ANSPACH DISSECTION TOOLS

K113476 · The Anspach Effort, Inc. · HBE · Dec 16, 2011 · Neurology

Device Facts

• Record ID: K113476
• Device Name: ANSPACH DISSECTION TOOLS
• Applicant: The Anspach Effort, Inc.
• Product Code: HBE · Neurology
• Decision Date: Dec 16, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dissection tools are intended for cutting and shaping bone including spine and cranium.

Device Story

Anspach Dissection Tools are surgical cutting accessories for pneumatic or electric motor systems. They function as bone-cutting and shaping instruments for spine and cranium procedures. Operated by trained medical/surgical personnel in clinical settings, the tools feature a standardized attachment mechanism to secure them to the handpiece. The device is single-use and disposable. The primary design modification in this submission is an updated locking mechanism to secure the tool to the motor handpiece. The tools provide surgeons with precise bone removal capabilities, facilitating surgical access and bone contouring.

Clinical Evidence

Bench testing only. Design verification testing was conducted to challenge the locking mechanism design against functional requirements and performance standards.

Technological Characteristics

Materials: tool steel, stainless steel, carbide, and diamond chip coatings. Form factor: surgical dissection tool with standard attachment mechanism for pneumatic/electric motors. Single-use, disposable. Sterilized.

Indications for Use

Indicated for cutting and shaping bone, including spine and cranium, in patients requiring surgical bone procedures.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• eMax2 Plus System (K080802)
• Minimal Access Spinal Attachment (MASA) System (K042783)

Submission Summary (Full Text)

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The Anspach Effort, Inc. Special 510(k) Premarket Notification - Dissection Tools

K113476

DEC 1 6 2011

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter | The Anspach Effort, Inc.<br>4500 Riverside Drive<br>Palm Beach Gardens, FL 33410 |
|-----------|----------------------------------------------------------------------------------|
|-----------|----------------------------------------------------------------------------------|

- Official Correspondent Jeannette G. Dailey Regulatory Affairs Manager Tel. [phone] Fax. [phone] Email [e-mail]
Class II

Dissection Tools

(Compound Powered)

Date Prepared December 13, 2011

Device Name

..............................................................................................................................................................................

Classification Name

Device Classification

Predicate Devices

Neurological Devices Panel 21 CFR §882.4310 HBE

Drills, Burrs, Trephines & Accessories

eMax2 Plus System (Component to system) K080802

Minimal Access Spinal Attachment (MASA) System (Component to system) K042783

Device Description

The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The

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K113476

The Anspach Effort, Inc. Special 510(k) Premarket Notification - Dissection Tools

> base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems.

The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system.

Indications for Use Dissection tools are intended for cutting and shaping bone including spine and cranium.

> Dissection Tools are sterilized, individually packaged, are for single use and disposable.

Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors both electric and pneumatic, and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips.

#### Performance Testing

Technological

Characteristics

Design verification was conducted on the proposed design change of the locking mechanism of the Dissection Tools.

These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards.

#### Conclusion

Based on the testing, risk analysis and comparison to the predicate devices, the Dissection Tools described in this submission perform as intended and raises no new safety or effectiveness issues.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

The Anspach Effort, Inc. c/o Ms. Jeanette G. Dailey Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, FL 33410

DEC 1 6 2011

Re: K113476

Trade/Device Name: Dissection Tools Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, bores, trephines, and their accessories Regulatory Class: Class II Product Code: HBE Dated: November 18, 2011 Received: November 22, 2011

Dear Ms. Dailey:

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. Ilsting 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.

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Page 2 - Ms. Jeanette G. Dailey

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 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,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): __K113476

Device Name:_Dissection Tools

Indications For Use:

Dissection tools are intended for cutting and shaping bone including spine and cranium.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

1000

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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K113476 510(k) Number _