(37 days)
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.
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.
The provided text describes the Infinity Trident NMT Pod and its 510(k) submission (K042003) to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, the Organon Teknika Corp. Tof-Watch Sx (K992598). However, it does not explicitly detail acceptance criteria in a quantitative table or a study proving the device meets specific acceptance criteria, as one might find for a novel device undergoing extensive clinical trials with predefined performance metrics.
Instead, the submission relies on demonstrating equivalence to an existing device through non-clinical and clinical performance data. Therefore, the information provided below is extracted from the available text, and specific details that are not present in the document (like exact sample sizes for clinical studies, expert qualifications, or detailed ground truth establishment methods) will be noted as "Not specified in the provided text."
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of specific quantitative acceptance criteria. Instead, the "acceptance criteria" can be inferred as demonstrating equivalence to the predicate device in terms of safety and effectiveness for its intended use, particularly for measurements of Train of Four (TOF), Post Tetanic Count (PTC), and Single Twitch Percentage.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use (neuromuscular transmission monitoring) equivalent to predicate device. | "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." (Section 7) |
| Measurement values of TOF, PTC, and Single Twitch Percentage equivalent to 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." (Section 8) "Similar to the TOF-Watch SX, the Infinity Trident NMT pod measures Train of Four (TOF), Post Tetanic Count (PTC), and Single Twitch Percentage." (Section 6) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text for either non-clinical or clinical performance data. The text mentions "the analysis of the data collected" but gives no numbers.
- Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or its country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not specified in the provided text. The submission focuses on direct comparison of device measurements rather than interpretation by human experts to establish ground truth for clinical cases.
4. Adjudication Method for the Test Set
Not specified in the provided text. It appears the "ground truth" or reference for comparison was the measurements from the predicate device itself, not an adjudicated expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. The document describes a comparison between devices, not a study evaluating human reader performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in principle. The assessment of the 'Infinity Trident NMT pod' is described as a standalone device performance comparison against the predicate device. The device automatically measures muscle response, processes the information, and relays it for display. The "analysis of the data collected demonstrates that the measurement values of the test device are equivalent to that of the referenced predicate device." (Section 8). This implies an algorithm-only comparison of readings.
7. Type of Ground Truth Used
The "ground truth" for the performance assessment appears to be the measurements provided by the predicate device (Organon Teknika Corp. Tof-Watch Sx). The study's aim was to demonstrate that the new device's measurements were equivalent to those of the predicate device.
8. Sample Size for the Training Set
Not specified in the provided text. The document refers to "testing" and "data collected" but does not distinguish between training and test sets, nor does it provide sample sizes for any data collection. This device is an NMT monitor, and typically such devices are not "trained" in the machine learning sense, but rather validated through engineering and clinical performance testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of a "training set" for an AI algorithm, as this is a device performance validation, not an AI model. For the performance validation, the predicate device served as the reference standard (ground truth for "equivalence"). The document states the device was "tested in accordance with applicable standards and internal design control procedures."
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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 | ClassificationNumber | 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.
Page 1of 2
COMPANY CONFIDENTIAL
Draeger Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
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- 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.
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- 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
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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.
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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
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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:
Page 1 of 1
§ 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).