RP CUTTING NEEDLE

K092059 · Riverpoint Medical · KNW · Sep 24, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K092059
• Device Name: RP CUTTING NEEDLE
• Applicant: Riverpoint Medical
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone. The RP Cutting Needle is provided sterile as a single use device.

Device Story

The RP Cutting Needle is a sterile, single-use biopsy instrument designed for use with the Bard® Magnum® reusable biopsy device. It consists of a stainless steel cannula and a notched stainless steel stylet, both featuring molded plastic hubs and an attached spacer for integration into the reusable instrument. The device is used by medical professionals in clinical settings to collect soft tissue samples from organs such as the liver, lung, kidney, or prostate. The needle is protected by an LDPE sheath until use. By facilitating tissue specimen collection, the device assists clinicians in diagnostic procedures. It is not intended for bone biopsies.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through dimensional, quality, and material verification.

Technological Characteristics

Materials: Stainless steel cannula/stylet, molded plastic hubs, LDPE sheath. Design: Cannula with notched stylet and spacer for Bard® Magnum® compatibility. Dimensions: 14-20 gauge, 10-25 cm length. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for medical professionals performing soft tissue biopsies (liver, lung, kidney, prostate) using the Bard® Magnum® reusable biopsy instrument. Not for use in bone.

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

• Biopty-Cut® Needle
• Magnum® Needle
• MLL Needle
• M-Needle
• Cook Biopsy Needle

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letters 'rp' stacked on top of each other. The top of each letter 'r' is stylized into a circle. Below the logo, the word 'riverpoint' is written in lowercase letters. The logo appears to be for a company or organization named Riverpoint.

SEP 24 2009

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# 510(k) Summary

#### Submitter Information

Submitter's Name:

Address:

825 NE 25th Ave. Portland, OR 97232

[phone] or 866 445-4923

Riverpoint Medical

Phone Number:

Fax Number:

Registration Number:

Contact Person:

Douglas Rowley

3006981798

[phone]

Date of Preparation:

[phone]

July 1st, 2009

#### Device Name

RP Cutting Needle Trade Name: Biopsy Needle (Disposable) Common Name: Instrument, Biopsy Classification Name:

2

#### Device Classification

FDA Class:

Product Classification:

Code:

876.1075(a) Gastroenterology-Urology-Urology Instrument, Needle KNW

Classification Panel:

Gastroenterology-Urology

### Predicate Devices

C.R. Bard®: Remington Medical: Cook® Medical:

Biopty-Cut® Needle; Magnum® Needle MLL Needle; M-Needle Cook Biopsy Needle

510(k) Summary - RP Cutting Needle

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Image /page/1/Picture/0 description: The image shows a logo with the word "riverpoint" in lowercase letters at the bottom. Above the word, there are two stylized "r" letters, each with a circle at the top. The "r" on the left is lighter in color, while the "r" on the right is darker, creating a contrasting effect.

K092059
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#### Special Controls

Not applicable for this device

#### Device Description

The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm. The predicate devices listed contain identical or substantially equivalent materials and characteristics as described above.

#### Intended Use

The RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone. The RP Cutting Needle is provided sterile as a single use device.

#### Safety and Effectiveness

The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness. All materials used were selected based on known biocompatibility and established histories of use in the medical device industry for non-implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed.

The RP Cutting Needle has been designed to have the same general shape, size and method of function as the predicate devices. Dimensional and quality verifications. along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle emblem on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## SEP 2 4 2009

Mr. Doug Rowley RA/QA Manager Riverpoint Medical 825 NE 25th Avenue PORTLAND OR 97232

Re: K092059

Trade/Device Name: RP Cutting Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II · Product Code: KNW Dated: July 1, 2009 Received: July 7, 2009

### Dear Mr. Rowley:

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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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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K092059

Device Name:

RP Cutting Needle

#### Indications for Use:

The RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone. The RP Cutting Needle is provided sterile as a single use device.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| Labels | Values |
|---------------|---------|
| 510(k) Number | K092059 |

510(k) Indications for Use Statement - RP Cutting Needle

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