(74 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and function of a catheter for guiding other instruments, with no mention of AI or ML capabilities.
No.
The device is described as a delivery catheter intended to provide access and guide other devices, not to directly treat a medical condition.
No
The descriptions state that the device is intended to provide access and guide other devices during endoscopic procedures, rather than make a diagnosis.
No
The device description clearly states it is a "flexible triple lumen delivery catheter with three Luer-Lock delivery ports," which is a physical hardware component. The summary also describes its use in guiding other physical devices during endoscopic procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access to the ureteral canal and guide other devices during endoscopic procedures. This is a procedural device used in vivo (within the body) for access and guidance, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a catheter used for physical access and guidance within the body. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic tests.
The device is clearly intended for surgical/interventional use within the body, which is not the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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. (The original text has a typo, "bionsy" should be "biopsy".)
Product codes (comma separated list FDA assigned to the subject device)
EYB
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral canal, urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / endoscopic procedures
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)
Bench test results were conducted. No further details 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.
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
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
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.
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.
1
· 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 Stonebuster
Endoscopic System for
Stone Removal (SESSR) |
|---------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA 510(k) # | K032521 | K022135 | N/A |
| Indications for Use | allow access to and navigation
of a torturous ureter using
standard endoscopic techniques | The UASS is indicated for use in
endoscopic procedures to
facilitate the passage of
endoscopes, urological
instruments and for the injection
of fluids into the urinary tract
percutanously and retrograde. | 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 |
| 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 Multiple
Lumens | 2 | N/A | 3 |
Table 1 . .
2
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.
3
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.
4
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
5
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)