(70 days)
The Diego RF Powered Dissector and Drill System's intended use is the cutting and removal of soft and hard tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- applications in the most moidectorny, polypectorny, septoplasty and
- procedures such as endoscopic DCR antrostomy frontal sinus trephination and irrigation frontal sinus drill-out trans-spehnoidal procedures septal spurs removal
Nasõpharyngeal/laryngeal procedures would comprise:
adenoidectomy laryngeal polypectomy tonsillectomy
laryngeal lesion de-bulking tracheal procedures
Head & Neck procedures would encompass:
soft tissue shaving
rhinoplasty (narrowing of the bony vault & 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.
The new Diego RF Powered Dissector and Drill System Console is identical to the console cleared in 510(k) # 020594 (3.08.02). However an additional panel was added to operate the current handpieces with new RF blades that can provide coagulation in addition to powered dissection. Other than coagulation during procedures, there are no new indications for use.
This document is a 510(k) summary for the Diego™ RF Powered Dissector and Drill System. It focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, particularly regarding the addition of RF coagulation capabilities. As such, the information typically requested for AI/ML device evaluations (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable to this type of device submission.
The acceptance criteria for this device and the "study" that proves it meets them are established through a comparison to predicate devices in terms of intended use, functions, and power ratings, rather than a clinical study with performance metrics in the way an AI/ML device would be evaluated. The core of the acceptance is "substantial equivalence."
Here's an breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of medical device clearance:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (an electrical surgical drill/shaver with added RF coagulation), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is compared in terms of features and power, not diagnostic accuracy or clinical outcomes in a quantified sense like an AI product.
| Feature / Criteria (Derived from Predicate Comparison) | Reported Device Performance (Diego™ RF) |
|---|---|
| Intended Use | General ENT, Head & Neck, and Otoneurologic Procedures |
| Functions | Tissue Removal and RF Coagulation |
| Default Power Rating | 10 Watts |
| Maximum Power Rating | 40 Watts |
| Regulatory Class | Class II |
| Product Code | ERL |
| K020594 Equivalence (Console) | Identical to console cleared in 510(k) #020594 (3.08.02) |
| New Features | Additional panel to operate current handpieces with new RF blades for coagulation |
| New Indications for Use | No new indications for use, other than coagulation during procedures (which is a new feature, not a new clinical indication for use beyond the scope of existing procedures). |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. This is not a study involving patient data or a test set in the context of an AI/ML device. The "test" for the Diego RF System involves engineering and performance validation against internal specifications and comparison to predicate devices, not analysis of a clinical dataset.
- Data Provenance: N/A.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth in the context of diagnostic accuracy studies is not relevant here. The ground for this device would be its engineering specifications and safe operation relative to its intended use and predicate devices. Regulatory experts within the FDA review the submission.
4. Adjudication method for the test set
- N/A. This concept is typically applied to clinical studies involving human interpretation or assessment, not for the clearance of a surgical instrument.
5. 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
- N/A. MRMC studies are specific to evaluating AI/ML devices that assist human readers in diagnostic tasks. This device is a surgical tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device is a surgical instrument operated by a human surgeon. It is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A for the definition usually applied to AI/ML devices. For a surgical device, the "ground truth" would relate to its engineering performance as designed (e.g., power output, coagulation effectiveness in a lab setting, safety features) and its stated intended use, all compared against established predicate devices and recognized standards.
8. The sample size for the training set
- N/A. This device is not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
- N/A. This device is not an AI/ML algorithm that requires training data.
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510(k) Summary - K 034004
Diego™ RF Powered Dissector and Drill System
Date Revised February 19, 2004
| MAR - 3 2004 | 510(k) Summary |
|---|---|
| Submitter's Name | Gyrus ENT LLC |
| Submitter's Address | 2925 Appling Road,Bartlett, TN 38133 |
| Submitter's Phone Number | (901) 373-0200 |
| Contact Person | Alicia E. Farage |
| Date Revised: | February 19, 2004 |
| Proprietary Name: | Diego™ RF Dissector and Drill System |
| Common Name: | Electrical Surgical Drill/Shaver |
| Classification Name: | Ear, Nose and Throat electric or pneumaticsurgical drill (§ 874.4250) |
| Classification | Class II |
| Classification Panel | Ear, Nose, Throat |
| Device Product Code | 77 ERL |
KO34004
Subject Device Description
The new Diego RF Powered Dissector and Drill System Console is identical to the console cleared in 510(k) # 020594 (3.08.02). However an additional panel was added to operate the current handpieces with new RF blades that can provide coagulation in addition to powered dissection. Other than coagulation during procedures, there are no new indications for use.
Applicable 510(k)s - Predicate Devices
| Device | Manufacturer | FDA Clearance |
|---|---|---|
| Diego Powered Dissector and DrillSystem | Gyrus ENT LLCBartlett, TN 38133 | K020594 |
| Smith & Nephew Dyonics®ElectroBlade™ ArthroscopySystem | Smith & Nephew, Inc.Endoscopy DivisionAndover, MD 001810 | K994365K012314K031675 |
| Gyrus ENT Plasmacision | Gyrus ENT LLCBartlett, TN 38133 | K021777 |
| Arthrocare ENTec CoblatorSurgery System | Arthocare CorporationSunnyvale, CA 94085 | K030108 |
| Surgitron IEC II | Ellman InternationalHewlett, NY 11557 | K001986 |
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510(k) Summary - K 034004 Diego™ RF Powered Dissector and Drill System Date Revised February 19, 2004
Subject Device Intended Use
The Diego RF Powered Dissector and Drill System's intended use is the cutting and The Dlego KF Fowered Bissector and Brill Cycleme in a broneurologic procedures.
Sinus applications include:
- ethmoidectorny/sphenoethmoidectomy .
- polypectomy .
- septoplasty and .
- procedures such as .
- the removal of septal spurs .
- antrostomy, .
- frontal sinus trephination and irrigation .
- frontal sinus drill-out .
- . endoscopic DCR
- 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
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Comparison Chart of Power Ratings
Diego RF Powered Dissector and Drill System
Vs.
Gyrus ENT Plasmacision vs. Arthrocare ENTec Coblation Plastma Surgery vs. Ellman Surgitron IEC
| Diego RFGyus ENT(K034004) | Gyrus ENTPlasmacision(K021777) | Arthrocare ENTecCoblation PlastmaSurgery (K030108) | Ellman Surgitron IEC(K001986) | |
|---|---|---|---|---|
| Intended Use | General ENT, Head &Neck, andOtoneurologicProcedures | General ENT, Head &Neck, andOtoneurologicProcedures | General ENTProcedures | General ENT Procedures |
| Functions | Tissue Removal andRF Coagulation | Tissue Removal and RFCoagulation | Ablation, Resection andCoagulation of SoftTissue and Hemostasisof Blood Vessels | Resection, Ablation, andCoagulation of SoftTissues and Hemostasisof Blood Vessels |
| Default PowerRating | 10 Watts | 30 Watts | 284 Watts | Cut 100 WattsCut/Coag 75 WattsHemo 35 WattsFulgurate 35 WattsBipolar 40 Watts |
| MaximunPower Rating | 40 Watts | 40 Watts | 284 Watts | 100 Watts |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Gyrus ENT c/o Alicia E. Farage Manager Clinical/Regulatory Affairs 2925 Appling Road Bartlett, TN 38133
Re: K034004
Trade/Device Name: Diego™ RF Powered Dissector and Drill System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: December 22, 2003 Received: December 24, 2003
Dear Ms. Farage:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the 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 encreate for togenty the enactment date of the Medical Device Amendments, or to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices that nave been receasined in assere approval of a premarket approval application (PMA). and Costietic Act (Tec) that to not requent to the general controls provisions of the Act. The You may, dicierole, market the act include requirements for annual registration, listing of general controls provisions of and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassified (600 world) in Existing major regulations affecting your device can may be subject to subject to successions, Title 21, Parts 800 to 898. In addition, FDA may ov round in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I reast of advised that I Dr F instantes a vour device complics with other requirements of the Act mat I DT has made a actern administered by other Federal agencies. You must of any Federal statutes and regulations , including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement; anie (21 CFR Part 807), laboralle (21 OFR Part 820); and if applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Alicia E. Farage
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Ahalye 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
Enclosure
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Food and Drug Administration 1 ood and Brug Administration - Diego™ RF Powered Dissector and Drill System December 22, 2003
Indications for Use:
510(k) Number:
Device Name:
.
Diego™ RF Powered Dissector and Drill System
Indications for Use:
indications for Soci The Diego R. Fowere and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- applications in the most moidectorny, polypectorny, septoplasty and .
- procedures such as endoscopic DCR antrostomy frontal sinus trephination and irrigation frontal sinus drill-out trans-spehnoidal procedures septal spurs removal
Nasõpharyngeal/laryngeal procedures would comprise:
adenoidectomy laryngeal polypectomy tonsillectomy
laryngeal lesion de-bulking tracheal procedures
Head & Neck procedures would encompass:
soft tissue shaving
rhinoplasty (narrowing of the bony vault & 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.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Amalohul- |
|---|
| ----------- |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
§ 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.