STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS

K032943 · Stryker Corp. · KNW · Dec 17, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032943
• Device Name: STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
• Applicant: Stryker Corp.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.

Device Story

Manual biopsy tool for vertebral body tissue sampling; utilizes coring, cutting, or aspiration techniques. Capture kits provide additional functionality for maintaining surgical site access via guidewire. Used by clinicians in surgical or clinical settings. Device facilitates diagnostic tissue collection; aids in clinical decision-making by providing samples for pathology. Benefits include minimally invasive access to vertebral bone for diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Manual biopsy needles and kits for vertebral bone sampling. Includes coring, cutting, and aspiration components; some kits include guidewires for site access. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients requiring bone tissue sampling from a vertebral body for diagnostic purposes via coring, cutting, or aspiration techniques. Also indicated for providing and maintaining access to the surgical site.

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

• Parallax Clearview Plus Bone and Vertebral Biopsy Needles (K022169)
• Parallax Bone and Vertebral Body Biopsy Needles (K011206)
• IMS Mathis Vertebral and Bone Biopsy System (K990515)

Submission Summary (Full Text)

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DEC 1 7 2003

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KO32943

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## 510(k) Summary

| Trade Name: | Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and<br>Vertebral Body Biopsy Kit |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Vertebral Bone Biopsy Needles |
| Classification Name: | 876.1075 Gastroenterology-Urology Biopsy Instruments |
| Equivalent to: | Parallax Clearview Plus Bone and Vertebral Biopsy Needles (K022169),<br>Parallax Bone and Vertebral Body Biopsy Needles (K011206), IMS Mathis<br>Vertebral and Bone Biopsy System (K990515) |
| Device Description: | Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.<br>Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand-alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site. |
| Technological<br>Comparison: | Stryker's Bone and Vertebral Biopsy Kits are equivalent and<br>operate similar to the predicate devices listed. |
| Submitted by: | Dannielle C. Wheeler<br>Regulatory Affairs Representative, Stryker Instruments |
| | 9/19/2003 |

Signature

Date

Date Submitted: 9/19/2003

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## DEC 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Danielle C. Wheeler Regulatory Affairs Representative Stryker Corporation Stryker Instruments Division 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K032943

Trade/Device Name: Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Vertebral Body and Bone Biopsy Kit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 18, 2003 Received: September 23, 2003

Dear Ms. Wheeler:

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. Danielle C. Wheeler

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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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## Indications for Use

510(k) Number: K032943

Device Name: Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Vertebral Body and Bone Biopsy Kit

## Indications For Use:

Stryker's Bone and Vertebral Body Biopsy Kits can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.

Stryker's Capture Vertebral Body and Bone Biopsy Kits can be used as a stand alone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique. The Stryker Capture Bone and Vertebral Body Biopsy Kit and Kit with Guidewire is used to remove a sample of bone tissue from a vertebral body for diagnostic purposes, as well as to provide and maintain access to the same surgical site.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

vision Sign-Off) Division of General, Restorative and Neurological Devices

710(k) Number K032943

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