(16 days)
Not Found
No
The description focuses on a mechanical biopsy needle and its intended use under imaging guidance, with no mention of AI/ML capabilities or image processing beyond the guidance itself.
No
The device is used for diagnostic tissue biopsy, not for treating a condition, disease, or injury.
No
The device is a biopsy needle, used to collect tissue samples. While these samples are then used for diagnostic purposes, the needle itself is an interventional tool for obtaining a specimen, not for performing the diagnosis itself.
No
The device description explicitly states it is a "Soft Tissue Biopsy Needle," which is a physical, hardware medical device used for tissue collection.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This examination is performed outside of the body (in vitro).
- Device Function: The Mananths Soft Tissue Biopsy Needles are used to collect a tissue specimen from the body (in vivo). The device itself is the tool for obtaining the sample, not for analyzing it.
- Intended Use: The intended use clearly states the device is used for "percutaneous soft tissue... biopsies effected via the insertion of the device... manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle." This describes a procedure to obtain a sample, not to perform a diagnostic test on a sample.
While the collected tissue specimen will likely be used for in vitro diagnostic testing later (e.g., pathology examination), the biopsy needle itself is a surgical/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy) and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
Product codes
KNW
Device Description
These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, Ultrasound, Sequential Mammography, or Fluoroscopy
Anatomical Site
Soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
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)
K944837, K851831, K851835, K851837, K851838, K852426, K852427, K873208
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
Image /page/0/Picture/0 description: The image shows a logo for MD Tech Power Drive Technologies Inc. The logo is in black and white, with the text "MD TECH" in large, bold letters at the top. Below the text is the phrase "POWER DRIVE TECHNOLOGIES INC." in smaller letters. The logo has a rectangular shape with rounded corners.
JAN 30 1998
ainesville, Florida 3 TEL: 352/338-0440 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™ Soft Tissue Biopsy Needles |
| COMMON NAME: | Manual biopsy needles for soft tissue biopsies |
| SIFICATION NAME: | Needle, Biopsy, Cardiovascular, No. 79DWO |
SUBSTANTIAL EQUIVALENCE:
CLASS
| Company Name | Product Name | 510(k) No |
|---|---|---|
| Medical Device Technologies, Inc. | Manual Biopsy Needles | K944837 |
| Manan Medical Products | Franseen Needle | K851831 |
| Manan Medical Products | Greene Needle | K851835 |
| Manan Medical Products | Westcott Needle | K851837 |
| Manan Medical Products | Chiba Needle | K851838 |
| Manan Medical Products | Trocar Needle | K852426 |
| Manan Medical Products | Spinal Needle | K852427 |
| Manan Medical Products | Turner Needle | K873208 |
DESCRIPTION OF DEVICE:
These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
1
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Mr. Karl Swartz Ouality Assurance Manager Medical Device Technologies, Incorporated 4445-310 S.W. 35th Terrace Gainesville, Florida 32608
Re: K980122
Trade Name: Manan™ Soft Tissue Biopsy Needles Regulatory Class: II Product Code: KNW Dated: December 31, 1997 Received: January 14, 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 Ouality 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 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Swartz
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,
to sollyz
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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445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page 1 of 1
510(k) Number (if known): __ K980122
Device Name: Manan™ Soft Tissue Biopsy Needles
Indications for Use:
The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
(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 | K980122 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
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