(203 days)
The DEEG-LITE-OXY is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).
The DEEG-LITE-OXY system consists of (a) a laptop computer with liquid crystal display, (b) a MicroCoder which consists of State) Signa components such as: a mgil resolution Analog to Digital converter, a DSP (Digital Signal processor a safe low voltage includes supply and (d) a wearable, 32 channel EEG amplifier/recorder, and (e) an internal pulse ossimeter module supplied by Neilcor(model Mr 205). The DDLG De De oximeter module, all of the foregoing power supply. With the exception of the pulse oximeter modules income DEEC I ITE power supply. With the excopiton of unded in the predicate device DEEG-LITE.
The provided document is a 510(k) summary for the DEEG-LITE-OXY device, which is a portable EEG recorder with an integrated pulse oximeter. The document focuses on demonstrating substantial equivalence to a predicate device (DEEG-LITE) and does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically described for AI/ML devices.
Instead, the submission relies on the following:
1. Acceptance Criteria and Device Performance (Implicit - based on Substantial Equivalence):
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, DEEG-LITE (K972202), and that the addition of the pulse oximeter does not alter its safety or effectiveness. The device performance is affirmed by claiming identity of components and performance where relevant.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| EEG Functionality: Equivalent to predicate device (DEEG-LITE). | "The DEEG-LITE-OXY electronic is identical to that of the DEEG-LITE and has been carried out with careful attention to compliance with these standards." "The resulting system [DEEG-LITE-OXY] portable and more easily set up in both the office and home environment. The performance of the DEEG-LITE-OXY remains in no way degraded by the performance of the DEEG-LITE." The device claims "equivalent noise performance of the DEEG-LITE OXY system to that of the DEEG-LITE." |
| Pulse Oximeter Functionality: Meets Nellcor's specifications. | "Bench test data which confirms that the internal Nellcor oximeter (equivalent to that documented in Nellcor's document for their 510(k) #K962424) meets Nellcor's specifications when installed in the DEEG-LITE-OXY electronic environment." The pulse oximeter is described as an "OEM module" from Nellcor (model N-205). |
| Electrical Safety: Complies with UL2601-1 and IEC601-1. | "Electrical safety for EEG monitoring equipment is well specified by the UL2601-1 and IEC601-1 and IEC601-1 standards. The design of the DEEG-LITE-OXY electronics is identical to that of the DEEG-LITE and has been carried out with careful attention to compliance with these standards." |
| Battery Life Impact: Not significantly affected by oximeter. | "The DEEG-LITE-OXY has increased power consumption by only 300 milliwatts per additional function; this does not significantly affect battery life." |
| Overall Safety and Effectiveness: Equivalent to predicate. | "It is our conclusion that the nonclinical (Bench Tests) and the substantially equivalent design of the DEEG-LITE-OXY to that of the DEEG-LITE, demonstrate that the DEEG-LITE-OXY is safe and effective and performs as well as the predicate device DEEG-LITE." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a clinical test set. The evaluation was primarily based on nonclinical (bench tests). The pulse oximeter module itself references Nellcor's 510(k) #K962424, implying that its performance was established separately by Nellcor.
- Data Provenance: The bench tests were conducted by Telefactor Corporation. The country of origin for this data is implicitly the United States, where Telefactor Corporation is located. The tests were likely prospective in nature, performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No clinical expert-driven ground truth establishment is described for the "test set" because no clinical trials or reader studies were performed for this submission. The "ground truth" for the EEG aspect is the established performance of the predicate DEEG-LITE, and for the oximeter, it's Nellcor's specifications documented in their respective 510(k).
4. Adjudication Method for the Test Set:
- Not applicable. No human readers or adjudication processes are described for evaluating the device's performance in a clinical setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Because of the identical performance confirmed by the Bench Tests, clinical performance tests are deemed unnecessary." This indicates reliance on non-clinical testing and substantial equivalence rather than human performance studies.
6. Standalone (Algorithm Only) Performance:
- Yes, the evaluation conducted was primarily a standalone (algorithm/device only) performance assessment through nonclinical bench tests. The device's electrical characteristics, noise performance, and adherence to established standards (for both EEG and the pulse oximeter module) were tested independently. There is no "human-in-the-loop" component to the described testing.
7. Type of Ground Truth Used:
- The "ground truth" for this submission is based on:
- Predicate Device Performance: The established performance and safety of the legally marketed predicate device, DEEG-LITE (K972202).
- Manufacturer Specifications/Standards: For the integrated Nellcor pulse oximeter, its performance is compared against Nellcor's own documented specifications and its previously cleared 510(k) (K962424).
- Industry Standards: Electrical safety compliance is measured against UL2601-1 and IEC601-1 standards.
8. Sample Size for the Training Set:
- Not applicable. This device is a hardware system for signal acquisition and recording, not an AI/ML algorithm that undergoes "training." Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).