(20 days)
The Onset Medical Pathway™ Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Balloon Expandable Ureteral Access Sheath." This type of document does not contain the detailed information requested regarding acceptance criteria and the specifics of a study proving device performance.
510(k) clearance signifies that a device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics, and that it is as safe and effective as the predicate. The FDA review for a 510(k) does not typically involve a new, comprehensive clinical trial for efficacy against specific acceptance criteria in the way a PMA approval might. Instead, it relies on demonstrating equivalence through comparison to existing devices, often including performance testing that is not detailed in the public clearance letter.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily states:
- Device Name: Pathway™ Balloon Expandable Ureteral Access Sheath
- 510(k) Number: K061009
- Indication for Use: To establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
- Regulatory Class: II
- Product Code: EZN
- Regulation Name: Ureteral dilator
- Predicate Device: The letter states the device is substantially equivalent to legally marketed predicate devices, but does not explicitly name them.
To obtain the detailed study information you're asking for, you would typically need to refer to the 510(k) summary document or the full 510(k) submission to the FDA, which are sometimes publicly available through different FDA databases, but are not part of this clearance letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a triple-stranded helix or staff with a serpentine form.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 2006
Onset Medical Corporation c/o Albert Rego, Ph.D. Consultant 27001 La Paz, Suite 312 MISSION VIEJO CA 92691
Re: K061009
Trade/Device Name: Pathway™ Balloon Expandable Ureteral Access Sheath Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN Dated: April 6, 2006 Received: April 12, 2006
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 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 (Premarket Approval), 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.
oling Public
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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 of 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.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/cdrh/industry/support/index.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
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Indications for Use
510(k) Number (if known): K061009
Onset Medical Pathway™ Balloon Expandable Ureteral Access Device Name: Sheath
Indications for Use:
The Onset Medical Pathway™ Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
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)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _
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§ 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).