(17 days)
The Manan™ Introducer Sheath/Needle is for the introduction of a .038 in. guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
The Manan Introducer Sheath/Needle is a 18 or 19 gauge trocar needle(Surgical grade 304 Stainless Steel) inside a 5 French radiopaque Teflon sheath. The sheath is tapered down to the trocar needle. The sheath accepts up to and including a .038 in. diameter guidewire. The usable length of this assembly is up to 20 cm.
This document is about a 510(k) submission for a medical device called the "Manan™ Introducer Sheath/Needle" and does not contain information about acceptance criteria, device performance from a study, or any details related to AI or algorithm performance.
The document is a notification of intent to market the device, a description of the device, and the FDA's letter of substantial equivalence. It compares the device to a predicate device based on its intended use and characteristics, not on a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested information, as it is not present in the provided text.
{0}------------------------------------------------
Image /page/0/Picture/9 description: The image shows a logo with the letters "MD" in a bold, sans-serif font. Below the letters, there are three horizontal lines that appear to be stacked on top of each other. The background of the logo is black, while the letters and lines are white, creating a strong contrast. The overall design is simple and modern.
974815
352/338-0440 FAX: 352/338-0662
JAN - 9 1998
510(k) SUMMARY Medical Device Technologies, Inc. APPLICANT: 4445-310 SW 35th Terrace Gainesville, FL 32608 Karl Swartz CONTACT: Quality Assurance Manager TELEPHONE: (352)338-0440 fax (352)338-0662 TRADE NAMES: Manan™ Introducer COMMON NAME: Guidewire introduction Needle(Sheath) CLASSIFICATION NAME: $878.4200-Introduction/Drainage Catheter and Accessories SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Introducer Sheath/Needle | K961216 |
DESCRIPTION OF DEVICE:
The Manan Introducer Sheath/Needle is a 18 or 19 gauge trocar needle(Surgical grade 304 Stainless Steel) inside a 5 French radiopaque Teflon sheath. The sheath is tapered down to the trocar needle. The sheath accepts up to and including a .038 in. diameter guidewire. The usable length of this assembly is up to 20 cm.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its head turned to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445 S.W. 35th Terrace, Suite 310 Gainsville, Florida 32608
JAN - 9 1998
Re: K974815 Trade Name: Manan™ Introducer Regulatory Class: II Product Code: FGE Dated: December 18, 1997 Received: December 23, 1997
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the ... current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
{2}------------------------------------------------
Page 2 - Mr. Swartz
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
- Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a logo with the letters "MD" in a bold, sans-serif font. The letters are white and stand out against a black background. Below the letters, there are three horizontal lines that appear to be a stylized representation of a bar or a design element. The overall design is simple and modern, with a focus on the contrast between the white letters and the black background.
Gainesville, Florida 320 TEL: 352/338-0440 FAX: 352/338-0662
Page 1 of 1
510(k) Number (if known): K974115
Device Name: Manan™ Introducer Sheath/Needle
Indications for Use:
The Manan™ Introducer Sheath/Needle is for the introduction of a .038 in. guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DaDila
14915
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.