(115 days)
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
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.
The provided text describes the Medtronic EM ENT Navigated Suctions device, focusing on its substantial equivalence to predicate devices rather than a standalone performance study with detailed acceptance criteria and ground truth. However, some information can be extracted and inferred from the "Discussion of the Performance Testing" and "Summary of the Technological Characteristics" sections to partially answer your request.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the "Summary of the Technological Characteristics" section, a key performance metric for the navigation aspect is system accuracy.
| Acceptance Criteria (Inferred from "System or Instrument Accuracy Requirements" of Predicate Device) | Reported Device Performance (Subject Device: EM ENT Navigated Suctions) |
|---|---|
| Equivalent to StealthStation® System GoldenEye™ Micro-Magnetic Tracking System and StealthStation® System Update regarding accuracy. | Within a standard controlled environment: navigated peg errors of 1.54 mm at 95% confidence and 99% reliability |
| Within a simulated surgical environment: navigated peg errors of 1.73 mm at 95% confidence and 99% reliability (Note: The document states "5% confidence" but this is highly likely a typo and should be 95% confidence to align with standard statistical reporting and the prior statement. Assuming 95% confidence for consistency, otherwise, a 5% confidence level would be unusual and indicate a low level of certainty). | |
| Suction functionality (Inferred from comparison to Medtronic Manual Suctions) | Yes (Substantially Equivalent to predicate) |
| Instrument Tip Configurations, Materials, Instrument Shaft Configurations, Reusability | Substantially equivalent/same as predicate devices (details are comparative, not absolute performance metrics with specific values) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the accuracy tests (e.g., how many pegs were measured, how many trials). It also does not explicitly state the data provenance (country of origin, retrospective/prospective). The testing appears to be prospective bench testing conducted by the manufacturer, Medtronic Navigation, Inc., in the USA (Louisville, Colorado is listed as the company address).
3. 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)
The document does not mention the involvement of experts for establishing ground truth for the test set. The accuracy testing described (navigated peg errors) implies a more objective, measurement-based ground truth established by physical reference points or precise measurement tools, not subjective expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. Given the nature of the accuracy testing (quantitative measurements), adjudication by expert readers would not be applicable.
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
A MRMC comparative effectiveness study was not conducted. This device is a surgical navigation instrument, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest comparison is its utility in guiding surgeons, but this is not typically assessed through an MRMC study as described for AI in image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The provided text focuses on the device's accuracy in navigation. The "algorithm only" performance is implicitly tested through the reported navigated peg errors. This reflects the system's ability to accurately determine the instrument's position relative to the digital model. There is no separate "human-in-the-loop" performance described in terms of diagnostic effectiveness or reading improvement. The human-in-the-loop component is the surgeon using the navigation system during a procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the accuracy testing, the ground truth was based on physical, objective measurements of "navigated peg errors." This implies the use of precise reference points and measurement systems to determine the true position of the pegs, against which the device's reported position was compared. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not mention a training set. Surgical navigation systems like this are typically developed based on engineering principles and tested for accuracy, rather than "trained" on large datasets like machine learning models. Therefore, the concept of a training set as it applies to AI/ML is not relevant here.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The device's operation relies on electromagnetic tracking and digital modeling, not on a trained algorithm with a ground truth established in the same manner as a diagnostic AI.
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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.
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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
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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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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.
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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 forUse | EM ENT Navigated Suctionsand TrackersEM ENT Instruments areindicated for use in navigatedENT procedures to locate pointson patient anatomy relative to aCT-based or MR-based digitalmodel and to remove fluids,semi-fluid substances, tissue,and bone dust. EM ENTInstruments are indicated for usewith Medtronic computer-assisted surgery systems. TheEM ENT instruments areindicated for use in ENTprocedures such as:•CSF leak repairs related to ENT | The EM ENT instruments canalso be used in the ENT surgicalapproach for the followingprocedures:• Pituitary tumor removal• Skull base procedures• Transsphenoidal procedures• Optic nerve decompressionprocedures• Encephalocele procedures | Medtronic Manual Suctions (non-navigated) Class I, 510k ExemptSame intended useStealthStation® System GoldenEye™Micro-Magnetic Tracking SystemOptionSame Indications for useStealthStation® System UpdateSame Indications for use |
| procedure | |||
| •Intranasal procedures | |||
| •Orbital decompressionprocedures | |||
| •Polyposis procedures | |||
| •Endoscopicdacryocystorhinostomy | |||
| •Sinus procedures, such asmaxillary antrostomies | |||
| •Ethmoidectomies | |||
| •Sphenoidotomies/sphenoidexplorations | |||
| •Turbinate resections and frontalsinusotomies | |||
| LocalizationTechnology | Electromagnetic (proximal tracker attached) | ||
| StealthStation® System UpdateSame | |||
| System orInstrumentAccuracyRequirements | EM ENT Navigated Suctions | StealthStation® System GoldenEye™Micro-Magnetic Tracking System | |
| Within a standard controlled environment: navigated peg errors of1.54 mm at 95% confidence and 99% reliability | OptionEquivalent | ||
| Within a simulated surgical environment: navigated peg errors of1.73 mm at 5% confidence and 99% reliability | StealthStation® System UpdateEquivalent | ||
| SuctionFunctionality | Yes | Medtronic Manual Suctions (non-navigated) Class I, 510k ExemptSubstantially Equivalent | |
| Instrument TipConfigurations | Standard (straight) | Medtronic Manual Suctions (non- | |
| AngleOliveBall/Angle | navigated) Class I, 510k ExemptSubstantially Equivalent | ||
| Materials | EM ENT Navigated Suctions | Medtronic Manual Suctions (non- | |
| Stainless Steel, titanium | navigated) Class I, 510k ExemptSame Material as Suction | ||
| Patient and Instrument Trackers | |||
| Patient contacting cable: AES Santoprene® 8281-90 material withColorant Pantone 301C | StealthStation® System UpdateSame Material as Tracker Cable | ||
| InstrumentShaftConfigurations | Fixed- Straight, Small Straight, 45° frontal, 70° curve, 90° curve, 90°frontal | Medtronic Manual Suctions (non-navigated) Class I, 510k ExemptSubstantially equivalent | |
| Supplied as"Reusable Use" | EM ENT Navigated Suctions | Medtronic Manual Suctions (non- | |
| Yes | navigated) Class I, 510k Exemptreusable | ||
| Patient and Instrument TrackersSupplied Sterile Single Use |
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IX. Identification of Legally Marketing Devices (Predicate Devices)
| Description(Substantial Equivalence Characteristic) | 510(k) Number | ClearanceDate |
|---|---|---|
| Manual Surgical Instruments (non-navigated), Class I(product code: LRC Regulation: 21CFR 874.4420) | Exempt | NotApplicable a |
| StealthStation® GoldenEye™ Micro-Magnetic TrackingSystem 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.
§ 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).