(85 days)
Not Found
No
The summary describes a surgical power tool system for bone manipulation and does not mention any AI/ML components or functionalities.
No
The device is described as an instrument for cutting, sawing, drilling, etc., bone and related tissue during surgical procedures; it is not described as providing therapy or treatment itself.
No
The device description indicates that it is used for surgical procedures such as cutting, sawing, drilling, etc., which are therapeutic actions, not diagnostic ones. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description explicitly lists hardware components such as an electric power supply, cables, foot/hand levers, handpieces, and head assemblies.
Based on the provided information, the MicroAire® 1000E System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for cutting, sawing, drilling, and manipulating bone and bone-related tissue during surgical procedures. This is a direct interaction with the patient's body for therapeutic or surgical purposes.
- Device Description: The description details components like a power supply, cables, handpieces, and head assemblies, which are typical of surgical power tools.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or components for analyzing biological samples.
Therefore, the MicroAire® 1000E System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MicroAire® 1000E System is intended for use in surgical procedures requiring the need for cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and bone related tissue.
The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.
Product codes
HBE, HBC
Device Description
The MicroAire® 1000E System consists of an electric power supply, powerconnecting cable(s), a foot and/or hand lever power activation control, modular and unitized handpieces, modular head assemblies and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
KO14060 1/2 5 2002 MAR
X . 510(k) Summary
| Date: | December 1, 2001 |
|---|---|
| Submitted By: | MicroAire® Surgical Instruments |
| 1641 Edlich Drive | |
| Charlottesville, VA 22911 | |
| Contact Person: | Carl Angles |
| Director of Quality and Regulatory Affairs | |
| Telephone: | |
| Facsimile: | 434-975-8000 |
| 434-975-4144 | |
| Proprietary Name: | |
| Common Name: | |
| Classification Name: | MicroAire® 1000E System |
| Electric Surgical System for Cutting and Drilling | |
| Powered simple cranial drills, burrs, trephines and | |
| their accessories (21 CFR § 882.4310) |
The MicroAire® 1000E System is substantially equivalent to the Stryker® HERMES-Ready™ Total Performance System (TPS™), 510(k) number K991696, predicate device. Although the 1000E system does not integrate irrigation, joint shaving and endoscopy features, the intended use, design, energy, materials, performance, safety, effectiveness, labeling, biocompatibility, and applicable standards are substantially equivalent to the Stryker TPS.
The MicroAire® 1000E System is intended for use in surgical procedures requiring the need for cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and bone related tissue.
The MicroAire® 1000E System consists of an electric power supply, powerconnecting cable(s), a foot and/or hand lever power activation control, modular and unitized handpieces, modular head assemblies and accessories.
1
KOLADGO 2/2
Technological Characteristic Summary - 1000E v. TPS
Power Source: Both sources are Class I, Type BF, electrically powered and controlled devices (50-60 Hz, 100-230 VAC input), which meet the same basic voluntary safety standards (UL, CSA, IEC). However, the TPS system integrates an irrigator pump into the power console while the 1000E does not. MicroAire markets and sells a "stand-alone" irrigation system for those customers that utilize irrigation.
Electric Motors: Both systems contain modular and unitized handpieces that operate at different cycle, speed and/or torque parameters necessary for various surgical procedures.
Foot Control: Both systems utilize foot-controlling throttle mechanisms.
Electric Connecting Cable: Both systems use electric cables to connect the power supply with the handpieces.
Head Assemblies: Both systems have head configurations facilitating high, medium and low speed drills, oscillating, sagittal and reciprocating saws and wire, pinning, reaming and drilling chucks.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002 MAR
Mr. Carl Angles Director of Quality and Regulatory Affairs MicroAire Surgical Instruments 1641 Edlich Drive Charlottesville, VA 22911
Re: K014060
Trade/Device Name: MicroAire® 1000E System Regulation Number: 882.4310, 882.4360 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Electric cranial drill motor Regulatory Class: II Product Code: HBE, HBC Dated: December 7, 2001 Received: December 10, 2001
Dear Mr. Angles:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard ment date of the Medical Device Amendments, or to conimeres prior to may 20, 1978, the exactions of the Federal Food, Drug, devices that have been rocussion in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, merelore, manot and include requirements for annual registration, listing of general controls provisions of ractice, 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 rr your device is classified (over a controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to sach additions, 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 r lease oc advised that I DTT of local that your device complies with other requirements of the Act that I Dr Hab intatutes and regulations administered by other Federal agencies. You must or any I cacial stututes and regulances including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 8077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable. the electronic for all in the quality byticins (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Carl Angles
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1
KO14060 510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Device Name:____MicroAire® 1000E System
Indications For Use:
The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter______________________________________________________________________________________________________________________________________________________________
Muriam C. Provost (Optional Format 1-2-96)
(Division Sign-Offi Division of General, Rentarative and Neurological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OR
51 Number K014060