(115 days)
Not Found
No
The description focuses on electromagnetic tracking and displaying the instrument's position on pre-existing patient images. There is no mention of AI/ML for image analysis, decision support, or other functions.
No.
The device is described as surgical instruments used for procedures and to remove substances, indicating it's an operative device rather than one primarily intended to treat or resolve a medical condition. Its function of "removing fluids, semi-fluid substances, tissue, and bone dust" and assisting in navigation during surgery aligns with surgical tools, which facilitate treatment but are not therapeutic devices themselves.
No
This device is a surgical navigation and fluid/tissue removal tool, not a diagnostic one. It assists in locating points within a digital model during ENT procedures and removing substances, but it does not diagnose medical conditions.
No
The device description explicitly states it includes "electromagnetically tracked, handheld, re-usable instruments" and "EM ENT Instrument Trackers," which are hardware components. The software is used in conjunction with these physical instruments and tracking system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that this device is an instrument used during surgical procedures (navigated ENT procedures) to locate points on a digital model and to remove substances. It is a surgical tool used directly on the patient, not for analyzing samples taken from the patient.
- Intended Use: The intended use is for surgical navigation and tissue/fluid removal during ENT procedures, not for diagnostic testing of patient samples.
The device is a surgical instrument that utilizes navigation technology, but its purpose is not to perform diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as:
•CSF leak repairs related to ENT procedure
- •Intranasal procedures
- ·Orbital decompression procedures
- •Polyposis procedures
- ·Endoscopic dacryocystorhinostomy
- ·Sinus procedures, such as maxillary antrostomies
- · Ethmoidectomies
- ·Sphenoidotomies/sphenoid explorations
- ·Turbinate resections and frontal sinusotomies
The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:
•Pituitary tumor removal
·Skull base procedures
·Transsphenoidal procedures
·Optic nerve decompression procedures
•Encephalocele procedures
Product codes (comma separated list FDA assigned to the subject device)
PGW
Device Description
The Electromagnetic Ear Nose & Throat (EM ENT) Navigated Suctions are electromagnetically tracked, handheld, re-usable instruments intended to be used with EM ENT Instrument Trackers and ENT software on a Medtronic computer-assisted surgery system. The EM ENT Instrument Tracker is attached to the EM ENT Navigated Suction to track its position. The navigation system's mobile emitter generates a lowenergy magnetic field to locate the tracker mounted on the instrument. Then, the software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-based or MR-based digital model
Anatomical Site
Ear, Nose & Throat (ENT)
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)
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with the StealthStation® System and EM ENT Suction instruments was conducted to ensure acceptable navigational accuracy, suction capability, conformance to design specifications and electrical safety testing. Test samples were subjected to simulated real-life use conditions including repeated functional testing.
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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7. 2016
Medtronic Navigation, Inc. Carey Brenner Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027
Re: K153555
Trade/Device Name: EM ENT Navigated Suctions Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: March 7, 2016 Received: March 8, 2016
Dear Carey Brenner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153555
Device Name
ENT EM Fusion and Supplemental Navigated Instruments
Indications for Use (Describe)
EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as:
·CSF leak repairs related to ENT procedure
- •Intranasal procedures
- ·Orbital decompression procedures
- •Polyposis procedures
- ·Endoscopic dacryocystorhinostomy
- ·Sinus procedures, such as maxillary antrostomies
- · Ethmoidectomies
- ·Sphenoidotomies/sphenoid explorations
- ·Turbinate resections and frontal sinusotomies
The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:
•Pituitary tumor removal
·Skull base procedures
·Transsphenoidal procedures
·Optic nerve decompression procedures
•Encephalocele procedures
| Type of Use (Select one or both, as applicable) |
|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Electromagnetic (EM) ENT Navigated Suctions 510(k) Summary December 11, 2015
- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Carey Brenner Contact: Regulatory Affairs Specialist
- II. Proprietary Trade Name:
EM ENT Navigated Suctions
-
III. Classification Name:
Stereotaxic Instrument -
IV. Classification:
21 CFR 882.4560 Stereotaxic Instrument -
V. Product Codes:
PGW -
VI. Product Description
The Electromagnetic Ear Nose & Throat (EM ENT) Navigated Suctions are electromagnetically tracked, handheld, re-usable instruments intended to be used with EM ENT Instrument Trackers and ENT software on a Medtronic computer-assisted surgery system. The EM ENT Instrument Tracker is attached to the EM ENT Navigated Suction to track its position. The navigation system's mobile emitter generates a lowenergy magnetic field to locate the tracker mounted on the instrument. Then, the software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
4
VII. Indications for Use
EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on patient anatomy relative to a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The ENT instruments are indicated for use in ENT procedures such as:
- . CSF leak repairs related to ENT procedure
- Intranasal procedures ●
- Orbital decompression procedures
- Polyposis procedures
- Endoscopic dacryocystorhinostomy
- Sinus procedures, such as maxillary antrostomies ●
- Ethmoidectomies ●
- Sphenoidotomies/sphenoid explorations
- Turbinate resections and frontal sinusotomies
The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:
- Pituitary tumor removal
- Skull base procedures
- Transsphenoidal procedures
- Optic nerve decompression procedures .
- . Encephalocele procedures
VIII. Summary of the Technological Characteristics
| | Subject Device:
EM ENT Navigated Suction Devices | | Predicate Devices: |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | EM ENT Navigated Suctions
and Trackers
EM ENT Instruments are
indicated for use in navigated
ENT procedures to locate points
on patient anatomy relative to a
CT-based or MR-based digital
model and to remove fluids,
semi-fluid substances, tissue,
and bone dust. EM ENT
Instruments are indicated for use
with Medtronic computer-
assisted surgery systems. The
EM ENT instruments are
indicated for use in ENT
procedures such as:
•CSF leak repairs related to ENT | The EM ENT instruments can
also be used in the ENT surgical
approach for the following
procedures:
• Pituitary tumor removal
• Skull base procedures
• Transsphenoidal procedures
• Optic nerve decompression
procedures
• Encephalocele procedures | Medtronic Manual Suctions (non-
navigated) Class I, 510k Exempt
Same intended use
StealthStation® System GoldenEye™
Micro-Magnetic Tracking System
Option
Same Indications for use
StealthStation® System Update
Same Indications for use |
| | procedure | | |
| | •Intranasal procedures | | |
| | •Orbital decompression
procedures | | |
| | •Polyposis procedures | | |
| | •Endoscopic
dacryocystorhinostomy | | |
| | •Sinus procedures, such as
maxillary antrostomies | | |
| | •Ethmoidectomies | | |
| | •Sphenoidotomies/sphenoid
explorations | | |
| | •Turbinate resections and frontal
sinusotomies | | |
| | Localization
Technology | Electromagnetic (proximal tracker attached) | |
| | | | |
| | | | |
| | | | |
| | | StealthStation® System Update
Same | |
| | | | |
| System or
Instrument
Accuracy
Requirements | EM ENT Navigated Suctions | StealthStation® System GoldenEye™
Micro-Magnetic Tracking System | |
| | Within a standard controlled environment: navigated peg errors of
1.54 mm at 95% confidence and 99% reliability | Option
Equivalent | |
| | Within a simulated surgical environment: navigated peg errors of
1.73 mm at 5% confidence and 99% reliability | StealthStation® System Update
Equivalent | |
| | | | |
| Suction
Functionality | Yes | Medtronic Manual Suctions (non-
navigated) Class I, 510k Exempt
Substantially Equivalent | |
| Instrument Tip
Configurations | Standard (straight) | Medtronic Manual Suctions (non- | |
| | Angle
Olive
Ball/Angle | navigated) Class I, 510k Exempt
Substantially Equivalent | |
| Materials | EM ENT Navigated Suctions | Medtronic Manual Suctions (non- | |
| | Stainless Steel, titanium | navigated) Class I, 510k Exempt
Same Material as Suction | |
| | Patient and Instrument Trackers | | |
| | Patient contacting cable: AES Santoprene® 8281-90 material with
Colorant Pantone 301C | StealthStation® System Update
Same Material as Tracker Cable | |
| Instrument
Shaft
Configurations | Fixed- Straight, Small Straight, 45° frontal, 70° curve, 90° curve, 90°
frontal | Medtronic Manual Suctions (non-
navigated) Class I, 510k Exempt
Substantially equivalent | |
| | | | |
| Supplied as
"Reusable Use" | EM ENT Navigated Suctions | Medtronic Manual Suctions (non- | |
| | Yes | navigated) Class I, 510k Exempt
reusable | |
| | Patient and Instrument Trackers
Supplied Sterile Single Use | | |
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6
IX. Identification of Legally Marketing Devices (Predicate Devices)
| Description
(Substantial Equivalence Characteristic) | 510(k) Number | Clearance
Date |
|--------------------------------------------------------------------------------------------------------|---------------|---------------------|
| Manual Surgical Instruments (non-navigated), Class I
(product code: LRC Regulation: 21CFR 874.4420) | Exempt | Not
Applicable a |
| StealthStation® GoldenEye™ Micro-Magnetic Tracking
System Option | K001284 | 06/12/2000 |
| StealthStation® System Update | K050438 | 06/02/2005 |
a The Class I Medtronic ENT suction devices were released to market on June 6, 1997. They were recently sold to another company in 2014.
X. Discussion of the Performance Testing
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with the StealthStation® System and EM ENT Suction instruments was conducted to ensure acceptable navigational accuracy, suction capability, conformance to design specifications and electrical safety testing. Test samples were subjected to simulated real-life use conditions including repeated functional testing.
XI. Conclusions
The EM ENT Navigated Suction Instruments have been shown through comparative and bench testing to be substantially equivalent to the identified predicate devices.