(40 days)
Not Found
No
The summary describes a standard electrically powered drill system for bone cutting and shaping, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is described as an electrically powered drill motor intended for cutting and shaping bone, which is a surgical tool, not a therapeutic device. It is used in surgical procedures rather than for treating a disease or condition therapeutically.
No
The device's intended use is "Cutting and shaping bone," which describes a surgical or interventional function, not a diagnostic one. It is a tool for modification, not for identifying or characterizing a condition.
No
The device description clearly states it includes hardware components such as a drill motor, control console, hand piece, and foot control switch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cutting and shaping bone including spine and cranium." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an electrically powered drill motor with attachments for bone work. This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. This device is used for direct surgical intervention.
N/A
Intended Use / Indications for Use
The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.
Product codes
HBC
Device Description
The eMax 2 Plus System is an electrically powered drill motor with a series of attachments designed for use on the bones of the cranium and spine. The system components include a control console, the motor hand piece and foot control switch. The control console supplies power to the motor through a detachable cable. This system is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
eMax Drill System-> K011444
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).
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.
4500 Riverside Drive
Palm Beach Gardens, FL 33410 | K080802 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Official Correspondent | Jim Banic
Senior Regulatory Affairs Specialist
The Anspach Effort, Inc.
4500 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-627-1080
Fax. 561-625-9110
Email: jimb@anspach.com | |
| Date Prepared | March 17, 2008 | |
| Device Name | eMax 2 Plus System | |
| Classification Name | Motor, Drill, Electric | |
| Device
Classification | Class II
Neurology
21 CFR § 882.4360 | |
| Predicate
Devices | eMax Drill System-> K011444 | |
| Performance | Performance standards have not been established by the
FDA under Section 514 of the Federal Food, Drug and
Cosmetic Act. | |
| Device Description | The eMax 2 Plus System is an electrically powered drill
motor with a series of attachments designed for use on the
bones of the cranium and spine. The system components
include a control console, the motor hand piece and foot
control switch. The control console supplies power to the
motor through a detachable cable. This system is non-
sterile. | |
| Indications for Use | The eMax 2 Plus System is intended use is for Cutting and
shaping bone including spine and cranium. | |
| Technological
Characteristics | The eMax 2 Plus System is made of the same materials and
contains features and functions which are similar to the
currently available eMax Drill System. The same cutters,
attachments and accessories which interface with the eMax
Drill System will interface with the eMax 2 Plus System. | |
| Conclusion | The eMax 2 Plus System is substantially equivalent to the
currently marketed eMax Drill System cleared by K011444
on August 8, 2001. | |
The Anspach Effort, 4500 Riverside Drive, Palm Beach Gardens, FL 33410
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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.
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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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