(261 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or specific performance metrics typically associated with AI/ML devices. The description focuses on mechanical and functional equivalence to a predicate device.
Yes.
The device is intended for cutting, drilling, and removal of bone and tissue in Medical procedures to treat issues.
No
The provided text explicitly states the device's intended use is for "cutting, drilling, and removal of bone, and soft and hard tissue." This describes a surgical tool for treatment, not a device that provides diagnostic information.
No
The device description explicitly details hardware components such as a drill base, attachments, burrs, tubeset, cleaning kit, and tray, and mentions plugging into a console and being activated by a footswitch. The performance studies also include extensive non-clinical and preclinical testing of physical properties and performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a drill and its accessories used in conjunction with a console and footswitch. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical procedures.
N/A
Intended Use / Indications for Use
The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console.
Specific procedures would include Mastoid/Neurotology (Mastoidectomy / Mastoidotomy) and Stapes procedures.
Product codes
ERL, EQJ, FSM
Device Description
The Diego Elite Drill is similar to the drills associated with the predicate Diego® RF Powered Dissector and Drill System cleared under K034004. The Diego Elite Drill is the next generation drill and it is functionally equivalent to the predicate Gyrus ACMI product and other predicates.
The proposed Drill and accessories are to be used only in conjunction with the Diego Elite system (K123429) for Otologic procedures. The Diego Elite system original submission did not include an Otologic drill, and the predicate (K034004) is not compatible with the Diego Elite system.
Accessories include straight and angled attachments, an irrigation clip, various burrs, an irrigation tubeset, a cleaning kit, and a cleaning / sterilization tray. The drill base plugs into the existing Diego Elite console and is activated by the existing Diego Elite footswitch. The drill base and the straight and angled attachments, and irrigation clip are provided non-sterile and are reusable. The burrs and tubeset are provided sterile and are single-use. The cleaning kit is provided non-sterile and is single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft and hard tissue in general ENT, and Otoneurologic
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)
Performance tests were executed to ensure that the system functioned as intended and met design specifications. The following non-clinical and preclinical tests, and usability studies, were conducted:
Non-Clinical / Preclinical Performance: Evidence of safety and effectiveness was obtained from two primary areas:
- non-clinical (electrical, mechanical, functional, biocompatibility, stability) performance testing
- preclinical (simulated use) evaluations and testing
Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: tip vibration, noise, torque strength, endurance, force testing, reliability, leak testing, ship testing, baseline performance testing, age testing, joint strength, environmental conditioning, durability, and other applicable tests.
Stability: Representative sterile samples were subjected to accelerated aging to confirm that the disposable devices maintain functionality and continue to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Representative samples were also subjected to environmental conditioning and ship testing.
Preclinical: Evidence obtained from preclinical simulated use studies demonstrate that the system performs substantially equivalent to the predicate device in relevant aspects associated with usability, cutting, drilling, and removal of tissue. For simulated use testing, the selected test medium (PHACON temporal bone analog) was confirmed to be appropriate for testing based on surgeon input. Testing included:
-Usability aspects such as device setup
-Overall design confidence
-Ergonomics and Control
-Performance
The simulated use testing established substantial equivalence with the predicate device for the intended use based on an assessment of non-clinical performance data, as per 807.92(b). The simulated use testing included feedback from five ENT surgeons using a PHACON temporal bone simulator for simulation of mastoidectomy / mastoidotomy and stapedectomy procedures, and a feasibility DVS study with ten ENT surgeons in which cadaver heads were used in a controlled cadaver lab to perform mastoid and middle ear procedures. The surgeons were asked a series of questions related to the procedures being simulated and in comparison to the predicate device.
The simulated use testing results were considered passing according to defined acceptance criteria in relation to the expectations of the user for the device type (average score of less than (but not equal to) 2.5 must be achieved for each of the three test sections (Set-up, Ergonomics, Performance)) tested across the surgeon evaluation base. Score options: 1 - Exceeds Expectations; 2 - Meets Expectations; 3 - Nearly Meets Expectations; 4 -Does Not Meet Expectations. The subject device scores were as follows:
- Set-up: 1.7
- Ergonomics: 2.0
- Performance: 2.0
The feasibility DVS study results were considered passing according to our acceptance criteria in relation to the expectations of the user for the device type (average score of less than (but not equal to) 2.3 must be achieved for each of the sections (Set-up, Ergonomics, Performance)) tested across the surgeon evaluation base. The individual survey responses show that in total all procedures were performed satisfactorily with the new device. Score options: 1 - Exceeds Expectations; 2 - Meets Expectations; 3 - Does not Meet Expectations. The subject device scores were as follows:
- Set-up: 1.6
- Ergonomics: 1.7
- Performance: 1.5
Testing demonstrated that the device performs substantially equivalent to the main predicate device in relation to the stated indications, and is as safe and effective, and performs as well as or better than the legally marketed predicate.
No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its head and neck. 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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Gyrus Acmi, Inc. Mr. Dolan Mills Sr. Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772
Re: K152744
Trade/Device Name: Diego Elite Drill Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: May 11, 2016 Received: May 12, 2016
Dear Mr. Mills:
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.
1
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 devicerelated adverse events) (21 CFR 803); 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.
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" (21 CFR 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.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Diego Elite Drill
Indications for Use (Describe)
The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console.
Specific procedures would include Mastoid Neurotology (Mastoidotomy) and Stapes procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Diego Elite Drill
General Information
| Manufacturer and 510(k) Submitter: | Gyrus ACMI, Inc., an Olympus company
136 Turnpike Road
Southborough, MA 01772-2104
Phone: 1-800-262-3540
Fax: 1-901-373-0260 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3003790304 |
| Manufacturing Site: | 2925 Appling Road
Bartlett , TN 38113
Phone: 1-800-262-3540
Fax: 1-901-373-0260 |
| Establishment Registration Number: | 1037007 |
| Contact Person: | Dolan Mills
Senior Specialist, Regulatory Affairs |
| Date Prepared: | September 22, 2015 |
Device Description
Classification Name:
ENT Electric or Pneumatic Surgical Drill
| Drill System | Bur, Ear, Nose & Throat | Tray, Surgical Instrument |
|---|---|---|
| 21 CFR 874.4250 | 21 CFR 874.4140 | 21 CFR 878.4800 |
| Ear, Nose, Throat | Ear, Nose & Throat | General & Plastic Surgery |
| ERL | EQJ | FSM |
Regulatory Class Regulation Number Review Panel Product Code
Project Name:
Class 2 21 CFR 874.4250 Ear, Nose, & Throat Panel ERL
Diego Elite Drill (12-002), High Speed Drill
Trade Name(s):
Diego Elite Drill
4
Generic/Common Name:
Electrical Surgical Drill / Shaver Burs, Instrument Tray
Predicate Devices
| Gyrus ACMI Diego® RF Powered Dissector & Drill System: | K034004 |
|---|---|
| Reference Predicates: | |
| Medtronic Midas Rex: | K081277 |
| Gyrus ACMI Diego Elite System: | K123429 |
The Gyrus ACMI predicate has not been subject to a design-related recall.
Product Description
The Diego Elite Drill is similar to the drills associated with the predicate Diego® RF Powered Dissector and Drill System cleared under K034004. The Diego Elite Drill is the next generation drill and it is functionally equivalent to the predicate Gyrus ACMI product and other predicates.
The proposed Drill and accessories are to be used only in conjunction with the Diego Elite system (K123429) for Otologic procedures. The Diego Elite system original submission did not include an Otologic drill, and the predicate (K034004) is not compatible with the Diego Elite system.
Accessories include straight and angled attachments, an irrigation clip, various burrs, an irrigation tubeset, a cleaning kit, and a cleaning / sterilization tray. The drill base plugs into the existing Diego Elite console and is activated by the existing Diego Elite footswitch. The drill base and the straight and angled attachments, and irrigation clip are provided non-sterile and are reusable. The burrs and tubeset are provided sterile and are single-use. The cleaning kit is provided non-sterile and is single-use.
Technological Characteristics
The Drill system is used in the same general way as the predicate RF Diego drills (K034004) and Diego Elite system handpieces (K123429). A reusable drill base connects to the existing Diego Elite console, is recognized by a unique Diego Elite Drill software version, and differentiated from other possible Diego Elite handpiece options. A reusable tip guard, 1 of 5 interchangeable attachments, is connected to the drill; each tip is detected by the drill hardware/software based on its intended use (Mastoid vs. Stapes), and default performance settings (speed, irrigation) are then displayed by the console on the graphical user interface. A disposable burr is then loaded into the drill/guard and locked in to place for use. The total assembly creates a variable speed drill.
5
A new sterile disposable tubeset delivers irrigation via the existing Diego Elite console pump to the operative site through either a guard-attachable clip or a separate suction / irrigation instrument (sold separately). The new tubeset also provides suction capabilities and is compatible with standard OR suction and the existing Diego Elite Suction Module (K123429). The existing Diego Elite footswitch connects to the console and is used to start and stop the drill operation.
Material
The Diego Elite Drill uses the same patient-contacting materials that are utilized in the predicate devices (K123429, K034004), as well as other legally marketed devices manufactured by Gyrus ACMI.
The patient contacting items are classified in accordance with ISO 10993-1, as an external communicating, tissue/bone/dentin device for limited exposure (