Macroduct Advanced Model 3710

K180627 · Elitechgroup, Inc. · KTB · Jul 27, 2018 · Physical Medicine

Device Facts

• Record ID: K180627
• Device Name: Macroduct Advanced Model 3710
• Applicant: Elitechgroup, Inc.
• Product Code: KTB · Physical Medicine
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2

Indications for Use

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

Device Story

Macroduct Advanced Model 3710 is a microprocessor-controlled, battery-powered iontophoresis device used in clinical laboratories. It stimulates sweat production via pilocarpine iontophoresis using Pilogel discs (0.5% pilocarpine nitrate). The device delivers a controlled current (ramp to 1.5 mA, hold 5 min, ramp down) to the patient's skin. A specialized collector captures the stimulated sweat; markings on the collector indicate if sufficient sweat rate is achieved. The collected sample is subsequently analyzed using external devices (Sweat-Chek conductivity analyzer or ChloroChek chloridometer) to diagnose cystic fibrosis. Operated by qualified medical personnel, the device features a touch screen interface providing step-by-step procedural guidance, status indicators, and audio alerts. It improves upon the predicate by using an elliptical collection area to better fit limb surfaces and providing a graphical user interface to standardize the collection process.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to confirm the performance of the modified device, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and compliance with CLSI C34-A3 standards for sweat collection. No clinical data was required to establish substantial equivalence.

Technological Characteristics

Microprocessor-controlled iontophoresis device. Materials: High Impact Polystyrene (STYRON 478) for collector; PC-ABS blend for instrument shell. Power: 3.6V Lithium-ion batteries. Iontophoresis: 0.5% pilocarpine nitrate in agar base. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI ES60601-1, CLSI C34-A3.

Indications for Use

Indicated for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

Regulatory Classification

Identification

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined. Additionally, an iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted: (A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended; (B) Testing of the ability of the device to maintain a safe pH level; and (C) If used in the ear, testing of the device to demonstrate mechanical safety. (ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following: (A) A description and/or graphical representation of the electrical output; (B) A description of the electrode materials and pH buffer; (C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and (D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning: *Warning:* Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile. (vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.

Predicate Devices

• Macroduct Model 3700-SYS (K853973)

Submission Summary (Full Text)

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July 27, 2018

ELITechGroup Inc. Bryce McEuen Managing Director and Business Unit Manager 370 W 1700 S Logan, Utah 84321

Re: K180627

Trade/Device Name: Macroduct Advanced Model 3710 Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class II Product Code: KTB Dated: May 3, 2018 Received: May 7, 2018

Dear Bryce McEuen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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.

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for 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) K180627

Device Name Macroduct Advanced Model 3710

Indications for Use (Describe)

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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### Section 6.0 - 510(k) Summary

Date: July 27, 2018

| Submitter: | ELITechGroup Inc., dba Wescor Inc. |
|---------------|-------------------------------------------------|
| Address: | 370 W 1700 S, Logan, UT 84321 USA |
| Phone number: | 435-752-6011 |
| Fax number: | 435-752-4127 |
| Contact: | Bryce McEuen (Email: [e-mail]) |

#### Device name:

Trade/proprietary Name: Macroduct® Advanced Model 3710

Common or Usual Name: Macroduct Advanced Sweat Collection System

| Code | Name | Class | Regulation | Regulation Name | Panel |
|------|-----------------------------------------|-------|--------------------|----------------------|----------------------|
| KTB | Device, Iontophoresis,<br>Specific Uses | II | 21 CFR<br>890.5525 | Iontophoresis Device | Physical<br>Medicine |

### Establishment Information:

The establishment registration number for ELITechGroup Inc. USA is 1717966. The owner operator number for ELITechGroup Inc. (Logan, UT, USA) is 1717966.

### Predicate device:

| Predicate Device | 510(k)<br>Number | Product code(s) |
|---------------------------|------------------|-----------------|
| Macroduct® Model 3700-SYS | K853973 | KTB |

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### Device description:

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model 3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion battery, battery charging power supply and cord for charging the battery, electrode cable assembly, and a kit of single-use supplies (Pilogel discs, collectors, and straps). The system safely and efficiently accomplishes the stimulation of human sweat through pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced Sweat Collector collects a sample of the stimulated sweat. Markings on the collection tube of the collector indicate if a sufficient sweat rate is achieved during the collection of sweat. The sample can then be analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek® Chloridometer® using the principle of coulometric titration.

The Macroduct Advanced cannot be used in combination with other medical devices.

### Substantial Equivalence:

| Similarities | | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | Current Device<br>Macroduct Advanced Model 3710 | Previous Device<br>Macroduct Model 3700-SYS |
| Indications for Use | The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. | Same |
| Iontophoresis current and time | Ramp (approximately 25 seconds) from 0 mA to 1.5 mA; hold at 1.5 mA for 5 minutes; ramp (approximately 5 seconds) from 1.5 mA to 0 mA. | Same |
| Pilogel Disc composition | 0.5% pilocarpine nitrate in agar base. | Same |

The Macroduct Advanced Model 3710 has demonstrated substantial equivalence to the predicate device, Macroduct Model 3700-SYS.

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| Similarities | | |
|----------------------------------|-------------------------------------------------------------------------------|---------------------------------------------|
| | Current Device<br>Macroduct Advanced Model 3710 | Previous Device<br>Macroduct Model 3700-SYS |
| Pilocarpine transferred per test | Up to 1 mg | Same |
| Current Safety limit | Controlled by software/hardware to 1.5 mA, limited by hardware alone to <4 mA | Same |
| Iontophoresis power supply | Microprocessor controlled | Same |
| Sweat Collector material | High Impact Polystyrene (STYRON 478) | Same |

| Differences | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| | Macroduct Advanced Model 3710 | Predicate device<br>Macroduct Model 3700-SYS |
| Sweat Collection area | .994 in² elliptical collection surface | .994 in² circular collection surface |
| Pilogel shape | Elliptical shape to match collector | Circular shape to match collector |
| Instrument Shell | Handheld, rounded rectangular<br>in custom molded clamshell<br>case in PC-ABS blend plastic | Handheld, rectangular, stock<br>clamshell case in ABS plastic. |
| Instrument User interface | Touch screen with graphics<br>showing step-by-step<br>procedure, on-screen touch<br>switch to start and stop iontophoresis, graphic indicator for<br>current/low battery, audio signal<br>for completion/error indication | Toggle switch to start and stop<br>iontophoresis, LED indicators<br>for current/low battery, audio<br>signal for completion/error indication |
| Power Source | Three rechargeable 3.6 V Lithium ion batteries | Two 9V alkaline batteries |

| Modifications | | |
|-----------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Characteristic | Modification | Rationale for Modification |
| Sweat Collection area | Changed the shape of the collection area from 0.994 in2 round to 0.994 in2 elliptical. | The collection area shape changed to elliptical to better fit limb skin surface, including small radius arms. |

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| Modifications | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Modification | Rationale for Modification |
| Pilogel shape | Changed the Pilogel shape from round to elliptical. | The Pilogel shape was changed to match the elliptical shape of the collector. |
| Instrument Shell | The size, shape and material of the instrument shell changed. | To accommodate the touch screen |
| Instrument User inter-face | Touch screen with graphics showing step-by-step procedure, on-screen touch switch to start and stop iontophoresis, graphic indicator for current/low battery, audio signal for completion/error indication | Provide users with detailed vi-sual instructions and information to further enhance and standardize the process of pilocarpine iontophoresis and sweat collection. |

# Performance Standards:

| Regulation / Standard | Organization | Regulation / Standard Description |
|-----------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21 CFR 890.5525 | US Code of Federal<br>Regulations - FDA | Iontophoresis device intended for certain specified uses |
| C34-A3 | CLSI | Sweat Testing: Sample Collection and<br>Quantitative Chloride Analysis |
| IEC 60601-1:2005<br>(Third Edition) + CORR.<br>1:2006 + CORR. 2:2007<br>+ A1:2012 | IEC | Medical Electrical Equipment – Part 1:<br>General requirements for basic safety<br>and essential performance |
| IEC 60601-1-2:2014 | IEC | Medical Electrical Equipment – Part 1-<br>2: General requirements for basic<br>safety and essential performance –<br>Collateral Standard: Electromagnetic<br>disturbances – Requirements and tests |
| ANSI/AAMI ES60601-<br>1:2005 / A2:2010 | ANSI | US National Differences to IEC 60601-<br>1:2005 |
| EN 55022:2010 | European Commis-<br>sion | Information technology equipment –<br>Radio disturbance characteristics –<br>Limits and methods of measurement |
| 47 CFR Part 15, Sub-<br>part B | US Code of Federal<br>Regulations - FCC | Unintentional Radiators |
| ICES-003, Issue 6 | Industry Canada | Information technology equipment –<br>Radio disturbance characteristics –<br>Limits and methods of measurement |
| ISTA 3A (2008) | ISTA | Packaged products for parcel delivery<br>system shipments 70kg (150 lb) or less |
| Directive 2011/65/EU | European Parlia-<br>ment and the | Restriction of the use of certain haz-<br>ardous substances in electrical and |

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| | Council of the Eu-<br>ropean Union | electronic equipment |
|--|------------------------------------|----------------------|
| | | |

#### Indications for Use:

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

## Conclusion:

The modifications to the predicate device Macroduct Model 3700-SYS did not affect the use of the device or alter the fundamental scientific technology of the device. The design control process results for the Macroduct Advanced Model 3710 demonstrate that the Macroduct Advanced Model 3710 is substantially equivalent to the predicate device, Macroduct Model 3700-SYS, cleared under K853973.

The data demonstrates that the system is appropriate for its use and does not raise new issues of safety or effectiveness. A detailed summary of the verification, validation and risk analysis of these modifications are provided in Section 11 and complete risk analysis reports are provided in Appendix 1.