K Number
K061766
Device Name
EXPRESSWAY INTERMITTENT CATHETER
Date Cleared
2007-03-09

(260 days)

Product Code
Regulation Number
876.5130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.
Device Description
The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.
More Information

EZD

Not Found

No
The summary describes a simple mechanical device (a catheter with a preloaded film membrane) and makes no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in medical devices.

Yes.
The device drains fluids from and instills fluids into the bladder, which is a therapeutic function.

No
The device is intended for draining and instilling fluids, and providing lubricity for catheter advancement, which are functional purposes rather than diagnostic purposes.

No

The device description clearly states it is a physical catheter with a film membrane, indicating it is a hardware device, not software-only.

Based on the provided information, the Expressway Intermittent Catheter is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Expressway Intermittent Catheter is a device used to drain or instill fluids directly into the bladder. It is a physical device used for a procedure, not a test performed on a sample outside the body.
  • Intended Use: The intended use clearly describes a procedure involving the bladder, not a diagnostic test on a biological sample.

Therefore, the Expressway Intermittent Catheter falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.

Product codes

EZD

Device Description

The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bladder

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not required.

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

Not Found

Predicate Device(s)

SLIP Urology Catheter, Percutaneous Systems, Inc.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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K061766

510(k) SUMMARY

Percutaneous Systems, Inc.'s Expressway Intermittent Catheter

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 Mountain View, CA 94043-1359

Phone:(650) 969-8800
Facsimile:(650) 969-8801

Contact Person: Thomas Lawson

Date Prepared: March 1, 2007

Common or Usual Name

Urology catheter

Classification Name

G-U Devices

Predicate Device

SLIP Urology Catheter, Percutaneous Systems, Inc.

Intended Use

The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.

Technological Characteristics

The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.

Performance Data

Not required.

MAR 0 3 2007

1

K061766

Substantial Equivalence

The Expressway Intermittent Catheter has the same intended use, indications for use, principles of operation and technological characteristics as the predicate device. Thus, the Expressway Intermittent Catheter is substantially equivalent to the cleared predicate device.

:

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Thomas Lawson, Ph.D. Vice President, Clinical & Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 MOUNTAIN VIEW CA 94043

MAR 0 9 2007

Re: K061766

Trade/Device Name: Expressway Intermittent Catheter, Models IC 2410-06 through IC 2440-18 Regulation Number: 21 CFR §876.5130

Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: February 13, 2007 Received: February 15, 2007

Dear Dr. Lawson:

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 (Premarket Approval), 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.

Image /page/2/Picture/11 description: The image is a circular logo with the text "1906-2006" at the top and the letters "FDA" in large, bold font in the center. Below the letters "FDA" is the word "Centennial" in a cursive font, and below that are three stars. The text around the circle reads "Leading the advancement of consumer protection & public health". The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.

Protecting and Promoting Public Health

3

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxxx(Obstetrics/Gynecology)240-276-0115
21 CFR 892.xxxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) Number (if known): K061766

Device Name: Expressway Intermittent Catheter

Indications for Use:

The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of l

David R. Bergman

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K061142