(238 days)
Not Found
No
The description focuses on standard signal processing and calculation based on volume plethysmography, with no mention of AI or ML terms or methodologies. The device is described as using "proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals," which is typical of traditional signal analysis rather than AI/ML.
No.
The device is used for assessment and diagnosis of vascular disease by measuring blood volume changes and calculating results predictive of Peripheral Artery Disease (PAD); it does not provide therapy or treatment.
Yes
The device is described as assisting in the "identification of vascular disease" and aiding "clinicians in the diagnosis of vascular disease." These functions clearly indicate its purpose is diagnostic.
No
The device description explicitly states that the device uses a "sensor" that detects changes in arterial blood volume and sends the signal to a computer via a "wired connection." This indicates the presence of hardware components beyond just software.
Based on the provided text, the PADnet Xpress is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- PADnet Xpress Function: The PADnet Xpress is a non-invasive device that assesses the arterial circulatory system by measuring blood volume changes using pulse volume recording. This is a physical measurement taken on the body, not a test performed on a specimen taken from the body.
Therefore, the PADnet Xpress falls under the category of a non-invasive diagnostic device used for physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.
Product codes
JOM
Device Description
PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial/Dorsalis Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Artery Disease (PAD). Following each test PADnet Xpress provides documented results, including waveforms, as part of the final report, which may be viewed on the system display, in printed form, and/or digitaly saved. PADnet Xpress was designed, in response to consumer feedback, to perform a subset of tests, namely PAD screening, which the predicate PADnet 2.0 device is capable of in a smaller, more portable form factor. The design modifications did not alter the intended use and are modest departures from the existing, previously cleared technological characteristics of the PADnet 2.0. While the intended use is not altered, there are minor modifications for use to remove elements of the indication not associated with arterial pulse contour analysis, and segmental systolic blood pressure measurements, as well as to allow for home use by a trained operator.
When performing an assessment, the clinician places a sensor and takes a measurement on each lower extremity. The sensor detects changes in arterial blood volume. This signal is digitized and sent to a computer via a wired connection, where it runs a proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals from the Brachial, Anterior Tibial arterial distributions. The indications for use are almost identical to the PADnet 2.0, the predicate device, but PADnet Xpress has also been tested for compliance with IEC 60601-1-11 home use electrical safety standards and is indicated for use in that environment as well with no change to the safety or effectiveness of the device. The PADnet Xpress sensor used with the predicate, is made from Makrolon plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower and upper extremity arterial circulatory systems
Indicated Patient Age Range
adults
Intended User / Care Setting
healthcare professionals in either a professional medical or home 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)
Since the underlying technology for aiding in the disease is unchanged between the predicate PADnet 2.0 device and the modified PADnet Xpress, a risk analysis determined that additional performance testing was not needed to demonstrate the substantive equivalence of the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
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 & 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.
October 20, 2022
Collaborative Care Diagnostics LLC, d.b.a. Biomedix James Hartnett Quality Manager 860 Blue Gentian Rd Suite 180 Eagan, Minnesota 55121
Re: K220527
Trade/Device Name: PADnet Xpress Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, Or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM Dated: September 20, 2022 Received: September 20, 2022
Dear James Hartnett:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K220527 Device Name
PADnet Xpress
Indications for Use (Describe)
The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary | Prepared on: 2022-02-23 | |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Collaborative Care Diagnostics LLC, d.b.a. Biomedix | |
| Applicant Address | 860 Blue Gentian Rd Suite 180 Eagan MN 55121 United States | |
| Applicant Contact Telephone | 651-280-5570 | |
| Applicant Contact | Mr. James Hartnett | |
| Applicant Contact Email | jhartnett@biomedix.com |
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Name
Device Trade Name
Common Name
Classification Name
Regulation Number
Product Code
Legally Marketed Predicate Devices
PADnet 2.0
Predicate #
Predicate Trade Name (Primary Predicate is listed first)
PADnet Xpress
Plethysmographs
870.2780
JOM
JOM
Product Code
21 CFR 807.92(a)(3)
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(2)
Device Description Summary
PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial/Dorsalis Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Artery Disease (PAD). Following each test PADnet Xpress provides documented results, including waveforms, as part of the final report, which may be viewed on the system display, in printed form, and/or digitaly saved. PADnet Xpress was designed, in response to consumer feedback, to perform a subset of tests, namely PAD screening, which the predicate PADnet 2.0 device is capable of in a smaller, more portable form factor. The design modifications did not alter the intended use and are modest departures from the existing, previously cleared technological characteristics of the PADnet 2.0. While the intended use is not altered, there are minor modifications for use to remove elements of the indication not associated with arterial pulse contour analysis, and segmental systolic blood pressure measurements, as well as to allow for home use by a trained operator.
When performing an assessment, the clinician places a sensor and takes a measurement on each lower extremity. The sensor detects changes in arterial blood volume. This signal is digitized and sent to a computer via a wired connection, where it runs a proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals from the Brachial, Anterior Tibial arterial distributions. The indications for use are almost identical to the PADnet 2.0, the predicate device, but PADnet Xpress has also been tested for compliance with IEC 60601-1-11 home use electrical safety standards and is indicated for use in that environment as well with no change to the safety or effectiveness of the device. The PADnet Xpress sensor used with the predicate, is made from Makrolon plastic.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in
4
the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professional medical or home environment. The device is not intended for pediatic or fetal use. It is also not intended for the use on or near non-intact skin.
Indications for Use Comparison
PADnet Xpress has largely the same indicate for use as the predicate device with the only major differences being that the intended environment has been expanded to include home use, and that the device is only capable of performing a subset of the tests of the predicate PADnet 2.0 device. Accordingly, this new device is compliant with IEC 60601-1-11 Home Use electrical safety standards in addition to the IEC 60601-1-1 General Electrical Safety standards for medical devices. The device remains indicated for prescription use only by a medical professional for aiding in the diagnosis of vascular disease. Moving into the home setting does not constitute a new intended use, but instead constitutes an expansion of the current intended use of the predicate device to a new setting, allowing medical professionals to make house calls and screen for vascular disease. Additionally, the removal of the ability to assess the venous system does not constitute a new intended use as it is still able to perform a subset of the predicated for, and a removal of scope does not imply a new use.
Technological Comparison
PADnet Xpress does not represent a change in technology from the predicate. It is comprised of only a subset of the technology from the predicate PADnet 2.0 device. The design includes only the original device and, as such, has a significantly smaller form factor. The principle of operation is the predicate device and it operates from the same energy source, but the electrical components are simplified to reflect the removal of the pneumoplethysmography functionality. The same material as the sensor on the PADnet 2.0, and the included accessory clip is made from the same material as well.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Since the underlying technology for aiding in the disease is unchanged between the predicate PADnet 2.0 device and the modified PADnet Xpress, a risk analysis determined that additional performance testing was not needed to demonstrate the substantive equivalence of the safety and effectiveness of the device.