balloon is filled with a sterile saline solution (0.9%), until the blood flow is blocked. The maximum filling volume of the balloon, as identified in the user guide, should not be exceeded in order to prevent possible balloon perforations. The prescribed medication is then administered through the central lumen and will rno procensbur medication in the tip of the catheter. Once the medication has had adequate contact time, the medication can then be aspirated and removed from the patient. The balloon is then emptied, through the separate balloon lumen, and the catheter is removed from the patient.
The KAVS Catheter prevents the prescribed medication from being washed away by normal blood flow. This results in a controlled contact time of the medication with the venous wall for an improved therapeutic use.
The KAVS catheter is a double-lumen catheter made of radio-opaque polyurethane, which is equipped with a latex balloon at the distal end. At the proximal end of the coaxial catheter there is a double attachment, consisting of a Luer-lock adapter for access to the main catheter lumen, for injection of prescribed medication, and a laterally mounted Luer-lock adapter with a stopcock for filling the balloon. The rounded catheter tip is closed, underneath the balloon there are three openings, which serve as outlet openings for the main catheter lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
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.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Richter & Rothe AG Wilhelm Leuschner Platz 12
Phone: +49-341-2254-1220 Fax: +49-341-2254-1222
04107 Leipzig
Germany
MAR 2 0 2006
Image /page/0/Picture/2 description: The image shows the logo for RICHTER & ROTHE AG MEDICAL TECHNOLOGY. The logo consists of a black square with a white arrow pointing to the right. The text "RICHTER & ROTHE AG" is written in a sans-serif font to the right of the square. Below the company name is the text "MEDICAL TECHNOLOGY".
Date: October 3, 2005
Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
510(K) SUN
s required by section 807.92(c)
Submitter of 510(k) a.
| Company name: | Richter & Rothe AG |
|---|---|
| Registration # | 3005186310 |
| Address: | Wilhelm Leuschner Platz 12 |
| 04107 Leipzig | |
| Germany | |
| Contact Person: | Joachim Richter |
| CEO | |
| Phone: | +49-341-2254-1220 |
| Fax: | +49-341-2254-1222 |
Device Name: b.
Trade/Proprietary Name: KAVS Catheter Common/Usual Name: Intravascular Catheter Cardiovascular, intravascular occluding, temporary Classification Name: 21 CFR 870.4450, Product Code: MJN Device:
Legally Marketed Predicate Device(s) C.
Our device is substantially equivalent to the legally marketed predicate devices cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| VeinRx | InfusionCath | K041517 |
| Cook Inc. | LDOB Occlusion Balloon Catheter | K002286 |
d. Description
The KAVS catheter is an intravascular catheter that is introduced into the patient's vein for short-term therapeutic use. The catheter has a balloon at the distal end, that when expanded, will temporarily block the blood flow in that segment of the vein. This allows the physician to inject medication through the central lumen of the catheter for patient treatment. Once the treatment is complete the physician can then remove the medication, prior to removing the catheter.
Procedure: The catheter is advanced through a phlebotomy (incision in the vein under observation) or through an introducer sheath under ultrasound control, into the vein. The ultrasound control and radio-opaque catheter allow the physician to guide the catheter until the tip is positioned at the vascular area of interest. Once this position is verified, under ultrasound, the balloon is filled with a sterile saline solution (0.9%), until the blood flow is blocked. The maximum filling volume of the balloon, as identified in the
1
user guide, should not be exceeded in order to prevent possible balloon perforations. The prescribed medication is then administered through the central lumen and will rno procensbur medication in the tip of the catheter. Once the medication has had adequate contact time, the medication can then be aspirated and removed from the patient. The balloon is then emptied, through the separate balloon lumen, and the catheter is removed from the patient.
The KAVS Catheter prevents the prescribed medication from being washed away by normal blood flow. This results in a controlled contact time of the medication with the venous wall for an improved therapeutic use.
The KAVS catheter is a double-lumen catheter made of radio-opaque polyurethane, which is equipped with a latex balloon at the distal end. At the proximal end of the coaxial catheter there is a double attachment, consisting of a Luer-lock adapter for access to the main catheter lumen, for injection of prescribed medication, and a laterally mounted Luer-lock adapter with a stopcock for filling the balloon. The rounded catheter tip is closed, underneath the balloon there are three openings, which serve as outlet openings for the main catheter lumen.
Intended use e.
The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
Summary of technological considerations f.
The KAVS Catheter is substantially equivalent to the predicate devices. Both catheters are designed to block the blood flow in order to inject a prescribed medication for therapeutic use. The KAVS Catheter is as safe, as effective, and performs as well as or better than the predicate device. 807.92(b)(3).
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
MAR 2 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richter & Rothe AG c/o Mr. Joachim Richter Wilhelm Leuschner Platz 12 D04107 Leipzig GERMANY
Re: K052844 KAVS Catheter, Models 1107100 and 1107060 Regulation Number: 21 CFR 870.4450 - Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: II (two) Product Code: MJN Dated: March 13, 2006 Received: March 14, 2006
Dear Mr. Richter:
We have reviewed your Section 510(k) premarket notification of intent to market the device wone reveal 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, I'DA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Joachim Richter
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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
R. buchner
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052844
Device Name: KAVS Catheter
Indications for Use:
The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use Over the Counter Use _ _______________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. bichner
(Division Sic - Off Division of Callery Comments Devices
510(k) Number: K052844