(57 days)
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. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as facilitating the passage of instruments and injection of fluids, functioning as a conduit rather than treating a disease or condition.
No
The device is designed to create a conduit for urological procedural instruments and facilitate the passage of endoscopes, instruments, and fluids. It does not mention any function related to diagnosing diseases or conditions. Its purpose is to facilitate interventional procedures, not to detect or identify medical conditions.
No
The device description clearly details physical components (dilator, sheath) made of materials like radiopaque and hydrophilic coated substances, and mentions physical characteristics like French sizes and lengths. It also describes packaging and sterilization, all indicative of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the passage of instruments and inject fluids into the urinary tract during endoscopic procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a physical tool (sheath and dilator) used to create a conduit for other instruments. It is used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health.
This device is clearly designed for use within the body for a procedural purpose, not for analyzing samples outside the body for diagnostic information.
N/A
Intended Use / Indications for Use
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, FED
Device Description
The UASS II 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 hydrophilic coating. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 46cm. The UASS II 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 x-ray (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 device. The device will be packaged in a labeled, single polyfilm/tyvek peel pouch double sealed, 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
x-ray (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)
Results of physical comparison and functional testing support a determination of substantial equivalence for the proposed device when compared to the predicate device. The proposed device is substantially equivalent to devices previously cleared via the 510(k) path in terms of technology, principles of operation, intended use, and materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ureteral Access Sheath Set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of a human figure with outstretched arms, which is meant to symbolize care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
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 Senior Regulatory Affairs Specialist, Urology One Boston Scientific Place Natick, MA 01760-1537
JUL 2 7 2015
K030956 Re: Trade/Device Name: Ureteral Access Sheath Set II Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD, FED Dated (Date on orig SE ltr): May 2, 2003 Received (Date on orig SE ltr): May 5, 2003
Dear Ms. McGrath,
This letter corrects our substantially equivalent letter of May 23, 2003.
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 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
Special 510 (k) Premarket Notification Ureteral Access Sheath Set II
Boston Scientific Corporation March 26, 2003
.. –
.. ». "
Indications for Use Statement
510(k) Number (if Known):
UASS II Device Name:
Indications for Use:
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)
Prescription Use / OR
Over-The-Counter Use (Optional Format 1-2-96)
David G. Seager
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Confidential and Proprietary to Boston Scientific Corporation
000002
3
Boston Scientific Corporation March 26, 2003
Summary of Safety and Effectiveness
| | 510(k) Summary: UASS II
MAY 23 2003 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SPONSOR: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 |
| CONTACT PERSON: | Janet A. McGrath
Senior Regulatory Affairs Specialist
Or
Lorraine M. Hanley
Director Regulatory Affairs |
| DEVICE: | Ureteral Access Sheath Set II |
| TRADE NAME: | Navigator™ Access Sheath Set |
| COMMON NAME: | Ureteral Access Sheath Set |
| CLASSIFICATION: | Class II; 876.1500, Endoscope and Accessories
Class II; 876.5130, Urological Catheter and Accessories |
| PREDICATE DEVICE: | Ureteral Access Sheath Set |
| DESCRIPTION: | The UASS II 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 hydrophilic coating. The device
is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths
up to 46cm.
The UASS II 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 x-ray (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 device. The device will be packaged in a labeled, single
Confidential and Proprietary to Boston Scientific Corporation
4
Special 510 (k) Premarket Notification Ureteral Access Sheath Set II
Boston Scientific Corporation March 26. 2003
polyfilm/tyvek peel pouch double sealed, which will be placed in a labeled, paperboard shelf carton.
INTENDED USE: The UASS II 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 antegrade and/or retrograde access. TECHNOLOGICAL The proposed device is substantially equivalent in design and CHARACTERISTICS: materials to previously cleared devices. The proposed device has hydrophilic coating to facilitate device placement and
withdrawal. Results of physical comparison and functional testing support a PERFORMANCE DATA: determination of substantial equivalence for the proposed device when compared to the predicate device. The proposed device is substantially equivalent to devices previously cleared via the 510(k) path in terms of technology, principles of operation, intended use, and materials.
Confidential and Proprietary to Boston Scientific Corporation