(78 days)
Not Found
Not Found
No
The summary describes a mechanical device (expandable ureteral sheath) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is used to create a working channel during endoscopic urological procedures, rather than actively treating a disease or condition. While it is used in a therapeutic context, it serves as an accessory for therapeutic procedures.
No
The device is described as an expandable ureteral sheath intended to establish a working channel during endoscopic urological procedures, which is an interventional or access function, not a diagnostic one.
No
The device is described as an "Expandable Ureteral Sheath," which is a physical medical device used to establish a working channel. The description does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to establish a working channel during endoscopic urological procedures to access the ureter. This is a surgical or interventional procedure, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a tool used to facilitate a medical procedure within the body, not a test performed on a sample.
N/A
Intended Use / Indications for Use
The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish access, and to facilitate the introduction of endoscopes and instruments into the urinary tract during endoscopic urological procedures, facilitating passage of instruments into the ureter by way of the urethra and bladder.
Product codes
78 EZN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, ureter, urethra, bladder
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services-USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter of the circle. Inside the circle is a stylized image of a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2005
Onset Medical Corporation c/o Albert Rego, Ph.D. Consultant 27001 La Paz, Suite 312 MISSION VIEJO CA 92691
K043254 Re:
Ro4323-1
Trade/Device Name: Pathway Ureteral Access Sheath/Pathway Expandable Ureteral Access Sheath Regulation Number: 21 CFR § 876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: 78 EZN Dated: January 14, 2005 Received: January 18, 2005
Dear Dr. Rego:
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 the cholors's to e 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 do incl. require to the general controls provisions of the Act. The general controls provisions of the Act de not, subject to an general and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your rippto rary, it 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 I loase or advisod that cover 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 I caraf statues and rogalding, 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) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter watification. The FDA finding of substantial equivalence of your device to a legally premaince noticate 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 11 you dees office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Kc 43254
Indications for Use
510(k) Number (if known):__Unknown
Device Name:_______Pathway™ Expandable Ureteral Sheath
Indications For Use:
The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) The Onset Medical Pathway - Exparing endoscopic urological procedures, facilitating is intended to establish a ochault, admig the sureter by way of the ureter by way of the urethra and bladder.
Prescription Use
(Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dennis G. Thompson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ...
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