The Kerberos Proximal Solutions Rinspiration System is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.

Device Description

The system consists of a Rinspiration™ Catheter, and a Rinspirator™ with accessories. The Rinspiration Catheter is a multi-lumen, rail configuration 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 vasculature of a patient over a guide wire. The Rinspiration Catheter is offered with a standard tip and a short tip. 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 Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration."

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and study information for the Kerberos Proximal Solutions Rinspiration System:

It's important to note that the provided documents are a 510(k) summary for a medical device submitted in 2005, and an administrative correction letter from 2021. This type of submission focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than establishing de novo clinical effectiveness through a new clinical trial with specific performance acceptance criteria and a detailed study report. For Substantial Equivalence (SE), the primary goal is to show that the new device is as safe and effective as a predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, the information you're asking for, particularly around "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics, is generally not directly present or required in the same detailed manner for a 510(k) submission as it would be for a PMA (Premarket Approval) application or a de novo classification.

However, I can extract the relevant information presented in the 510(k) summary related to testing and "acceptance" in the context of functional and safety equivalence.

Acceptance Criteria and Device Performance (Context: 510(k) Substantial Equivalence)

Given the nature of a 510(k) submission, the "acceptance criteria" are primarily established against industry standards and the performance of predicate devices, focusing on demonstrating equivalence in safety and functional attributes.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Implied/Stated)	Reported Device Performance
Functional Performance	Device functions according to its Instructions for Use.	"All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended."
Material Biocompatibility	Materials are biocompatible when used as directed.	"The KPS Rinspiration System materials passed the necessary biocompatibility tests, complying with ISO 10993-1..."
Sterility Assurance	Achieves a sterility assurance level (SAL) of 10⁻⁶.	"Sterilization Validation was conducted according to ISO 11135... to assure a sterility assurance level (SAL) of 10⁻⁶."
Mechanical System Integrity	Catheter integrity, aspiration/infusion performance. (Implied by ISO 10555)	"Functional testing was performed per KPS protocol and referenced International Standard ISO 10555, Sterile, Single Use Intravascular Catheters - Part 1..."
Substantial Equivalence	Equivalent to predicate devices in intended use, function, materials, and sterilization.	Stated that the device "is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method."
No New Safety/Effectiveness Concerns	No differences that have a significant effect on safety or effectiveness.	Stated that the device "does not have any differences that have a significant effect on safety or effectiveness."

Study Details (Based on available 510(k) information)

Sample Size Used for the Test Set and Data Provenance:
- Test Set (Functional/Biocompatibility/Sterility): The summary does not specify the exact sample sizes (e.g., number of catheters, material samples tested) for the functional, biocompatibility, or sterility testing. This level of detail is typically found in the full test reports referenced in the 510(k), not in the summary.
- Data Provenance: The testing was conducted internally by Kerberos Proximal Solutions ("KPS protocol"). It's in vitro and in-house testing, not clinical data from patients. No country of origin for clinical data is applicable as this is not a clinical study report. It is prospective testing performed for the submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for functional, biocompatibility, and sterility testing is typically defined by established engineering specifications, published standards (ISO 10555, ISO 10993-1, ISO 11135), and the performance of predicate devices, not by expert human consensus on clinical cases.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical endpoint adjudication by multiple experts, typically in a clinical trial. The testing described here is laboratory-based (functional, material, sterility).
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is a type of clinical comparative effectiveness study, often used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is an embolectomy catheter, a therapeutic device, and the submission is a 510(k) focused on substantial equivalence based on in vitro testing and comparison to predicates, not a clinical effectiveness trial for human reader improvement.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical catheter system for mechanical intervention, not an algorithm, AI, or software-only device. Performance inherently involves human operation.
The Type of Ground Truth Used:
- For Functional Testing: The "ground truth" or reference standard for functional testing is adherence to predefined engineering specifications and the ability to perform the intended mechanical actions (infuse and aspirate) as described in the Instructions for Use, validated against relevant ISO standards.
- For Biocompatibility: The ground truth is compliance with the toxicological and biological safety requirements outlined in ISO 10993-1.
- For Sterility: The ground truth is achieving a specified Sterility Assurance Level (SAL) of 10⁻⁶, validated against ISO 11135.
- For Substantial Equivalence: The ultimate "ground truth" for the 510(k) process is demonstrating that the device is as safe and effective as a legally marketed predicate device(s).
The Sample Size for the Training Set:
- Not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product. The term might broadly apply to the design and development cycle (e.g., initial prototypes or manufacturing runs used for internal testing and refinement), but it's not a formal "training set" in the context of AI.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above (not an AI/ML device).

Summary of Device and 510(k) Context:

The Kerberos Proximal Solutions Rinspiration System is an embolectomy catheter. The 510(k) submission (K050130) demonstrates Substantial Equivalence (SE) to predicate devices by focusing on:

Identical Intended Use.
Similar technological characteristics (multi-lumen, rail configuration, infusion/aspiration mechanism).
Compliance with recognized international standards for functional performance (ISO 10555), biocompatibility (ISO 10993-1), and sterilization (ISO 11135).
No new safety or effectiveness concerns identified.

The FDA's decision to clear the device is based on this demonstration of SE, rather than a de novo clinical trial demonstrating quantitative performance against specific clinical acceptance criteria for a novel technology. The "limitations" noted in the 2005 letter are important, clarifying that while secondary thrombus removal may occur, the system's safety and effectiveness have not been established for the exclusive use of thrombectomy or embolic protection. This further emphasizes that the clearance was for the primary stated intended use, not for broader claims requiring more extensive clinical evidence.

Summary

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October 8, 2021

Kerberos Proximal Solutions, Inc. Tom Mason Vice President, RA & Qa 10600 North Tantau Ave. Cupertino, California 95014

Re: K050130

Trade/Device Name: Kerberos Proximal Solutions Rispiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Tom Mason:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 13, 2005. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2005

Kerberos Proximal Solutions C/O Mr. Tom Mason Vice President, Regulatory Affairs and Quality Assurance 10600 N. Tantau Avenue Cupertino, CA 95014

K050130 Re:

Trade/Device Name: Kerberos Proximal Solutions Rinspiration System Regulation Number: 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: April 8, 2005 Received: April 11, 2005

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The Kerberos Proximal Solutions Rinspiration System may result in secondary removal of thrombus while using the Rinspiration System in a manner consistent with the indications and instructions for use presented in the product labeling; however, please note the following: The safety and effectiveness of the Kerberos Proximal Solutions Rinspiration System has NOT been established for the exclusive or sole use of thrombectomy or embolic protection. Complications

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from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed I he I Dr I muning ever Its in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting (1 wirt), it thay be san 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 I voord 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276your device (2) on or the regulation entitled, "Misbranding by reference to premarket o the first in the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, responsionner 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,

Donna-Be Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

. . . ....

SECTION 4

Indications for Use

510(k) Number (if known): __ K 050130 ------------------------------------------------------------------------------

Device Name: Kerberos Proximal Solutions Rinspiration System_

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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

luation (ODE)
Nece
5/12/05

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KPS Rinspiration™ System

SECTION 8 510(k) Summary of Safety and Effectiveness

This 510(k) summary for the KPS Rinspiration System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.

Applicant Information

MAY 13 2005

Kerberos Proximal Solutions. Inc. 10600 North Tantau Avenue Cupertino. CA 95014

Contact Person:	Tom Mason
Phone Number:	(408) 253-3319
FAX Number:	(408) 253-6118

Device Information

Classification:	Class II
Trade Name:	KPS Rinspiration™ System
Generic/Common Name:	Embolectomy Catheter (21 CFR 870.5150)

Predicate Devices

The subject device is substantially equivalent in intended use and/or method of operation to the following cleared devices.

Kerberos Proximal Solutions Rinspiration System (Coronary/Perioheral) K041123 (1)
(2) Medtronic Export Catheter K040869
(3) Vascular Solutions, Inc., PRONTO Extraction Catheter K032763
(4) Kerberos Proximal Solutions Rinspiration System (Peripheral) K041291

Intended Use

Device Description

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Substantial Equivalence

The KPS Rinspiration System is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method.

All necessary testing was performed on the KPS Rinspiration System to ensure the product is substantially equivalent to the predicate devices and to ensure that the KPS Rinspiration System does not have any differences that have a significant effect on safety or effectiveness.

Functional Test Results

Functional testing was conducted on the KPS Rinspiration System to ensure that the product will function according to its Instructions for Use. This functional testing was performed per KPS protocol and referenced International Standard ISO 10555, Sterile, Single Use Intravascular Catheters - Part 1, All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended.

Biocompatibility and Sterility

Biocompatibility testing was conducted on the KPS Rinspiration System materials to ensure acceptability when used as directed. The KPS Rinspiration System materials passed the necessary biocompatibility tests, complying with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing requirements.

Sterilization Validation was conducted according to ISO 11135, Industrial Ethylene Oxide Sterilization. Validation and Routine Control, on the KPS Rinspiration System to assure a sterility assurance level (SAL) of 10°.

Summary

Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device is safe and effective when used in accordance with its Instructions for Use and has been shown to be substantially equivalent to currently marketed predicate devices.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).