(53 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is intended for harvesting bone and/or bone marrow specimens, which is a diagnostic or collection procedure, not a therapeutic intervention.
No
The device is intended for harvesting bone and/or bone marrow specimens; it is a biopsy needle used to collect samples, not to perform a diagnosis. Diagnostic devices are those that analyze samples or images to determine the presence or characteristics of a disease.
No
The device description clearly outlines a physical, sterile, disposable biopsy instrument with a cannula, snare, handle, stylet, and cap, available in different sizes and lengths. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The SnareLok Bone Marrow Biopsy Needle is a surgical instrument used to obtain a sample of bone and/or bone marrow from the body. It is a tool for collecting the specimen, not for analyzing it.
- Intended Use: The intended use clearly states "harvesting bone and/or bone marrow specimens." This is a collection process, not a diagnostic test performed on a sample.
While the collected bone marrow sample might later be used for in vitro diagnostic testing, the SnareLok Bone Marrow Biopsy Needle itself is the device used to acquire the sample, not the device that performs the diagnostic test.
N/A
Intended Use / Indications for Use
The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
The biopsy instrument is a sterile disposable device which features a cannula assembly containing an outer cannula with an inner spiral snare tube at the distal tip. The device has a handle with a snare lever that can be rotated 180° to engage the snare when a biopsy sample needs to be taken. Finally the device has a stationary stylet to prevent coring during advancement, and a stylet cap which mates to the handle. Three sizes are available; 8, 11 and 13 gauge needles. The 8 and 11 gauge needles are sold in 4" and 6" lengths and have a tip configuration identical to the geometry of the existing Medical Device Technologies Manan Bone and Bone Marrow Biopsy Needle. The 13 gauge needles are sold in 2" and 3" lengths and have a less tapered tip configuration identical to a bone marrow needle currently manufactured by Ranfac.
The needle is used by advancing it with the stylet in place, to the site of bone or marrow sampling. The needle is advanced with gentle but firm pressure, with alternating clockwise-counterclockwise rotational motion. Once the needle is in position, the stylet and stylet cap are removed and the needle is advanced with additional rotation to obtain the marrow sample. Aspiration can be used to obtain the sample by positioning a syringe to the hub of the needle and applying suction. For biopsy, the needle is advanced to a new location with rotating motion until adequate marrow is obtained. The Snare lever is rotated clockwise to its closed position to capture the marrow sample. A probe is provided which has markings that can be used to estimate the length of the sample before the needle is removed from the patient. Once the needle is removed, the SnareLok lever is turned to the open position. The sample can then be expelled from the proximal end of the needle using the probe.
A Probe Guide is also included with the SnareLok Bone Marrow Needle to provide an easy method to align the probe in the needle tip for sample expulsion, and to protect users from the sharp tip during handling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone or marrow
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
Medical Device Technologies, Inc. Traditional 510(k) SnareLok Bone Marrow Biopsy Needle
December, 2004
『EB』】2005
TAB 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
| December | , 2004 |
|---|---|
| ---------- | -------- |
| Trade Name: | InterV® brand SnareLok Bone Marrow Biopsy Needle | |
|---|---|---|
| Common Name: | Biopsy needle | |
| Classification Name: | Instrument, biopsy (per 21 CFR section 876.1075) | |
| Manufacturer's Name: | Medical Device Technologies, Inc. | |
| 3600 SW 47th Avenue | ||
| Gainesville, FL 32608 | ||
| 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): | Medsol Corporation Goldenberg Bone Marrow Biopsy | |
| Needle, K983187. | ||
| Medical Device Technologies, Inc. Manan Bone and Bone | ||
| Marrow Biopsy Needle, K980196 | ||
| Device Description: | The biopsy instrument is a sterile disposable device which | |
| features a cannula assembly containing an outer cannula with | ||
| an inner spiral snare tube at the distal tip. The device has a | ||
| handle with a snare lever that can be rotated 180° to engage | ||
| the snare when a biopsy sample needs to be taken. Finally | ||
| the device has a stationary stylet to prevent coring during | ||
| advancement, and a stylet cap which mates to the handle. | ||
| Three sizes are available; 8, 11 and 13 gauge needles. The 8 | ||
| and 11 gauge needles are sold in 4" and 6" lengths and have | ||
| a tip configuration identical to the geometry of the existing | ||
| Medical Device Technologies Manan Bone and Bone | ||
| Marrow Biopsy Needle. The 13 gauge needles are sold in 2" | ||
| and 3" lengths and have a less tapered tip configuration | ||
| identical to a bone marrow needle currently manufactured by | ||
| Ranfac. |
CONFIDENTIAL This document and the information contained herein nay not be reproduced, used or disclosed without written permission from Medical Device Technologies, Ins.
1
December, 2004
The needle is used by advancing it with the stylet in place, to the site of bone or marrow sampling. The needle is advanced with gentle but firm pressure, with alternating clockwisecounterclockwise rotational motion. Once the needle is in position, the stylet and stylet cap are removed and the needle is advanced with additional rotation to obtain the marrow sample. Aspiration can be used to obtain the sample by positioning a syringe to the hub of the needle and applying suction. For biopsy, the needle is advanced to a new location with rotating motion until adequate marrow is obtained. The Snare lever is rotated clockwise to its closed position to capture the marrow sample. A probe is provided which has markings that can be used to estimate the length of the sample before the needle is removed from the patient. Once the needle is removed, the SnareLok lever is turned to the open position. The sample can then be expelled from the proximal end of the needle using the probe.
A Probe Guide is also included with the SnareLok Bone Marrow Needle to provide an easy method to align the probe in the needle tip for sample expulsion, and to protect users from the sharp tip during handling.
Intended Use: For harvesting bone and/or bone marrow specimens.
Technological Characteristics:
The biopsy needles are available in 8-13 gauge sizes and lengths from 2 to 6 inches.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2005
Ms. Nichol Wilding Manager Regulatory Affairs Medical Device Technologies, Inc. 241 W. Palatine Road Wheeling, Illinois 60090
Re: K043523
K043323
Trade/Device Name: InterV® Brand SnareLok Bone Marrow Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW and FCG Dated: December 7, 2004 Received: December 20, 2004
Dear Ms. Wilding:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars the Medical Device Amendments, or 10 conimeres prod to May 20, 1978, are excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Fee) that do not requent of the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations af may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found interests 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 that I DA has made a decermination administered by other Federal agencies. You must or any I caelul suttated and registements, including, but not limited to: registration and listing (21 Compry with an the Act 31equirements, as a manufacturing practice requirements as set CFR Part 6077, adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Nichol 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,
R. Mark A. Millmann
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K043523
Device Name: InterV® brand SnareLok Bone Marrow Biopsy Needle
Indications for Use:
The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.
Prescription Use X (Part 21 CFR 801 Subpart D)
1
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evalyation (ODE)
L. Mark A. Milburn
Division of General, Restorative, and Neurological Devices
510(k) Number_
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