(37 days)
The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use where continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
The CONTACT™ EMG Rotatable Endotracheal Tube is a flexible, cuffed, Endotracheal tube manufactured from silicone elastomer, reinforced with an embedded stainless steel spiral. Four stainless steel wires are longitudinally embedded in the tube and serve, over an exposed length, as a pair of sensing/recording electrodes designed to interface with an electromyographic monitor.
The provided text describes a 510(k) submission for the Medtronic XOMED CONTACT™ EMG Rotatable Endotracheal Tube. It does not present a detailed study with acceptance criteria and reported device performance in the format requested.
Instead, it's a regulatory document demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device, rather than providing new clinical study data with specific performance metrics and acceptance criteria.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and how established) cannot be extracted from this document, as they pertain to detailed performance validation studies which are not characteristic of a standard 510(k) submission focused on substantial equivalence.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance acceptance criteria in a new study.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document states that "In-house laboratories conducted studies verifying the design of this device; all followed scientific protocols." However, it does not specify the nature, sample size, or provenance of any test sets used in these "in-house" studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. As no specific test set data is presented for performance evaluation, there is no mention of expert involvement in establishing ground truth.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No, a MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission is for a medical device (endotracheal tube with EMG detection), not an AI-assisted diagnostic tool that would typically involve a reader study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This device is a component for use with an electromyographic monitor and directly interfaces with human physiology. It's not an algorithm operating in a standalone capacity.
7. The Type of Ground Truth Used:
This information is not provided. The document mentions "in-house laboratories conducted studies verifying the design," but it does not detail how ground truth was established for any specific performance evaluations.
8. The Sample Size for the Training Set:
This information is not provided. The concept of a "training set" typically applies to AI/ML models, which is not the focus of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established:
This information is not provided.
Summary of Conclusions from the Submission:
The document states:
- "In-house laboratories conducted studies verifying the design of this device; all followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7." - This indicates internal testing was performed, but details are not published here.
- "The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the specified indication(s)." - This is the core claim of substantial equivalence.
- "The risks of the subject device, as well as the benefits to the patient, are the same as those attributed to the use of the predicate devices." - Further reinforcing substantial equivalence.
The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence to a previously cleared predicate device, rather than meeting specific novel performance benchmarks. The "study" here is the entire 510(k) submission, comparing the new device's design, materials, and intended use to existing devices. The key comparison is provided in the table on page 2, highlighting similarities and differences with the predicate devices (K003745 and K925640).
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MAR 3 - 2005
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Summary of 510(k) Submission: CONTACT™ EMG Rotatable Endotracheal Tube
| Name andaddress ofsubmitter | Medtronic Xomed Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216Contact: David S. DoddPhone: (904) 332-8746Date Prepared: January 24, 2005 |
|---|---|
| Identificationof Devices | Trade name: CONTACT™ EMG Rotatable Endotracheal Tube(name not finalized and may change at a later date) Common or usual name: Endotracheal Tube with EMG Detectionelectrodes, EMG ET Tube Classification Name(s):Surgical Nerve Stimulator/locator (per 21 CFR §874.1820)Tracheal Tube, Inflatable Cuff (per 21 CFR §868.5730 and868.5750) FDA Classification: Class II |
| PredicateDevice(s) | Xomed EMG Endotracheal Tubes (K925640)., and RLN Systems Inc., Laryngeal Surface Electrode-EndotrachealTube (LSE-ET) (K003745) |
| Description ofDevice | The CONTACT™ EMG Rotatable Endotracheal Tube is a flexible,cuffed, Endotracheal tube manufactured from silicone elastomer,reinforced with an embedded stainless steel spiral. Four stainlesssteel wires are longitudinally embedded in the tube and serve, overan exposed length, as a pair of sensing/recording electrodesdesigned to interface with an electromyographic monitor. |
| Continued on next page |
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KOS-0162
| Summary of 510(k) Submission: |
|---|
| CONTACT™ EMG Rotatable Endotracheal Tube, Continued |
The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as Intended Use a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use where continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
| Conclusionsdrawn fromstudies | Validity ofScientific Data | In-house laboratories conducted studies verifyingthe design of this device; all followed scientificprotocols. The data were determined to bescientifically valid under 21 CFR 860.7. |
|---|---|---|
| SubstantialEquivalence | The data presented in this Premarket Notificationsupport that the subject device is safe and effectiveand performs in the same manner as the predicatedevices when used in accordance with the labeleddirections for use and for the specifiedindication(s). | |
| Risk andBenefits | The risks of the subject device, as well as thebenefits to the patient, are the same as thoseattributed to the use of the predicate devices. |
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COMPARISON OF SUBJECT DEVICE TO PREDICATE DEVICES
| Predicate Device:(K003745) | Predicate Device:(K925640) | Subject Device: | |
|---|---|---|---|
| RLN Systems Inc.Laryngeal SurfaceElectrode-ET(LSE-ET) | Xomed EMGEndotracheal Tube | New Xomed EMGEndotracheal Tube | |
| Laryngeal SurfaceElectrode | Yes | Yes | Yes |
| Endolaryngeallocation | Yes | Yes | Yes |
| Functions withcommercial EMGunits? | Yes | Yes | Yes |
| Number of discreteelectrodes? | 2 | 4 | 4 |
| Number ofchannels? | 1 | 2 | 1 |
| Electrode Surface | Carbon w/Ag | Stainless Steel Wire | Stainless Steel Wire |
| Intended Use | Intended to be used asa disposable, self-adhesive electrodeattached to anendotracheal tube andpositioned forcontinuous EMGmonitoring of the larynxduring surgicalprocedures. It isintended for use only bya licensed physicianand in conjunction witha commerciallyavailable, medicalgradeelectromyographicmonitor. | Intended for use as atracheal tube for theadministration ofanesthesia gases andto maintain an openairway for the patientduring surgery. TheEMG electrodes areintended to serve ascontact electrodes withthe vocal cords of thepatient and whenconnected to an EMGmonitor, the wireelectrodes facilitate theintra-operativemonitoring of the vocalcords for locating andmapping the RecurrentLaryngeal Nerve and itsbranches duringsurgery of the neck. | Intended for use as ameans of providing bothan open airway forpatient ventilation andfor intra-operativemonitoring of EMGactivity of the intrinsiclaryngeal musculaturewhen connected to anappropriate EMGmonitor.The EMG Tube isindicated for use wherecontinuous monitoringof the integrity of thenerves supplying thelaryngeal musculatureis required duringsurgical procedures. |
| Tube Lengths | N/A | Approx. 12.8 inches | Approx. 12.8 inches |
| TubeInside Diameter | N/A | 4.0 – 8.0 mm | 5.0 - 8.0 mm |
| Tube material | N/A | Silicone | Silicone |
| Cuff material | N/A | Silicone | Silicone |
| Reinforcing material | N/A | N/A | Stainless steel wire |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAR 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Xomed c/o David Dodd Manager, Regulatory Affairs 6743 Southpointe Drive N. Jacksonville, Florida 32216-0980
Re: K050162
K030102
Trade/Device Name: CONTACT™ EMG Rotatable Endotracheal Tube Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: January 25, 2005 Received: January 25, 2005
Dear Mr. Dodd:
We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave reviewed your boother is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce the stated in the encrosure) to logally has of the Medical Device Amendments, or to devices that production in way 26, 1770, the characterial with the provisions of the Federal Food, Drug, and Cosmetic have bech reclassified in accordance with a proval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, matice the detect active as an assimments for annual registration, listing of devices, good Controls provisions of the of the many of the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sach adon Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register
Please be adviscd that FDA's issuance of a substantial equivalence determination does not mean 1 tease be act bod that 7 27 vination that your device complies with other requirements of the Act or that 117A has made a decemination and inistered by other Federal agencies. You must comply with ally 1 ederal shatates and regulared to: registration and listing (21 CFR Part an the Act 3 requirements medial good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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) 827-8910. 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/industry/support/index.html.
Sincerely vours.
A. Ralph 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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: CONTACTTM EMG Rotatable Endotracheal Tube
Intended Use/Indications For Use
The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use where continuous monitoring of the integrity of the The INTS Tues is in the laryngeal musculature is required during surgical procedures.
Prescription Use (Part 21 CFR Subpart D) AND/OR
Over-the-Counter Use (Part 21 CFR Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kaurt H. Baker
510(k) Number K050162
103/158
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.