(83 days)
Not Found
Not Found
No
The summary describes a mechanical device for introducing catheters and instruments, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is an introducer sheath intended to facilitate the introduction of other instruments or catheters, and to act as a barrier. It does not directly treat a disease or condition itself.
No
The device is an introducer sheath designed to facilitate the insertion of catheters or instruments into the urethra, not to diagnose a condition.
No
The device description clearly lists physical components (sheath, pusher tube, twist ring, guide ring), indicating it is a hardware medical 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 the device is for facilitating the introduction of catheters or instruments into the urethra and acting as a barrier. This is a direct interaction with the patient's body for a procedural purpose.
- Device Description: The description details a physical device (sheath, tubes, rings) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
This device falls under the category of a medical device used for a procedural purpose within the body, not an IVD used for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The SLIP Urology 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
78 KNY
Device Description
The SLIP Urology Catheter consists of a sheath, pusher tube, a twist ring, and a guide ring. The pusher tube is pre-loaded with the sheath.
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)
The SLIP Urology Introducer Sheath is identical to the Memcath Urology Introducer Sheath. Thus, no performance data were provided.
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.
Memcath’s Urology Introducer Sheath
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.
0
Koy0520
MAY 2 0 2004
510(k) SUMMARY
Percutaneous Systems, Inc.'s SLIP Urology Introducer Sheath™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
SLIP Urology Introducer Sheath™
Percutaneous Systems, Inc. 1300 Crittenden Lane, #301 Mountain View, CA 94043-1359
(650) 969-8800 x201 Phone: Facsimile: (650) 969-8801
Robert Behl, President and CEO Contact Person:
Date Prepared: February 24, 2004
Common or Usual Name
Urology Introducer Sheath
Classification Name
Accessories, Catheter, G-U
Predicate Device
Memcath's Urology Introducer Sheath
Intended Use / Indications for Use
The SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The SLIP Urology 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.
1
page 2 of 2
K040520
Technological Characteristics
The SLIP Urology Catheter consists of a sheath, pusher tube, a twist ring, and a guide ring. The pusher tube is pre-loaded with the sheath.
Performance Data
The SLIP Urology Introducer Sheath is identical to the Memcath Urology Introducer Sheath. Thus, no performance data were provided.
Substantial Equivalence
The SLIP Urology Introduction Sheath is identical to the Memcath Urology Introduction Sheath (except for the trade name). The SLIP Urology Introduction Sheath has the same intended use, indications for use, technological characteristics, and principles of operation. Thus, the SLIP Urology Introduction Sheath is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three curved lines above it, representing the department's mission to enhance the health and well-being of Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2004
Percutaneous Systems, Inc. c/o Mr. Howard M. Holstein Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington DC 20004-1109
Re: K040520
Trade/Device Name: SLIP Urology Introducer Sheath; Models IS2400-08, IS2400-12, IS2400-14, IS2400-16, IS2400-18, IS2400-22 and IS2400-24 Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: April 30, 2004 Reccived: April 30, 2004
Dear Mr. Holstein:
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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conner or prior to may 2007 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetto Act (110.) that 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 (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 or uny with all the Act's requirements, including, but not limited to: registration and listing Contry with and I 100 5 10 (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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notlication. The FDA inding of sassification 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 (2) CFR Part 801), please If you desire specific advice tol your device on our lacemage of
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
8xx. 1xxx | (301) 594-4591 |
---|---|
876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and assessmone the regulation entitled, "Masbranding
Office of Compliance at (301) 594-4639. Also, please note the collection of Othce of Compliance at (301) 574-1057. Fabs, promobile of a Part 807.97) you may obtain. Other general by reterence to premarket nombation (21 Of Act may be obtained from the Division of Small
information on your responsibilities under the Act may be totally for crumber (800) information on your responsibilities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-frements http:// Manufacturers, International and Collisation Filmow.fda.gov/cdrt/dsma/dsmamain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmamain.html.
Sincerely yours,
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
Indications for Use Statement
510(k) Number (if known): Ko405 ZO
Device Name: SLIP Urology Introduction Sheath
Indications for Use:
The SLIP Urology Introduction Sheath is intended to facilitate the introduction of catheters and instruments into the urethra.
The SLIP Urology 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.
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 __
Nancy brogdon
Division Sign Off
inn of Renrod and Radiological Devi 510(k) Number