(90 days)
The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.
Not Found
This document is a 510(k) premarket notification letter from the FDA to Fortune Medical Instrument Corp. for a Suprapubic Catheter. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Critical information for describing acceptance criteria and a study demonstrating device performance is absent from this document. Section {0} is the FDA's acceptance letter, and Section {2} is the Indications for Use statement for the device. Neither of these sections
contain information about:
- Acceptance criteria
- Reported device performance
- Details of any study (sample size, data provenance, ground truth, adjudication, MRMC, standalone performance, training set details).
This document primarily serves as regulatory clearance, not a performance study report. Therefore, I cannot provide the requested information based solely on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2002 MAR
Mr. Abe Wang CEO/President Fortune Medical Instrument Corp. 12-9, Lin 5, Mao-Chang Village San-Chih Hsiang Taipei Hsien TAIWAN
Re: K014002
Trade/Device Name: Suprapubic Catheter Regulation Number: 21 CFR §876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: II
Product Code: 78 KOB Dated: October 20, 2001 Received: December 4, 2001
Dear Mr. Wang:
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 for association 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 r ou may, utere, mains of the Act include requirements for annual registration, listing of general condemanufacturing 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 r road be act not a letermination 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.
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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 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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Image /page/2/Picture/0 description: The image shows the logo and contact information for Fortune Medical Instrument Corp. The logo includes the word "FORTUNE" and a graphic of a stylized electrical outlet. The contact information includes a P.O. Box address in Taipei, Taiwan, phone and fax numbers (886-2-28360488 and 886-2-28360434), a website (http://www.fortunemed.com), and two email addresses (fortunel@fortunemed.com and fortunel@ms11.hinet.net).
KO14002 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Suprapubic Catheter
Indication for Use:
.:
The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.
Daniel A. Szycher
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K014002
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CDR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | --------------- |
Image /page/2/Picture/8 description: The image shows two logos. The first logo is the CE marking, which indicates that a product meets certain safety, health, and environmental protection requirements. Next to the CE marking is the number 0123. The second logo is the TUV SUD certification mark, which indicates that a product has been tested and certified by TUV SUD, a German testing and certification organization. The logo also includes the text "ISO 9001" and "EN 45001".
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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.