(14 days)
Not Found
Not Found
No
The device description mentions an 8-bit microprocessor controlling the console, which is a standard component for basic device control and does not indicate AI/ML capabilities. There are no mentions of AI, DNN, ML, image processing, or any data sets typically associated with AI/ML training or testing.
No
The device is described as an Electrical Surgical Drill/Shaver used for cutting and removing bone and tissue, which is an active surgical tool, not a therapeutic device.
No
The device's intended use is the cutting and removal of bone and tissue, indicating a surgical, not diagnostic, function.
No
The device description clearly states it consists of a console, footswitch, irrigation pump, and handpieces, which are all hardware components.
Based on the provided information, the Diego Powered Dissector and Drill System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is the cutting and removal of bone and tissue in vivo (within the living body) during surgical procedures. IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the living body) to provide information about a person's health.
- Device Description: The device is described as an Electrical Surgical Drill/Shaver used for surgical procedures. This aligns with a surgical instrument, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Diego Powered Dissector and Drill System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody: ethmoidectory/sphenoethmoidectomy, polypectomy, septoplasty, and procedures such as antrostomy, endoscopic DCR, frontal sinus drill-out, frontal sinus trephination and irrigation, septal spurs removal, trans-spehnoidal procedures. Nasopharyngeal/laryngeal procedures would comprise: adenoidectomy, laryngeal lesion de-bulking, laryngeal polypectomy, tracheal procedures, tonsillectomy. Head & Neck procedures would encompass: soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face, acoustic neuroma removal. Otology procedures would include: mastoidectomy, mastoidotomy.
Product codes (comma separated list FDA assigned to the subject device)
ERL
Device Description
The Diego Powered Dissector and Drill System is an Electrical Surgical Drill/Shaver. It consists of a console with an integrated irrigation pump, a separate electric footswitch, and various handpieces (Diego, Stapes, Viper Straight and Angled). It operates with Forward, Reverse, and Oscillate modes, and has digital speed indication with operating speeds up to 18,000 rpm for sinus surgery and up to 44,000 rpm for otologic, otoneurologic, and acoustic neuroma procedures. The system supports 4 handpieces. The handpieces are made of stainless steel and aluminum, with suction capability for shaver handpieces and irrigation capability for most, with the exception of the Stapes Drill Handpiece. Chucking mechanisms vary by handpiece type. The system is controlled by an 8-bit Microprocessor, which is re-programmable (Factory Only). The device can be sterilized by Autoclave or EO.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose and Throat, Head & Neck including maxillary and mandibular regions of the face, otoneurologic sites.
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.
Turbo 7000 System
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
§ 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.
0
KO 20594
Food and Drug Administration 510(k) Notification - Diego™ Powered Dissector and Drill System February 21, 2002
MAR 8 2002
510(k) Summary of Safety and Effectiveness
| Trade Name:
Common Name:
Classification Name: | Diego Dissector and Drill System
Electrical Surgical Drill/Shaver
Ear, Nose and Throat electric or pneumatic surgical
drill (§ 874.4250) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Greg Sredin
Sr. Regulatory Affairs Specialist
Gyrus ENT LLC
2925 Appling Road
Bartlett, TN 38133 |
| Telephone:
Telefax: | (901) 373-0200
(901) 373-0242 |
| Date Prepared: | February 21, 2002 |
The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody ethmoidectomy/sphenoethmoidectomy, polypectomy, septoplasty, and procedures such as the removal of septal spurs, antrostomy, frontal sinus trephination and irrigation, frontal sinus drill-out, endoscopic DCR and trans-spehnoidal procedures. Nasopharyngeal/laryngeal procedures would comprise adenoidectorny, laryngeal lesion de-bulking, laryngeal polypectomy, tracheal procedures, and tonsillectomy. Head & neck procedures would encompass soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Otology procedures would include mastoidectomy and mastoidotomy.
The Diego Powered Dissector and Drill system that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended uses are substantially equivalent to the described predicate Turbo 7000 System. The Diego Powered Dissector and Drill system is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011. Class B.
The Diego Powered Dissector and Drill System is substantially equivalent to the Turbo 7000 System and difference of the processors that control the units should not affect the safety or effectiveness of the device.
1
Comparison Chart
vs
vs.
Turbo 7000 Shaver/Drill Syster
Console, Footswitch, and Irrigation Pump
| Diego Powered Dissector and Drill System | Turbo 7000 Shaver Drill System | |
|---|---|---|
| Intended Use | General ENT, Head and Neck, and Otoneurologic Procedures | General ENT, Head and Neck, and Otoneurologic Procedures |
| Driver Configuration | ||
| Operating Modes | Console with separate footswitch | |
| Forward, Reverse, Oscillate | Console with separate footswitch | |
| Forward, Reverse, Oscillate | ||
| Operating Speeds | Up to 18,000 rpm for sinus surgery and | |
| up to 44,000 rpm for otologic, | ||
| otoneurologic, and acoustic neuroma | ||
| procedures | Up to 7,000 rpm for sinus surgery and | |
| up to 44,000 rpm for otologic, | ||
| otoneurologic, and acoustic neuroma | ||
| procedures | ||
| Speed Indication | Digital | Digital |
| Footswitch | Electric | Electric |
| Irrigation Pump | Yes, integrated into console | Yes, integrated into console |
| Number of Handpieces supported | 4 | 5 |
| Diego, Stapes, and Viper Straight and | ||
| Angled | Turbo 7000, Enhanced ESSential | |
| Shaver, Stapes, and Viper Straight and | ||
| Angled | ||
| Processor Control | 8-bit Microprocessor, Re- | |
| programmable (Factory Only) | FPGA (Field Programmable Gate | |
| Array) chip. Not re-programmable | ||
| Diego Powered Dissector and Drill System | Turbo 7000 Shaver Drill System | |
| Intended Use | General ENT, Head and Neck, and Otoneurologic Procedures | General ENT, Head and Neck, and Otoneurologic Procedures |
| Enhanced ESSential Shaver and Stapes | ||
| Material of Housing | Diego - Stainless Steel Nosecone and Aluminum Housing | |
| Viper Handpiece - Stainless Steel Nosecone and Aluminum Housing | - Stainless Steel | |
| Viper Handpiece - Stainless Steel Nosecone and Aluminum Housing | ||
| Turbo 7000 – Aluminum with Stainless Steel Sleeve | ||
| Suction Capability | Yes for Shaver Handpiece | |
| No for Drill Handpiece | Yes for Shaver Handpiece | |
| No for Drill Handpiece | ||
| Irrigation Capability | Yes, with the exception of the Stapes Drill Handpiece | Yes, with the exception of the Stapes Drill Handpiece |
| Chucking Mechanism | Diego is Spring Loaded and able to chuck in multiple positions. The Viper handpieces utilize locking rings and the Stapes uses a collet to secure the burrs | Spring Loaded; ESSential Shaver and Turbo 7000 Shaver Blades/Burrs are able to chuck in multiple positions. |
| The Viper handpieces utilize locking rings and the Stapes uses a collet to secure the burrs | ||
| Sterilization Method | Autoclave or EO | Autoclave or EO |
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Handpieces
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three horizontal lines that curve downwards, resembling a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Gyrus ENT LLC c/o Gregory Sredin Sr. Regulatory Affairs Specialist 2925 Appling Road Bartlett, TN 38133
Re: K020594
Trade/Device Name: Diego™ Powered Dissector and Drill System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT Pneumatic or Electric Drill Regulatory Class: Class II Product Code: ERL Dated: February 21, 2002 Received: February 22, 2002
Dear:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
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) 594-4613. 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Food and Drug Administration 510(k) Notification -- Diego™ Powered Dissector and Drill System February 21, 2002
KU20594
510(k) Number: Device Name:
Diego™ Powered Dissector and Drill System
Indications for Use:
The Diego Powered Dissector and Drill System's intended use is the cutting and The Dlego Powered Dissociol and Bhil System. Beath and otoneurologic procedures.
Sinus applications would embody:
- ethmoidectory/sphenoethmoidectomy .
- polypectomy .
- septoplasty and .
- procedures such as .
- antrostomy ●
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation ●
- septal spurs removal .
- trans-spehnoidal procedures .
Nasopharyngeal/laryngeal procedures would comprise:
- adenoidectomy .
- laryngeal lesion de-bulking .
- laryngeal polypectomy .
- tracheal procedures ●
- tonsillectomy .
Head & Neck procedures would encompass:
- soft tissue shaving .
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
- minopial of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
- acoustic neuroma removal .
Otology procedures would include:
- mastoidectomy ●
- mastoidotomy. .
6
Food and Drug Administration 510(k) Notification - Diego™ Powered Dissector and Drill System February 21, 2002
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| Counter | |
| (Per 21 CFR 801.109) |
OR
Over-the-
(Optional Format 1-2-96)
are
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number
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