ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM

K112945 · Inrad, Inc. · KNW · Nov 3, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K112945
• Device Name: ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
• Applicant: Inrad, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 3, 2011
• Decision: SESE
• Submission Type: Special
• 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, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

Device Story

The EliteCore™ Full Core Biopsy Device is a sterile, disposable, mechanically actuated instrument used to obtain full core tissue specimens. It features a stainless steel cutting cannula with a spoon, a rotating coring cannula, and a stylet housed within a plastic body. The device includes a variable throw feature allowing users to select throw settings between 13 and 25 mm. It is operated by a clinician to perform biopsies on soft tissues such as the liver, kidney, prostate, spleen, lymph nodes, and various tumors. The device is manually triggered to capture tissue samples. By providing a full core specimen, it assists healthcare providers in obtaining sufficient tissue for diagnostic evaluation, potentially improving the accuracy of disease diagnosis.

Clinical Evidence

Bench testing only. Testing included package inspection, burst testing, device inspection, dimensional verification of throw settings, firing force measurements, and tissue sampling efficacy in chicken and liver models. Results confirmed the device meets performance specifications and is equivalent to the predicate device.

Technological Characteristics

Materials include stainless steel (cannula, spoon, stylet) and plastic (housing). The device is a mechanically actuated, disposable biopsy instrument. It features a variable throw mechanism (13-25 mm). No electronic components, software, or energy sources are utilized. Sterilization method is not specified.

Indications for Use

Indicated for obtaining biopsies from soft tissues including liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors in patients requiring tissue sampling.

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

• Revolution® Full Core Biopsy Device (K090611)

Submission Summary (Full Text)

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K112945

NOV - 3 2011

Image /page/0/Picture/2 description: The image shows the word "INRAD" in bold, black letters. To the left of the word is a black square with a white diagonal line running from the top left corner to the bottom right corner. A small "R" with a circle around it is in the top right corner of the image.

# September 30, 2011

#### Contact Information

Ryan Goosen President Phone: [phone], ext. 105 Fax: [phone] E-mail: [e-mail]

#### Company Information

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

# Device Name(s)

EliteCore™ Full Core Biopsy Device EliteCore™ Full Core Biopsy Device w/HiLiter®

#### Device Summary

| Trade or Proprietary Name: | EliteCore™ Full Core Biopsy Device | |
|----------------------------|-----------------------------------------------------------------------------------|--|
| | EliteCore™ Full Core Biopsy Device w/HiLiter® | |
| Common or Usual Name: | Biopsy Instrument | |
| Classification Name: | Gastroenterology-urology biopsy instrument<br>(21 CFR 876.1075, Product code KNW) | |

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

K090611– Revolution® Full Core Biopsy Device

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#### Device Description

The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.

#### Indications for Use

The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

#### Substantial Equivalence

The EliteCore™ Full Core Biopsy Device has the same intended use as the Revolution® Full Core Biopsy Device with the exception of the omission of the word breast. 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 EliteCore™ Full Core Biopsy Device is equivalent to that of the predicate device as shown below:

| Test | Involved | How Equivalent |
|---------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| -Package inspection | Visually inspect packaging<br>for damage, loose components<br>tip protector secure, and variable<br>throw set at 22mm. | Identical testing<br>performed on predicate<br>device w/ equivalent<br>results. |
| -Burst test | Measure pressure at which<br>sealed tray fails. | Identical testing<br>performed on predicate<br>device. w/ equivalent<br>results. |
| -Device inspection | Visually inspect device<br>for damage | Identical testing<br>performed on predicate<br>device w/ equivalent<br>results. |

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K112945

#### -Dimensional

-Tissue test

-Tissue test cont.

Measure variable throw desired vs. actual.

Measure variable throw after dry fires, desired vs. actual.

Measure force to fire front triggers (RH / LH)

Measure force to fire rear trigger.

Able to take tissue sample in chicken and liver.

Identical testing performed on predicate device w/ equivalent results.

Identical testing performed on predicate device w/ equivalent results.

Identical testing performed on predicate device w/ equivalent results.

Additional testing that was not performed on predicate.

Identical testing performed on predicate device w/ equivalent results.

Able to take tissue samples at various throw distances.

Measure 1st sample as compared

to last sample for sample weight

and verify no loss of effectiveness.

Identical testing performed on predicate device w/ equivalent results.

Identical testing performed on predicate device w/ equivalent results.

Mates with adjustable coaxial Identical testing And able to take sample. performed on predicate

Section 5 - 3

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K//2945

device w/ equivalent results.

Identical testing. performed on predicate device w/ equivalent results.

Identical testing performed on predicate device w/ equivalent results.

ldentical testing performed on predicate device w/ equivalent results.

-Verify weld integrity

Visually inspect device for damage along weld joints after functional testing.

-Dimensional

Measure cannula, spoon, and stylet for migration.

Measure the joint strength for the cannula, spoon, and stylet.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and a snake winding around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Ryan Goosen President Inrad Inc. 4375 Donker CT SE GRAND RAPIDS MI 49512

NOV - 3 2011

Re: K112945

Trade/Device Name: EliteCore™ Full Core Biopsy Device EliteCore™ Full Core Biopsy Device w/HiLiter® Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 30, 2011 Received: October 4, 2011

Dear Mr. Goosen:

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.

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 of medical device-related

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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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Huker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological 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

12945

510(k) Number (if known):

Device Name:

Indications for Use:

EliteCore™ Full Core Biopsy Device EliteCore™ Full Core Biopsy Device w/HiLiter®

The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

)Division Sloחס-ח(
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112945

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