COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208

K070091 · Cardinal Health, Inc. · KNW · Apr 18, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070091
• Device Name: COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
• Applicant: Cardinal Health, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.

Device Story

Coaxial bone and vertebral body biopsy needle; single-use, sterile, prescriptive device. Used by physicians to remove bone tissue samples for diagnostic purposes; provides and maintains access to surgical site. Access cannula sizes: 8, 11, 13 gauge; coaxial needle sizes: 11, 14, 15.5 gauge; lengths: 19 and 22 cm. Operates via manual coring, cutting, or aspiration.

Clinical Evidence

Bench testing only. Materials evaluated for biological safety per ISO 10993 Part-1 and tested according to industry-recognized methods.

Technological Characteristics

Single-use, sterile, manual biopsy needle. Access cannula (8, 11, 13G) and coaxial needle (11, 14, 15.5G). Lengths 19 and 22 cm. Materials evaluated per ISO 10993-1.

Indications for Use

Indicated for use by physicians performing bone or vertebral body biopsies via coring, cutting, 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

• Cardinal Health Jamshidi Coaxial Bone Biopsy Needle (K813338)
• Stryker Bone and Vertebral Body Biopsy Kit (K032943)

Submission Summary (Full Text)

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K07-0091

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Cardinal Health
1430 Waukegan Road
McGaw Park, Illinois 60085-6787
McGaw Park, Illinois 60085-6787
FAX: [phone]
FAX: [phone]

CardinalHealth

APR 1 8 2007

### SMDA REQUIREMENTS

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Coaxial Bone and Vertebral Body Biopsy Needle

| Sponsor: | Cardinal Health<br>1430 Waukegan Road MPKB<br>McGaw Park, IL 60085 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs<br>Contact: | Sharon Nichols |
| Telephone: | [phone] |
| Date Summary Prepared: | March 2007 |
| Common Name: | Coaxial Bone and Vertebral Body<br>Biopsy Needle |
| Classification: | Class II per 21CFR §876.1075 |
| Predicate Devices: | Cardinal Health Jamshidi Coaxial<br>Bone Biopsy Needle, (K813338)<br>Stryker Bone and Vertebral Body<br>Biopsy Kit (K032943) |
| Description: | This device can be used as a<br>standalone device to remove a sample<br>of bone tissue from a vertebral body or<br>bone for diagnostic purposes using a<br>coring, cutting or aspiration technique<br>for diagnostic purposes as well as to<br>provide and maintain access to the<br>same surgical site. |
| | The access cannula sizes are 8, 11 and<br>13 gauge with coaxial needle of 11, 14,<br>and 15.5 gauges. The needle lengths<br>are 19 and 22 cm. This product is a<br>single use, sterile prescriptive device. |

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K070091

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Image /page/1/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a sans-serif font, with the word "Cardinal" in a bold font and the word "Health" in a regular font.

Cardinal Health
1430 Waukegan Road
McGaw Park, Illinois 60085-6787
847.578.6610 FAX: [phone]

# SMDA REQUIREMENTS (continued)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Coaxial Bone and Vertebral Body Biopsy Needle

| Intended Use: | This device is intended for use by a physician<br>performing a bone or vertebral body biopsy<br>using a coring, cutting, or aspiration technique. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Coaxial Bone and Vertebral Body<br>Biopsy Needle is substantially equivalent<br>to the Cardinal Health Coaxial Bone<br>Biopsy Needle and the Stryker Bone and<br>Vertebral Body Biopsy Kit in that the<br>intended use and the performance<br>attributes are equivalent. |
| Summary of<br>Testing: | All materials used in the fabrication of the<br>Coaxial Bone and Vertebral Body Biopsy<br>Needle were evaluated through biological<br>qualification safety tests as outlined in ISO<br>10993 Part-1 "Biological Evaluation of Medical<br>Devices". These materials also were tested in<br>accordance with industry recognized test<br>methods and were found to be acceptable for<br>the intended use. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing health and medicine. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health, Inc. % Ms. Sharon Nichols Regulatory Affairs Manager 1430 Waukegan Road McGaw Park, Illinois 60085

APR 1 8 2007

Re: K070091

Trade/Device Name: Coaxial Bone and Vertebral Body Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 12, 2007 Received: March 13, 2007

Dear Ms. Nichols:

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 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 - Ms. Sharon Nichols

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 your

five Dblmy

Mark N. Mellekerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of the company name, "CardinalHealth", in a bold, sans-serif font. Above the name is a graphic element that appears to be a stylized representation of lines or a network.

1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 6 847 785 2506

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510(k) Number (if known):

Device Name:

K070091

Coaxial Bone and Vertebral Body Biopsy Needle

Indications For Use:

This device is intended for use by a physician performing a bone or vertebral body biopsy using a coring, cutting, or aspiration technique.

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 801 Subpart C)

(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** | k070051