(70 days)
For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.
Not Found
The provided text K022287 is related to a 510(k) premarket notification for the 3T/Sewoon™ Temperature Sensing Foley Balloon Catheters. This document is an FDA clearance letter, which means the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this type of document (a 510(k) clearance letter) typically does not include detailed study results, acceptance criteria, or performance data in the format of a clinical trial or performance study report. The FDA's substantial equivalence determination for 510(k) devices often relies on comparison to existing devices and verification of manufacturing and safety controls, rather than extensive new clinical efficacy studies.
Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the device's performance will not be found in this document.
The document only states the "Indications For Use" for the various types of Foley catheters offered (Two-Way, Three-Way, Radiopaque, Temperature Sensing).
If such detailed performance data and acceptance criteria exist, they would be in the original 510(k) submission itself, which is a much more extensive document not
publicly available in this format.
To answer your request based on the provided text, I must state that the information requested is not present.
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Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sewoon Medical Co., Inc. c/o Mr. Robert P. Eaton Manager of Regulatory Affairs 3T Medical Systems, LLC 12553 South Wamblee Valley Road
Re: K022287
SEP 23 2002
Trade/Device Name: 3T/Sewoon™ Temperature Sensing Foley Balloon Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: September 4, 2002 Received: September 9, 2002
Dear Mr. Eaton:
CONIFER CO 80433
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 (PMA), it may be subject to 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy Chogden
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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3T Medical Systems, LLC (Regulatory Office) 12553 South Wamblee Valley Road Conifer, Colorado 80433
INDICATIONS FOR USE STATEMENT
Special 510 (k) Device Modification: K O222267
Device Name: 3T/Sewoon™ Temperature Sensing Foley Balloon Catheters (various sizes)
INDICATIONS FOR USE: For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.
Prescription Use
Daniel A. Lyman
ision Sian-O inn of Ronroducti
§ 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.