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.

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.

AI/ML Overview

This 510(k) summary is for a medical device (SLIP Urology Introducer Sheath) seeking substantial equivalence to a predicate device, not for an AI/ML-driven device that typically undergoes performance studies with acceptance criteria, test sets, and ground truth establishment.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not applicable to this document.

Here's an explanation based on the provided text:

Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts "identicality" to a predicate device rather than presenting new performance data against specific criteria.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): Not applicable. No performance study, as typically understood for new AI/ML devices, was conducted or presented.
Type of Ground Truth: Not applicable. This concept is relevant for performance studies where a reference standard is needed to evaluate the device's output. Since no new performance data was provided, no ground truth was established for the SLIP Urology Introducer Sheath.
Training Set Sample Size and Ground Truth Establishment (for training): Not applicable. This device is not an AI/ML model requiring a training set.

Summary of what can be extracted from the document:

The core of this 510(k) submission is based on substantial equivalence.

Device: SLIP Urology Introducer Sheath
Predicate Device: Memcath's Urology Introducer Sheath
Key Argument for Substantial Equivalence: The submitter states: "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."
Performance Data: "No performance data were provided" because the device is claimed to be identical to the predicate.

In a traditional 510(k) for a device like this, the 'study' to prove it meets acceptance criteria is often a comparison to a legally marketed predicate device demonstrating that it's just as safe and effective, without raising new questions of safety or effectiveness. For an identical device, the "acceptance criteria" can implicitly be considered "is identical to the predicate."

Summary

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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

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.