(14 days)
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) .
- minopial of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
- acoustic neuroma removal .
Otology procedures would include:
- mastoidectomy ●
- mastoidotomy. .
The Diego Powered Dissector and Drill System is an Electrical Surgical Drill/Shaver. It consists of a console with a separate footswitch and integrated irrigation pump. It supports 4 handpieces (Diego, Stapes, and Viper Straight and Angled). The console is controlled by an 8-bit Microprocessor. The handpieces have suction capability for the Shaver Handpiece and no suction for the Drill Handpiece. Irrigation capability is present with the exception of the Stapes Drill Handpiece. The chucking mechanism varies by handpiece type. The system is sterilizable by Autoclave or EO.
The provided text is a 510(k) premarket notification for the Diego™ Powered Dissector and Drill System. It focuses on demonstrating substantial equivalence to a predicate device (Turbo 7000 System) rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies for an AI/algorithm-based device is not applicable to this document.
However, I can extract the relevant information where available and explicitly state when information is not provided.
Acceptance Criteria and Device Performance
The "acceptance criteria" for this type of device (a powered surgical instrument) are typically met by demonstrating substantial equivalence to a legally marketed predicate device and compliance with recognized safety standards. The document primarily focuses on the latter.
| Acceptance Criterion (Compliance Standard) | Reported Device Performance (Compliance) |
|---|---|
| UL 2601-1 (including Australian deviations) | Designed to meet |
| CSA 22.2 No. 601 | Designed to meet |
| IEC 601-1-1 (EN 60601-1) | Designed to meet |
| IEC 601-1-2 (EN 60601-1-2) | Designed to meet |
| IEC 601-1-4 (EN 60601-1-2) | Designed to meet |
| IEC 61000-4-2 | Designed to meet |
| IEC 61000-4-3 | Designed to meet |
| IEC 61000-4-4 | Designed to meet |
| IEC 61000-4-5 | Designed to meet |
| IEC 529 | Designed to meet |
| ISO 10993-1 | Designed to meet |
| EN 55011. Class B | Designed to meet |
The primary "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to the predicate device (Turbo 7000 System) and compliance with the listed safety standards. The document asserts that the "Diego Powered Dissector and Drill system has the same technological characteristics, power modality and mode of operation as the predicate device" and that the "difference of the processors that control the units should not affect the safety or effectiveness of the device."
Additional Information (Not Applicable or Not Provided for this Device Type)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This is a traditional mechanical/electrical medical device, not an AI/algorithm-based one that would typically require a test set of data for performance evaluation in the context of this question. The assessment is based on design specifications, compliance with standards, and comparison to a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. Ground truth in the context of AI/algorithm performance is not relevant here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This is not an AI-assisted diagnostic or interpretative device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The "ground truth" for this device's safety and effectiveness implicitly relies on established engineering principles, material science, and the safety track record of the predicate device.
-
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of what the document does provide:
- Intended Use & Indications for Use: Clearly defined and found substantially equivalent to the predicate.
- Technological Characteristics Comparison: A detailed table comparing the Diego system to the Turbo 7000 system, showing similarities and minor differences (e.g., processor type, specific handpieces supported, operating speeds for sinus surgery). The submitter argues these differences do not affect safety or effectiveness.
- Compliance with Standards: A list of international and national safety and performance standards the device is designed to meet.
- Regulatory Conclusion: The FDA's finding of substantial equivalence based on the provided information, classifying it as a Class II device.
{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 SystemElectrical Surgical Drill/ShaverEar, Nose and Throat electric or pneumatic surgicaldrill (§ 874.4250) |
|---|---|
| Official Contact: | Greg SredinSr. Regulatory Affairs SpecialistGyrus ENT LLC2925 Appling RoadBartlett, 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 ConfigurationOperating Modes | Console with separate footswitchForward, Reverse, Oscillate | Console with separate footswitchForward, Reverse, Oscillate |
| Operating Speeds | Up to 18,000 rpm for sinus surgery andup to 44,000 rpm for otologic,otoneurologic, and acoustic neuromaprocedures | Up to 7,000 rpm for sinus surgery andup to 44,000 rpm for otologic,otoneurologic, and acoustic neuromaprocedures |
| 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 andAngled | Turbo 7000, Enhanced ESSentialShaver, Stapes, and Viper Straight andAngled | |
| Processor Control | 8-bit Microprocessor, Re-programmable (Factory Only) | FPGA (Field Programmable GateArray) 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 ProceduresEnhanced ESSential Shaver and Stapes |
| Material of Housing | Diego - Stainless Steel Nosecone and Aluminum HousingViper Handpiece - Stainless Steel Nosecone and Aluminum Housing | - Stainless SteelViper Handpiece - Stainless Steel Nosecone and Aluminum HousingTurbo 7000 – Aluminum with Stainless Steel Sleeve |
| Suction Capability | Yes for Shaver HandpieceNo for Drill Handpiece | Yes for Shaver HandpieceNo 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
: 上一
.
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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
Page 4
§ 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.