(260 days)
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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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
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 |
Other | 240-276-0100 |
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
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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