(15 days)
The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment.
EEG recording in OR environment.
Headpiece for EEG Monitoring in Operating Room
The OR e-Net is designed to fit patients with a head size in the range of 54 - 62 cm in circumference. It is constructed using the same materials and manufacturing processes as the predicate device, Large e-Net which is described in K930080.
The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment.
The OR e-Net is fabricated from the same materials as the larger version. Two changes were made to make the product more suitable for the OR environment. First, the material located below the ear was removed and secondly, the inion tab was extended to allow it be secured to the neck.
The provided text for device K961609 (Physiometrix, Inc., OR e-Net) is a regulatory document (510(k) Premarket Notification summary and an FDA letter), which focuses on device description, intended use, and substantial equivalence to a predicate device. It does not contain information about acceptance criteria or specific study data to prove performance against those criteria.
Therefore, I cannot populate the requested table or answer most of the questions, as the necessary information is not present in the provided text.
Here's what I can state based on the available information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document primarily describes the device and its regulatory status, not a performance study.
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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 as no performance study is detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no performance study is detailed.
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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 or AI assistance is mentioned. This device is a passive EEG electrode net, not an AI-driven diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a passive EEG electrode net.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable as no performance study is detailed.
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The sample size for the training set:
- Not applicable as no machine learning algorithm or training set is mentioned for this device.
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How the ground truth for the training set was established:
- Not applicable as no machine learning algorithm or training set is mentioned.
Summary of available information related to performance/validation:
The document for K961609 describes the OR e-Net as being designed to fit patients with a head size of 54 - 62 cm. It states that the device is "constructed using the same materials and manufacturing processes as the predicate device, Large e-Net which is described in K930080." It also mentions "Two changes were made to make the product more suitable for the OR environment. First, the material located below the ear was removed and secondly, the inion tab was extended to allow it be secured to the neck."
The basis for clearance is substantial equivalence to the predicate device K930080 (HydroDot NeuroMonitoring System), implying that its performance characteristics are similar or identical, given the material and manufacturing commonalities, and minor design changes focused on OR suitability rather than fundamental function. The document does not detail specific performance studies, rather it relies on the similarity to the already cleared predicate device.
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Physiometrix, Inc. 510(k), Premarket Notification OR e-Net (54 - 62 cm)
MAY 10 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
:
| Date: | April 22, 1996 |
|---|---|
| Company: | Physiometrix, Inc.Five Billerica Park101 Billerica AvenueN. Billerica, MA 01862 |
| Contact: | Dawn E. FrazerDirector, Regulatory Affairs & Quality Assurance(508) 670-2422(800) 474-9746 |
| Subject Device: | Model 1220 , OR e-Net (54 - 62 cm) |
| Predicate Device: | K930080, HydroDot NeuroMonitoring System |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Description: | The OR e-Net is designed to fit patients with a head size in the range of54 - 62 cm in circumference. It is constructed using the same materialsand manufacturing processes as the predicate device, Large e-Netwhich is described in K930080. |
| Intended Use: | The e-Net serves two functions as a part of the Hydro DotNeuroMonitoring System. First, it locates the EEG electrodes accordingthe 10-20 International System. Secondly, it conducts the electricalsignal sensed by the electrodes from the skin to the EEG equipment. |
| Indication for Use: | EEG recording in OR environment. |
| Design/Materials: | The OR e-Net is fabricated from the same materials as the largerversion. Two changes were made to make the product more suitablefor the OR environment. First, the material located below the ear wasremoved and secondly, the inion tab was extended to allow it besecured to the neck. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Dawn E. Frazer Director, Regulatory Affairs & Quality Assurance Physiometrix, Inc. Five.Billerica Park 101 Billerica Avenue N. Billerica, Massachusetts 01862
APR - 9 2012
Re: K961609
Trade/Device Name: Model 1220, OR e-Net (54-62 cm) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): April 22, 1996 Received (Date on orig SE Itr): April 25, 1996
Dear Ms. Frazer:
This letter corrects our substantially equivalent letter of May 10, 1996.
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.
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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); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Kesia Alexander
Image /page/2/Picture/7 description: The image contains a handwritten word, "for", in cursive script. The letter 'f' is characterized by a long, sweeping stroke that descends below the baseline and curves back up to form the main body of the letter. The 'o' is a simple, closed loop connected to the 'f', and the 'r' is a small, curved stroke that extends from the 'o'. The writing is in black ink against a white background.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Physiometrix, Inc. 510(k), Premarket Notification OR e-Net (54 - 62 cm)
| 510(K) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name:
Model 1220, OR e-Net (54 - 62 cm)_
Unknown_
Indications for Use:
Headpiece for EEG Monitoring in Operating Room_
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K961609 |
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
8
§ 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).