(299 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a disposable electrode for EMG monitoring, with no mention of data processing, analysis, or algorithms that would suggest AI/ML.
No
The device is described as an electrode for continuous EMG monitoring, which is a diagnostic function, not a therapeutic one. It's used to monitor a physiological process during surgery, not to treat a condition.
No
The device is used for continuous EMG monitoring during surgical procedures, which is a monitoring function, not a diagnostic one.
No
The device description clearly describes physical electrodes made of materials like polyester film and carbon loaded vinyl, intended to be attached to an endotracheal tube. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Dragonfly Laryngeal Surface Electrode is used in vivo (inside the body) during surgery. It's attached to an endotracheal tube and positioned to monitor electrical activity (EMG) of the larynx. It does not analyze bodily specimens.
- Intended Use: The intended use clearly states it's for "continuous EMG monitoring of the larynx during surgical procedures." This is a physiological monitoring function, not an in vitro diagnostic test.
Therefore, based on the provided information, the Dragonfly Laryngeal Surface Electrode is a medical device used for physiological monitoring in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors:
- Neurovision Medical Products
- Nerveana
- Axon Eclipse
- Medtronic - NIM
- XLTEK EP Works
- Nicolet Viking
- Cadwell Cascade
- Neurosign Avalanche
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
Spes Medica Dragonfly Laryngeal Surface Electrode are single used electrodes for evoked EMG monitoring of the larynx and it to be inserted and retained in position against the larvngeal muscle by use of an endotracheal tube. The Electrodes are intended to be used as disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Spes Medica produces two different families of electrodes: Family A and Family B.
The family A and B mentioned above are the same product because, have been developed with same intended use, design, materials, packaging and other technological characteristics. The manufacturing processes are the same for both configurations (Family A and Family B) but the substrates and the shape of the electrodes are different. Indeed, for the family A the substrate for the Silver ink is a polyester film and for the family B the substrate for the Silver ink is carbon loaded vinyl. Furthermore, both families use the same connection to the EMG unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician
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.
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
§ 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.
0
Spes Medica s.r.l.
510(k)NOTIFICATION Dragonfly Laryngeal Surface Electrodes
510 (k) Summary of safety and effectiveness
AUG 2 4 2010
SUBMITTER INFORMATION
-
A. Company Name:
B. Company Address: -
C. Company Phone: Company Fax:
D. Contact Person:
Spes Medica s.r.l.
Via Europa - Zona industriale Battipaglia (SA) - Italy 84091
- 39 0828 614191 + 39 0828 341788
Alfredo Spadavecchia Quality Assurance Manager Spes Medica s.r.l. e-mail: a.spadavecchia@spesmedica.com
- E. Date Summary Prepared:
October 21, 2009
DEVICE IDENTIFICATION
| A. Device name: | Dragonfly Laryngeal Surface Electrodes |
|---|---|
| B. Trade/Proprietary name: | Dragonfly Laryngeal Surface Electrodes |
| C. Classification name: | Surgical nerve stimulator/locator (21 CFR §874.1820) |
| D. Product code: | ETN |
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
| Predicate device | 510(k) Holder/Applicant | 510(k) number |
|---|---|---|
| LARYNGEAL SURFACE | ||
| ELECTRODE-ENDOTRACHEAL TUBE | RLN SYSTEM, INK | K003745 |
| NEUROSIGN LARYNGEAL | ||
| ELECTRODES | THE MAGSTIM COMPANY | |
| LTD. | K071349 | |
| XOMED-TREACE EMG | ||
| ENDOTRACHEAL TUBEEN | XOMED-TREACE, INC. | K925640 |
1
DEVICE DESCRIPTION
Spes Medica Dragonfly Laryngeal Surface Electrode are single used electrodes for evoked EMG monitoring of the larynx and it to be inserted and retained in position against the larvngeal muscle by use of an endotracheal tube. The Electrodes are intended to be used as disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Spes Medica produces two different families of electrodes: Family A and Family B.
The family A and B mentioned above are the same product because, have been developed with same intended use, design, materials, packaging and other technological characteristics. The manufacturing processes are the same for both configurations (Family A and Family B) but the substrates and the shape of the electrodes are different. Indeed, for the family A the substrate for the Silver ink is a polyester film and for the family B the substrate for the Silver ink is carbon loaded vinyl. Furthermore, both families use the same connection to the EMG unit.
INTENDED USE
The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors:
| Manufacturer and Device name | | | COMPARISON CHART LARYNGEAL SURFACE ELECTRODES
DRAGONFLY LARYNGEAL SURFACE ELECTRODES
(Submitted Product) | | | | | | |
|------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--|--|
| Neurovision Medical Products | | | FAMILY A
New Device | FAMILY B
New Device | LEGALLY MARKETED
PREDICATE DEVICES OF
RLN System Inc.
K003745 | LEGALLY MARKETED
PREDICATE DEVICES OF
Xomed Treace Inc.
K925640 | LEGALLY MARKETED
PREDICATE DEVICES OF
The Magstim Company Ltd.
K071349 | | |
| Nerveana | | Code | Yes | Yes | Yes | Yes | Yes | | |
| Axon Eclipse | | EMG units | Yes | Yes | Yes | Yes | Yes | | |
| Medtronic - NIM | | Electrode attachment | Attached to the surface of the endotracheal tube | Attached to the surface of the endotracheal tube | Attached to the surface of the endotracheal tube | Embedded within the endotracheal tube
Stainless Steel Wire | Attached to the surface of the endotracheal tube
Conductive ink on a polyester substrate | | |
| XLTEK EP Works | | | Silver conductive ink on a polyester substrate | Carbon w/Ag | Carbon w/Ag | | | | |
| Nicolet Viking | | | Trachea/larynx | Trachea/larynx | Trachea/larynx | Trachea/larynx | Trachea/larynx | | |
| Cadwell Cascade | | | Continuous EMG monitoring | Continuous EMG monitoring | Continuous EMG monitoring | Continuous EMG monitoring | Continuous EMG monitoring | | |
| Neurosign Avalanche | | | Yes | Yes | Yes | Yes | Yes | | |
| | | ETO | ETO | ETO | ETO | ETO | | | |
| | | Non-invasive | Non-invasive | Non-invasive | Non-invasive | Non-invasive | | | |
| | | The Laryngeal Surface Electrodes is intended
to be used as disposable, self-adhesive
electrode attached to an endotracheal tube
and positioned for continuous EMG
monitoring of the larynx during surgical
procedures.
It is intended for use only by a licensed
physician and in conjunction with these listed
below medical grade electromyographic
monitors:
Neurovision Medical Products
Nerveana
Axon Eclipse
Medtronic - NIM
XLTEK EP Works
Nicolet Viking
Cadwell Cascade | The Laryngeal Surface Electrodes is intended to
be used as disposable, self-adhesive electrode
attached to an endotracheal tube and
positioned for continuous EMG monitoring of
the larynx during surgical procedures.
It is intended for use only by a licensed
physician and in conjunction with these listed
below medical grade electromyographic
monitors:
Neurovision Medical Products
Nerveana
Axon Eclipse
Medtronic - NIM
XLTEK EP Works
Nicolet Viking
Cadwell Cascade | The Laryngeal Surface Electrodes
is intended to be used as
disposable, self-adhesive
electrode attached to an
endotracheal tube and positioned
for continuous EMG monitoring of
the larynx during surgical
procedures. It is intended for use
only by a licensed physician and
in conjunction with a commercially
available, medical grade
electromyographic monitor | The Xomed EMG
Endotracheal Tube is intended
for use as a tracheal tube for
the administration of
anesthesia gases and to
maintain an open airway for
the patient during the surgery.
The EMG electrodes are
intended to serve as contact
electrodes with the vocal
cords of the patient and when
connected to an EMG monitor,
the wire electrodes facilitate
the intra-operative monitoring
of the vocal cords for locating
and mapping the Recurrent
Laryngeal Nerve and its | The non-invasive Laryngeal
Electrode is intended for use
as an intraoperative method of
monitoring the laryngeal
nerves during thyroid surgery,
and of the Xth cranial nerve
during skull-base surgery | | | |
2
Spes Medica s.r.l
0(k)NOTIFICATION Dragonfly Laryngeal Surface Electrodes
SUBSTANTAL EQUIVALENCE
The Dragonify Laryngel Surface are similar in intended use, design, materials, packaging and other technological characteristics and
Section 9
Page 9-4
3
ﺗ
CONCLUSION
The Dragonfly Laryngeal Surface Electrodes are similar in intended use, design, materials, packaging and other technological characteristics to the predicate devices. After analyzing performance and safety testing, it is the conclusion of Spes Medica s.r.l. that the Dragonfly Laryngeal Surface Electrodes are safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spes Medica s.r.l. %Alfredo Spadavecchia Viale Europa - Zona Industriale 84091 Battipaglia SA, Italy 0828 342168
AUG 2 4 2010
Re: K093373
Trade Name: Dragonfly Laryngeal Surface Electrodes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: July 19, 2010 Received: July 21, 2010
Dear Mr. Spadavecchia:
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. Iisting 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.
5
Page 2 - Mr. Alfredo Spadavecchia
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/vcm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Srinivas Nandkumar, Ph.D.
Branch Chief, Ear. Nose, and Throat Devices Branch Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
K093373
510(k) Number (if known):
Device Name:
Dragonfly Laryngeal Surface Electrodes
Indications for Use:
The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors:
| Manufacturer and Device name |
|---|
| Neurovision Medical Products |
| Nerveana |
| Axon Eclipse |
| Medtronic - NIM |
| XLTEK EP Works |
| Nicolet Viking |
| Cadwell Cascade |
| Neurosign Avalanche |
Prescription Use × (21 CFR 801 Subpart C) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sr. Nani
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
umber K093373
510(k) Number
(Per 21 CFR 801.109)