(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
Explanation: This device is explicitly described as a "biopsy needle" intended for "obtaining biopsy material from tissues." Biopsy procedures are diagnostic, not therapeutic, as they involve collecting samples for analysis rather than treating a condition.
No
The device is a biopsy needle, used to obtain tissue samples for later analysis, not to diagnose conditions itself.
No
The device description explicitly states it is a "biopsy needle" and includes a "syringe," indicating it is a physical medical device, not software only.
Based on the provided information, the Manan Techna-Cut biopsy needle 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 or other conditions. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Manan Techna-Cut biopsy needle is a device used to obtain tissue samples from within the body. It is a tool for collecting the material, not for analyzing it.
- Intended Use: The intended use clearly states it's for "obtaining biopsy material from tissues". This is a sample collection function, not a diagnostic test performed on the sample.
Therefore, the Manan Techna-Cut biopsy needle is a medical device used for sample collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
Product codes
KNW
Device Description
The Manan Techna-Cut biopsy needle is a cutting biopsy needle based upon the Menghini cutting tip geometry. A syringe is included with the syringe used is a locking syringe. The Manan Techna-Cut biopey needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
MD
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
JAN - 8 1998
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™ Techna-Cut Biopsy Needle | |
| COMMON NAME: | Biopsy needle | |
| CLASSIFICATION NAME: | §878.4800-Manual surgical instrument for general
use; disposable aspiration and injection needle. | |
| SUBSTANTIAL EQUIVALENCE: | | |
| Company Name | Product Name | 510(k) No. |
| Manan Medical Products | Techna-Cut Biopsy Needle | K943651 |
DESCRIPTION OF DEVICE:
The Manan Techna-Cut biopsy needle is a cutting biopsy needle based upon the Menghini cutting tip geometry. A syringe is included with the syringe used is a locking syringe. The Manan Techna-Cut biopey needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
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 depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainsville, Florida 32608
Re: K974766 Trade Name: Manan™ Techna-Cut Biopsy Needle Regulatory Class: II Product Code: KNW Dated: December 18, 1997 Received: December 22, 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 Onality 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 vour 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
MD
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Manan™M
Indications for Use:
The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as 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 | Device Evaluation (ODE) |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | IL974766 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1 -- -