(254 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is indicated for electro-physiological testing, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is indicated for "electro-physiological testing," which involves measuring physiological responses to diagnose conditions related to pelvic organs. This aligns with the definition of a diagnostic device.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the "Solar Neuro Module" is software-only or includes hardware components for electro-physiological testing.
Based on the provided information, the Solar Neuro Module is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes electro-physiological testing of pelvic organs, including nerve conduction, reflex, and EMG tests. These are tests performed on the patient's body to measure electrical activity, not tests performed on samples taken from the patient's body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Solar Neuro Module's function falls under the category of in vivo diagnostic or monitoring devices, as it interacts directly with the patient's body.
N/A
Intended Use / Indications for Use
The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.
Product codes (comma separated list FDA assigned to the subject device)
84 GWF, 84 JXE, 78 FEN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pelvic organs
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services.
MAR - 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karin Ogink-Somhorst Quality Assurance and Regulatory Affairs Manager Medical Measurement Systems, B.V. Colosseum 25, 7521 PV Enschede P.O. Box 580, 7500 AN Enschede THE NETHERLANDS
Re: K031930
Trade/Device Name: Solar Neuro Module Regulation Number: 21 CFR §882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: 84 GWF Regulation Number: 21 CFR §882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: 84 JXE Regulation Number: 21 CFR 876.§1620 Regulation Name: Urodynamics measurement system Regulatory Class: II Exempt Product Code: 78 FEN Dated: January 29, 2004 Received: February 2, 2004
Dear Ms. Ogink-Somhorst:
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 for are navaior 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 (sce 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (scctions 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocglif marketing your antial equivalence of your device to a legally premarket notification. The FDA inding of sacculting of saccomments of this, 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 on If you desire specific advice for your device on our are of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of the production and and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Othce of Compliance at (301) 594-4057. Tass, part 807.97) you may obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain of Sma by reference to premarket notification (21Gr Act on 1) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } information on your responsibilities unect Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-demoments htt Manufacturers, International and Consumior Pissional Posted on the Marian an html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
Indications for Use
510(k) Number (if known): K031930
Device Name:
Solar Neuro Module
Indications For Use:
The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.
Prescription Use
(Part 21 CFR 801 Subpart D)
Yes
AND/OR
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)
Nancy C. Gordon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Page 1 of __
No