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.

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.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification for the Macroduct Advanced Model 3710 Sweat Collection System. This device is an iontophoresis device intended for the stimulation and collection of sweat for the diagnosis of cystic fibrosis.

The document focuses on demonstrating substantial equivalence to a predicate device (Macroduct Model 3700-SYS) rather than presenting a study proving a specific performance claim against established acceptance criteria using a novel algorithm or AI. Therefore, many of the requested elements for an AI/algorithm-based study (like MRMC studies, training/test set sample sizes, ground truth establishment for AI, etc.) are not applicable to this type of submission.

The "acceptance criteria" in this context refer to the device meeting the requirements for substantial equivalence, primarily by demonstrating that modifications do not introduce new safety or effectiveness concerns and that the device performs like the predicate.

Here's a breakdown of what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance

For a substantial equivalence submission like this, "acceptance criteria" are typically related to maintaining the same fundamental function, safety, and effectiveness as the predicate device. The performance is demonstrated by showing that the modifications do not negatively impact these aspects.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Indications for Use: Must be the same as the predicate device.	Same: "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."
Fundamental Scientific Technology: Must utilize the same core technology.	Same: Pilocarpine iontophoresis for sweat stimulation and collection. Iontophoresis current and time (Ramp 0-1.5mA, hold 1.5mA for 5 min, ramp down). Pilocarpine transferred per test (up to 1 mg). Current safety limit controlled by software/hardware to 1.5mA, limited by hardware alone to <4mA. Iontophoresis power supply is microprocessor controlled. Sweat Collector material (High Impact Polystyrene).
Safety and Effectiveness: Modifications must not raise new issues of safety or effectiveness.	Addressed by: Compliance with relevant performance standards (e.g., IEC 60601-1 for basic safety and essential performance, IEC 60601-1-2 for electromagnetic disturbances, CLSI C34-A3 for sweat testing sample collection). A "design control process results" and "risk analysis" were conducted (referenced in Section 11 and Appendix 1, though not detailed in the provided excerpt). The change in sweat collection area shape from circular to elliptical was rationale as "to better fit limb skin surface, including small radius arms," implying a usability improvement without compromising collection.
Performance Standards Compliance: Device must meet relevant industry standards.	Met: Adherence to standards like 21 CFR 890.5525 (Iontophoresis device regulation), CLSI C34-A3 (Sweat Testing protocol), IEC 60601-1 for medical electrical equipment safety, IEC 60601-1-2 for EMC, ANSI/AAMI ES60601-1, EN 55022, 47 CFR Part 15, ICES-003, ISTA 3A (packaging), and Directive 2011/65/EU (ROHS).
Minor Differences: Differences from the predicate device should not alter the fundamental safety or effectiveness of the device.	Identified and Justified:
Differences/Modifications	Rationale/Impact
Sweat Collection area: .994 in² elliptical	Changed from .994 in² circular to better fit limb skin surface, including small radius arms. (No change in area, only shape).
Pilogel shape: Elliptical	Changed from circular to match the elliptical shape of the collector. (Ensures proper contact/delivery).
Instrument Shell: Handheld, rounded rectangular in custom PC-ABS blend plastic	Changed from handheld, rectangular, stock ABS plastic case to accommodate the touch screen. (Aesthetic and functional improvement for user interface).
Instrument User interface: Touch screen with graphics, step-by-step procedure, on-screen touch switch, graphic indicator, audio signal	Changed from toggle switch, LED indicators, audio signal. Rationale: "Provide users with detailed visual instructions and information to further enhance and standardize the process of pilocarpine iontophoresis and sweat collection." (Enhances usability, standardizes procedure).
Power Source: Three rechargeable 3.6 V Lithium ion batteries	Changed from two 9V alkaline batteries. (Modernization, sustainability, no direct impact on core function).

2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the sense of a dataset for an algorithm's performance evaluation. The substantial equivalence relies on demonstrating that the device itself functions as intended and safely, often through bench testing and compliance with standards rather than a clinical study comparing its output to a gold standard on patient data. There is no mention of a specific sample size for a test set or data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/algorithm submission that would require expert-established ground truth for a test set. The "ground truth" for this device's performance is adherence to established measurement principles for sweat collection and analysis (as referenced by CLSI C34-A3).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a device for sweat collection, not an AI system assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm being evaluated.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's functionality is its ability to accurately stimulate and collect sweat conforming to established clinical guidelines (e.g., CLSI C34-A3) for subsequent analysis. It's not about diagnosing a condition itself, but providing the sample. The "truth" is whether the system performs its intended physical function reliably and safely.

8. The sample size for the training set
Not applicable. There is no AI algorithm with a training set.

9. How the ground truth for the training set was established
Not applicable. No AI algorithm/training set.

In summary:

This FDA 510(k) submission is for a medical device (an iontophoresis sweat collection system) seeking substantial equivalence to a previously cleared device. It relies on demonstrating that modifications to the predicate device do not raise new questions of safety or effectiveness and that the device continues to meet relevant performance standards and clinical guidelines for sweat collection. It does not involve a novel AI algorithm or a study comparing AI performance against human interpretation, hence many of the requested details about test sets, AI training, and ground truth establishment for AI are not present in this document.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: b.mceuen@elitechgroup.com)

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,Specific Uses	II	21 CFR890.5525	Iontophoresis Device	PhysicalMedicine

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)Number	Product code(s)
Macroduct® Model 3700-SYS	K853973	KTB

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Device description:

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

Substantial Equivalence:

Similarities
	Current DeviceMacroduct Advanced Model 3710	Previous DeviceMacroduct 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 DeviceMacroduct Advanced Model 3710	Previous DeviceMacroduct 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 deviceMacroduct 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 rectangularin custom molded clamshellcase in PC-ABS blend plastic	Handheld, rectangular, stockclamshell case in ABS plastic.
Instrument User interface	Touch screen with graphicsshowing step-by-stepprocedure, on-screen touchswitch to start and stop iontophoresis, graphic indicator forcurrent/low battery, audio signalfor completion/error indication	Toggle switch to start and stopiontophoresis, LED indicatorsfor current/low battery, audiosignal 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 FederalRegulations - FDA	Iontophoresis device intended for certain specified uses
C34-A3	CLSI	Sweat Testing: Sample Collection andQuantitative Chloride Analysis
IEC 60601-1:2005(Third Edition) + CORR.1:2006 + CORR. 2:2007+ A1:2012	IEC	Medical Electrical Equipment – Part 1:General requirements for basic safetyand essential performance
IEC 60601-1-2:2014	IEC	Medical Electrical Equipment – Part 1-2: General requirements for basicsafety and essential performance –Collateral Standard: Electromagneticdisturbances – Requirements and tests
ANSI/AAMI ES60601-1:2005 / A2:2010	ANSI	US National Differences to IEC 60601-1:2005
EN 55022:2010	European Commis-sion	Information technology equipment –Radio disturbance characteristics –Limits and methods of measurement
47 CFR Part 15, Sub-part B	US Code of FederalRegulations - FCC	Unintentional Radiators
ICES-003, Issue 6	Industry Canada	Information technology equipment –Radio disturbance characteristics –Limits and methods of measurement
ISTA 3A (2008)	ISTA	Packaged products for parcel deliverysystem shipments 70kg (150 lb) or less
Directive 2011/65/EU	European Parlia-ment and the	Restriction of the use of certain haz-ardous substances in electrical and

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	Council of the Eu-ropean Union	electronic equipment

Indications for Use:

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.

Regulation Number and Section

§ 890.5525 Iontophoresis device.

(a)
Iontophoresis device intended for certain specified uses —(1)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.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. 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.(2)
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.