BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
Device Facts
| Record ID | K101832 |
|---|---|
| Device Name | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT |
| Applicant | Medical Device Technologies, Inc. |
| Product Code | KNW · Gastroenterology, Urology |
| Decision Date | Aug 27, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
Intended Use
The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.
Device Story
Automatic, disposable biopsy instrument for percutaneous full-core soft tissue sampling. Features two firing trigger buttons, indicator window, and safety button. Mechanism cuts full core specimen; expels specimen upon re-cocking for subsequent sampling. Available in 14G, 16G, 18G, 20G needle sizes and 10cm, 15cm, 20cm lengths. Used by clinicians for histological analysis of soft tissue, tumors, or masses (e.g., kidney, liver, breast, prostate).
Clinical Evidence
Bench testing only.
Technological Characteristics
Automatic, disposable, spring-loaded biopsy instrument. Available in 14-20G needle sizes and 10-20cm lengths. Mechanical cutting mechanism with manual re-cocking and specimen expulsion. No software or electronic components.
Indications for Use
Indicated for patients requiring percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis, including kidney, liver, breast, prostate, and other soft tissue lesions.
Regulatory Classification
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.
Predicate Devices
- BioPince™ Full Core Biopsy Instrument (K904987)
- Tru. Core™ Disposable Automatic Biopsy Instrument (K982960)
- V-Core™ Full Core Breast Biopsy Instrument (K042464)
- Easy Core™ Biopsy System (K050120)
Related Devices
- K153337 — Corvocet Biopsy System · Merit Medical Systems, Inc. · Mar 25, 2016
- K212820 — Disposable Semi Automatic Biopsy Instrument · Suzhou Leapmed Healthcare Corporation · Jul 6, 2022
- K133948 — BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT · Bard Peripheral Vascular, Inc. · Feb 21, 2014
- K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit · Bard Peripheral Vascular, Inc. · Jul 10, 2025
- K171953 — Bard Mission Disposable Core Biopsy Instrument · Bard Peripheral Vascular, Inc. · Sep 14, 2017
Submission Summary (Full Text)
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Angiotech - Confidential Information - Not for Public Distribution
Page 1 of 2
AUG 2 7 2010
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## Section 5 - 510(k) Summary
Date Prepared: Company:
June 30, 2010
Angiotech 3600 S.W. 47th Ave., Gainesville, FL 32608
Contact:
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Trudy D. Estridge, Ph.D. Vice President, Regulatory Affairs Angiotech 1618 Station Street Vancouver, British Columbia Canada V6A 1B6 Voice: 604-221-6916 Fax: 703-673-0061 Email: testridge@aangio.com
BioPince™ Ultra Full Core Biopsy Instrument Device trade name:
Device Common Name:
Device classification:
Instrument, Biopsy Product code KNW 21 CFR 876.1075 Class II
Instrument, Biopsy
K904987 BioPince™ Full Core Biopsy Instrument Legally marketed devices to which the K982960 Tru. Core™ Disposable Automatic Biopsy Instrument device is substantially equivalent:
Description of the device:
K042464 V-Core™ Full Core Breast Biopsy Instrument K050120 Easy Core™ Biopsy System The BioPince™ Ultra Full Core Biopsy Instrument is an automatic, disposable biopsy instrument that cuts a full core specimen of soft tissue. The instrument is designed to expel the specimen upon re-cocking of the instrument which prepares the instrument for taking another sample (i.e., ready to be fired). The instrument has two firing trigger buttons with an indicator
window and safety button. The instrument is available in 14G, 16G, 18G and 20G needle sizes and 10cm, 15cm and 20cm lengths.
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Angiotech - Confidential Information - Not for Public Distribution
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## Indications for Use:
The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.
Substantial Equivalence: The BioPince™ Ultra Full Core Biopsy Instrument has the same intended use as the BioPince™ Full Core Biopsy Instrument and the Easy Core™ Biopsy System, and the same size ranges as the Tru. Core™ Disposable Automatic Biopsy Instrument. The BioPince™ Ultra Full Core Biopsy Instrument has an equivalent cutting mechanism as the V-Core™ Instrument. The BioPince™ Ultra Full Core Biopsy Instrument has the same technological characteristics in terms of design and materials as its predicates.
## Performance tests:
Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Angiotech % Trudy D. Estridge, Ph.D. Vice President, Regulatory Affairs 1618 Station Street Vancouver, British Columbia Canada V6A 1B6
AUG 2 7 2010
Re: K101832
Trade/Device Name: BioPince™ Ultra Full Core Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 30, 2010 Received: July 01, 2010
Dear Dr. Estridge:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Trudy D. Estridge, Ph.D.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Pto Vhm
Dep De
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Angiotech - Confidential Information - Not for Public Distribution
**Section 4 – Indications for Use Statement**
510k number if known:
K.101 832
Device Name: BioPince™ Ultra Full Core Biopsy Instrument
Indications for Use:
The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.
Prescription Use X (Part 21 CFR 801 Subpart D)
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 Evaluation (ODE)
Neil R. Ogden for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101832
