(140 days)
Not Found
No
The description focuses on a microprocessor-controlled device for sweat collection and does not mention any AI or ML capabilities.
No
The device is used for the diagnosis of cystic fibrosis by stimulating and collecting sweat for analysis, not for therapeutic intervention.
Yes
The device is intended for "stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis", indicating its role in providing data for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including a microprocessor-controlled device, battery, power supply, electrode cable assembly, and single-use supplies.
Based on the provided information, the Macroduct Advanced Model 3710 Sweat Collection System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis." This analysis is performed in vitro (outside the body) on the collected sweat sample.
- Device Description: The description further clarifies that the collected sweat sample is then "analyzed for indications of cystic fibrosis" using other devices like the Sweat-Chek™ Sweat Conductivity Analyzer or the ChloroChek® Chloridometer®. These analyzers are clearly IVD devices themselves, and the Macroduct system is designed to provide the sample for these in vitro analyses.
- Clinical Laboratory Use: The device is intended for "clinical laboratory use," which is a common setting for IVD testing.
While the Macroduct system itself is a collection device, its sole purpose is to obtain a sample for in vitro diagnostic testing. Therefore, it falls under the definition of an IVD device as it is used in conjunction with other devices to perform a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KTB
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.
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
clinical laboratory use by qualified medical personnel
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)
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.
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
§ 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.
0
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 and 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.
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
1
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)
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: 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 CFR | |||
| 890.5525 | Iontophoresis Device | Physical | |||
| 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)
Number | Product code(s) |
|---------------------------|------------------|-----------------|
| Macroduct® Model 3700-SYS | K853973 | KTB |
4
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 | ||
| Macroduct Advanced Model 3710 | Previous Device | |
| 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.
5
| Similarities | ||
|---|---|---|
| Current Device | ||
| Macroduct Advanced Model 3710 | Previous Device | |
| 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 |