(175 days)
To pass fluid to and from the urinary bladder after prostatectomy.
Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for a device based on the provided text. The document is a 510(k) clearance letter from the FDA, which confirms that a medical device (Fortune All-Silicone 2-Way and 3-Way Hematuria Catheter Models) is substantially equivalent to a legally marketed predicate device.
This type of letter does not include information about specific acceptance criteria or an analytical study with performance metrics, sample sizes, expert qualifications, or ground truth methods. It simply states that the FDA has reviewed the premarket notification and determined substantial equivalence, allowing the device to be marketed.
Therefore, the requested information (such as a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, or training set details) is not present in the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three lines representing the body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GCT 01 2002
Re: K021142
Ms. Jessica Chan QA Section Fortune Medical Instrument Corp. 12-9, Lin 5, Mao-Chang Village San-Chih Hsiang Taipei Hsien, Taiwan REPUBLIC OF CHINA
Trade/Device Name: Fortune All-Silicone 2-Way and 3-Way Hematuria Catheter Models 4861, 62, 63, 64 and 65 Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL and KOD Dated: June 27, 2002 Received: July 5, 2002
Dear Ms. Chan:
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 (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.
{1}------------------------------------------------
Page 2
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 vours,
Nancy Chrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) NUMBER (if Known):
K021142/S1
DEVICE NAME:
Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.
INDICATIONS FOR USE:
To pass fluid to and from the urinary bladder after prostatectomy.
(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 CFR 801.109)
OR
Over-The-Counter-Use
David A. Lyman
ivision Sinn-Off Division of Renmons and Radiological D 510(k) Numb
(Optional Format 1/2/96)
§ 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.