(136 days)
Not Found
No
The device description focuses on mechanical components and manual activation, with no mention of AI, ML, or related concepts.
No
The device is intended to infuse and aspirate in the peripheral vasculature. This function, while part of a medical procedure, does not directly treat or diagnose a disease or condition, which is typically what defines a therapeutic device. It is a tool for fluid management.
No
The device is described as being "intended to infuse and aspirate in the peripheral vasculature" and "allows for simultaneous irrigation and aspiration of the treatment site." These functions are therapeutic or interventional, not diagnostic. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly outlines physical hardware components: a catheter and a mechanical hand-activated device with syringes. There is no mention of software as a component of the system.
Based on the provided information, the KPS Rinspiration™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "infuse and aspirate in the peripheral vasculature." This describes a direct intervention within the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a catheter system designed for delivering fluids and removing substances from blood vessels. This is a therapeutic or interventional device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The KPS Rinspiration™ System does not fit this description.
N/A
Intended Use / Indications for Use
The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
Product codes
DQO
Device Description
The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ and its accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a guide wire. The Rinspiration™ Catheter is available in over the wire and rail configurations. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ and its accessories is a sterile, single-use mechanical device. This hand-activated device allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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
Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
K974067, K981417, K873004, K003288
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
9.0 APPENDIX A: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: May 9, 2003
510(k) number:
Applicant Information:
Kerberos Proximal Solutions, Inc. 1400 Terra Bella Ave Suite K Mountain View, CA 94043
| Contact Person: | Tom Mason |
|---|---|
| Phone Number: | (650) 254-1005 |
| FAX Number: | (650) 254-1034 |
Device Information:
Classification: Class II Trade Name: KPS Rinspiration™ System Classification Name: Catheters, Intravascular, Diagnostic (21 CFR 870.1200)
Predicate Device:
The subject device is substantially equivalent in intended use and/or method of operation to a combination of the Merit Medical Fountain Infusion System (K974067/K981417), the Mallinckrodt Guiding Catheter (K873004) and the OriGen Dual Lumen Catheter (K003288).
Intended Use:
The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
Device Description:
The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ and its accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a guide wire. The Rinspiration™ Catheter is available in over the wire and rail configurations. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ and its accessories is a sterile, single-use mechanical device. This hand-activated device allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™."
Functional Test Results:
Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use.
1
Biocompatibility:
The materials used in the KPS Rinspiration™ System have been shown to be biocompatible when tested in accordance with ISO 10993-1 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing requirements.
Summary:
Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle.
Public Health Service
SEP 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kerberos Proximal Solutions c/o Mr. Tom Mason 1400 Terra Bella, Suite K Mountain View, CA 94043
Re: K031485 KPS Rinspiration™ System Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II (two) Product Code: DQO Dated: July 22, 2003 Received: July 23, 2003
Dear Mr. Mason:
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.
3
Page 2 - Mr. Tom Mason
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 (301) 594-4648. 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/dsma/dsmamain.html
Sincerely yours,
Delattre, M.D.
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
1 031485 510(k) Number:
Device Name:
KPS Rinspiration™ System
Indications for Use:
The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation ODE
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031485
Prescription Use
(Per 21 CFR 801.199)
OR
Over the Counter Use
(Optional Format 1-2-96)