(74 days)
Not Found
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device facilitates the passage of instruments and fluids and creates a conduit, but it does not directly treat a disease or condition itself.
No
The device is described as facilitating the passage of instruments and injection of fluids, and creating a conduit for instruments. Its functions are mechanical (e.g., dilating, creating a channel), not for diagnosis.
No
The device description clearly outlines physical components (dilator, sheath) made of materials like radiopaque and lubricous coated materials, and mentions packaging and sterilization. It is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (endoscopic procedures in the urinary tract) to facilitate the passage of instruments and inject fluids. This is an in vivo use, meaning it's used within the living body.
- Device Description: The description details a physical device designed to create a conduit for instruments within the urinary tract. It's a tool used for access and delivery, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples.
Therefore, the UASS is a medical device used for procedural access and instrument delivery, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
KOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
xray (fluoroscopy)
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific Corporation Imager™ II Urology Torque Catheter, Applied Medical Applied Forté 14 XE Ureteral Access Sheath Set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
Page 2 -
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
() 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
3
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: (508) 650-8144
Lorraine Hanley Director Regulatory Affairs Boston Scientific/ Urology Phone: (508) 650 - 8172 Fax: (508) 650-8144
- 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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