K Number
K062275
Device Name
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
Date Cleared
2006-09-20

(44 days)

Product Code
Regulation Number
870.5150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kerberos Proximal Solutions Rinspiration Catheter System is intended to infuse physician specified fluid and remove/aspirate 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 quide wire. The catheter includes a radiopaque marker band at the distal tip and two radiopague marker bands designating the infusion 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®." The only difference between the cleared Rinspiration System and the Rinspiration Catheter System with Fluid Infusion Stopcock Port is the addition of a 4-way stopcock and a co-extruded paratube that replaces the infusion and aspiration lines. The fluid infusion stopcock port consists of a 4-way stopcock which attaches directly to the infusion check valve. This addition provides the user another means to infuse physician specified fluids. In order to streamline the appearance of the Rinspiration Catheter System, a coextruded paratube replaces the infusion and aspiration lines.
More Information

Not Found

No
The description focuses on the mechanical and structural components of the catheter system and its function of simultaneous infusion and aspiration. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Yes
The device is intended to infuse physician-specified fluid and remove/aspirate fresh, soft emboli and thrombi from the coronary and peripheral vasculature, which directly addresses a medical condition.

No

The device description clearly states its purpose is to infuse fluid and remove/aspirate emboli/thrombi, which are therapeutic actions, not diagnostic ones.

No

The device description clearly outlines physical components including a catheter, a mechanical hand-activated device (Rinspirator), syringes, a stopcock, and tubing. There is no mention of software as a component of the system.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "infuse physician specified fluid and remove/aspirate fresh, soft emboli and thrombi from the coronary and peripheral vasculature." This describes a therapeutic intervention performed directly on the patient's body (in vivo).
  • Device Description: The device is a catheter system designed to be placed in the patient's vasculature. It involves mechanical action (simultaneous infusion and aspiration) within the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples. This device is used inside the body for a therapeutic purpose.

N/A

Intended Use / Indications for Use

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

Product codes

QEZ, KRA, DXE

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 quide wire. The catheter includes a radiopaque marker band at the distal tip and two radiopague marker bands designating the infusion 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®."

The only difference between the cleared Rinspiration System and the Rinspiration Catheter System with Fluid Infusion Stopcock Port is the addition of a 4-way stopcock and a co-extruded paratube that replaces the infusion and aspiration lines.

The fluid infusion stopcock port consists of a 4-way stopcock which attaches directly to the infusion check valve. This addition provides the user another means to infuse physician specified fluids.

In order to streamline the appearance of the Rinspiration Catheter System, a coextruded paratube replaces the infusion and aspiration lines.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and peripheral vasculature

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K050130

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 15, 2021

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

Re: K062275

Trade/Device Name: Rinspiration 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 September 20, 2006. Specifically, FDA is updating this SE Letter 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: 2021.09.15 09:21:58 -04'00'

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

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2006

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

Re: K062275

Trade/Device Name: Kerberos Proximal Solutions Rinspiration System Regulation Number: 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: September 1, 2006 Received: September 5, 2006

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

2

Page 2 - Mr. Tom Mason

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 predicate device results 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 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.

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.

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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

[signature]

Donna-Bea Tillman, Ph.D Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known): K O62275

Device Name: Kerberos Proximal Solutions Rinspiration Catheter System

Indications for Use:

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

Prescription Use X (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)

Duna R. Vachner

(Division Sign-C'l) Division of Cardiovascular Devices

510(k) Number K062275

Page 1 of 1

Kerberos Proximal Solutions

Page 3-1

4

K062275

Rinspiration Catheter System

SEP 2 0 2006

Special 510(k)

SECTION 4 510(k) Summary

This 510(k) summary for the KPS Rinspiration Catheter System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information

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

Trade Proprietary Name

Rinspiration Catheter System

Device Classification

The FDA Cardiovascular Devices Panel has classified devices for the KPS Rinspiration System as follows:

Classification NameClass21 CFRProduct Code
Embolectomy CatheterII870.5150DXE

Predicate Device

Name:Rinspiration System
Manufacturer:Kerberos Proximal Solutions, Inc.
Status:Post-enactment
510(k) #K050130

Indications for Use

The Indications for Use for the Rinspiration Catheter System remains identical to the cleared device indication.

ProductIndication for Use
Kerberos Proximal Solutions
Rinspiration Catheter System
Applied for in this premarket notificationPROPOSED:
The Kerberos Proximal Solutions Rinspiration
Catheter System is intended to infuse physician
specified fluid and remove/aspirate fluid, fresh,
soft emboli and thrombi from the coronary and
peripheral vasculature.
Kerberos Proximal Solutions
Rinspiration System
K050130The 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.

5

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 quide wire. The catheter includes a radiopaque marker band at the distal tip and two radiopague marker bands designating the infusion 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®."

The only difference between the cleared Rinspiration System and the Rinspiration Catheter System with Fluid Infusion Stopcock Port is the addition of a 4-way stopcock and a co-extruded paratube that replaces the infusion and aspiration lines.

The fluid infusion stopcock port consists of a 4-way stopcock which attaches directly to the infusion check valve. This addition provides the user another means to infuse physician specified fluids.

In order to streamline the appearance of the Rinspiration Catheter System, a coextruded paratube replaces the infusion and aspiration lines.

Substantial Equivalence

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

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

Summary

Based on the intended use and product performance 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 the currently marketed predicate device.