CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.

Device Description

The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of fluids or a guidewire.

AI/ML Overview

The provided document is a 510(k) summary for the CIRCON SURGITEK Snap-N-Peel™ Introducer, seeking market clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically found for novel or high-risk devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing predicate devices (Cook Peel-Away® Introducer and Microvasive® Banana Peel™ Sheath) in terms of design, materials, operating principles, lengths, diameters, and smoothly finished contours. The document explicitly states that "Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness."
Reported Device Performance: The document does not report specific quantitative performance metrics against pre-defined acceptance criteria in a tabular format as would be expected from a device study. Instead, it asserts that the device is substantially equivalent to the predicate devices, implying similar performance.

Detailed Information Request (where applicable from the document):

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from 510(k) process)	Reported "Device Performance" (Based on Substantial Equivalence Claim)
Design Considerations: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same design considerations" as predicate devices.
Materials of Construction: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same... materials of construction" as predicate devices.
Operating Principles: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same... operating principles" as predicate devices.
Physical Characteristics (Lengths, Diameters, Smoothly Finished Contours): Similar to predicate devices.	CIRCON SURGITEK devices "also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices."
Safety and Effectiveness: Differences should not raise new questions regarding safety or effectiveness. (Implied for substantial equivalence).	"Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness."
Sterility: Supplied sterile, for single use. (This is a common requirement for such devices, though not explicitly compared to predicates for equivalence).	CIRCON SURGITEK devices "are supplied sterile, for single use."
Energy Delivery: No active energy delivery. (Important for safety classification).	"None of the devices actively delivers any form of energy to the patient."

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A: The document does not describe a "test set" in the context of a clinical study or performance evaluation with a specified sample size. The substantial equivalence claim is based on comparison of technological characteristics with predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- N/A: No ground truth establishment by experts for a test set is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A: No test set or adjudication method is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A: This device is an introducer sheath and dilator, not an AI or imaging device. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A: This is a physical medical device, not an algorithm, so this concept is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A: No "ground truth" in the typical sense of a clinical study is established or used for this 510(k) submission. The "truth" for substantial equivalence is based on engineering design, material characteristics, and operational principles as compared to legally marketed predicate devices.
The sample size for the training set
- N/A: No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established
- N/A: Not applicable.

In summary, this 510(k) filing demonstrates substantial equivalence to predicate devices, which is a regulatory pathway that typically relies on bench testing, material characterization, and comparison of design and intended use, rather than extensive clinical efficacy studies with ground truth establishment. The document does not provide the detailed performance study information requested because it falls outside the scope of a typical 510(k) summary for this type of device.

Summary

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July 3 0 1998

510(k) Summary: #K981611

CIRCON SURGITEK Snap-N-Peel™ Introducer

(Introducer Sheath & Dilator)

Name of Submitter: CIRCON SURGITEK Division of Circon Corporation 1)

Address:	3037 Mount Pleasant Street
	Racine, WI 53404

(414) 639-7205 Telephone:

Dr. Ronald J. Ehmsen Contact Person: Vice President, Regulatory Affairs Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117
Telephone: (805) 961-3290 Fax: (805) 968-7385

Date Submitted: July 14, 1998

Name of Device: Introducer Sheath and Dilator 2)
Proprietary/Trade Name: Snap-N-Peel™ Introducer

Common/Usual Name: Introducer Sheath and Dilator

Classification: Various (see attached table)

Classification Names: Various (see attached table)

1. Name of Predicate or Legally Marketed Device:
  The CIRCON SURGITEK Snap-N-Peel™ Introducer is substantially equivalent to the Cook Peel-Away® Introducer that was approved by FDA for marketing on October 18, 1996, under 510(k) No. K961904, and to the Microvasive® Banana Peel M Sheath that was approved by FDA for marketing on July 23, 1997, under 510(k) No. K971165.

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510(k) Summary: #K981611 CIRCON SURGITEK Division of Circon Corporation Shap-N-Peel™ Introducers July 14, 1998 Page 2

Description of Device: 4)

Intended Use of Device: રો

୧) Comparison of Technological Characteristics:

CIRCON SURGITEK's Snap-N-Peel™ Introducers are substantially equivalent' to the legally marketed Cook Peel-Away® Introducers and the Microvasive® Banana Peel™ Sheaths. CIRCON SURGITEK's devices employ the same design considerations, materials of construction and operating principles. The CIRCON SURGITEK devices also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices and are supplied sterile, for single use. Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness. None of the devices actively delivers any form of energy to the patient.

"The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.

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510(k) Summary: #K981611

CIRCON SURGITEK Division of Circon Corporation Snap-N-Peel™ Introducers Bily 14, 1998
Page 3

1998年4月

Classification Names

CDRHStandard ProductNomenclature	ProductCode	Class
Catheter,Nephrostomy	78LJE	II
Catheter,Nephrostomy,General & PlasticSurgery	79GBO	I
Catheter and Tube,Suprapubic	78FEZ	II
Catheter,Suprapubic andAccessories	78KOB	II
Catheter, Ureteral,Gastro-Urology	78EYB	II
Catheter, Ureteral,General & PlasticSurgery	78GBL	II
Catheter, Urethral	78GBM	II
Catheter,Urological	78KOD	II
Dilator, Catheter	79GCC	I
Dilator, Catheter,Ureteral	78EZN	II
Dilator, Urethral	78KOE	II

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 1998

Ronald J. Ehmsen, Sc.D. ·Vice President, Regulatory Affairs Circon Corporation 6500 Hollister Avenue Santa Barbara, California 93117

Re: K981611 Trade Name: Snap-N-Peel Introducers Regulatory Class: II Product Code: KNY Dated: May 4, 1998 Received: May 6, 1998

Dear Dr. Ehmsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Dr. R.J. Ehmsen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

tbolle

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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F. 277

510(k) Number: K981611

Device Name: CIRCON SURGITEK Snap-N-PeelTM Introducers

Indications for Use:

ﺮ ﺍﻟﻤﺴﺎﺑﻘﺎ

CIRCON SURGITEK's Snap-N-Peel™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical. procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract. a september 2017 - 11:20 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office od Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801,109)

Over-The-Counter Use__
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981611

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.