(7 days)
The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ with 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 quide wire. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ with accessories is a hand activated mechanical device that connects to the hub of the catheter. It 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™ ,"
The provided text describes a 510(k) premarket notification for the KPS Rinspiration™ System and does not contain detailed information about specific acceptance criteria, a study that rigorously proves device performance against those criteria, or the methodology for establishing ground truth or training data. The document focuses on demonstrating substantial equivalence to a previously cleared device (K031485).
However, I can extract the information that is present and indicate what is not available.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "safe for its intended use" |
| Effectiveness | "effective for its intended use" |
| Biocompatibility | "shown to be biocompatible when tested in accordance with ISO 10993-1" |
| Intended Use | "intended to infuse and aspirate in the peripheral vasculature" |
Missing Information:
- Specific numerical targets or thresholds for "safe" and "effective."
- Detailed metrics or quantitative results from the "bench testing" that demonstrated safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information:
- There is no mention of a "test set" in the context of clinical data or a specific cohort of patients.
- The document states "Results of bench testing prove that the KPS Rinspiration™ System is safe and effective for its intended use." This implies the testing was done in a laboratory environment, not on human patients or a derived dataset from human patients. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Missing Information:
- No information is provided about experts used to establish a ground truth. Since the reported testing was "bench testing," it's unlikely that clinical expert review for ground truth was part of this submission's provided summary.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Missing Information:
- No information is provided about an adjudication method, as there's no mention of a test set requiring expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improvement with AI vs. without AI assistance:
Missing Information:
- No MRMC comparative effectiveness study was mentioned. The device is a mechanical system, not an AI or imaging-based diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Missing Information:
- This device is not an algorithm or AI system. It is a physical catheter system for infusion and aspiration. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Missing Information:
- For the "bench testing," the "ground truth" would likely be engineering specifications, measurable physical properties, and established industry standards for material compatibility and performance. However, the specific type of "ground truth" used for each aspect of safety and effectiveness (e.g., flow rate measurements, pressure tolerance, material degradation assessment) is not detailed in the summary.
8. The sample size for the training set:
Missing Information:
- There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Missing Information:
- Not applicable, as there is no "training set" for this device.
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MAY 2 1 2004
8.0 APPENDIX A: 510(K) SUMMARY
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 13, 2004
| 510(k) number: | k04129 |
|---|---|
| ---------------- | -------- |
Applicant Information:
Kerberos Proximal Solutions, Inc. 1400 Terra Bella Ave Suite K Mountain View, CA 94043
| Contact Person: | Tom Mason, VP, Regulatory Affairs and Quality Assurance |
|---|---|
| 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)
Cleared Device:
The subject device is identical in intended use and method of operation to the currently cleared Rinspiration System (K031485).
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™ with 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 quide wire. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ with accessories is a hand activated mechanical device that connects to the hub of the catheter. It 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™ ,"
Verification Test Results:
Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use.
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.
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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 Rinspiration System.
、
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 other bird with its wings spread, facing to the right. The bird's body is formed by three curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2004
Kerberos Proximal Solutions c/o Mr. Tom Mason 1400 Terra Bella, Suite K Mountain View, CA 94043
Re: K041291 KPS Rinspiration™ System Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter. Intravascular, Diagnostic Regulatory Class: Class II (two) Product Code: DQO Dated: May 13, 2004 Received: May 14, 2004
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 Codc of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Tom Mason
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oc advised that I Dri 3 ibsudice Cr our device complies with other requirements of the Act that 1DA has made a acterimations administered by other Federal agencies. You must or any I coccar statutes and regerients, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CIN Fart 607), labeling (21 CFR Part 820), good if applicable, the electronic form in the quality by events (Sections 531-542 of the Act); 21 CFR 1000-1050. product familion only of provisions (2006) every of the end in your Section 510(k) I this letter writi anow you to organ maine of substantial equivalence of your device to a legally prematics notification. The promotion 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
Sincercly yours,
Dona R. lochner
(J.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
K041291 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_ KPS Rinspiration™ System
Indications For Use:
The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (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)
D'Nura R. kline 1
Division Sign-Off
sion of Cardiovascular Devices
012:01 number K041291
§ 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).