(17 days)
Not Found
No
The 510(k) summary describes a mechanical biopsy needle and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for obtaining tissue biopsies, which is a diagnostic procedure, not a therapeutic one. It collects samples for analysis rather than treating a condition.
Yes
Explanation: The device is used to obtain soft tissue biopsies, which are then analyzed to diagnose diseases. Obtaining a biopsy is a step in the diagnostic process.
No
The device description clearly states it is a "spring loaded biopsy needle fitted into a plastic handle," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Manan™ Super-Core Biopsy Needle is a tool used to obtain the tissue sample from the body. It is a surgical instrument used within the body (in vivo) to collect material for subsequent analysis.
- Lack of Diagnostic Function: The description focuses on the mechanism of obtaining the sample (spring-loaded needle, single-handed operation, visualization). It does not describe any process of analyzing the collected tissue or providing a diagnostic result based on that analysis.
The tissue sample obtained by this needle would likely be sent to a laboratory for in vitro diagnostic testing, but the needle itself is not the diagnostic device.
N/A
Intended Use / Indications for Use
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
Product codes
KNW
Device Description
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. It is composed of a echogenic spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement position of the needle may be visualized by either x-ray or ultrasonography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray or ultrasonography
Anatomical Site
liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "AMD" 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 the company AMD.
Gainesville, Florida 320 TEL: 352/338-0440 FAX: 352/338-0662
97 4814
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: | Manan™ Super-Core Biopsy Needle |
| COMMON NAME: | Spring loaded biopsy needle |
| CLASSIFICATION NAME: | §878.4800 - Needle, biopsy (Manual surgical instrument for
general use) |
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Super-Core Biopsy Needle | K950732 |
DESCRIPTION OF DEVICE:
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. It is composed of a echogenic spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement position of the needle may be visualized by either x-ray or ultrasonography.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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 - 8 1998
Re: K974814
Trade Name: Manan™ Super-Core Biopsy Needle Regulatory Class: II Product Code: KNW 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 compirance 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,
Celta 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 "AMD" in bold, white font against a black background. Below the letters, there are several lines of smaller text, also in white. The text appears to be a company name or slogan associated with the AMD brand. The overall design is simple and modern, with a focus on the company's initials.
145-310 S.W. 35th Gainesville, Florida 3260 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ Super-Core Biopsy Needle.
Indications for Use:
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Rach
510(k) Number K974814
Prescription Use
(Per 21 CFR 801(109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96.)