(219 days)
No
The description focuses solely on the physical components and intended use of an EEG electrode array for signal acquisition, with no mention of data processing or analysis capabilities, let alone AI/ML.
No.
The device is described as an EEG electrode array for recording STAT EEGs, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The NeuroCap is an EEG electrode array used for recording STAT EEGs, which is a method of acquiring physiological signals for diagnostic purposes. It is intended for use with an EEG device and for prescription use in healthcare facilities.
No
The device description explicitly states that the NeuroCap is an "Electroencephalogram (EEG) electrode array" and a "disposable electrodes system made of polycarbonate based film with applied conductive paths and sensors." This indicates it is a physical hardware component, not solely software.
Based on the provided information, the NeuroCap (model DEC18) 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 diagnostic purposes.
- NeuroCap's Function: The NeuroCap is an electrode array used to record electrical activity directly from the patient's scalp (EEG). It is applied externally to the body and does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use is for recording STAT EEGs in a clinical setting, which is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, the NeuroCap falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older.
Product codes
GXY
Device Description
The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older. NeuroCap is intended for use with amplifiers of medical signals equipped with appropriate plug or by special adapter will not be included in subject device). NeuroCap is a disposable electrodes system made of polycarbonate based film with applied conductive paths and sensors. Each sensor is equipped with a sponge with a conductive gel for providing sensor contact with the skin surface. NeuroCap is fixed on the patient by means of adhesive tape. NeuroCap could be connected to amplifier directly or via a special adapter.
The NeuroCap disposable electrode system is 16 channels. The headband is non-sterile and disposable for single patient use and designed to be used with the Neuro EEG device (K173460) for EEG acquisition and recording. NeuroCap is intended for prescription use in healthcare facilities, or clinical research environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients of 18 years of age and older.
Intended User / Care Setting
ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older.
Trained Technician
prescription use in healthcare facilities, or clinical research environments.
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 proposed NeuroCap has been evaluated the safety and performance by lab bench testing as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Risk management according to ISO 14971:2012 standards
- Performance test according to ANSI/AAMI EC12:2000 Disposable ECG electrodes standards
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 27, 2018
Memory MD INC % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510006 Cn
Re: K172866
Trade/Device Name: NeuroCap Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 7, 2018 Received: February 12, 2018
Dear Cassie Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172866
Device Name NeuroCap
Indications for Use (Describe)
The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating of STAT EEGs in patients of 18 years of age and older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: MemoryMD INC Establishment Registration Number: Applying Address: 205 E 42nd Street, 14th Floor New York, New York 10017 USA Phone: +1 (215)341-6373 Fax: +7 (8634) 614-323 Contact Person: Abdus-Salaam Muwwakkil, Chief Quality Officer E-mail: abdus@memorymd.com
Application Correspondent:
Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: NeuroCap Model: DEC18 Common Name: Cutaneous electrode Disposable Classification name: Cutaneous electrode Disposable Review Panel: Neurology Product Code: GXY Regulation Class: 2 Regulation Number: 882.1320
3. Predicate Device Information
510(K) Number: K092828 Company Name: HydroDot, Inc. Trade/Device Name: StatNet Regulation Number: 882.1320 Requlatory Class: 2 Product Code: GXY
4. Device Description
The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in
4
| Sponsor: | Memory MD INC |
|---|---|
| Subject Device: | NeuroCap, Model: DEC18 |
| Document Name: | FDA 510(k) Submission Report |
patients of 18 years of age and older. NeuroCap is intended for use with amplifiers of medical signals equipped with appropriate plug or by special adapter will not be included in subject device). NeuroCap is a disposable electrodes system made of polycarbonate based film with applied conductive paths and sensors. Each sensor is equipped with a sponge with a conductive gel for providing sensor contact with the skin surface. NeuroCap is fixed on the patient by means of adhesive tape. NeuroCap could be connected to amplifier directly or via a special adapter.
The NeuroCap disposable electrode system is 16 channels. The headband is non-sterile and disposable for single patient use and designed to be used with the Neuro EEG device (K173460) for EEG acquisition and recording. NeuroCap is intended for prescription use in healthcare facilities, or clinical research environments.
5. Intended Use / Indications for Use
The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older.
6. Test Summary
The proposed NeuroCap has been evaluated the safety and performance by lab bench testing as following:
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Risk management according to ISO 14971:2012 standards
- � Performance test according to ANSI/AAMI EC12:2000 Disposable ECG electrodes standards
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of the proposed NeuroCap is substantially equivalent to the predicate devices quoted below. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Device Name | |||
| and Model | NeuroCap (Model: DEC18) | StatNet (model: 3100, 3110) | -- |
| 510(k) Number | Applying | K092828 | -- |
| Product Code | GXY | GXY | SE |
5
| Sponsor: | Memory MD INC |
|---|---|
| Subject Device: | NeuroCap, Model: DEC18 |
| Document Name: | FDA 510(k) Submission Report |
| Intended Use /
Indications for
Use | The NeuroCap (model
DEC18) is an
Electroencephalogram
(EEG) electrode array
intended for use in ER
(emergency room), ICU
(intensive care unit) and OR
(operating room) for
recording of STAT EEGs in
patients of 18 years of age
and older. | An Electroencephalogram
(EEG) electrode array intended
for use in the ER, ICU and OR
for recording of STAT EEGs in
patients of 18 years of age and
older. | SE |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Patient
population | Adults only (>18 years old) | Adults only (>18 years old) | SE |
| User | Trained Technician | Trained Technician | SE |
| Number of
electodes | 18 | 18 | SE |
| Electrode
material | Ag/AgCl | Ag/AgCl | SE |
| Type of
conducting
medium | Conductive gel | Conductive gel | SE |
| Sizes of EEG -
caps (by head
circumference) | S (47-53 cm)
M (50-56 cm)
L (56-62 cm) | M (50-56)
L (56-62) | SE
Note 1 |
| Surface area of
each electrode | 1.13 cm² | 1.56 cm² | SE
Note 1 |
| Work duration
after the
package
opening | 4 hours | 4 hours | SE |
| Storage life | 18 months | 18 months | SE |
| Package
dimensions | less 490x460x15 mm | less 520x290x15 mm | SE
Note 1 |
| Net Weight | less 25 grams | less 40 grams | SE
Note 1 |
| Gross Weight | less 200 grams | less 80 grams | SE
Note 1 |
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- SE means " substantially equivalent".
Comparison in Detail(s):
Note 1: The "Sizes of EEG-caps", "Surface area of each electrode", "Net Weight", "Gross Weight", "Package Dimensions" have little difference between the subject device and the predicate one. They are all the appearance specifications and complying with the ISO 10993 biocompatibility requirements and ISO14971:2012 harm control application to medical device. Therefore, the differences between the two have no impacts on the safety and effect.
Finial Conclusion:
The subject product the NeuroCap is Substantial Equivalent to the predicate product.
- Date of the summary prepared: April 27, 2018