(7 days)
The Manan™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.
The Manan Co-Axial Introducer Needle is a general purpose introducer-type needle assembly intended for a range of biopsy applications of soft tissue. The device is composed of a cannula, available in various lengths in the range of 2 ins. to 8 in. and gauges of between 8 and 22, constructed of 304 stainless steel into which a stainless steel stylet fits. The molded hub holding the cannula is comprised of medical grade plastic. The combination of the stylet and needle terminates in a trocar-type needle point.
This 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document is a standard 510(k) premarket notification for a medical device (Manan™ Co-Axial Introducer Needles). It focuses on establishing substantial equivalence to previously marketed devices based on device description and intended use, rather than presenting performance study data.
Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, experts, adjudication, or ground truth, as none of that data is present in the provided text.
Based on the provided text, here is what can be inferred:
- Device: Manan™ Co-Axial Introducer Needles
- Intended Use: "A range of biopsy applications of soft tissue."
- Regulatory Decision: The FDA determined the device is substantially equivalent to predicate devices, allowing it to be marketed. This decision is based on comparing the new device's characteristics and intended use to those of legally marketed predicate devices, not on specific performance data against acceptance criteria.
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MD
980004
JAN - 9 1998
4445-310 S.W. 35th Terra Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608 |
|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager |
| TELEPHONE: | (352)338-0440fax (352)338-0662 |
| TRADE NAMES: | Manan™ Co-Axial Introducer Needles |
| COMMON NAME: | General introducer needle, biopsy needle |
| CLASSIFICATION NAME: | §878.4800-Manual Surgical Instrument for General Use; DisposableAspiration and Injection Needle |
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Co-Axial Introducer Needles | K940024 |
| Medical Device Technologies, Inc. | Hawkins-Akins Blunt Needle | K881957 |
DESCRIPTION OF DEVICE:
The Manan Co-Axial Introducer Needle is a general purpose introducer-type needle assembly intended for a range of biopsy applications of soft tissue. The device is composed of a cannula, available in various lengths in the range of 2 ins. to 8 in. and gauges of between 8 and 22, constructed of 304 stainless steel into which a stainless steel stylet fits. The molded hub holding the cannula is comprised of medical grade plastic. The combination of the stylet and needle terminates in a trocar-type needle point.
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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 perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445 S.W. 35th Terrace, Suite 310 Gainsville, Florida 32608
Re: K980004
Trade Name: Manan™ Co-Axial Introducer Needles Regulatory Class: II Product Code: KNW Dated: December 31, 1997 Received: January 2, 1998
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
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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
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Image /page/3/Picture/0 description: The image shows a logo with the letters "MD" in a bold, sans-serif font. Below the letters, there are three lines of smaller text. The background of the logo is black, while the letters and text are white. The logo appears to be for a company or organization with the initials "MD".
145-310 S.W. 35th Gainesville, Florida 326 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
K9/0004
510(k) Number (if known):
Device Name: Manan™ Co-Axial Introducer Needles
Indications for Use:
The Manan™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.
(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_
(Optional Format 1-2-96)
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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.