URETERAL ACCESS SHEATH SET (UASS)

K022135 · Boston Scientific Corp · KOD · Sep 13, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022135
• Device Name: URETERAL ACCESS SHEATH SET (UASS)
• Applicant: Boston Scientific Corp
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

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.

Device Story

UASS (Ureteral Access Sheath Set) creates conduit for urological instruments; consists of inner tapered semi-rigid dilator and outer flexible sheath. Dilator advances over .038" guidewire to guide sheath into body orifice; components lock together. Radiopaque for fluoroscopic visualization; features UroGlide lubricous coating. Available in 11/13 Fr and 13/15 Fr sizes, lengths up to 49cm. Used in clinical settings by physicians during endoscopic procedures; facilitates instrument passage and fluid injection. Single-use, sterile device.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Components: inner semi-rigid dilator, outer flexible sheath. Materials: radiopaque, UroGlide lubricous coating. Dimensions: 11/13 Fr and 13/15 Fr, lengths up to 49cm. Connectivity: None. Sterilization: Sterile, single-use.

Indications for Use

Indicated for use in endoscopic procedures to facilitate passage of endoscopes, urological instruments, and fluid injection into the urinary tract via antegrade and/or retrograde access.

Regulatory Classification

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).

Predicate Devices

• Boston Scientific Corporation Imager™ II Urology Torque Catheter (CFR 21 part 876.5130)
• Applied Medical Applied Forté 14 XE Ureteral Access Sheath Set (CFR 21 part 876.1500)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Corporation Microvasive Urology Ms. Janet A. McGrath Sr. Regulatory Affairs Specialist One Boston Scientific Place NATICK, MA 01760-1537

JUL 2 7 2015

Re: K022135

Trade/Device Name: UASS (Ureteral Access Sheath Set) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated (Date on orig SE ltr): June 28, 2002 Received (Date on orig SE ltr): July 1, 2002

Dear Ms. McGrath,

This letter corrects our substantially equivalent letter of September 13, 2002.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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() rigual Abhreviated (5) 0K) ામરડ June 28, 2002

Indications for Use Statement

510(k) Number (if Known):

0221 35

Device Name: UASS

Indications for Use:

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 via antegrade and/or retrograde access.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 OR Prescription Use

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

Jancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominel,
and Radiological Devices
510(k) Number_ K022135

000017

Confidential and Proprietary to Boston Scientific Corporation

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Original Abbreviated (SIOK) UASS June 28, 2002

022135

### Summary of Safety and Effectiveness

#### 510(k) Summary: UASS

- A. Sponsor Boston Scientific/ Urology I Boston Scientific Place Natick, MA 01760
- B. Contact Janet A. McGrath Sr. Specialist, Regulatory Affairs OR Boston Scientific/ Urology Phone: (508) 650 - 8726 Fax: [phone]

Lorraine Hanley Director Regulatory Affairs Boston Scientific/ Urology Phone: (508) 650 - 8172 Fax: [phone]

- C. Device Name (Common) Ureteral Access Sheath Set
#### D. Predicate Device(s)

- Boston Scientific Corporation Imager™ II Urology Torque Catheter 1. CFR 21 part 876.5130, Urological Catheter and Accessories .
- Applied Medical Applied Forté 14 XE Ureteral Access Sheath Set 2.
- CFR 21 part 876.1500, Endoscope and Accessories .

#### E. Device Description:

The UASS is designed to create a conduit for urological procedural instruments. This set consists of two components: an inner tapered semi-rigid dilator and an outer more flexible sheath. The outer flexible sheath fits over the semi-rigid inner dilator and it may be locked into place. These components are radiopaque and have a lubricous coating UroGlide™. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 49cm.

The UASS may be placed retrograde and/or antegrade. To guide the access sheath into the body orifice the dilator is advanced over up to a .038" guidewire. The device can be visualized under xray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's working channel of 11 and 13 Fr, respectively.

The proposed device is provided sterile single use. The packaging materials used for the proposed UASS are commonly used materials for packaging medical devices and similar to the predicate devices. The device will be packaged in a labeled, single mylar and tyvek peel pouch, which will be placed in a labeled, paperboard shelf carton.

#### F. Intended Use

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.

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#### Confidential and Proprietary to Boston Scientific Corporation