← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K050120 # EASY CORE BIOPSY SYSTEM II (K050120) _Boston Scientific Corp · FCG · Feb 8, 2005 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K050120 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md) - **Decision Date:** Feb 8, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The proposed device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. ## Device Story Easy Core Biopsy System II is a manual biopsy instrument for soft tissue sampling. Device features a handle with a thumb-tab activated drive mechanism, side/rear fire buttons, and a cannula with a needle tip. Operation involves simultaneous firing of a stylet followed by a cannula to capture tissue samples. Cannula may include 1 cm marker bands for depth guidance. Yellow indicator confirms device is fully loaded. Used by clinicians in endoscopic or percutaneous procedures to obtain tissue for histological analysis. Benefits include minimally invasive tissue retrieval for diagnosis of tumors or masses in organs such as breast, liver, kidney, and prostate. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on design and technological similarities to the predicate device. ## Technological Characteristics Manual biopsy instrument; handle with thumb-tab drive mechanism; cannula with needle tip and 1 cm marker bands. Materials and operating principles are identical to the predicate device. No electronic components or software. ## Regulatory 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 - Easy Core Biopsy System ([K040893](/device/K040893.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Special 510(k) Premarket Notification EasyCore Biopsy System II January 14, 2004 ## 510 (k) SUMMARY K050120 | SPONSOR: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Michelle M. Berry
Regulatory Affairs Specialist | | | Or | | | Lorraine M. Hanley
Director Regulatory Affairs | | DEVICE:
Trade Name:
Common Name:
Classification: | To Be Determined
Biopsy Instrument
Class II, per 21 CFR Part 876.1075 | | PREDICATE DEVICE: | Easy Core Biopsy System (K040893) | | DESCRIPTION: | The proposed device is designed to simultaneously fire a stylet
followed by a cannula to capture a biopsy sample of soft organs,
tumor or masses for histological analysis. The design includes a
handle with a thumb tab activated drive mechanism, a side fire
button, a rear fire button, and a cannula with a needle tip. The
cannula may have marker bands spaced at 1 cm (10 mm)
intervals starting from the stylet tip and extending various
lengths depending upon the needle. When the device is fully
loaded, the yellow indicator is visible when looking at the top of
the handle. | | INTENDED USE: | The proposed device is indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors
or masses for histological analysis. Soft tissue sampling includes
but not limited to organs such as breast, liver, kidney and
prostate. | | TECHNOLOGICAL
CHARACTERISTICS: | The intended use, design, operating principles and materials are
similar to devices previously cleared via the 510(k) process. | | PERFORMANCE DATA: | Performance standards have not been established by FDA under
Section514 of the Food, Drug and Cosmetic Act. | Proprietary and Confidential Information of Boston Scientific Corporation {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. ## Public Health Service FEB - 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Boston Scientific Corporation c/o Ms Michelle M. Berry One Boston Scientific Place NATICK, MA 01760 1537 RE: K050120 Trade/Device Name: Easy Core Biopsy System Regulation Number: 21 CFR & 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: 78 FCG Dated: January 14, 2005 Received: January 18, 2005 Dear Ms Berry: 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. {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 C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Boston Scientific Corporation K050120 ## INDICATIONS FOR USE STATEMENT | 510(k)
Number | To be determined | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | To be determined (Biopsy Instrument) | | Indications
For Use | The proposed device is indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes but
not limited to organs such as breast, liver, kidney and prostate. | ## PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prescription Use (Per 21 CFR 801.109) ---------------- --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K050120](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K050120) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com