EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL

K080802 · The Anspach Effort, Inc. · HBE · Apr 30, 2008 · Neurology

Device Facts

• Record ID: K080802
• Device Name: EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
• Applicant: The Anspach Effort, Inc.
• Product Code: HBE · Neurology
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.

Device Story

The eMax 2 Plus System is an electrically powered drill motor used for cutting and shaping bone in the spine and cranium. The system consists of a control console, a motor handpiece, and a foot control switch. The control console provides power to the motor via a detachable cable. The device is operated by a surgeon in a clinical setting. It is designed to be compatible with the same cutters, attachments, and accessories used with the predicate eMax Drill System. The device is non-sterile.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrically powered drill motor system. Components include control console, motor handpiece, and foot control switch. Compatible with existing eMax Drill System cutters and attachments. Non-sterile.

Indications for Use

Indicated for cutting and shaping bone in the spine and cranium.

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

• eMax Drill System (K011444)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary of Safety and Effectiveness

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 | K080802 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Official Correspondent | Jim Banic<br>Senior Regulatory Affairs Specialist<br>The Anspach Effort, Inc.<br>4500 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email: [e-mail] | |
| Date Prepared | March 17, 2008 | |
| Device Name | eMax 2 Plus System | |
| Classification Name | Motor, Drill, Electric | |
| Device<br>Classification | Class II<br>Neurology<br>21 CFR § 882.4360 | |
| Predicate<br>Devices | eMax Drill System-> K011444 | |
| Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and<br>Cosmetic Act. | |
| Device Description | The eMax 2 Plus System is an electrically powered drill<br>motor with a series of attachments designed for use on the<br>bones of the cranium and spine. The system components<br>include a control console, the motor hand piece and foot<br>control switch. The control console supplies power to the<br>motor through a detachable cable. This system is non-<br>sterile. | |
| Indications for Use | The eMax 2 Plus System is intended use is for Cutting and<br>shaping bone including spine and cranium. | |
| Technological<br>Characteristics | The eMax 2 Plus System is made of the same materials and<br>contains features and functions which are similar to the<br>currently available eMax Drill System. The same cutters,<br>attachments and accessories which interface with the eMax<br>Drill System will interface with the eMax 2 Plus System. | |
| Conclusion | The eMax 2 Plus System is substantially equivalent to the<br>currently marketed eMax Drill System cleared by K011444<br>on August 8, 2001. | |

The Anspach Effort, 4500 Riverside Drive, Palm Beach Gardens, FL 33410

のお気になる。

. .

: 上一篇:

000007

{1}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of th

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

The Anspach Effort, 4500 Riverside Drive, Palm Beach Gardens, FL 33410

: 上一篇: 上一篇:

:

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2008

The Anspach Effort, Inc. % Mr. Jim Banic Senior Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K080802

Trade/Device Name: eMax 2 Plus System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: March 17, 2008 Received: March 31, 2008

Dear Mr. Banic:

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.

{3}------------------------------------------------

Page 2 - Mr. Jim Banic

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N. Millman

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K080802_

Device Name: eMax 2 Plus System

Indications for Use:

The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.

Prescription Use > (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel ke Ql. Frrm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080802