(59 days)
For the measurement of galvanic skin response.
The development of the Epi-Scan P100 has been based on the combined principles of instrumentation and the electrophysiological effects of innervation of the sweat glands. This provides a noninvasive, painless instrument system fore the quantitative measurement of Selective Tissue Conductance, which has been operationally defined as "…the relative ability of biological tissue to conduct a weak (DC) electrical signal, which is applied for a selected period of time to a selected, limited and restricted surface area of that tissue ... " and which shares those same neuroanatomic reflex pathways as other tests of sympathetic skin activity or regional perspiration levels.
The provided text is a 510(k) premarket notification for the EDX Epi-Scan P100 device, which is a Galvanic Skin Response Measurement Device. This document primarily focuses on establishing substantial equivalence to a predicate device (K874850, Epi-Scan Selective Tissue Conductance Meter) and does not contain detailed information about acceptance criteria or a specific study proving the device meets particular performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text. The document is a regulatory submission for market clearance based on equivalence, not a direct report of a performance study with detailed statistical outcomes.
Here's what can be extracted based on the input, with clear indications where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device K874850: | The Epi-Scan P100 was compared to predicate device K874850 in the areas below and found to have similar technological characteristics and to be equivalent. |
| - Indications for use | Similar |
| - Skin conductance range | Similar |
| - Display | Similar |
| - Components | Similar |
| - Standards met | Similar |
| - Software | Similar |
Explanation: The document does not provide specific quantitative acceptance criteria (e.g., minimum accuracy, specificity, sensitivity values) or numerical performance metrics. Instead, "acceptance" is framed within the context of substantial equivalence to a legally marketed predicate device. The claim is that the technological characteristics of the new device are similar to the predicate, implying that if the predicate performed adequately, the new device will as well.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided. The document does not describe a clinical performance study with a test set of subjects or data.
- Data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set. Equivalence is claimed based on engineering and design characteristics compared to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no described test set or adjudication process relating to clinical performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was described. The device is a Galvanic Skin Response Measurement Device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies standalone performance comparison of the device's characteristics against the predicate device's characteristics; however, this is not a detailed "standalone performance study" in the typical sense of algorithm-only evaluation for diagnostic accuracy. It's a review of technological features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not directly applicable in the conventional sense of a clinical performance study. The "ground truth" for the substantial equivalence claim is the performance and characteristics of the legally marketed predicate device (K874850). The new device's characteristics (indications, skin conductance range, display, components, standards, software) are evaluated against those of the predicate device.
8. The sample size for the training set
- Not provided. The document does not describe a machine learning algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. No machine learning algorithm or training set is described.
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EDA Epi Scan
K032935 1/2
NOV 2 0 2003
EDX Epi-Scan
130 Main Road Huntsville, AL 35811 256-858-6666
SUMMARY
| Submitter's name: | EDX Epi-Scan |
|---|---|
| Address: | 130 Main Road |
| Huntsville, AL 35811 | |
| Phone: | 256-858-6666 |
Greg Holland Requlatory Specialists. Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
Date the summary was prepared: September 4, 2003
Name of the device: Trade or proprietary name: Common or usual name:
Classification name:
Name of contact person:
EDX Epi-Scan EDX Epi-Scan Galvanic Skin Response Measurement Device Galvanic Skin Response Measurement Device
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
K874850. Epi-Scan Selective Tissue Conductance Meter submitted by EDX Epi-Scan Inc
Description of the device:
The development of the Epi-Scan P100 has been based on the combined principles of instrumentation and the electrophysiological effects of innervation of the sweat glands. This provides a noninvasive, painless instrument system fore the quantitative measurement of Selective Tissue Conductance, which has been operationally defined as "…the relative ability of biological tissue to conduct a weak (DC) electrical signal, which is applied for a selected period of time to a selected, limited and restricted surface area of that tissue ... " and which shares those same neuroanatomic reflex
REGULATORY SPECIALISTS, INC.
Page 8
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pathways as other tests of sympathetic skin activity or regional perspiration levels.
Indications:
For the measurement of galvanic skin response.
Summary of the technological characteristics of our device compared to the predicate device:
The Epi-Scan Selective Tissue Conductance Meter, K874850 and Epi-Scan P100 were compared in the following areas and found to have similar technological characteristics and to be equivalent.
Indications for use Skin conductance range Display Components Standards met Software
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EDX Epi-Scan c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606
Re: K032935
Trade/Device Name: Epi-Scan P100 Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: October 23, 2003 Received: October 31, 2003
Dear Mr. Holland:
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 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050,
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Page 2 - Mr. Greg Holland
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 vour 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) 594-4659. 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 vours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | K032935 |
|---|---|
Device Name: _ Epi-Scan P100
Indications For Use:
For the measurement of galvanic skin response.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K632935 510(k) Number_
REGULATORY SPECIALISTS, INC.
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.