ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS

K133604 · The Anspach Effort, Inc. · HBC · Jan 10, 2014 · Neurology

Device Facts

• Record ID: K133604
• Device Name: ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
• Applicant: The Anspach Effort, Inc.
• Product Code: HBC · Neurology
• Decision Date: Jan 10, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.

Device Story

Anspach eG1 High Speed Electric System is an electrically powered surgical drill system; consists of control console, handpiece, and various attachments. Used for cutting and shaping bone in spine and cranium procedures. Operated by surgeons in clinical settings. System provides power for applications ranging from demanding bone removal to delicate dissection. Device is non-sterile and reusable. Healthcare providers use the system to perform precise bone resection; output directly facilitates surgical access or bone modification, benefiting patients by enabling controlled surgical outcomes.

Clinical Evidence

Bench testing only. Design verification testing was conducted to challenge the device design against established physical characteristics, functional requirements, and performance standards.

Technological Characteristics

Electrically powered surgical drill system. Components include control console, handpiece, and attachments. Provided non-sterile and reusable. Design utilizes materials similar to predicate eMax system. System is a mechanical/electromechanical surgical instrument.

Indications for Use

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

Regulatory Classification

Identification

An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• eMax Drill System (K011444)

Submission Summary (Full Text)

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## K133604

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### 510(k) Summary

JAN 10 2014 The 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<br>Regulatory Affairs Manager<br>Tel. [phone]<br>Fax. [phone]<br>Email: [e-mail] |
| Date Prepared | November 22, 2013 |
| Device Name | Anspach eG1 High Speed Electric System |
| Common Name | Electric Drill Motor System |
| Classifications | Class II<br>Neurological Devices<br>21 CFR § 882.4360<br>HBC<br>Class II<br>Ear, Nose and Throat Devices<br>21 CFR § 874.4250<br>ERL |
| Predicate Devices | eMax Drill System<br>The Anspach Effort, Inc.<br>K011444<br>HBC, ERL |
| Device Description | The Anspach eG1 High Speed System, which consists of a<br>control console, handpiece, and various attachments, is an<br>electrically powered surgical drill that handles a range of<br>surgical procedures ranging from power-demanding<br>applications to delicate dissection. |
| Indications for Use | The Anspach eG1 High Speed Electric System is intended<br>for cutting and shaping bone including spine and cranium. |

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# K133604 Page 2 of 2

Technological Characteristics The Anspach eG1 High Speed Electric System and attachments are provided non-sterile, reusable. The Anspach eG1 High Speed Electric System and attachments are designed utilizing the same materials and contains features and functions which are similar to the predicate devices. Design verification was conducted on the proposed design Performance Testing changes of the Anspach eG1 High Speed Electric System and attachments. 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. Based on the testing, risk analysis and comparison to the Conclusion predicate devices, the Anspach eG1 High Speed Electric System and attachments described in this submission perform as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

The Anspach Effort, Inc. Ms. Jeannette G. Dailey Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, Florida 33410

January 10, 2014

Re: K133604

Trade/Device Name: Anspach eG1 High Speed Electric System Dissection Tools Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, ERL Dated: December 12, 2013 Received: December 13, 2013

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

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Page 2 - Ms. Jeannette G. Dailey

forth in the quality systems (OS) regulation (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K133604

Device Name: Anspach eG1 High Speed Electric System

Indications for Use:

The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

By Ugmed by Long N. Chen . A
Art, But J. Constructions, may Long H. ... Chen -A Date: 2014.91.10 1 2014.91.10 1 209-02 -05 00 for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number: K133604

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