(27 days)
Not Found
No
The 510(k) summary describes a mechanical biopsy system and does not mention any AI or ML components or functionalities.
No
The device is used to obtain tissue samples for biopsy, which is a diagnostic procedure, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is used to obtain core samples from soft tissue, and these samples are then analyzed to diagnose various conditions and diseases. The act of obtaining samples for analysis is a key step in the diagnostic process.
No
The device description clearly states it is a "System" used to "obtain multiple core samples," which implies a physical device (biopsy instrument and needles) is involved, not just software.
Based on the provided information, the Manan™ Pro-Mag Automatic Biopsy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device is used to obtain the tissue samples, not to analyze them.
- The description focuses on the method of obtaining tissue samples (biopsy) from living patients.
- There is no mention of analyzing or testing the collected samples with this device.
The Manan™ Pro-Mag Automatic Biopsy System is a medical device used for a surgical procedure (biopsy) to collect tissue samples. The subsequent analysis of these samples in a laboratory would likely involve IVD devices, but the biopsy system itself is not an IVD.
N/A
Intended Use / Indications for Use
The Manan Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
Product codes
KNW
Device Description
The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions.
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.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "MD" in a bold, sans-serif font. Below the letters, there are several horizontal lines, creating a striped effect. The logo is white against a black background, providing a strong contrast.
445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
FEB 1 8 1998
5980226
510(k) SUMMARY Medical Device Technologies, Inc. APPLICANT: 4445-310 SW 35th Terrace Gainesville, FL 32608 Karl Swartz CONTACT: Quality Assurance Manager (352)338-0440 TELEPHONE: fax (352)338-0662 Manan™ Pro-Mag Automatic Biopsy System TRADE NAMES: Core Biopsy Device COMMON NAME: Biopsy Instrument CLASSIFICATION NAME:
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Manan Prostatic Biopsy Needle | K895897 |
| Manan Medical Products | Pro-Mag Automatic Biopsy Instrument | K914874 |
| Medical Device Tech. | Ultra-Core Biopsy Needles | K921418 |
DESCRIPTION OF DEVICE:
The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
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
K980226 Re:
Trade Name: Manan™ Pro-Mag Automatic Biopsy System Regulatory Class: II Product Code: KNW Dated: December 18, 1997 Received: January 22, 1998
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A-substantially equivalent determination assumes compliance with the wor 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 Page 2 - Mr. Swartz
2
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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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 vours.
A coelha
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 are three horizontal lines, followed by text that is too small to read. The background of the logo is black, and the letters and lines are white. The logo appears to be for a company or organization with the initials "MD".
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™
Indications for Use:
The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
(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 Restorative Devices
510(k) Number. K980226
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)