CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT by CABOT MEDICAL CORP.

The Surgitek Classic Double Pigtail Ureteral Stent is an indwelling device used to provide drainage from the kidney to the bladder and stenting of the ureter without external catheters. The stent may be placed using endoscopic, percutaneous or open procedures.

Device Description

The Circon-Surgitek Classic Double Pigtail Ureteral Stent is a ureteral stent without a hydromer coating. The function of the double pigtail ureteral stent is to provide drainage from the kidney to the bladder and stenting of the ureter without the aid of internal catheters.

The Circon-Surgitek Classic Double Pigtail Ureteral Stent has a flexible pigtail curl at both the proximal (kidney) and distal (bladder) end of the stent. The kidney curl of the double pigtail is similar to the Circon-Surgitek Lubri-Flex™ kidney curl [K905289] while the bladder curl is similar to the Circon-Surgitek Multi-Flex [K913928]. These curls minimize upward and downward migration of the device. The curls at each end are formed in opposite directions from each other. The proximal kidney curl hooks, laterally into the lower colon or renal pelvis while the distal bladder curl curves medially into the bladder. The kidney curl, located at the proximal end of the device, is easily distinguished by the open tapered tip (or tail) which extends beyond the curl. The bladder curl, located at the distal end of the device, is distinguished by its open blunt end which does not extend beyond the curl.

Drainage holes are located at approximately 2.0 cm intervals in a spiral configuration along the mainshaft of the stent.

The Circon-Surgitek Classic Double Pigtail Ureteral Stent is designed for endoscopic or open surgical placement. A medial line is imprinted along the mainshaft of the stent on the side opposite the proximal curl to assist the physician in correctly orienting the curls within the kidney and bladder. The medial line terminates at the axial ring, parallel to the center radius of the distal curl. The axial ring serves as a visual marker to the physician for placement of the stent. The physician advances the stent until the ring is adjacent to the ureterovesical junction. This allows a sufficient amount of the stent to remain in the bladder to fully form the distal curl.

A non-absorbable monofilament trailing suture is provided in the distal curl to assist the physician in stent placement and positioning. To protect the suture, a retaining tube is placed over the tapered end of the stent.

Other currently marketed components to be packaged with the Circon-Surgitek Classic Double Pigtail Ureteral Stent include:

One (1) Push Catheter .

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Circon-Surgitek Classic Double Pigtail Ureteral Stent:

Important Note: The provided document is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria in the way a PMA (Premarket Approval) would. Therefore, the "acceptance criteria" here relate to demonstrating similar performance characteristics to predicate devices. The "study" largely consists of comparisons of material properties and design features.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Material used should be similar to or the same as previously cleared devices.	Tecoflex material: "The Tecoflex material used to manufacture the device has been used in other commercially available stents that have been determined as substantially equivalent."
Design Feature Equivalence: Curvature, drainage holes, and other design elements should be comparable to predicate devices.	Kidney Curl: Similar to Circon-Surgitek Lubri-Flex™ [K905289]
	Bladder Curl: Similar to Circon-Surgitek Multi-Flex [K913928]
	Drainage holes: Located at approximately 2.0 cm intervals in a spiral configuration.
	Medial line: Imprinted along the mainshaft for orientation.
	Axial ring: Visual marker for placement.
	Non-absorbable monofilament trailing suture: Provided in the distal curl.
Mechanical Strength Equivalence: Key mechanical properties (e.g., curl strength, break strength, elongation) should be comparable to predicate devices.	Kidney curl strength, bladder curl strength, break strength and elongation: "similar to other commercially available double pigtail stents that have been determined as substantially equivalent."
Intended Use Equivalence: Device should perform the same function as predicate devices.	Intended Use: "indwelling device used to provide drainage from the kidney to the bladder and stenting of the ureter without external catheters." This is consistent with predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated for any formal "test set" in the context of clinical performance. The comparison seems to be based on design specifications, material properties, and a general understanding of predicate device performance.
Data Provenance: The data appears to be primarily from internal testing (for material and mechanical properties comparisons), and references to regulatory submissions (510(k) numbers like K860267, K930731, K905289, K946296) for predicate devices. There is no indication of clinical data from patients for a specific "test set." The information is retrospective since it refers to already cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. This submission is about substantial equivalence, not establishing clinical "ground truth" through expert consensus on a test set of patient data. The "ground truth" here is the established safety and effectiveness of the predicate devices.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication method: Not applicable. No clinical test set requiring adjudication is described.

5. 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

MRMC Study: No MRMC study was done.
Effect Size: Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate devices (Microvasive Mardis Stent, Cook Double Pigtail Stent, Circon-Surgitek Lubri-Flex, Circon-Surgitek Quadra-Coil™). The applicant is asserting that their new device is "substantially equivalent" to these already cleared devices, implying similar safety and efficacy. The excerpt from Resnick, "A guide to double-pigtail stents," provides clinical context and suggests general acceptance of ureteral stents for urinary drainage.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary

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MAR 2 5 1996 1. Applicant's Name Circon-Surgitek Corporation (formerly known as Cabot-Surgitek, Surgitek or Medical Engineering Corporation)
1. Owner/Operator's Name and Establishment Registration Number: Owner/Operator's Address: Circon Corporation 6500 Hollister Avenue Santa Barbara, CA 93117 Establishment Registration Number 9920160
1. Contact Person, Contact Person's Address, Telephone Number and Establishment Registration Number: Todd J. Polk Circon-Cabot 2150 Cabot Boulevard West Langhorne, PA 19047 (215) 752-8300 X 6628 Establishment Registration Number 2522397
1. Manufacturing Site Address and Establishment Registration Number: Circon-Surgitek 3037 Mt. Pleasant Avenue Racine, WI 53404 Establishment Registration Number 2124979
Device Trade/Proprietary Name: ব . Circon-Surgitek Classic Double Pigtail Ureteral Stent
റ്റ് Classification Name and Panel Classification Number: Classification Name: Ureteral Splint Classification Code; 78FAD Regulation Number: 21CFR §876.4620 Common/Usual Name: Ureteral Stent
1. Marketed Devices Used for Substantial Equivalence: The Circon-Surgitek Classic Double Pigtail Ureteral Stent is substantially equivalent to Ureteral Stents which were available prior to May 28, 1976 and to devices marketed after May 28, 1976 and were determined as substantially equivalent by the US FDA. The Circon-Surgitek Classic Double Pigtail Ureteral Stent is substantially equivalent to the following devices; 1) the Microvasive Mardis Stent [K860267], 2) the Cook Double Pigtail Stent [K930731]; 3) the Circon-Surgitek Lubri-Flex [K905289] and 4) the Circon-Surgitek Quadra-Coil™ [K946296].

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7. Device Description and Intended Use of the Marketed Device:

Indications for Use

Device Description

Drainage holes are located at approximately 2.0 cm intervals in a spiral configuration along the mainshaft of the stent.

Note: THE SUTURE RETAINING TUBE MUST BE REMOVED PRIOR TO USE.

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Other currently marketed components to be packaged with the Circon-Surgitek Classic Double Pigtail Ureteral Stent include:

One (1) Push Catheter .
1. Summary of Safety and Effectiveness

Double-pigtail stents provide a safe and effective method of ensuring urinary drainage. Resnick described the use of Ureteral Stents "to provide urinary drainage when renal obstruction occurs secondary to a chronic process, such as malignancy, edema, and stricture or in obstructed patients, to maintain constant drainage through the course of the illness. Other uses include temporary insertion to relieve obstruction, usually in association with a ureteral stone, intra-operatively during renal procedures, such as pyeloplasty; or during ureteral procedures such as repair of ureteral injuries; or in association with urinary diversion."1

The Tecoflex material used to manufacture the device has been used in other commercially available stents that have been determined as substantially equivalent. The kidney curl strength, bladder curl strength, break strength and elongation of the Circon-Surgitek Double Pigtail Stent is similar to other commercially available double pigtail stents that have been determined as substantially equivalent.

4 Resnick MI: A guide to double-pigtail stents, Contemp Urology, Oct. 1994, pp. 59-66.

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).