← Product Code [KOI](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI) · K023342 # NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG (K023342) _Hdc Corp. · KOI · Mar 2, 2004 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K023342 ## Device Facts - **Applicant:** Hdc Corp. - **Product Code:** [KOI](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI.md) - **Decision Date:** Mar 2, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.2775 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Indications for Use The NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the acceleromotive motor neuron, as a peripheral nerve stimulator (without the objective respecific first in a subjective monitoring and for locating specific nerves. It is measuring raneword 191 basyolock procedures to obtain effective regional anesthesia blocks. ## Device Story NeuroTrace III functions as an electrical peripheral nerve stimulator and objective monitor; utilizes accelerometry to measure muscle contractions following motor neuron stimulation; assists clinicians in locating specific nerves during regional anesthesia procedures; provides subjective monitoring capabilities; device components include a kit, regional block cable, nerve mapping probe, nerve monitoring cable, and accelerometer cable; used in clinical settings by healthcare providers to facilitate effective nerve blocks. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices. ## Technological Characteristics Electrical peripheral nerve stimulator; utilizes accelerometry for objective monitoring; current range 0.5 to 5.0 kiloOhms; supports post-tetanic stimulation up to 5 seconds; includes various cables and probes for nerve mapping and monitoring. ## Regulatory 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. ## Predicate Devices - Fisher & Paykel Innervator 242 ([K883868](/device/K883868.md)) - Fisher & Paykel Innervator 252 ([K882438](/device/K882438.md)) - Organon Teknika TOF Watch S ([K992596](/device/K992596.md)) - Life-Tech MaxiStim ([K955031](/device/K955031.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K023342 MAR - 2 2004 # 510(k) Summary NeuroTrace III | Name of Device:
Common or Usual Name:
Classification Name:
CFR Section:
Product Code: | NeuroTrace III
Stimulator, Nerve, Peripheral, Electrical
Electrical Peripheral Nerve Stimulator
21 C.F.R. § 868.2775
KOI | |---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | HDC Corporation
628 Gibraltar Court
Milpitas, CA 95035 | | Phone Number:
Facsimile: | (408) 942-7340
(408) 586-8680 | | Contact Person: | Earl Smart | | Alternate Contact Person: | Jonathan Kahan, Esq.
Hogan & Hartson, L.L.P.
555 Thirteenth Street, NW
Washington, DC 20004-1109
(202) 637-5794 – Telephone
(202) 637-5910 – Facsimile | ## Predicate Devices: Fisher & Paykel Innervator 242 - K883868 Fisher & Paykel Innervator 252 - K882438 Organon Teknika TOF Watch S - K992596 Life-Tech MaxiStim - K955031 ## Intended Use/Indications: The NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the acceleromotive motor neuron, as a peripheral nerve stimulator (without the objective respecific first in a subjective monitoring and for locating specific nerves. It is measuring raneword 191 basyolock procedures to obtain effective regional anesthesia blocks. ## Substantial Equivalence: The NeuroTrace III has the same intended use and indications for use as a combination of predicate devices. Specifically, it is intended for nerve location as a combination of prod as an objective monitor using accelerometry for measuring {1}------------------------------------------------ the muscle contraction following stimulation of the respective motor neuron, as a the muscle oontractions (without the objective measuring function) for perfineral new cannator or locating specific neurons. The NeuroTrace III is Subjective momborning that 10 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 particularly useful in nerve becall predicate devices have the same blocks. Unificary, the reals chnological characteristics, including a current range principics of operation and volumes ranging from 0.5 to 5.0 kiloOhms, maximum from I to oo mix mo the range of currents and resistance values, the use of an power business the muscle contraction, and a post-Tetanic stimulation accession of up to 5 seconds. Thus, the NeuroTrace III can be found to be substantially equivalent. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 2 2004 HDC Corporation C/O Mr. Jonathan Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004-1109 Re: K023342 Trade/Device Name: NeuroTrace III Kit, NeuroTrace III Regional Block Cable, ader Do Race III Nerve Mapping Probe, NeuroTrace Nerve Monitoring Cable, NeuroTrace III Accelerometer Cable Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: KOI Dated: January 29, 2004 Received: January 29, 2004 Dear Mr. Kahan: 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 approvisions 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 NET), it hay 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 - Mr. Kahan 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 rever any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifome (2 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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) rms reter 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, 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 Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: NeuroTrace III Kit, NeuroTrace III Regional Block Cable, NeuroTrace Neurorraco In ing Probe, NeuroTrace Nerve Monitoring Cable, NeuroTrace III Accelerometer Cable Indications for Use: The NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of accelerometry tor mousuring than beripheral nerve stimulator (without the the respective mover, aoulers, aou sective monitoring and for locating objective modering particularly useful in nerve block procedures to obtain effective regional anesthesia blocks. Prescription Use __ V __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jin G. Han 7/27/2004 ision of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number. __ K023342 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K023342](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K023342) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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