(46 days)
Not Found
No
The summary describes a standard surgical drill system and does not mention any AI or ML components or functionalities.
No
The device is used for cutting and shaping bone, which is a surgical procedure, not a therapeutic treatment. It's an instrument for intervention, not therapy.
No
The device is described as an "electrically powered surgical drill that handles a range of surgical procedures," intended for "cutting and shaping bone." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states that the system consists of a control console, handpiece, and various attachments, which are hardware components. It is described as an electrically powered surgical drill.
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 describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an "electrically powered surgical drill." This is a surgical instrument used during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to diagnose, monitor, or screen for diseases or conditions by analyzing samples taken from the body. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.
Product codes
HBC, ERL
Device Description
The Anspach eG1 High Speed System, which consists of a control console, handpiece, and various attachments, is an electrically powered surgical drill that handles a range of surgical procedures ranging from power-demanding applications to delicate dissection.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4360 Electric cranial drill motor.
(a)
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.(b)
Classification. Class II (performance standards).
0
K133604
Page 1 of 2
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.
4500 Riverside Drive
Palm Beach Gardens, FL 33410 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Jeannette G. Dailey
Regulatory Affairs Manager
Tel. 561-494-3710
Fax. 561-625-9110
Email: dailey.jeannette@synthes.com |
| Date Prepared | November 22, 2013 |
| Device Name | Anspach eG1 High Speed Electric System |
| Common Name | Electric Drill Motor System |
| Classifications | Class II
Neurological Devices
21 CFR § 882.4360
HBC
Class II
Ear, Nose and Throat Devices
21 CFR § 874.4250
ERL |
| Predicate Devices | eMax Drill System
The Anspach Effort, Inc.
K011444
HBC, ERL |
| Device Description | The Anspach eG1 High Speed System, which consists of a
control console, handpiece, and various attachments, is an
electrically powered surgical drill that handles a range of
surgical procedures ranging from power-demanding
applications to delicate dissection. |
| Indications for Use | The Anspach eG1 High Speed Electric System is intended
for cutting and shaping bone including spine and cranium. |
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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)
この……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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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