(119 days)
Not Found
No
The device description focuses on electrical stimulation parameters and hardware capabilities, with no mention of AI/ML algorithms for data analysis, interpretation, or control.
No
The device is described as a stimulator used for neurological monitoring and assessment, not for treating a condition or disease.
No
The device is described as a "stimulator" intended for "neurological monitoring and assessment," which implies it is used to induce a response for observation rather than directly diagnose a condition. Its function is to provide "constant current high voltage pulses" for "percutaneous stimulation," not to process or analyze signals for diagnostic interpretation.
No
The device description explicitly details hardware components like a stimulator providing constant current high voltage pulses, variable output current and voltage, and an isolated output stage. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "neurological monitoring and assessment in a clinical environment" by applying electrical stimuli to nerve and muscle tissue. This is a direct interaction with the patient's body.
- Device Description: The device delivers electrical pulses for percutaneous stimulation. This is a physical intervention on the patient.
- Anatomical Site: The device targets "Nerve and muscle tissue," which are parts of the living body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the living body).
N/A
Intended Use / Indications for Use
The DS7A and DS7AH are stimulators intended for use during neurological monitoring and assessment in a clinical environment.
They are intended for use by trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
The Digitimer DS7A Stimulator provides constant current high voltage pulses of brief duration for percutancous stimulation during investigation of the electrical activity of nerve and muscle tissue. The output current is continuously variable over the range 0 to 100 milliamps, from a source voltage continuously variable from less than 100 volts to 400 volts, to meet the requirements of human pathological cases. Short pulse durations have been made available to minimise any discomfort to the subject. The pulse width range can be varied from 50 microsconds to 2 milliscconds in six steps. A specially designed isolated output stage maintains a square (current) pulse shape while minimising stimulus artefacts.
The Digitimer DS7AH Stimulator is a variant of the DS7A providing a higher maximum current at reduced pulse width. This option is offered to overcome the difficulty of stimulating deep peripheral nerves with large area electrode pads. The DS7AH option will provide a maximum stimulus current of 1 amp at up to 400 volts compliance at pulse widths up to 200 us.
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
Not Found
Intended User / Care Setting
trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.
clinical environment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DIGITIMER Ltd - DS7A/DS7AH, 510(k) application
E - 510(k) Summary
| Submitted by | |
|---|---|
| Name: | John Smale |
| Managing Director | |
| Company: | Digitimer Ltd |
| Address: | 37 Hydeway |
| Welwyn Garden City | |
| Herts | |
| AL7 3BE | |
| UK | |
| Telephone: | (44) 1707 328347 |
| FAX: | (44) 1707 373153 |
| Authorised | |
| corespondent | |
| Name: | Harry J Benedict |
| Managing Partner | |
| Company: | MEPS-LLC |
| Address: | One East Broward Blvd |
| Suite 700 | |
| Fort Lauderdale | |
| FL 33301 | |
| Telephone: | (954) 713-8017 |
| FAX: | (954) 523-1911 |
| Contact person: | Harry J Benedict |
| Preparation date: | December 07, 2004 |
| Device names: | Digitimer DS7A and DS7AH Constant Current High Voltage |
| Stimulators | |
| Common name: | Evoked Potential Stimulator |
| Classification name: | Evoked response electrical stimulator, per 21 CFR § |
| 882.1870 | |
| Device class: | 2 |
| Product code: | GWF |
| Predicate device | |
| 510(k) Number: | K020400 |
| Device Name: | Digitimer D185 Multipulse Cortical Stimulator |
| Common name: | Evoked Potential Stimulator |
| Classification Name: | Evoked response electrical stimulator, per 21 CFR § 882.1870 |
| Device class: | 2 |
| Product Code: | GWF |
| Date Received: | 02/06/2002 |
| Decision Date: | 08/23/2002 |
1
DIGITIMER Ltd - DS7A/DS7AH, 510(k) application
Device Description
The Digitimer DS7A Stimulator provides constant current high voltage pulses of brief duration for percutancous stimulation during investigation of the electrical activity of nerve and muscle tissue. The output current is continuously variable over the range 0 to 100 milliamps, from a source voltage continuously variable from less than 100 volts to 400 volts, to meet the requirements of human pathological cases. Short pulse durations have been made available to minimise any discomfort to the subject. The pulse width range can be varied from 50 microsconds to 2 milliscconds in six steps. A specially designed isolated output stage maintains a square (current) pulse shape while minimising stimulus artefacts.
The Digitimer DS7AH Stimulator is a variant of the DS7A providing a higher maximum current at reduced pulse width. This option is offered to overcome the difficulty of stimulating deep peripheral nerves with large area electrode pads. The DS7AH option will provide a maximum stimulus current of 1 amp at up to 400 volts compliance at pulse widths up to 200 us.
Indications for use
The DS7A and DS7AH are stimulators intended for use during neurological monitoring and assessment in a clinical environment.
They are intended for use by trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.
| Parameter | Predicate Device D185 | DS7A | DS7AH |
|---|---|---|---|
| Intended application | Transcranial stimulation | Percutaneous stimulation | Percutaneous stimulation |
| Mode of operation | Constant voltage | Constant current | Constant current |
| Stimulus Output | Selected by continuously variable, multi-turn control, 0 to 1000 V (into 1k load) | Selected by continuously variable, multi-turn control and x1/x10 switch. Dial reading 0.00 to 9.99 giving 0 to 9.99 mA for x1 setting, and 0 to 99.9 mA for x10 setting | Selected by continuously variable, multi-turn control and x1/x10 switch. Dial reading 00.0 to 99.9 giving 0 to 99.9 mA for x1 setting, and 0 to 999 mA for x10 setting |
| Output Pulse | 50 microseconds (μs) wide pulses, user selectable from 1 to 9 pulses, repetition rate user variable between 1 and 9.9 ms | 50, 100, 200, 500, 1000, 2000 microseconds (μs) wide, single pulse | 50, 100, 200 microseconds (μs) wide, single pulse |
| Compliance | Max current 1.5A peak | Continuously variable from |