(106 days)
Not Found
No
The description focuses on mechanical load monitoring and secondary depth measurement, with no mention of AI or ML terms or concepts.
No
The device is described as a drill intended to bore holes into bone for the insertion of other implants, which is a surgical tool, not a therapeutic agent or device that directly treats a medical condition.
No
The device is described as a drill for creating holes in bone and measuring drill bit depth, which are therapeutic and measurement functions, not diagnostic ones. Although it "determines drill bit location" and "provides the measurement of the drill bit depth", this information is for guiding a surgical procedure rather than diagnosing a medical condition.
No
The device description explicitly lists hardware components such as a drill unit, control console, and sterilization tray, indicating it is not software-only.
Based on the provided information, the IntelliSense Drill is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, or disease.
- The IntelliSense Drill is a surgical tool. Its intended use is to bore a hole directly into bone for the insertion of medical implants. It operates on the patient's body, not on a specimen taken from the body.
The description clearly outlines a mechanical device used for a surgical procedure, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IntelliSense Drill is intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such as the femur, tibia, fibula, humerus, ulna, and radius.
Product codes (comma separated list FDA assigned to the subject device)
HWE, GEY, GFG, HTW
Device Description
The IntelliSense Drill device will contain a drill unit (with attached cable), Control Console, and Sterilization Tray. Proprietary Drill Bits and Drill Bit Bushing will be sold separately as accessories. The drill bits and companion bushings are sold as a pair and are disposable (single-procedure). The IntelliSense Drill's design combines the drilling and depth measurement processes into one procedure, which determines drill bit location. By monitoring the load placed upon the drilling mechanism, the precise location of the drill bit may be determined relative to the bone. Secondary depth monitoring will provide the measurement of the drill bit depth and appropriate screw size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bicortical long bone, such as the femur, tibia, fibula, humerus, ulna, and radius.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Image /page/0/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 three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
McGinley Orthopaedic Innovations % Mr. Justin Eggleton MCRA, LLC 1311 H Street North West, 12th Floor Washington, District of Columbia 20005
Re: K143191
Trade/Device Name: McGinley Innovations IntelliSense Drill Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: Class I Product Code: HWE, GEY, GFG, HTW Dated: January 30, 2015 Received: February 3, 2015
Dear Mr. Eggleton:
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education 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.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143191
Device Name McGinley Innovations IntelliSense Drill
Indications for Use (Describe)
The IntelliSense Drill is intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such are the fibri, fiber, fibel, f.but, f.but, humerus, ulna, and radius.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center, surrounded by a decorative gold border. To the right of the emblem, the words "MCGINLEY INNOVATIONS" are written in gold, with the tagline "REDEFINING MEDICINE" underneath in a smaller font.
| Section 5: 510(k) Summary | |
|---|---|
| DATE OF PREPARATION: | November 5, 2014 |
| COMPANY/OWNER: | Dr. Joseph McGinley |
| McGinley Orthopaedic Innovations | |
| 2435 King Blvd, Ste 230 | |
| Casper, WY 82604 | |
| CONTACT: | Dr. Joseph McGinley |
| McGinley Orthopaedic Innovations | |
| 2435 King Blvd, Ste 230 | |
| Casper, WY 82604 | |
| TELEPHONE | 215-847-1462 |
| FAX: | 435-304-1170 |
| EMAIL: | mcgjoe26@yahoo.com> |
| DEVICE TRADE NAME: | IntelliSense Drill |
| COMMON NAME: | Surgical Drill and accessories |
| CLASSIFICATION NAME: | Surgical instrument motors and accessories/attachments |
| REGULATION NUMBER: | 21 CFR §878.4820 |
| PRODUCT CODE: | HWE |
| SUBSEQUENT PRODUCT | |
| CODE: | GEY, GFG, HTW |
| DEVICE CLASS: | Class I |
| PREDICATE DEVICES: | Stryker Total Performance (TPS) System, K943589 |
| DEVICE DESCRIPTION: | The IntelliSense Drill device will contain a drill unit (with |
| attached cable), Control Console, and Sterilization Tray. | |
| Proprietary Drill Bits and Drill Bit Bushing will be sold | |
| separately as accessories. The drill bits and companion bushings | |
| are sold as a pair and are disposable (single-procedure). | |
| The IntelliSense Drill's design combines the drilling and depth | |
| measurement processes into one procedure, which determines | |
| drill bit location. By monitoring the load placed upon the drilling | |
| mechanism, the precise location of the drill bit may be | |
| determined relative to the bone. Secondary depth monitoring will | |
| provide the measurement of the drill bit depth and appropriate | |
| screw size. | |
| INTENDED USE: | The IntelliSense Drill is intended to bore a hole into bone for |
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Image /page/4/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center, surrounded by a decorative border. To the right of the emblem, the words "MCGINLEY INNOVATIONS" are written in a serif font, with the tagline "REDEFINING MEDICINE" underneath in a smaller font.
insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such as the femur, tibia, fibula, humerus, ulna, and radius.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The IntelliSense Drill demonstrates substantial equivalence to the Stryker Total Performance (TPS) System, K943589. Table 5-1 summarizes the key technological characteristics and features of both the predicates and the new device.
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Image /page/5/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center, followed by the company name "MCGINLEY INNOVATIONS" in gold lettering. Below the company name is the tagline "REDEFINING MEDICINE" in a smaller font.
Table 5-1: Comparison of Proposed Device with Predicate Devices
| Predicate | ||
|---|---|---|
| Feature | IntelliSense Drill | Stryker Total Performance |
| System | ||
| 510(k) Number | K943589 | |
| Intended Use | The IntelliSense Drill is | |
| intended to bore a hole into | ||
| bone for insertion of a screw, | ||
| wire, cable, plate, pin, bolt, | ||
| etc. In Bicortical mode, the | ||
| IntelliSense Drill is indicated | ||
| to be used in bicortical long | ||
| bone, such as the femur, tibia, | ||
| fibula, humerus, ulna, and | ||
| radius. | The Stryker Total | |
| Performance (TPS) System is | ||
| intended for use in the cutting, | ||
| drilling, reaming, | ||
| decorticating, and smoothing | ||
| of bone, teeth and other bone | ||
| related tissue in a variety of | ||
| surgical procedures, including | ||
| but not limited to Dental, | ||
| ENT, Neuro, and Endoscopic. | ||
| It is also usable in the | ||
| placement of cutting of | ||
| screws, wires, pins, and other | ||
| fixation devices. It can also be | ||
| used to cut metal | ||
| Outer profile: Console | Control Console has a 7 inch | |
| diagonal graphical touch | ||
| screen for the user interface. | Bench-top style console with | |
| touch screen display and | ||
| optional irrigation pump. | ||
| Operating Parameters: | User adjusts operating | |
| parameters via touch screen | User adjusts operating | |
| parameters via touch screen | ||
| System Status Display | Displayed on Touch Screen | |
| interface | Displayed on Touch Screen | |
| interface | ||
| Software | Microprocessor | Microprocessor |
| Non-volatile memory | System setup parameters such | |
| as touch screen calibration | ||
| data, cortex breakthrough | ||
| detection parameters and drill | ||
| bit offsets. The setup | ||
| parameters can be viewed, | ||
| updated, and set to their | ||
| default values, using the | ||
| internal USB port on the SBC. | All current setting are stored | |
| when the power is down. | ||
| Energy (input)/Power | ||
| Source | AC | AC |
| Console Controller | ||
| Operation: | commercial bidirectional | |
| motor controller | Bidirectional | |
| Weight | 1.5 Kg (3.3 lbs) | 1.36 Kg (3.0 lbs) [TPS |
| Universal Driver] | ||
| Dimensions: Drill | Drill to fit in envelope of size | Not stated |
| Feature | IntelliSense Drill | Predicate |
| Stryker Total Performance | ||
| System | ||
| Materials: Drill | ||
| Accessories | Stainless Steel AISI 316 | Stainless Steel |
| Materials: | ||
| Sterilization Tray | 5052-H32 Aluminum, | |
| Silicone, 302 Stainless Steel, | ||
| 304 Stainless Steel Radel, 430 | ||
| Stainless Steel | N/A | |
| Materials: Drill Bit | Stainless Steel: AISI 17-4 | N/A |
| Materials: Drill Arm | ||
| Bushing | Polycarbonate | N/A |
| Technological Characteristics | ||
| Design: | The IntelliSense Drill is | |
| comprised of three primary | ||
| subsystems: the Drill Unit | ||
| (with attached cable), the | ||
| Control Console, and the | ||
| proprietary Drill Bits. | The device description of the | |
| Stryker System includes | ||
| drills, shavers, shields, | ||
| guards, motors, attachments, | ||
| saws, wire drivers, collets, | ||
| console, irrigation pump, | ||
| cords, footswitch, handswitch, | ||
| clips, tubing, cutting | ||
| accessories, and sterilization | ||
| cases. | ||
| Bidirectional Motor | Forward / Reverse Trigger | Forward / Reverse Trigger |
| Drill RPM | speeds up to 1,200 rpm | 1,500 rpm [TPS Universal |
| Driver] | ||
| Torque | Peak torque 1.9Nm with 0.3 | |
| Nm continuous torque at | ||
| speeds up to 1,200 RPM | 3.3 Nm [Stryker System | |
| 2000] | ||
| Drill Bit Depth | ||
| Measurement | By monitoring the load placed | |
| upon the drilling mechanism, | ||
| the precise location of the drill | ||
| bit may be determined relative | ||
| to the bone. Secondary depth | ||
| monitoring will provide the | ||
| measurement of the drill bit | ||
| depth and appropriate screw | ||
| size | Manual depth gauge to | |
| determine proper screw size |
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Image /page/6/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center. To the right of the emblem, the words "MCGINLEY INNOVATIONS" are written in gold, with the tagline "REDEFINING MEDICINE" underneath in a smaller font. The overall design is elegant and professional.
Conclusions:
McGinley Innovations provided sufficient information to demonstrate the IntelliSense Drill is substantially equivalent to predicate Stryker Total Performance System (K943589).