EASY CORE BIOPSY SYSTEM II

K050120 · Boston Scientific Corp · FCG · Feb 8, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050120
• Device Name: EASY CORE BIOPSY SYSTEM II
• Applicant: Boston Scientific Corp
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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.

Indications for Use

Indicated for endoscopic or percutaneous soft tissue biopsy (organs, tumors, masses) for histological analysis; includes breast, liver, kidney, and prostate. Prescription use only.

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

• Easy Core Biopsy System (K040893)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification EasyCore Biopsy System II January 14, 2004

## 510 (k) SUMMARY

K050120

| SPONSOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Michelle M. Berry<br>Regulatory Affairs Specialist |
| | Or |
| | Lorraine M. Hanley<br>Director Regulatory Affairs |
| DEVICE:<br>Trade Name:<br>Common Name:<br>Classification: | To Be Determined<br>Biopsy Instrument<br>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<br>followed by a cannula to capture a biopsy sample of soft organs,<br>tumor or masses for histological analysis. The design includes a<br>handle with a thumb tab activated drive mechanism, a side fire<br>button, a rear fire button, and a cannula with a needle tip. The<br>cannula may have marker bands spaced at 1 cm (10 mm)<br>intervals starting from the stylet tip and extending various<br>lengths depending upon the needle. When the device is fully<br>loaded, the yellow indicator is visible when looking at the top of<br>the handle. |
| INTENDED USE: | The proposed device is indicated for use endoscopically or<br>percutaneously to retrieve tissue sampling of soft organs, tumors<br>or masses for histological analysis. Soft tissue sampling includes<br>but not limited to organs such as breast, liver, kidney and<br>prostate. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The intended use, design, operating principles and materials are<br>similar to devices previously cleared via the 510(k) process. |
| PERFORMANCE DATA: | Performance standards have not been established by FDA under<br>Section514 of the Food, Drug and Cosmetic Act. |

Proprietary and Confidential Information of Boston Scientific Corporation

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## 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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Boston Scientific Corporation

K050120

## INDICATIONS FOR USE STATEMENT

| 510(k)<br>Number | To be determined |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | To be determined (Biopsy Instrument) |
| Indications<br>For Use | The proposed device is indicated for use endoscopically or<br>percutaneously to retrieve tissue sampling of soft organs, tumors or<br>masses for histological analysis. Soft tissue sampling includes but<br>not limited to organs such as breast, liver, kidney and prostate. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use
(Per 21 CFR 801.109)

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