(37 days)
No
The summary describes a device that measures muscle response to electrical stimulation and processes this information. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The processing described appears to be standard signal processing and calculation of metrics like TOF and PTC.
No
Explanation: The device is described as a monitor that measures muscle response, not one that treats a condition. Its function is diagnostic/monitoring, not therapeutic.
Yes
The device is intended for use as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve, which is a diagnostic function. It also measures key metrics like Train of Four (TOF), Post Tetanic Count (PTC), and Single Twitch Percentage, which are used to assess neuromuscular status.
No
The device description explicitly mentions "NMT sensors" and a "pod" that captures muscle response and skin temperature, indicating the presence of hardware components beyond just software.
Based on the provided information, the Infinity Trident NMT pod is not an In Vitro Diagnostic (IVD) device.
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.
- Infinity Trident NMT Pod Function: The description clearly states that the device measures the muscle response to electrical stimulation of a peripheral nerve. This is a measurement taken directly from the patient's body using surface electrodes, not from a specimen collected from the body.
Therefore, the Infinity Trident NMT pod falls under the category of a physiological monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
The Infinity Trident NMT pod is intended for use as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve.
Product codes
KOI
Device Description
The Infinity Trident NMT Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides automatic measurements of muscle response to electrical stimuli transmitted via surface electrodes placed over a peripheral nerve. The NMT sensors capture the muscle response as well as skin temperature. The pod then processes this information and relays it to the Infinity patient monitor for display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve
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)
The Infinity Trident NMT pod was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.
The analysis of the data collected demonstrates that the measurement values of the test device are equivalent to that of the referenced predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).
0
SEP - 1 2004
510(k) SUMMARY
as required per 807.92(c)
-
- Submitters Name, Address:
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: July 23, 2004
- Submitters Name, Address:
-
Trade Name, Common Name and Classification Name: 2.
- A. Trade Name: Infinity Trident NMT Pod
- Common Name, Classification Name, Class and Regulation Number: B
| Common Name | Classification
Number | Class | Regulation Number |
|-----------------------------------------|--------------------------|-------|-------------------|
| Stimulator, Nerve, Peripheral, Electric | KOI | II | 868.2775 |
- Predicate Device Identification: 3. Organon Teknika Corp. Tof-Watch Sx K992598
- Device Description: 4.
The Infinity Trident NMT Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides automatic measurements of muscle response to electrical stimuli transmitted via surface electrodes placed over a peripheral nerve. The NMT sensors capture the muscle response as well as skin temperature. The pod then processes this information and relays it to the Infinity patient monitor for display.
- Intended Use: 5.
The Infinity Trident NMT pod is intended for use as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve.
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COMPANY CONFIDENTIAL
Draeger Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
1
-
- Comparison to predicate device
Similar to the TOF-Watch SX, the Infinity Trident NMT pod measures Train of Four (TOF), Post Tetanic Count (PTC), and Single Twitch Percentage.
- Comparison to predicate device
7. Assessment of non-clinical performance data for equivalence:
The Infinity Trident NMT pod was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.
- Assessment of clinical performance data for equivalence: 8. The analysis of the data collected demonstrates that the measurement values of the test device are equivalent to that of the referenced predicate device.
-
- Biocompatability: Not applicable
-
- Sterilization: Not applicable
IEC 60601-1 11. Standards and Guidances:
Page 2 of 2
COMPANY CONFIDENTIAL
Draeger Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tei: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2004
Ms. Penelope H. Greco Regulatory Submissions Manager Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923
Re: K042003
Trade/Device Name: Infinity Trident NMT Pod Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: KOI Dated: July 23, 2004 Received: July 24, 2004
Dear: Ms. Greco:
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 (1 ml ), it a 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.
3
Page 2 - Ms. Greco
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. or the recess and 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 (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.
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) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Infinity Trident NMT Pod
Indications for Use:
The Infinity Trident NMT pod can be used as an objective neuromuscular transmission monitor The milliny I rident NNT pour can or assures as the material nerve.
Prescription Use_ > (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cun Svelson
(Division Sign-Om (Division Sign-Oth)
Division of Anesthesiology, General Hospital.
Control Control Dental Devices Division Control, De
510(k) Number:
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