(70 days)
No
The summary describes a powered surgical dissection and drill system with added RF coagulation capabilities. There is no mention of AI or ML in the intended use, device description, or any other section.
No
This device is for cutting and removing tissue in surgical procedures, not for treating disease or health conditions.
No
The device's intended use is "cutting and removal of soft and hard tissue" and it provides "coagulation in addition to powered dissection." These are therapeutic, not diagnostic, functions.
No
The device description explicitly states it is a "System Console" and mentions "handpieces with new RF blades," indicating it is a hardware device with software components, not a software-only device.
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 the "cutting and removal of soft and hard tissue" in various surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical system with a console, handpieces, and blades for dissection and coagulation. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device performs a surgical function directly on the patient.
N/A
Intended Use / Indications for Use
The Diego RF Powered Dissector and Drill System's intended use is the cutting and ablating of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications include:
- 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
- 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
ERL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, Throat, Head & Neck, Sinus, Nasopharyngeal, Laryngeal, Maxillary, Mandibular
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)
K020594, K994365, K012314, K031675, K021777, K030108, K001986
Reference Device(s)
Not Found
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.
0
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 pneumatic |
| surgical 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 Drill | ||
| System | Gyrus ENT LLC | |
| Bartlett, TN 38133 | K020594 | |
| Smith & Nephew Dyonics® | ||
| ElectroBlade™ Arthroscopy | ||
| System | Smith & Nephew, Inc. | |
| Endoscopy Division | ||
| Andover, MD 001810 | K994365 | |
| K012314 | ||
| K031675 | ||
| Gyrus ENT Plasmacision | Gyrus ENT LLC | |
| Bartlett, TN 38133 | K021777 | |
| Arthrocare ENTec Coblator | ||
| Surgery System | Arthocare Corporation | |
| Sunnyvale, CA 94085 | K030108 | |
| Surgitron IEC II | Ellman International | |
| Hewlett, NY 11557 | K001986 |
1
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
2
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 RF
Gyus ENT
(K034004) | Gyrus ENT
Plasmacision
(K021777) | Arthrocare ENTec
Coblation Plastma
Surgery (K030108) | Ellman Surgitron IEC
(K001986) |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | General ENT, Head &
Neck, and
Otoneurologic
Procedures | General ENT, Head &
Neck, and
Otoneurologic
Procedures | General ENT
Procedures | General ENT Procedures |
| Functions | Tissue Removal and
RF Coagulation | Tissue Removal and RF
Coagulation | Ablation, Resection and
Coagulation of Soft
Tissue and Hemostasis
of Blood Vessels | Resection, Ablation, and
Coagulation of Soft
Tissues and Hemostasis
of Blood Vessels |
| Default Power
Rating | 10 Watts | 30 Watts | 284 Watts | Cut 100 Watts
Cut/Coag 75 Watts
Hemo 35 Watts
Fulgurate 35 Watts
Bipolar 40 Watts |
| Maximun
Power Rating | 40 Watts | 40 Watts | 284 Watts | 100 Watts |
3
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
5
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