SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018

K093256 · Inrad · KNW · Nov 17, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K093256
• Device Name: SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
• Applicant: Inrad
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

Device Story

SelectCore™ Variable Throw Biopsy Device is a sterile, disposable, mechanically actuated biopsy instrument. Features stainless steel cutting cannula and stylet housed in plastic. User-selectable operation modes: single fire or fully automatic. Variable throw setting (10 to 25 mm) allows adjustment of sample depth. Used by clinicians to obtain soft tissue samples for diagnostic purposes. Device operation is purely mechanical; no electronic or software components. Benefits include precise tissue sampling for diagnostic evaluation.

Clinical Evidence

Bench testing only; no clinical data provided. Performance testing confirmed sample quality equivalent to predicate device.

Technological Characteristics

Stainless steel cutting cannula and stylet; plastic housing. Mechanically actuated. Variable throw (10-25 mm). Sterile, disposable. No electronic components or software.

Indications for Use

Indicated for obtaining soft tissue biopsies (liver, breast, kidney, prostate, spleen, lymph nodes, tumors). Breast biopsy for diagnostic 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

• Temno Achieve Biopsy Needle (K960064)

Submission Summary (Full Text)

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SECTION 5: 510(k) SUMMARY

K093256

Image /page/0/Picture/2 description: The image shows the logo for INRAD. The logo consists of a square with a diagonal line in the upper left corner, followed by the text "INRAD" in bold, sans-serif font. A small "R" in a circle is located in the upper right corner of the logo.

NOV 1 7 2009

November 9, 2009

# Contact Information

Melissa Lalomia Director of Quality & Regulatory Affairs Phone: [phone], ext. 102 Fax: [phone] E-mail: [e-mail]

## Company Information

Inrad, Inc 4375 Donker Court SE Kentwood, MI 49512 Phone: [phone] Fax: [phone]

# Device Name(s)

SelectCore™ Variable Throw Biopsy Device

#### Device Summary

Trade or Proprietary Name: SelectCore™ Variable Throw Biopsy Device Common or Usual Name: Biopsy Instrument Gastroenterology-urology biopsy instrument Classification Name: (21 CFR 876.1075, Product code KNW)

## Name of Predicate(s) or Legally Marketed Device(s)

K960064 – Temno Achieve Biopsy Needle

Also known as:

> Achieve® Programmable Automatic Biopsy System (Cardinal Health)

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#### SECTION 5: 510(k) SUMMARY

#### Device Description

The SelectCore™ Variable Throw Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The device offers the user the choice of either single fire or fully automatic modes. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.

#### Indications for Use

The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

#### Substantial Equivalence

The SelectCore™ Variable Throw Biopsy Device has the same intended use as the Achieve® Programmable Automatic Biopsy System. The device and the predicate device have the same technological characteristics in terms of design and materials.

### Performance Testing Summary

Performance testing confirms that the quality of samples obtained with the SelectCore™ Variable Throw Biopsy Device is equivalent to that of the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV 1 7 2009

Inrad, Inc. % Ms. Melissa Lalomia Director of Quality and Regulatory Affairs 4375 Donker Court SE Kentwood, Michigan 49512

Re: K093256

Trade/Device Name: SelectCore™ Variable Throw Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: November 10, 2009 Received: November 12, 2009

Dear Ms. Lalomia:

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); medical device reporting (reporting of medical

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Page 2 - Ms. Melissa Lalomia

device-related adverse events) (21 CFR 803); 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.

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/CDRH/CDRHOffices/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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
for Peter Rimm
CEO Dir

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 4: INDICATIONS FOR USE STATEMENT

# Indications for Use

K093256

510(k) Number (if known):

Device Name:

Indications for Use:

SelectCore™ Variable Throw Biopsy Device

The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

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 OF NEEDED)

MilRP Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093256

Section 4 - 1

INRAD, INC. - CONFIDENTIAL