The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.

The indications for use of the catheter are in urological applications.

Device Description

The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endossopic procedures.

The SESSR Delivery Catheter is introduced into the desired anatomical location through the SESS sheath with a minimum working channel diameter of 4.3mm. The distal tip of the SESSR is straight or benefit at minimum of 6.5 mm from the distal tip of 10 degrees providing the physician with (when using visualization devices) a wider field of view.

AI/ML Overview

The provided document (K083788) describes the Stonebuster Endoscopic System for Stone Removal (SESSR) and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical trial data as requested.

The basis for clearance is demonstrating substantial equivalence to legally marketed predicate devices, not through a study proving predefined acceptance criteria. Therefore, most of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" assessment is based on a comparison to predicate devices, focusing on design, materials, and intended use.

Acceptance Criteria	Reported Device Performance
Not specified in the document. The primary "acceptance criterion" was demonstrating substantial equivalence to predicate devices based on design, materials, and intended use rather than specific quantitative performance metrics.	Substantially Equivalent to Bard's Dual Lumen Ureteral Catheter (K032521) and Boston Scientific Ureteral Access Sheath Set (UASS) (K022135) in terms of safety and effectiveness. The document states that "Any differences that have been identified between the devices are believed to be insignificant with respect to safety and effectiveness."

2. Sample size used for the test set and the data provenance
Not applicable. This was a 510(k) submission based on substantial equivalence, not a clinical study with a "test set" in the context of AI/algorithm performance. The data provenance includes material specifications and sterilization validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.

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
Not applicable. This device is a medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (catheter), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an algorithm's ground truth. The "truth" for this submission was demonstrating that the device's design, materials, and intended use were comparable to existing, legally marketed predicate devices, and that it met relevant standards for sterility.

8. The sample size for the training set
Not applicable. No training set was used, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

Summary of what the document does provide regarding device evaluation:

Sterility Testing: A full cycle, single lot batch validation was completed to ensure sterility using ethylene oxide (EtO) gas, contracted with STS Life Sciences Division of Ethox. The reports of these results were included in Section 14.1 of the submission.
Shelf Life: Currently set at six months, with ongoing monitoring of samples to ensure sterility and functionality, with plans to adjust the shelf life based on these observations.
Bench Testing: The conclusion mentions "bench test results conducted with the Stonebuster Endoscopic System for Stone Removal (SESSR)." However, the document does not detail these bench tests, their methodologies, or specific quantitative results beyond stating they support substantial equivalence.
Comparison to Predicate Devices: The primary "proof" of meeting safety and effectiveness is through a detailed comparison (Table 1) to two predicate devices:
- Boston Scientific Corporation UASS Ureteral Access Sheath (K022135)
- Bard Dual Lumen Ureteral Catheter (K032521)
  This comparison covers indications for use, shaft material, hub material, sterility, single-use nature, and number of lumens. The sponsor argues that any differences are "insignificant with respect to safety and effectiveness."

In essence, for a traditional 510(k) such as this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, supported by foundational tests like sterility validation and general engineering/material specifications, rather than a clinical trial or algorithm performance study.

Summary

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K083788

Traditional 510(k) Stonebuster Endoscopic System for Stone Removal (SESSR) December 4, 2008

510(k) SUMMARY

MAR 3 2009

SPONSOR: Endo Optiks, Inc. 39 Sycamore Ave. Little Silver, NJ 07739

CONTACT INFORMATION:

Donald Watson Endo Optiks, Inc. 39 Sycamore Ave. Little Silver, NJ 07739 TEL: 732-530-6762 FAX: 732-530-5344 e-mail: dwatson@endooptiks.com

DEVICE COMMON NAME:

Urological Catheter and Accessories

PREDICATE DEVICE:

Boston Scientific Corporation UASS Ureteral Access Sheath K022135 . (CFR 21 part 876.5130, Urological Catheter and Accessories)
Bard Dual Lumen Uretera! Catheter K032521 . (CFR 21 part 876.5130, Urological Catheter and Accessories)

DEVICE DESCRIPTION

STATEMENT OF INTENDED USE OF THE CATHETER FOR ENDOSCOPY

The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualizes and accessory devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.

The indications for use of the catheter are in urological applications.

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· EXECUTIVE SUMMARY

Device Description

The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is a sterile, single-use device comprised of one main component: a flexible triple lumen delivery catheter with three Luer-Lock delivery ports. This device is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic procedures.

The Stonebuster Endoscopic System for Stone Removal (SESSR) Delivery Catheter is introduced into the desired anatomical location through an access sheath with a minimum working channel diameter of 4.3mm. The distal tip of the Stonebuster Endoscopic System for Stone Removal (SESSR) is straight or bent at a minimum of 6,5 mm from the distal tip at 10 degrees providing the physician with (when using visualization devices) a wider field of view.

Table 1, provided below, is a comparison of the Endo Optiks Stonebuster Endoscopic System for Stone Removal (SESSR) device, Bards' Dual Lumen Ureteral Catheter and the Boston Scientific Ureteral Access Sheath Set (UASS). The similarities and differences between these devices are discussed in further detail in Section 12, Substantial Equivalence Discussion.

Item/Description	Bard Device	BSC Device	Endo Optiks StonebusterEndoscopic System forStone Removal (SESSR)
FDA 510(k) #	K032521	K022135	N/A
Indications for Use	allow access to and navigationof a torturous ureter usingstandard endoscopic techniques	The UASS is indicated for use inendoscopic procedures tofacilitate the passage ofendoscopes, urologicalinstruments and for the injectionof fluids into the urinary tractpercutanously and retrograde.	To provide access to the ureteralcanal and to be used to guide thecurrently available visualizationdevices and accessory devices,such as biopsy forceps, cytologybrushes, stone retrieval baskets,etc. during endoscopicprocedures
Shaft Material	Polyurethane	N/A	Pellethane 75D
Hub Material	Polyurethane	N/A	Pellethane 80A
Provided Sterile	Yes	Yes	Yes
Single Use	Yes	Yes	Yes
No. of MultipleLumens	2	N/A	3

Table 1 . .

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Sterility Testing & Shelf Life

The Stonebuster Endoscopic System for Stone Removal (SESSR) catheter is provided sterile to the customer. The Stonebuster Endoscopic System for Stone Removal (SESSR) will be sterilized using ethylene oxide (EtO). Endo Optiks has contracted with STS Life Sciences Division of Ethox, located in Rush, NY to perform the sterilization. A full cycle, single lot batch validation was completed and the product found to be sterile using ethylene oxide (ExO) gas. The reports of these results are included in Section 14.1.

The shelf life of this product is currently set at six months. Samples of the product will be segregated and monitored periodically to ensure product sterility and that the device is fully functional. Results of these observations will be used to adjust the length of time the product will be permitted on the shelf.

CONCLUSION:

Endo Optiks, Inc. has reviewed the intended use, specifications for performance and bench test results conducted with the Stonebuster Endoscopic System for Stone Removal (SESSR). Catheter for Endoscopy, and finds that it is substantially equivalent to Bards' Dual Lumen Ureteral Catheter and the Boston Scientific Ureteral Access Sheath Set .

The Endo Optiks Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is as safe and effective as the predicate devices. Any differences that have been identified between the devices are believed to be insignificant with respect to safety and effectiveness. Further details may be found in the table of similarities and differences located in Section 12.1 Substantial Equivalence Discussion. Endo Optiks believes there are no significant differences and no new questions of safety and effectiveness relative to the technological specifications and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2009 MAR

Mr. Donald Watson QA/RA Manager Endo Optiks, Inc. 39 Sycamore Avenue LITTLE SILVER NJ 07739

Re: K083788

Trade/Device Name: Stonebuster Endoscopic System for Stone Removal (SESSR) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EYB Dated: February 16, 2009 Received: February 20, 2009

Dear Mr. Watson:

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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 comply with all the Act's requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (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,

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-011
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-011
21 CFR 892.xxx	(Radiology)	(240) 276-012
Other		(240) 276-010

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems of 240 (776-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.support/index.html.

Sincerely yours,

Janine M. Morris

Acting 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

510(k) Number (if known): K083788

Device Name:

Endo Optiks Stonebuster Endoscopic System for Stone Removal (SESSR)

Indications for Use:

The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to quide the currently available visualization devices and accessory devices such as bionsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures.

The indications for use of the catheter are in urological applications.

Hales Reimer

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices S10(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.