(90 days)
Not Found
No
The device description focuses on the mechanical design of the biopsy needle and its manual operation, with no mention of AI or ML.
No
The device is described as a biopsy needle used for tissue sampling, not for treating a condition or disease.
No
Explanation: This device, a biopsy needle, is used to collect tissue samples. While these samples are later analyzed for diagnostic purposes, the needle itself is an instrument for sample collection, not for performing the diagnostic analysis or interpretation.
No
The device description clearly describes a physical biopsy needle made of stainless steel, which is a hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens outside of the body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and genetic tests.
- The Maxi-Cell Biopsy Needles are used to collect tissue samples from within the body. The device itself is a tool for obtaining a specimen, not for analyzing it.
The description clearly states the needles are used for "fine needle biopsies of various soft organs and tissues" and that the physician uses them to "collect tissue sample". This is a procedure for obtaining a sample, which would then likely be sent to a laboratory for in vitro analysis (which would be performed using IVD devices).
Therefore, the Maxi-Cell Biopsy Needles are a surgical or procedural device used for tissue collection, not an IVD device.
N/A
Intended Use / Indications for Use
For use in fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate tissue.
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The biopsy needle is a single lumen needle, identical in design to the predicate, from Sherwood Medical. The shaft of the needle has been modified to provide additional sampling sites approximately 0.40inches proximal to the needle tip. Once the needle is positioned at the site of interest, the stylet is removed and the needle is manually advanced to obtain a freehand needle biopsy of tissue, or aspirate, while suction is applied with a syringe. Then as the needle is withdrawn, the side-sampling site will also remove tissue, allowing the physician to collect at least twice the amount of tissue sample typically removed by a biopsy needle. The needle is made of ASTM type 304 stainless steel, as is the stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate
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
3 200 SEP
Biopsy Sciences, LLC Traditional 510(k) Maxi-Cell Biopsy Needle
TAB 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
- May, 2002
| Trade Name: | Maxi-Cell biopsy needle |
|---|---|
| Common Name: | Biopsy needle |
| Classification Name: | Instrument, biopsy (per 21 CFR section 876.1075) |
| Manufacturer's Name: | Biopsy Sciences, LLC |
| 1011 North Craycroft Road, Suite 302 | |
| Tucson, AZ 85711 | |
| Corresponding Official: | Sharon Rockwell |
| Vice-President RA/QA | |
| 5582 Chalon Road | |
| Yorba Linda, CA 92886 | |
| Phone: (714) 695-9269 | |
| Fax: (714) 779-0406 | |
| Predicate Device(s): | Kendall/Sherwood Medical Plastic Hub Spinal Needle, |
| K822630 and, Manan Westcott Biopsy Needles, K851838. | |
| Device Description: | The biopsy needle is a single lumen needle, identical in |
| design to the predicate, from Sherwood Medical. The shaft | |
| of the needle has been modified to provide additional | |
| sampling sites approximately 0.40inches proximal to the | |
| needle tip. Once the needle is positioned at the site of | |
| interest, the stylet is removed and the needle is manually | |
| advanced to obtain a freehand needle biopsy of tissue, or | |
| aspirate, while suction is applied with a syringe. Then as the | |
| needle is withdrawn, the side-sampling site will also remove | |
| tissue, allowing the physician to collect at least twice the | |
| amount of tissue sample typically removed by a biopsy | |
| needle. The needle is made of ASTM type 304 stainless | |
| steel, as is the stylet. |
1
Biopsy Sciences, LLC Traditional 510(k) Maxi-Cell Biopsy Needle
P
Pg 2 of 2
Intended Use:
For use in fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate tissue.
Technological Characteristics:
The biopsy needles are available in 20-22 gauge sizes and lengths from 3 ½ to 9 inches. A stylet is provided with the needle to avoid coring tissue during advancement to the lesion site.
Confidential: This document and the information contained herein may not be reproduced, used or disclosed without written permission from Biopsy Sciences, LLC.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling three abstract human profiles or a triple helix design. The symbol is rendered in black, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 SEP
Ms. Sharon Rockwell Vice President RA/QA Biopsy Sciences, LLC. 5582 Chalon Road YORBA LINDA CA 92886
Re: K021847
Trade/Device Name: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles Regulation Number: 21CFR § 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: May 31, 2002 Received: June 5, 2002
Dear Ms. Rockwell:
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 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.
3
Page 2
This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TAB 3
INDICATIONS FOR USE
510(k) Number: x 021847
Device Name: Maxi-Cell Biopsy Needle
Indications for Use:
The Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are intended to be used for fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Regan
Image /page/4/Picture/12 description: The image shows the words "Prescription Use" and "(per 21 CFR 801.109)". There is a box to the left of the words "Prescription Use" that has been marked with an X. The text is in black and the background is white.
Or
] Over-The-Counter Use
Confidential: This document and the information contained herein may not be reproduced, used or disclosed without written permission from Biopsy Sciences, LLC.