CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES

K022169 · Parallax Medical, Inc. · KNW · Jul 25, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022169
• Device Name: CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
• Applicant: Parallax Medical, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.

Device Story

Clearview Plus Bone and Vertebral Body Biopsy Needles are manual surgical instruments used by physicians to obtain bone or vertebral body tissue samples. The device consists of a cannula/stylet assembly (11 gauge) with an additional 13.5 gauge inner cannula, a 10cc VacLok syringe, and a Luer cap. The device is used to perform biopsies via coring or aspiration techniques. It is provided sterile for single use. The device facilitates tissue collection for diagnostic purposes, aiding clinical decision-making regarding bone pathology.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual biopsy needle assembly; 11 gauge cannula/stylet; 13.5 gauge inner cannula; 10cc VacLok syringe; Luer cap; 4.565 inch (11.6 cm) useable length; sterile; single-use.

Indications for Use

Indicated for use by physicians performing bone or vertebral body biopsies via coring or aspiration techniques.

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

• Clearview Bone and Vertebral Body Biopsy Needles (K011206)

Submission Summary (Full Text)

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## IV. 510(k) Summary

# JUL 2 5 2002

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

#### A. Date Prepared

June 28, 2002

#### B. General Information

| Manufacturer: | Parallax Medical, Inc.<br>940 Disc Drive<br>Scotts Valley, CA 95066-4544 |
|---------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Richard M. Ruedy<br>Director, Regulatory and Clinical Affairs<br>[phone] phone<br>[phone] fax |

#### C. Device Information

| Trade Name: | Clearview Plus Bone and Vertebral Body Biopsy Needles |
|----------------------------|-------------------------------------------------------|
| Common Name: | Bone Biopsy Needle |
| Device Classification: | II |
| Classification Name: | Gastroenterology-Urology Biopsy Instrument |
| Product Code(s): | 78 KNW |
| Classification Regulation: | |

21 CFR §876.1075 - Gastroenterology-urology biopsy instrument

#### D. Predicate Device Identification

The subject device is substantially equivalent to Clearview Bone and Vertebral Body Biopsy Needles (K011206, July 18, 2001).

#### E. Intended Use

Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.

#### F. Product Description

The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm).

The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include:

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- . 10cc VacLok syringe
- Luer cap .
- 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) .

The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.

#### G. Substantial Equivalence

The subject device is equivalent in intended use, design, and technological characteristics to the Clearview Bone and Vertebral Body Biopsy Needles, K011206.

#### H. Summary

Based on the information provided in this notification, the subject device is substantially equivalent to the predicate devices in intended use, technological characteristics, and design.

#### l. Signature of Preparer

The 510(k) summary was prepared and submitted by the following Parallax Medical employee.

Richard M. Ruedy Director, Regulatory and Clinical Affairs

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 5 2002

Parallax Medical, Inc. Richard M. Ruedy Director, Regulatory and Clinical Affairs 940 Disc Drive Scotts Valley, California 95066-4544

Re: K022169

Trade Name: Clearview Plus Bone and Vertebral Body Biopsy Needles Regulation Number: 876.1075 Regulation Name: Gastroenterology/Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: July 2, 2002 Received: July 3, 2002

Dear Mr. Ruedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 such 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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Page 2 -- Mr. Richard M. Ruedy

This letter will allow you to begin marketing your device as described in your Section 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21CFR 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.

Stypt Aurelius

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Statement of Indications for Use III.

| Indications for Use |
|---------------------|
|---------------------|

| 510(k) Number (if known): | K022169 |
|---------------------------|-------------------------------------------------------|
| Device Name: | Clearview Plus Bone and Vertebral Body Biopsy Needles |

### Indications for Use:

Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K022169 | |
|---------------------------------------|---------------|-----------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | <div>OR</div> | Over-The Counter Use (Optional Format 1-2-96) |