(156 days)
Not Found
No
The description focuses on standard signal acquisition, processing, and alerting based on predefined thresholds, with no mention of AI/ML techniques.
No.
The "Intended Use" states that the device is for "monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ)," which describes a diagnostic or monitoring function, not a therapeutic one.
Yes
The EPAD is intended for use in "monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ)," which directly relates to diagnosing or assisting in diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a headbox, tablet computer, cables, and electrodes, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ)." This involves measuring electrical signals from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The components described are for stimulating nerves and acquiring electrical signals from the patient's skin using electrodes. There is no mention of reagents, test strips, or any components designed for analyzing biological samples.
- Lack of IVD Characteristics: The description does not include any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of substances in biological samples.
- Use of reagents or kits for testing.
The EPAD is a medical device used for physiological monitoring, specifically neurophysiological monitoring. It falls under the category of devices that interact directly with the patient's body to measure and record electrical activity.
N/A
Intended Use / Indications for Use
The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).
Product codes
GWF, IKN, GXY
Device Description
The EPAD system consists of the following components/accessories:
EPAD Headbox EPAD Headbox Power Supply EPAD Tablet Computer (includes power supply and USB cable) Stimulator Left Blue Cable Assembly (110 inches) Stimulator Right Yellow Cable Assembly (110 inches) Acquisition Left Red Cable Assembly (91 inches) Acquisition Right White Cable Assembly (92 inches) Stimulator Left Blue Short Cable Assembly (67 inches) Stimulator Right Yellow Short Cable. Assembly (67 inches) Acquisition Left Red Short Cable Assembly (44 inches) Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing) Upper Limb Electrodes package Lower Limb Electrodes package
The EPAD Headbox contains a complete data acquisition system that has built-in amplifiers, analog to digital converters, and digital signal processors. User interface is via tablet touchscreen computer provided with the EPAD System and running the Android operating system. The EPAD software application is preloaded onto the tablet. Data can be transferred to an external computer for archiving purposes. Communication between the EPAD Headbox and tablet is via Bluetooth wireless or USB connection.
Electrode cables are provided for left and right stimulation and left and right acquisition, color coded for correct connection to the EPAD Headbox: Custom cutaneous electrodes for stimulus and acquisition are provided by SafeOp for use with the EPAD. A total of 11 electrodes are applied for full patient monitoring (upper and lower limbs). The SafeOp electrodes are wet qel, single patient use, disposable, and biocompatible for short term (50%) and increased latency (>10%) under all noise conditions.
Key Metrics
Not Found
Predicate Device(s)
Protektor 32, K093304, NeuroEPG, K123843
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
EPAD™ 510(k)
Revised Section 4: 510(k) Summary
| 4.1 Date Prepared | January 23, 2014 | JAN 24 2014 |
|---|---|---|
| 4.2 Contact Person | Curt LaBelle, MD | |
| CEO, SafeOp Surgical, Inc. | ||
| T: (203) 629-8700 | ||
| Curt@Safeopsurgical.com | ||
| 4.3 Device Trade Name | EPAD TM (Evoked Potential Assessing Device). | |
| 4.4 Classification Name | ||
| and Regulation | Evoked Response Electrical Stimulator | |
| 21 CFR 882.1870, GWF, Class II | ||
| 4.5 Device Manufacturer | SafeOp Surgical, Inc. | |
| 263 Tresser Blvd | ||
| Stamford, CT 06901 | ||
| 4.6 Predicate Device(s) | Protektor 32, K093304 | |
| NeuroEPG, K123843 |
4.7 Indications for Use
The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).
Summary Device Description 4.8
The EPAD system consists of the following components/accessories:
EPAD Headbox EPAD Headbox Power Supply EPAD Tablet Computer (includes power supply and USB cable) Stimulator Left Blue Cable Assembly (110 inches) Stimulator Right Yellow Cable Assembly (110 inches) Acquisition Left Red Cable Assembly (91 inches) Acquisition Right White Cable Assembly (92 inches) Stimulator Left Blue Short Cable Assembly (67 inches) Stimulator Right Yellow Short Cable. Assembly (67 inches) Acquisition Left Red Short Cable Assembly (44 inches)
Revised 510(k) Summary - Page 1 of 14
1
Revised Section 4: 510(k) Summary
Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing)
Upper Limb Electrodes package
Lower Limb Electrodes package
The EPAD Headbox contains a complete data acquisition system that has built-in amplifiers, analog to digital converters, and digital signal processors. User interface is via tablet touchscreen computer provided with the EPAD System and running the Android operating system. The EPAD software application is preloaded onto the tablet. Data can be transferred to an external computer for archiving purposes. Communication between the EPAD Headbox and tablet is via Bluetooth wireless or USB connection.
Electrode cables are provided for left and right stimulation and left and right acquisition, color coded for correct connection to the EPAD Headbox: Custom cutaneous electrodes for stimulus and acquisition are provided by SafeOp for use with the EPAD. A total of 11 electrodes are applied for full patient monitoring (upper and lower limbs). The SafeOp electrodes are wet qel, single patient use, disposable, and biocompatible for short term (50 MΩ | >50 MΩ | Not stated | No difference |
| Common mode
rejection ratio
(CMRR) | >93 dB | >93 dB | Not stated | No difference |
| Category | Proposed
SafeOp EPAD™ | Predicate
Protektor 32
(K093304)* | Predicate
NeuroEPG
(K123843)** | Discussion of
Differences &
Justification for SE |
| Low frequency
filter | 0.1 Hz to 500 Hz | 0.1 Hz to 500 Hz | Not stated | No difference |
| High frequency
filter | 30 Hz to 3 kHz | 30 Hz to 15 kHz | Not stated | The Protektor is a general
purpose device with broad
neurological monitoring
modes. As such it is
capable of acquiring signals
using high frequency filters
(HFF) up to 15 kHz. The
SSEP and NMJ tests of the
EPAD only require a HFF of
3 kHz. |
| Notch filter | 50 or 60 Hz | 50 or 60 Hz | Not stated | No difference |
| Noise level | 50%) and increased latency (>10%) under all noise conditions.
Conclusions Regarding Substantial Equivalence 4.11
The information and testing presented in this 510(k) demonstrate that the EPAD Evoked Potential Assessing Device is safe and effective for its intended use and substantially equivalent to the named predicate devices. The EPAD has the same intended use and substantially equivalent
13
Section 4: 510(k) Summary
indications for use. The main difference between the EPAD and the predicate devices is that the EPAD was designed specifically for peripheral nerve response (somatosensory evoked potential (SSEP)) and neuromuscular junction (NMJ) monitoring, while the predicate devices offer a broader range of monitoring modes, including auditory evoked responses. However, the technical specifications for electrical stimulation and waveform acquisition using the EPAD are within those of the predicate devices based on the publicly available information.
14
Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2014
Safeop Surgical, Inc. c/o Ms. Sheila Hemeon-Heyer 125 Cherry Lane Amherst, MA 01002
Re: K132616
Trade/Device Name: EPAD Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response clectrical stimulator Regulatory Class: Class II Product Code: GWF. IKN, GXY Dated: December 23, 2013 Received: December 27, 2013
Dear Ms. Hemeon-Heyer:
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 cvaluate 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 cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Tixisting 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
15
Page 2 - Ms. Hemeon-Heyer
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practicc requirements as set forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industrv/default.htm.
Sincerely vours.
Carlos L. Pena -S
Carlos L. Peña. PhD. MS | Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
16
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132616
Device Name EPAD
Indications for Use (Describe)
The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).
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)
、------ -- -------
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S 2014.01.24 17:44:37 -05'00'
FORM FDA 3881 (1/14)
1774174741131134146741
17
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