(29 days)
Not Found
No
The description details a mechanical biopsy needle with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for harvesting biopsy specimens, which is a diagnostic procedure, not a therapeutic one.
No
The device is described as a biopsy needle used for "harvesting soft tissue biopsy specimens." This indicates it is used for specimen collection, not for diagnosing a condition itself. The collected specimens would then be examined for diagnostic purposes.
No
The device description clearly describes a physical, sterile, disposable biopsy needle made of stainless steel and plastic, which is a hardware device. There is no mention of any software component.
Based on the provided information, the Bio-Cut Soft Tissue Biopsy Needle is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "harvesting soft tissue biopsy specimens." This describes a procedure to obtain a sample from the body.
- Device Description: The description details a physical instrument used for tissue collection.
- Lack of IVD Characteristics: An IVD device is typically used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. This device's function is to collect the specimen, not to analyze it.
The Bio-Cut Soft Tissue Biopsy Needle is a surgical/procedural device used to obtain a sample for subsequent in vitro diagnostic testing or pathological examination. The analysis of the collected tissue would be performed using IVD devices or other laboratory methods, but the biopsy needle itself is not an IVD.
N/A
Intended Use / Indications for Use
The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The biopsy instrument is a sterile disposable device which features a stainless steel cannula with an echogenic tip, and a stainless steel stylet which is spring loaded and fitted into a plastic handle permitting single handed specimen collection. Sizes are available in 14 - 20 gauge needles. The length of the needles ranges between 9 and 20 cm. The needle is used by advancing the entire device to the site of soft tissue sampling. The needle is advanced with gentle but firm pressure. Once the needle is in position, the sample is taken and the device is removed from the sampling site. The sample can then be expelled from the stylet notch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): 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
Manan Medical Products, Inc. Special 510(k) Manan Bio-Cut Soft Tissue Biopsy Needle
NOV - 1 2005 TAB 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
Trade Name: | Manan Bio-Cut Soft Tissue Biopsy Needle |
---|---|
Common Name: | Biopsy needle |
Classification Name: | Instrument, biopsy (per 21 CFR section 876.1075) |
Manufacturer's Name: | Manan Medical Products, Inc. |
241 W. Palatine Road | |
Wheeling, IL 60090 | |
Corresponding Official: | Nicohl Wilding |
Manager Regulatory Affairs | |
241 W. Palatine Road | |
Wheeling, IL 60090 | |
Phone: (800) 424-6779 ext, 331 | |
Fax: (847) 637-3334 | |
Predicate Device(s): | Manan Super-Core Biopsy Needle K950732. |
Medical Device Technologies Super-Core Biopsy Needle | |
K974814 | |
Device Description: | The biopsy instrument is a sterile disposable device which |
features a stainless steel cannula with an echogenic tip, and a | |
stainless steel stylet which is spring loaded and fitted into a | |
plastic handle permitting single handed specimen collection. |
Sizes are available in 14 - 20 gauge needles. The length of
the needles ranges between 9 and 20 cm.
The needle is used by advancing the entire device to the site
of soft tissue sampling. The needle is advanced with gentle
but firm pressure. Once the needle is in position, the sample
is taken and the device is removed from the sampling site.
The sample can then be expelled from the stylet notch. |
| Intended Use: | For harvesting soft tissue biopsy specimens. |
| Technological
Characteristics: | The biopsy needles are available in 14 - 20 gauge sizes and
lengths from 9 to 20 centimeters. |
4-1
CONFIDENTIAL
This document and the information contained herein may not be reproduced, used or disclosed without written permission from Manan Medical Products, Inc.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of the human form. The human form is depicted with three abstract figures, symbolizing the department's focus on health and well-being. The seal is in black and white.
Public Health Service
NOV - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nicohl Wilding Manager Regulatory Affairs Manan Medical Products, Inc. 241 West Palatine Road Wheeling, Illinois 60090
Re: K052802
Trade/Device Name: Manan Bio-Cut Soft Tissue Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 26, 2005 Received: October 27, 2005
Dear Ms. Wilding:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Nicohl Wilding
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Bruckner
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number:
Device Name: Manan Bio-Cut Soft Tissue Biopsy Needle
Indications for Use:
The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.
× Prescription Use (per 21 CFR 801.109) and/or
] Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchup
(Division Sign-Off)
Division of General, Restora and Neurological Devices
510(k) Number K052802