(87 days)
The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study results related to the Manan™ VS Access Needle/Set. The document is a 510(k) summary for a medical device cleared in 1998, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against specific acceptance criteria.
The 510(k) summary states the following about the device:
- Device Name: Manan™ VS Access Needle/Set
- Intended Use: For the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
- Substantial Equivalence: To the Manan Medical Products V.S. Access Needle/Set (K963767).
To address your request, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical file that outlines the device's performance characteristics and how they were evaluated against specific acceptance criteria.
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APR 27 1998
Pint
45-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
510(k) SUMMARY
APPLICANT:
Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, FL 32608
CONTACT:
Karl Swartz Quality Assurance Manager
TELEPHONE:
(352)338-0440 fax (352)338-0662
TRADE NAMES:
Guidewire introduction needle
Manan™ VS Access Needle/Set
§878-4200 - Introduction/Drainage Catheter and Accessories
CLASSIFICATION NAME:
SUBSTANTIAL EQUIVALENCE:
COMMON NAME:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | V.S. Access Needle/Set | K963767 |
DESCRIPTION OF DEVICE:
The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
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- L
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Inc. 4445 S.W. 35th Terrace Gainesville, FL 32608
Re: K980372 Manan V.S. Access Needle/Set Dated: April 16, 1998 Received: April 17, 1998 Regulatory Class: II 21 CFR $876.5010/Procode: 78 FGE
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 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 (OS) 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 542 of the Act for 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) 594-4613. 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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known):
Device Name: Manan™ VS Access Needle/Set
Indications for Use:
The Manan™ VS Access Needle/Set is intended for the introduction of a .038" 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)
Robert D. Satting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K980372
OR
Prescription Use_ (Per 21 CFR 801.109)
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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.