(16 days)
Not Found
No
The summary describes physical biopsy and localization needles and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used to obtain biopsies, which is a diagnostic procedure, not a therapeutic one.
Yes
The device obtains biopsies of various tissues, including breast lesion tissue, which are then used for diagnostic purposes.
No
The device description clearly describes physical needles used for biopsy and localization procedures, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- The description clearly states that these needles are used to obtain biopsies of various tissues and breast lesion tissue from the body. They are tools for collecting samples, not for analyzing those samples in a laboratory setting.
The device is a biopsy needle, which is a surgical instrument used for tissue collection. The analysis of the collected tissue would likely be performed using IVD devices in a laboratory, but the needle itself is not an IVD.
N/A
Intended Use / Indications for Use
These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
The breast localization needles can be used in MRJ, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, Fluoroscopic, CT, Mammographic
Anatomical Site
various tissues, breast lesion
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a close-up of a word or abbreviation in bold, white letters against a black background. The letters appear to be "AAD" or a similar combination, with some horizontal lines underneath. The contrast between the white text and the black background makes the letters stand out.
4445-310 S.W. 35th Te Gainesville, Florida 320 TEL: 352/338-0440 FAX: 352/338-0662
9p0211
FEB
| 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™ | MRI Chiba Needle |
| MRI Spinal Needle | ||
| MRI Automatic Cutting Needle | ||
| MRI General Purpose Introducer Needle | ||
| MRI Techna-Cut Biopsy Needle | ||
| MRI Super-Core Biopsy Needle | ||
| MRI Breast Localization Needle | ||
| MRI Simon Breast Localization Needle | ||
| COMMON NAME: | Hand-held biopsy needles. | |
| CLASSIFICATION NAME: | §878.4800 - Manual Surgical Instruments | |
| SUBSTANTIAL EQUIVALENCE: | ||
| Company Name | Product Name | 510(k) No. |
| Manan Medical Products | MRI Chiba Needle | |
| MRI Spinal Needle | ||
| MRI Automatic Cutting Needle | ||
| MRI General Purpose Introducer Needle | ||
| MRI Techna-Cut Biopsy Needle | ||
| MRI Super-Core Biopsy Needle | ||
| MRI Breast Localization Needle | K962977 |
DESCRIPTION OF DEVICE:
The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
MRI Simon Breast Localization Needle
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 stylized eagle or bird symbol, with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainesville, Florida 32608
Re: K980211
Trade Name: Manan™ MRI Chiba, Spinal, Automatic Cutting, General Purpose Introducer, Techna-Cut Biopsy, Super-Core Biopsy, Breast Localization and Simon Breast Localization Needles Regulatory Class: II Product Code: KNW Dated: January 20, 1998 Received: January 21, 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 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. 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
2
Page 2 - Mr. Swartz
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 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 "AMD" in a bold, sans-serif font. Below the letters, there are three horizontal lines, each consisting of several small rectangles. The logo is white against a black background, creating a high-contrast image.
TEL: 352/338-0440 FAX: 352/3
Page_1_of_1
510(k) Number (if known): K980211
- Device Name: Manan™M MRI Chiba Needle MRI Spinal Needle MRI Automatic Cutting Needle MRI General Purpose Introducer Needle MRI Techna-Cut Biopsy Needle MRI Super-Core Biopsy Needle
Indications for Use:
These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion of Gen 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
4
Image /page/4/Picture/0 description: The image shows a logo with the letters "AAD" in bold, white font against a black background. The letters are large and fill the left side of the logo. Below the letters, there are three horizontal lines, also in white, that appear to be part of the logo's design. The right side of the logo is a solid black rectangle, providing a contrast to the white letters and lines on the left.
Gainesville, Florida 3260 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1
510(k) Number (if known): K980211
Device Name: Manan™ MRI Breast Localization Needle MRI Simon Breast Localization Needle
Indications for Use:
The breast localization needles can be used in MRJ, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deale
(Division Sign-Off)
Division of General Restorative Devices K980211
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)