The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. It is intended to be used by healthcare professionals in a hospital or clinic 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.

Device Description

The primary goal of the PADnet 2.0 system is to assess the blood vascular system and assist on the diagnosis of arterial and venous vascular disease. The currently released PADnet+ system already provides this type of functionality. With focus on the venous system, PADnet+ permits the assessment of venous reflux in the venous valvular system of the lower extremity. Its native functionality also permits the assessment of venous obstruction in the deep venous system. It accomplishes these ends using photo-plethysmography. Photo-plethysmography refers to a technique whereby localized volume changes due to an optically scattering/absorbant substance (e.g. blood) are measured. PADnet 2.0 adds the air plethysmography modality to the pre-existing venous test suite. Thus, only the methodology used for testing has been augmented. Indications for use are unchanged. With focus on the arterial system, PADnet+ permits the assessment of arterial insufficiency. It accomplishes this end using pneumo-plethysmography (air plethysmography). Pneumo-plethysmography refers to a technique whereby localized volume changes as measured by pressure changes in an inflated blood pressure cuff are recorded. This signal is assessed for waveform morphology and amplitude. Additional information regarding arterial insufficiency may be obtained by measurement of peak arterial systolic blood pressure. . PADnet 2.0 uses oscillometry to assess limb blood pressure.

AI/ML Overview

This 510(k) summary does not contain sufficient information to describe specific acceptance criteria and detailed study data in the way typically required for AI/ML device submissions. This document is a 510(k) for a medical device (PADnet 2.0) that primarily describes hardware and software modifications of an existing plethysmograph, and its safety and effectiveness are established through technological comparison to a predicate device and compliance with general safety and EMC standards. It does not describe a study involving specific performance metrics for an AI/ML algorithm or human reader performance.

Therefore, many of the requested data points (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of submission.

However, I can extract the information that is present and indicate where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way for specific disease identification performance in the context of an AI/ML model compared to a gold standard. Instead, it relies on the device meeting established standards and being "as safe, as effective, and performs as well as or better than the non-modified device" (the predicate).

Criterion Type	Acceptance Criteria	Reported Device Performance
Safety	Compliance with IEC 60601-1 (General Requirements for Safety)	Met (implied by "tested" and "complies")
EMC	Compliance with EN/IEC 60601-1-2 (Electromagnetic Compatibility)	Met (implied by "tested" and "complies")
Effectiveness (General)	As safe, as effective, and performs as well as or better than the predicate device.	Device performs as well as or better than the predicate (PADnet+).
Functionality (Venous)	Addition of air plethysmography modality to venous test suite (compared to PADnet+).	PADnet 2.0 adds air plethysmography for venous tests. (Difference noted)
Functionality (Arterial)	Use oscillometry to assess limb blood pressure (same as predicate).	PADnet 2.0 uses oscillometry to assess limb blood pressure. (Same as predicate)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. This document refers to compliance with standards (IEC, EN) and performance comparison to a predicate device, rather than a clinical study with a defined test set for a new algorithm's diagnostic performance.
Data Provenance: Not applicable/not specified for a clinical performance test set in this context. The testing mentioned relates to electrical safety and EMC.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. There is no mention of a test set with expert-established ground truth for diagnostic accuracy in this submission.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring 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:

No. This is not an AI/ML device submission that would typically involve an MRMC study comparing human reader performance with and without AI assistance. The device is a plethysmograph, an instrument for physiological measurements.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI/ML algorithm submission. The device is a measurement system.

7. The Type of Ground Truth Used:

Not applicable for diagnostic accuracy in this context. The "ground truth" for the device's acceptable performance is its adherence to recognized electrical safety and EMC standards and demonstrating equivalence in functionality to its predicate device.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary

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510(k) Summary of Safety and Effectiveness

Date: 7/19/12

Submitter: BioMedix, Inc Street Address: 178 East Ninth Street City: St. Paul State: MN Zip Code: 55101 Telephone: 651-762-4010 Facsimile: 651-762-4014

Contact: Greg Hocking Phone: 651-762-4010 Facsimile: 651-762-4014 e-mail: ghocking@biomedix.com

Device Name/Trade Name: PADnet 2.0 Common Name: Plethysmograph Classification Name: Hydraulic, pneumatic, or photoelectric plethysmographs Classification: Listed as Class II Panel Code: JOM Regulation Number: 870.2780

Identification of Legally Marketed (Unmodified) Device (Predicate Device):

Name ofPredicate	Manufacturer	Use	510(k)	DateCleared
PADnet+	BioMedix	Plethysmograph	K073146	11/21/2007

Device Description:

AUG 2 9 2012

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Indications for Use:

Technological Comparison to (Unmodified) Predicate Device:

The following summary table of comparisons compares the PADNet 2.0 Device to the Previously Cleared PADNet+ Device.

#	Attribute	Modified DevicePADnet 2.0	Previously ClearedDevice: PADnet+	Same	Different
	Indications for Use
1	Patient Population	Male/Female Adult	Male/Female Adult	×
2	Environment	Hospital or Clinic	Hospital or Clinic	×
3	OTC orPrescription	Prescription	Prescrption	×
	Testing
4	Pulse VolumeRecording	Pneumo-Plethysmograph(Air Plethysmograph)	Pneumo-Plethysmograph(Air Plethysmograph)	×
5	SegmentalPressureMeasurementSystem	Oscillometric	Oscillometric	×
6	Venous Tests	Pneumo-Plethysmograph& Photo-Plethysmography	Photo-Plethysmography		×
	Contraindications
7	Contraindications	No contraindications	No contraindications	×
	Sterility/Expiration Dating
8	Supplied Non-sterile	Yes	Yes	×
Energy Supplied
9	Power Source	AC to DC Conversion	AC to DC Conversion	×
	Environmental Specifications
10	OperatingTemperature	0°C to +40°C	0°C to +40°C	×
11	Operating RelativeHumidity	15-90% RH	15-90% RH	×
12	StorageTemperature	-40°C to +50°C	-40°C to +50°C	×
13	Storage Humidity	5-95%RH	5-95%RH	×
	Physical

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(12228) +3/3

14	Weight	5 lbs.	4 lbs.		X
15	Size	12 1/2"W X 10" D X 3 " H	12 1/2"W X 10" D X 3 " H	X	X
	Software/Firmware
16	Data acquisition	Single Site	Single Site		X
17	Software Controls	Operator Initiated	Operator Initiated		X
	Standards
18	Electrical Safety	IEC/EN 60601-1-1	IEC/EN 60601-1-1		X
19	EMC Compliance	IEC/EN 60601-2-2	IEC/EN 60601-2-2		X
	Cuffs
20	Cuff Deflation Rate	3-5 mm Hg/Sec	3-5 mm Hg/Sec		X
21	Cuff Bladder Deflation Method	Automatic Loop	Automatic Loop		X
22	Inflation Method	Automatic	Automatic		X
23	Cuff Sizes	Multiple	Multiple		X
	Reports
24	Clinical Reports	Yes	Yes		X
25	Printed Reports	Yes	Yes		X

Summary of Performance Testing:

The PADnet 2.0 has been tested to meet the requirements of the applicable product and software requirements specifications. The PADnet 2.0 has also been tested or found otherwise to comply with applicable sections of the following standards:

Safety JEC 60601-1, Medical Electrica! Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
Electromagnetic Compatibility (EMC) EN/IEC 60601-1-2, Medical Electrical . Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).

Conclusions:

The results of the tests discussed above, indicate that the modified BioMedix PADnet 2.0 device is as safe, as effective, and performs as well as or better than the non-modified device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 9 2012

BioMedix, Inc. c/o Mr. Greg Hocking Regulatory Affairs Manager 178 East Ninth Street St. Paul. MN 55101

Re: K122281

Trade/Device Name: PADnet 2.0 Regulatory Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: II (two) Product Code: 74 JOM Dated: July 19, 2012 Received: July 30, 2012

Dear Mr. Hocking:

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

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Page 2 - Mr. Greg Hocking

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 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): To be determined

Device Name: PADnet 2.0

Indications for Use:

The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system. PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. It is intended to be used by healthcare professionals in a hospital or clinic 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.

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use
		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Birlsion Sign-Off Division of Cardiovascular Devices

510(k) Number_K (22281

Regulation Number and Section

§ 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).