The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.

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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the KAVS Catheter. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating its performance against specific acceptance criteria in the manner typically seen for new diagnostic or AI-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted directly from this document. This submission is for a catheter, a physical device, not a diagnostic algorithm or a device requiring extensive clinical performance studies in the same way an AI system would.

Here's a breakdown based on the information available in the document, and what is not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of device focus on equivalence to predicate devices in terms of safety, effectiveness, and performance.
Reported Device Performance: Not detailed in terms of quantitative clinical outcomes. The performance is described functionally (temporarily blocks blood flow, allows medication injection, prevents wash away).

Acceptance Criteria (Implied from 510(k) process)	Reported Device Performance (from submission)
Substantially equivalent to predicate devices	Yes, claimed to be substantially equivalent in design and function.
Safe	Claimed as safe as predicate devices.
Effective	Claimed as effective as predicate devices.
Performs as well as or better than predicate device	Claimed to perform as well as or better than predicate devices, specifically "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."
Intended Use as specified	Catheter temporarily inhibits blood flow in isolated sections of peripheral veins to inject physician prescribed medications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The submission relies on demonstrating substantial equivalence to existing devices through design comparison, material characteristics, and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No such "ground truth" establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is described.

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. This is not an AI-assisted device, nor does the submission describe an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market experience. The KAVS Catheter aims to match this established profile.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set is relevant to this submission.

Summary

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K052844

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 1204107 LeipzigGermany
Contact Person:	Joachim RichterCEO
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

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

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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.

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).

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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.

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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

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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

Regulation Number and Section

§ 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).