Digitimer DS7AP Constant Current Stimulator

K172381 · Digitimer , Ltd. · IPF · Mar 6, 2018 · Physical Medicine

Device Facts

• Record ID: K172381
• Device Name: Digitimer DS7AP Constant Current Stimulator
• Applicant: Digitimer , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

Device Story

The DS7AP is a constant current stimulator used by surgeons or neurophysiological scientists in clinical settings (e.g., neurosurgery operating theaters) to identify striated muscles during posterior sagittal anorectoplasty (PSARP) or 'pull-through' procedures. The device delivers pulsed mono-phasic, rectangular electrical stimuli to tissue via a bipolar stimulation probe. The operator controls pulse duration (200µs or 500µs) and current intensity (0-100mA) via front-panel dials and switches. The device provides visual feedback via LEDs for power, trigger status, compliance limits, and fault conditions. By stimulating tissue and observing muscle response, the clinician locates the target muscles for reconstruction. The device is mains-powered and includes an automatic overload trip for safety. It benefits patients by facilitating precise muscle identification during complex anorectal surgeries.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety and performance testing per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards.

Technological Characteristics

Mains-powered (115/230V) constant current stimulator. Output: pulsed mono-phasic rectangular waveform, 50Hz frequency, 0-100mA current, 200/500µs pulse width. Housing: UL94 V-0 flame retardant thermoplastic with metal panels. Connectivity: 4mm touch-proof sockets, 3.5mm jack for optional footswitch. Safety: Type BF applied part, automatic overload trip, compliance with 21 CFR 898. Dimensions: ~255x100x225mm. Weight: ~2.1kg.

Indications for Use

Indicated for use as an adjunct in the treatment of high and low anorectal malformations in pediatric patients (typically <3 years) to assist in the identification of striated muscles for anal reconstruction.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Radionics Pena Muscle Stimulator PS-1 (K980448)

Reference Devices

• Digitimer DS7A/AH Constant Current Stimulators (K051357)
• Technomed Neurosign Precision Bipolar Probe (K050325)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 6, 2018

Digitimer Ltd. John Smale Managing Director 37 Hydeway Welwyn Garden City, Hertfordshire, AL7 3BE, UK

Re: K172381

Trade/Device Name: Digitimer DS7AP Constant Current Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: January 3, 2018 Received: January 8, 2018

Dear John Smale:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice 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.

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 ([e-mail]) or phone [phone] 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) K172381

Device Name

Digitimer DS7AP Constant Current Stimulator

Indications for Use (Describe)

The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary

| Submitter: | Digitimer Ltd |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 37 Hydeway,<br>Welwyn Garden City,<br>Hertfordshire,<br>AL7 3BE, UK |
| Contact person: | John Smale<br>Managing Director<br>[phone] |
| Date Summary Prepared: | December 31, 2017 |
| 510(k) Number: | k172381 |
| Device Name: | DS7AP Constant Current Stimulator |
| Device Common Name | Powered Muscle Stimulator; CFR890.5850 |
| Device Classification: | Class II |
| Predicate Device: | Radionics Pena Muscle Stimulator PS-1 - 510(k) K980448 |
| Indications for Use: | The Digitimer DS7AP Constant Current Stimulator is indicated as an<br>adjunct in the treatment of high and low anorectal malformations by<br>helping the identification of striated muscle to be used in anal<br>reconstructions. |
| Device Description: | The DS7AP Constant Current Stimulator has been specially designed<br>to meet the requirements of pediatric surgeons who need a reliable<br>and easy to use muscle locating stimulator when carrying out the<br>Peña, "Pull-through" or posterior sagittal anorectoplasty (PSARP)<br>anorectal reconstruction technique. |
| Intended Patient Population | The reconstruction surgeries, for which the DS7AP is intended, are<br>typically carried out in young children (<3 years). |
| Intended Part of the Body to be Interacted With | The DS7AP is used in the treatment of anorectal malformations by<br>helping the identification of striated muscles to be used in anal<br>reconstructions. |
| Intended User Profile | The intended User is a specialist clinician trained in<br>Neurophysiological studies, or a surgeon trained in the specialist<br>reconstruction surgeries for which the DS7AP is intended. They are<br>likely to be either a doctor with neurology training or a Clinical<br>Neurophysiological Scientist for which the training requirement<br>recommendations (in the UK) is 4 years of undergraduate study. |

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| | Intended Conditions of Use | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | The DS7AP is intended for static table top use in a clinical | | |
| | environment, typically a neurosurgery operating theatre. | | |
| Electrical Performance: | Power: 100-120V or 200-240V (externally selected), 47-63Hz, 12VA.<br>Classification: IEC 60601-1 Class 1 with Type BF applied part.<br>Power: Push rod On/Off switch.<br>Pulse duration: LO (200µs) or HI (500µs), two position rotary switch.<br>Current: 0-100mA, continuously adjustable dial.<br>Compliance voltage: 100V.<br>Output frequency: 50Hz.<br>Output enable: Toggle Switch (On is Up, Off/Reset is down).<br>Output connections: 4mm shrouded, touch-proof sockets (red and<br>black) on 3/4" centers.<br>Footswitch connection rear panel 3.5mm mono jack socket (for<br>optional D185-FS1 contact closure footswitch). | | |
| Mechanical Performance: | Size: 10" x 4" x 10" (255 x 100 x 225 mm) - d x h x w<br>10.6" x 4.33" x 9" (270 x 110 x 225 mm) - d x h x w - over controls<br>and feet.<br>Weight: 4.5 pounds (2.1 kg) approx. | | |
| Temperature: | Operating Range 50°F to 104°F (10°C to 40°C) 30 to 75%, non-<br>condensing<br>Storage Range -40°F to 158°F (-40°C to 70°C) 10 to 100%, non-<br>condensing<br>Transport Range -40°F to 158°F (-40°C to 70°C) 10 to 100%, non-<br>condensing | | |
| Other: | Power: 115V or 230V @ 50/60 Hz<br>Rating: <30 VA<br>Case Material: UL94 V-0 Flame Retardant | | |
| Front Panel Indicators: | Power: Green LED, illuminated for power ON.<br>Trigger: Amber LED, illuminated to indicate stimulus trigger is active.<br>Compliance: Amber LED, illuminated if the compliance limit is<br>reached i.e. the current requested cannot be delivered (e.g. due to<br>high resistance between probe tips).<br>Reset/Fault: Amber LED illuminated and latched for sensed over<br>current and at power on. | | |
| Installation | The DS7AP does not need installation by Digitimer personnel as they<br>are supplied with comprehensive instructions and are easy to set up<br>& operate. | | |

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Footswitch: The footswitch is a medical grade foot switch that is sealed to IP68 so as to meet all the requirements of IEC 60601-1 for use within operating theatres.

## Disposable Precision Bipolar Stimulation Probe:

Available in packs of 10 probes, the Technomed Neurosign Precision Bipolar Probe is an ideal single-use stimulation probe. The probes are fitted with 1.5mm DIN 42 802 connectors and need to be used in conjunction with our 2m long D185-HB4-2m Output Extension Cable The Precision Bipolar Probe has been cleared for marketing by the FDA under number k050325. This included an evaluation of biocompatibility

### Technological Characteristics:

| Characteristic: | Subject Device: DS7AP | Predicate Device: PS-1 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K172381 | K980448 |
| Intended Use | Used to identify striated muscle in<br>the treatment of high and low<br>anorectal malformations | Used to identify striated muscle in<br>the treatment of high and low<br>anorectal malformations |
| Indications for Use | The DS7AP is indicated for use of<br>as an adjunct in the treatment of<br>high and low anorectal<br>malformations by helping in<br>helping in identification of the<br>striated muscle to be used in anal<br>reconstructions | The PS-1 is indicated for use of as<br>an adjunct in the treatment of<br>high and low anorectal<br>malformations by helping in<br>helping in identification of the<br>striated muscle to be used in anal<br>reconstructions |
| Classification | Class II | Class II |
| Product Code | IPF | IPF |
| Regulation Number | CFR 890.5850 | CFR 890.5850 |
| Power Source | Supply Mains (115/230V; 50/60Hz) | Primary battery (PP3 / 1604) |
| Number of Output<br>Channels | One | One |
| Output Control | Constant Current | Constant Current |
| Firmware Control? | No | No |
| Automatic Overload<br>Trip? | Yes | No |
| Compliance with 21<br>CFR 898? | Yes | No |
| Weight | 4.85lb | 1.52lb |
| Dimensions (wxhxd) | 8.6"x4.4"x 9.9" | 3.75"x3.5"x6.25" |
| Housing Materials | Thermo-plastic with metal front<br>and rear panels | Thermo-plastic with metal front<br>and rear panels |
| Waveform | Pulsed mono-phasic | Pulsed mono-phasic |
| Waveform Shape | Rectangular | Rectangular |
| Maximum Output<br>Voltage1 | 56V @ 500Ω<br>126V @ 2kΩ | 122V @ 500Ω<br>220V @ 2kΩ |

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| Characteristic: | Subject Device: DS7AP | Predicate Device: PS-1 |
|--------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------|
| Maximum Output<br>Current² | 112mA @ 500Ω<br>63mA @ 2kΩ<br>13mA @ 10k Ω | 244mA @ 500Ω<br>110mA @ 2kΩ<br>22mA @ 10k Ω |
| Pulse Width | 200µs / 500µs | 175µs |
| Pulse Frequency | 50Hz | 65Hz |
| Maximum Phase<br>Charge | 56µC @ 500Ω | 42.2µC @ 500Ω |
| Maximum Current<br>Density³ | 0.127mA/cm² @ 500Ω | 0.117mA/cm² @ 500Ω |
| Maximum Power<br>Density³ | 0.191W/cm² @ 500Ω | 0.161W/cm² @ 500Ω |
| Notes: | | |
| 1. Peak voltage, dependent upon the current control setting and the fixed load resistance. | | |

2. Peak current, limited by the maximum compliance voltage available.

3. Figures assume use of the G3604-00 Disposable Probe for both devices.

# Different Technological Characteristics:

The subject device and the predicate differ in the power source used, with the subject using mains power and the predicate using batteries.

The power supply of the subject device is identical to that of the Digitimer DS7A/AH Constant Current Stimulators, which are approved for marketing under number k051357.

Nonclinical Tests:

Nonclinical tests have been based on the compliance with the following international standards.

| Standard Utilized | FDA Consensus Standard | Comments |
|---------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------|
| EN 60601-1:2006 | AAMI ANSI ES60601-<br>1:2005/(R) 2012 and<br>A1:2012 | Differences<br>covered by<br>additional<br>testing |
| EN 60601-1-2:2007 | IEC 60601-1-2:2007 | Same |
| IEC 62366-1:2015 | AAMI ANSI IEC 62366-<br>1:2015 | Same |
| ISO 14971:2007 | ISO 14971:2007 | - |
| EN 60601-2-10:2015<br>+ A1:2016 | IEC 60601-2-10:2012 | - |
| FDA Guidance<br>Document for<br>Powered Muscle<br>Stimulator 510(k) | None | Comparison<br>of DS7AP and<br>predicate<br>device |

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Clinical Tests:

No clinical tests are required for this submission

#### Conclusions of Nonclinical & Clinical Tests:

The DS7AP Constant Current Stimulator meets the requirements of the non-clinical testing defined above.

The intended use and the technological characteristics have also been compared in detail with the predicate device and found to be substantially equivalent.

No clinical tests were required to support this 510(k)