(48 days)
PSI's UPDATED SLIP Urology Introducer Sheath, Cook Urological's Urethral Dilator Set
Not Found
No
The summary describes a physical medical device (sheath, hub, dilator) used for dilation and introduction of instruments. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance study compares it to a predicate device, focusing on physical performance, not algorithmic output.
Yes
The text explicitly states that the device is intended to facilitate the dilation of urethral strictures, which is a therapeutic intervention.
No
The device is described as a dilator and introducer sheath, facilitating the insertion of other instruments. Its function is to prepare the anatomical site for further procedures or to guide instruments, not to obtain diagnostic information.
No
The device description explicitly lists physical components (film, sheath, stabilizing hub, dilator), indicating it is a hardware device, not software-only.
Based on the provided information, the CYSTOGLIDE DILATING INTRODUCER SHEATH is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used to facilitate procedures within the body (dilation of urethral strictures, introduction of catheters/instruments into the urethra). IVD devices are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a physical device designed for insertion into the urethra. This is consistent with an in-vivo medical device, not an in-vitro diagnostic.
- Anatomical Site: The specified anatomical site is the urethra, which is an internal part of the body. IVD devices work with samples taken from the body (like blood, urine, tissue), not directly within the body.
Therefore, the CYSTOGLIDE DILATING INTRODUCER SHEATH is an in-vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to facilitate the dilation of urethral strictures and the introduction of catheters or instruments into the urethra. The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for use as a urethral dilator and as a guide for urological catheters or instruments into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
Product codes (comma separated list FDA assigned to the subject device)
FAH, KOE, KNY
Device Description
The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a sheath, a stabilizing hub, and over a urological guidewire.
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 DILATING INTRODUCER SHEATH and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PSI's UPDATED SLIP Urology Introducer Sheath, Cook Urological's Urethral Dilator Set
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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K052134
page 1 of 2
SEP 2 2 2005
510(k) SUMMARY
Percutaneous Systems, Inc.'s CYSTOGLIDE DILATING INTRODUCER
STORE Systems, Inc.'s CHEATH SHEATH
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
Thomas Lawson Contact Person:
July 25, 2005 Date Prepared:
Common or Usual Name
Urology Dilating Introducer Sheath
Classification Name
Accessories, Catheter, G-U
Predicate Device
PSI's UPDATED SLIP Urology Introducer Sheath Cook Urological's Urethral Dilator Set
Intended Use / Indications for Use
The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to The CTSTOOLIDE DiEATING Istrictures and the introduction of catheters
facilitate the dilation of urethral strictures and the RUATING facilitate the dilation of arethra. The CYSTOGLIDE DILATING or instruments into the arething. can a urethral dilator and as a INTRODUCEN SHEATT is indicated for attailed into the urethra and guide for urological catricters of increatival tissue and the catheter or instrument.
Image /page/0/Picture/17 description: The image shows the number 42 written inside of an oval. The number 42 is written in a simple, handwritten style. The oval is drawn around the number, enclosing it.
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K052134
pagl zifz
Technological Characteristics
The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a film,
The CYSTOGLIDE DILATING INTRODUCER - The dovice can be front-The CYSTOGLIDE DILATING INTROTRY (Notector. The device can be fronta sheath, a stablizing high and over a urological guidewire.
Performance Data
Performance data demonstrated no significant difference in the Performance data demonstrated no significant and of the coulder SHEATH
performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device.
Substantial Equivalence
The CYSTOGLIDE DILATING INTRODUCER SHEATH has similar The CYSTOGLIDE Dications for use, principles of operation and technological intended use, indications for docted devices. The CYSTOGLIDE DILATING
characteristics as the predicate devices. The CYST is substantially charactenstics as the predicate advanced on Sheath is substantially INTRODUCER SHEATH Orology Introducer Sheath and the Urethral Dilator Set.
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Image /page/2/Picture/2 description: The image shows a stylized drawing of a bird in flight. The bird is depicted with simple, bold lines, giving it an abstract appearance. To the left of the bird, text curves along the edge of the image, suggesting it might be part of a logo or emblem. The overall style is minimalist and graphic.
SEP 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas Lawson, Ph.D. VP, Clinical & Regulatory Affairs Percutaneous Systems, Inc. 1300 Crittenden Lane, Suite 101 MOUNTAIN VIEW CA 94043-1359
K052134 Re:
K052134
Trade/Device Name: CYSTOGLIDE DILATING INTRODUCER SHEATH CYSTOGEIDE DIDATHING IN CD2117, CD1915 and CD1713 Regulation Number: 21 CFR §876.5520 Regulation Name: Urethral dilator Product Code: FAH and KOE Froduct Countion Number: 21 CFR §876.5130 Regulation Number: 21 Gr St St St St St eter and accessories Product Code: KNY Regulatory Class: II Dated: July 25, 2005 ﺎﺭ ﻳﺮﺗﺒ Received: August 5, 2005
Dear Dr. Lawson:
We have reviewed your Section 510(k) prematicet notification of intent to market the device referenced We have reviewed your Section 510(K) picitialse indications for the indications for use stated in
above and have determined the device is substant in indications commerce pr above and have delemined the cevices is stedios in interstate comments prior to
the enclosure) to legally marketed predicated in interses or to devices that have the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Device Amendments, or to devices t May 28, 1976, the enactment and of the Medical Doug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and issues (PMA). You may, therefore, market the do not require approval of a prematics approval approvation of the general controls provisions of the Act
device, subject to the general controls provisions of the Act menufa device, subject to the general controls of the really as and manufacturing practice, labeling, merado requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Precuations affecting vour If your device is classified (see above) into claim and creations affecting your and Approval), it may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations: Title 21, Paris 800 to 8 device can be found in the Code of Federal Register. In the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issualice of a substance of the requirements of the Act of any
FDA has made a determination that your device complex with other comply with all FDA has made a determination that your devices. You must concess. You must comply with all the Federal statutes and regulations administered by registration and listing (21 CFR Part 807), labeling
Act's requirements, including, but not limited to registration as set fo Act 's requirements, including, but to million is reguirements as set forth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set for (21 CFR Part 801); good manufacturing practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the supportunity Black of substantial equivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA in a location for your device and thus, premarket notification. The FDA finding of substantial equivalence of your device of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (1) - 11 crail on 1977)
contact the Office of Compliance at one of the following numbers, based on th 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 prematic notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general intermation on your responsible of the manner (800)
Division of Small Manufacturers, International and Consumer Assistance at its toll-Division of Small Manalastar at its Internet address.
638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Office of Doevices and Radiological Health
Enclosure
4
Indications for Use Statement
K652134 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CYSTOGLIDE DILATING INTRODUCER SHEATH
Indications for Use:
The CYSTOGLIDE DILATING INTRODUCER SHEATH Urology is The CTSTOCEIDE DIEXTRYS: and to facilitate the introduction of catheters and instruments into the urethra.
The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for rne OTOTOOElDHilator and as a guide for urological catheters or use as a dreinfal and as a lubricious barrier between the urethral tissue and the catheter or instrument.
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)
Page 1 of __
David h. lyons
(Division Sign-Off) Division of Reproductiv and Radiological Devices 510(k) Number
Image /page/4/Picture/14 description: The image shows a handwritten number "47" enclosed in a circle. The number is written in a simple, slightly uneven style, typical of handwriting. The circle around the number is also hand-drawn and not perfectly round, giving the image an informal, hand-created appearance.