(476 days)
No
The summary describes a mechanical introducer sheath and does not mention any AI or ML components or functions.
No
The device is an introducer sheath and is intended to facilitate the introduction of other instruments or catheters, rather than to provide a therapeutic effect itself.
No
The device, the CYSTOGLIDE INTRODUCER SHEATH, is an introducer sheath intended to facilitate the introduction of other instruments into the urethra. Its function is to guide and provide a barrier, not to diagnose a condition.
No
The device description explicitly lists physical components (film, sheath, stabilizing ring, obturator), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for facilitating the introduction of catheters or instruments into the urethra. This is a procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device used for insertion, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and mechanical.
N/A
Intended Use / Indications for Use
The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
Product codes
KNY
Device Description
The CYSTOGLIDE INTRODUCER SHEATH consists of a film, a sheath, a stabilizing ring, and an obturator. The sheath is isolated from the skin microflora by the ViaShield film membrane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra
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)
Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052298, UPDATED SLIP Urology Introducer Sheath, LoFric Intermittent Catheter, MMG/O'Neil catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
DEC 1 2 2006
Percutaneous Systems, Inc.'s CYSTOGLIDE INTRODUCER SHEATH Advertising Claims
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Percutaneous Systems, Inc. 1300 Crittenden Lane, #101 Mountain View, CA 94043-1359
(650) 969-8800 x 204 Phone: Facsimile: (650) 969-8801
Contact Person: Thomas Lawson
Date Prepared: August 15, 2005
Common or Usual Name
Urology Introducer Sheath
Classification Name
Accessories, Catheter, G-U
Predicate Device
PSI's UPDATED SLIP Urology Introducer Sheath Astra Tech's LoFric catheter Rusch's MMG/O'Neil catheter
Intended Use / Indications for Use
The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
Image /page/0/Picture/17 description: The image shows an oval shape with three diagonal lines inside. The oval is slightly tilted to the right. The three diagonal lines are parallel to each other and are also tilted to the right.
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Technological Characteristics
The CYSTOGLIDE INTRODUCER SHEATH consists of a film, a sheath, a stabilizing ring, and an obturator. The sheath is isolated from the skin microflora by the ViaShield film membrane.
Performance Data
Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices.
Substantial Equivalence
The CYSTOGLIDE INTRODUCER SHEATH has similar intended use, indications for use, principles of operation and technological characteristics as the predicate devices. The CYSTOGLIDE INTRODUCER SHEATH is substantially equivalent to the cleared UPDATED SLIP Urology Introducer Sheath, the LoFric Intermittent Catheter and the MMG/O'Neil catheter.
Image /page/1/Picture/6 description: The image contains a hand-drawn oval shape with the number 112 written inside. The number is written in a simple, slightly slanted style. The oval shape is not perfectly symmetrical, giving it a casual, hand-drawn appearance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC 1 2 2006
Thomas Lawson, Ph.D. VP, Clinical and Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane Suite 101 MOUNTAIN VIEW CA 94043
Re: K052298
Trade/Device Name: CYSTOGLIDE INTRODUCER SHEATH Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: October 11, 2006 Received: October 12, 2006
Dear Dr. Lawson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro rolled your concerning the device is substantially equivalent (for the indications for referenced about and harv to legally marketed predicate devices marketed in interstate commerce ass mated in the enactment date of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic nave occh roomsbirred in accerantoval 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 (sec above) into either class II (Special Controls) or class III (Premarket If your devise is elasting (500 work) ditional controls. Existing major regulations affecting your Apploval), it they be saylor to out.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/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906 - 2006". The logo features the letters "FDA" in a stylized font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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Page 2 -
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use Statement
510(k) Number (if known):
Device Name: CYSTOGLIDE INTRODUCER SHEATH
Indications for Use:
The CYSTOGLIDE INTRODUCER SHEATH Urology is intended to facilitate the introduction of catheters and instruments into the urethra.
The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
_ X _ _ AND/OR Over-The-Counter Use_ Prescription Use
(Per 21 C.F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leperm
Page 1 of _/
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K052298
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