(88 days)
No
The summary describes a powered dissector and drill system integrated with an image-guided surgery system for real-time tracking. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device is a surgical tool used for cutting and removing bone and tissue, which is an intervention, not a therapeutic treatment itself aiming to cure or alleviate a disease.
No
The device is described as a "Powered Dissector and Drill System" intended for "cutting and removal of bone and tissue" in various surgical procedures. Its function is to perform physical interventions, not to diagnose conditions. While it is equipped with an image-guided surgery system for real-time tracking, this aids in surgical precision, not diagnosis.
No
The device description explicitly states it is a "Powered Dissector and Drill System Handpiece" which is a hardware component. While it integrates with image-guided surgery systems (which likely include software), the core device being modified and described is a physical tool.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting and removing bone and tissue within the body during various ENT, Head & Neck, and otoneurologic procedures. IVDs are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a powered dissector and drill system, which is a surgical tool. It is being modified to integrate with an image-guided surgery system, which assists in surgical navigation, not in analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a surgical instrument used for performing procedures directly on the patient's body, which falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system 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 .
- antrostomy .
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation .
- septal spurs removal .
- trans-shehnoidal 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)
HAW
Device Description
The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ENT, Head & Neck, otoneurologic procedures, Sinus, Nasopharyngeal, laryngeal, maxillary and mandibular regions of the face, Otology
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.
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.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
1630343
Food and Druq Administration
January 31, 2003
510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece
MAY = 2 2003 510(k) Summary
| Submitter's Name:
Submitter's Address:
Submitter's Telephone Number: | Gyrus ENT LLC
2925 Appling Road, Bartlett, TN 38133
901.373.0200 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Sredin |
| Date Summary Prepared: | January 31, 2003 |
| Proprietary Name: | Diego™ Powered Dissector Handpiece
with Starlink™ Image Guided Adapter
Mounting Interface |
| Common Name: | Instrument, Stereotaxic |
| Classification Name: | Instrument, Stereotaxic |
| Classification | Class II |
| Classification Panel: | Neurology |
| Device Product Code | HAW |
Subject Device Description
The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.
Applicable 510(k)'s
| Manufacturer | Submission Name | FDA Clearance |
|---|---|---|
| BrainLAB AG | Kolibri IGS System | K014256 |
| BrainLAB AG | Vectorvision2 IGS System | K003589 |
Subject Device Intended Use
The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- ethmoidectomy/sphenoethmoidectomy .
1
Food and Drug Administration
January 31, 2003
510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece
- 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 .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "HUMAN SERVICES • USA" and "DEPARTMENT OF" arranged around the top and bottom of the circle, respectively. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or progress.
MAY - 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gregory Sredin Senior Regulatory Affairs Specialist Gyrus ENT LLC 2925 Appling Road Bartlett, Tennessee 38133
Re: K030343
Trade/Device Name: Diego™ Powered Dissector Handpiece with Starlink™ Image Guided Adapter Mounting Interface
Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 21, 2003 Received: February 3, 2003
Dear Mr. Sredin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Gregory Sredin
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) 594-4659. 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) you may obtain. 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,
Miriam a. Provost
(W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Food and Drug Administration
January 31, 2003 510(k) Notification – Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece
Ko30343 510(k) Number:
Device Name: Diego™ Powered Dissector and Drill System Handpiece with Image Guided Surgery System Interface,
Indications for Use:
The intended use of the Diego Powered Dissector and Drill System is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- ethmoidectory/sphenoethmoidectorny .
- polypectomy ●
- septoplasty and .
- procedures such as .
- antrostomy .
- endoscopic DCR ●
- frontal sinus drill-out 해
- frontal sinus trephination and imgation
- septal spurs removal .
- . trans-spehnoidal procedures
Nasopharyngeal/laryngeal procedures would comprise:
- adenoidectory .
- laryngeal lesion de-bulking ●
- laryngeal polypectomy ●
- tracheal procedures ●
- tonsillectomy ●
Otology procedures would include:
- mastoidectomy .
- mastoidotomy. ●
- 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 ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K030343
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-the-Counter
(Optional Format 1-2-96)