(13 days)
No
The summary describes a mechanical biopsy kit and explicitly states "Not Found" for mentions of AI, DNN, or ML, and image processing.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used for obtaining biopsies, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is used to obtain biopsies, which are then analyzed to diagnose diseases or conditions. Obtaining a biopsy is a step in the diagnostic process.
No
The device description explicitly states it is composed of a cutting biopsy needle and a locking syringe, which are physical hardware components.
Based on the provided information, the Manan™ Liver Biopsy Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for obtaining liver biopsies or for other biopsies of soft tissue." This describes a device used to collect a sample from the body, not a device used to perform tests on a sample outside the body (which is the definition of an IVD).
- Device Description: The description details a needle and syringe for sample collection, not reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any aspects related to testing, analysis, or diagnosis performed on the collected sample. There's no mention of assays, reagents, or any process that would be carried out in vitro.
Therefore, the Manan™ Liver Biopsy Kit is a device used for sample collection, which is a step that might precede an in vitro diagnostic test, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
The Manan™ Liver Biopsy Kit is used for obtaining liver biopsies or for other biopsies of soft tissue.
Product codes
KNW
Device Description
The Manan Liver Biopsy Kit is composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver, soft tissue
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
AMD
FEB 1 8 1998
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 Gaillosvillo, 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: | Manan™ Liver Biopsy Kit | |
| COMMON NAME: | Menghini type biopsy needle with a locking syringe | |
| 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 | Liver Biopsy Kit | K943650 |
DESCRIPTION OF DEVICE:
The Manan Liver Biopsy Kit is composed of a cutting biopsy needle based upon the Menghini cutting tip geometry that is fitted to a locking syringe.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainesville, Florida 32608
Re: K980452 Trade Name: Manan™ Liver Biopsy Kit Regulatory Class: II Product Code: KNW Dated: February 4, 1998 Received: February 5, 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
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,
Authority, years,
lia M. Witten, Ph.D., M.D. Cel 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 T Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ Liver Biopsy Kit
Indications for Use:
The Manan™ Liver Biopsy Kit is used for obtaining liver biopsies or for other biopsies 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_
cotter
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K980452