K2M Fenestrated Tap System

K152872 · K2m · KNW · Jan 5, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K152872
• Device Name: K2M Fenestrated Tap System
• Applicant: K2m
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jan 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Device Story

K2M Fenestrated Tap System consists of surgical instruments for posterior access to vertebral bodies. Device functions as biopsy tool to remove bone tissue via aspiration; also serves as cement dispenser for vertebroplasty procedures. Used in clinical surgical settings by physicians. System provides access to surgical site, allows tissue sampling, and facilitates controlled injection of spinal bone cement. Benefits include minimally invasive access for diagnosis and vertebral augmentation. Operation involves manual manipulation by surgeon to tap into vertebral body, aspirate tissue, or dispense cement.

Clinical Evidence

Bench testing only; functional characteristics evaluated via cadaver testing to confirm the system achieves its intended use.

Technological Characteristics

Surgical instrument system for vertebral access. Features include fenestrations, specific diameters, and thread lengths. Manual operation. Materials and design are substantially equivalent to predicate systems.

Indications for Use

Indicated for patients requiring bone tissue biopsy of the vertebral body for diagnostic purposes or vertebral body augmentation via vertebroplasty using cleared spinal bone cement.

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

• Abbott Spinnaker (K052638)

Submission Summary (Full Text)

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

January 5, 2016

K2M, Incorporated Ms. Nancv Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175

Re: K152872

Trade/Device Name: K2M Fenestrated Tap System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, OAR Dated: November 24, 2015 Received: November 25, 2015

Dear Ms. Giezen:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510{k} Number (if known) K152872

Device Name K2M Fenestrated Tap System

#### Indications for Use (Describe)

The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) SUMMARY K2M Fenestrated Tap System

#### Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: [phone] Date Prepared: 12/02/2015

#### Classification

Trade Name: Common Name: Regulatory Class:

K2M Fenestrated Tap System Spinal Fixation System Class II

Classification Name(s): Gastroenterology-Urology Biopsy Instrument (21 CFR 876.1075, Product Code KNW) Cement Dispenser (21 CFR 888.4200, Product Code OAR)

# Predicate Device(s)

Primary Predicate: Abbott Spinnaker (K052638)

## Device Description

The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.

Function: The K2M Fenestrated Tap System can be used to access the vertebral body for obtaining bone biopsies. This system can also be used for the injection of bone cement into the vertebral body using vertebroplasty or kyphoplasty procedures.

## Intended Use

The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

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## Technological Comparison to Predicate(s)

The K2M Fenestrated Tap System was compared to predicate systems and design features such as the materials, number of fenestrations, diameters and thread lengths were found to be substantially the same as these systems.

### Non-clinical Performance Evaluation

The functional characteristics were evaluated in cadaver testing and the K2M Fenestrated Tap System was determined achieve its intended use.

#### Conclusion

There are no significant differences between the K2M Fenestrated Tap System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices when comparing materials, number of fenestrations, diameters and thread lengths. In addition the K2M Fenestrated Tap System is being offered for the same intended use as the predicates and was validated via cadaver testing.