The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. 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 BioMedix PADnet+ is a non invasive cardiovascular blood flow monitor. It is intended for use by trained medical professionals in a hospital or clinic. It is not to be operated in an explosive atmosphere or in the proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the PADnet Lab+.

The BioMedix PADnet Lab is a Prescription Device, not life supporting or life sustaining, not an implant, supplied non-sterile with pressure cuffs. It requires a Personal Computer with the following requirements:

Windows 2000 Operating System or Higher .
128 MB RAM .
20 GB Free Hard Disk Space .
600 MHZ Processor or Higher .

AI/ML Overview

This 510(k) summary does not contain sufficient information to describe the acceptance criteria, the study proving the device meets the acceptance criteria, or most of the requested details about the study. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through descriptive comparisons of features and intended use, rather than a detailed performance study with acceptance criteria.

Here's what can be extracted and what is missing:

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

This information is not provided in the document. The document primarily describes the device and its similarities/differences to predicate devices, but does not state specific performance metrics (e.g., accuracy, sensitivity, specificity) for the PADnet+ or the acceptance criteria it was evaluated against.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document makes no mention of a specific test set or clinical data used to evaluate the PADnet+ performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. No test set and thus no ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. No test set 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

This information is not provided. The device is described as a "non invasive cardiovascular blood flow monitor" and not as an AI-powered diagnostic tool intended to assist human readers. Therefore, an MRMC study related to AI assistance is unlikely and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. While the PADnet+ is a diagnostic device, the document does not present any standalone performance metrics or studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. No performance study with ground truth is mentioned.

8. The sample size for the training set

This information is not provided. As this document doesn't describe the development or evaluation of an AI/machine learning model, there is no mention of a training set.

9. How the ground truth for the training set was established

This information is not provided. No training set is mentioned.

Summary of available information related to the device and its acceptance/clearance:

The document is a 510(k) Summary, which is typically used to demonstrate substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a de novo study.

Predicate Devices: Flostat Vascular Lab (K973644, cleared Dec 23, 1997) and PADnet Lab (K042616, cleared Oct 12, 2004).
Basis for Substantial Equivalence: The BioMedix PADnet+ is considered substantially equivalent because:
- It has the same intended use as the predicate devices.
- It has the same technical characteristics as the predicate devices and does not raise any new types of safety or effectiveness concerns.
- It combines features (PPG from Flowstat Vascular Lab) with the original design of the PADnet Lab.
Intended Use (from the Indications for Use statement): "The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. 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."
Standards Met (indicating safety and some functionality):
- EN60601-1 Electrical Safety
- EN60601-1-2 EMC
- ISO 10993-1 Biological Evaluation

In essence, the "acceptance criteria" in this context are more about demonstrating that the new device is as safe and effective as the predicate devices, rather than meeting specific quantifiable performance thresholds outlined in a novel clinical study. The FDA's clearance (NOV 21 2007) signifies their agreement with this substantial equivalence claim.

Summary

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K073146
p1/4

510(K) Summary of Safety and Effectiveness

General Information

Submitter's Name:	BioMedix, Inc.
Address:	4215 White Bear Parkway
	St. Paul, MN 55110	NOV 2 1 2007
Telephone:	(651)762-4010
Contact Person:	Will Rogers
Date Prepared:	November 5th, 2007
Registration Number:	213492
Owner/Operator Number:	9032550
Device
Name:	PADnet+
Trade Name:	PADnet+
Common Name:	Plethysmograph
Classification Name:	Blood Flow Monitor
Product Code:	JOM
Class:	II
Regulation Number:	870.2780

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Identification of Legally Marketed Devices

Name:	Flostat Vascular Lab	PADnet Lab
K Number:	K973644	K042616
Date Cleared:	December 23, 1997	October 12, 2004

Description of the Device

The BioMedix PADnet Lab is a non invasive cardiovascular blood flow monitor. It is intended for use in the early detection of peripheral vascular disease. The PADnet Lab has been tested to the following standards.

EN60601-1 Electrical Safety .
EN60601-1-2 EMC .
ISO 10993-1 Biological Evaluation .

Windows 2000 Operating System or Higher .
128 MB RAM .
20 GB Free Hard Disk Space .
600 MHZ Processor or Higher .

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Intended Use Statement

Components/Part Numbers

Description	BioMedix Part Number
1 - USB Cable	100-1600
1 - Cuff Kit	7201
1 - BioMedix PADnet+ (Software Program CD ROM)	400-210
1 - AC Power Cord	350-215
1 - PADnet+ Operators Manual	10650

Table of Comparisons

The attached summary table compares the new device (PADnet+) to the predicate device: Flowstat Vascular Lab & PADnet Lab.

Discussion of Similarities and Differences

The PADnet+, PADnet Lab and the Flowstat Lab have the following similarities:

. Pulse Volume Recording
. Patient Population
. Environment
. Power Source
. Software Controls
Cuff Deflation Rate .
Operating Environment .

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Storage Environment ●
Safety Standards .
. EMC
Prescription Device .
Cuff Bladder Deflation .
Inflation Method .
Cuff Sizes .
Clinical Reports .
. Printed Reports
Supplied Non-Sterile .

The differences, with comments, are the following:

Segmental Pressure flow sensor The PADnet Lab uses Oscillometric not distal flow . sensor.
Weight PADnet Lab is significantly less. .
Data acquisition PADnet Lab is single site not bilateral. .
Size PADnet Lab is slightly smaller. .
PADnet+ and Flowstat Lab both have photoplethysmograph. .

Thus, even though the PADnet+ is not identical to the PADnet Lab and Flowstat Vascular Lab, we at BioMedix believe it should be granted substantial equivalence because:

It has the same intended use as the predicate devices. ●
It has the same technical characteristics as the predicate devices and does not raise any new types of safety or effectiveness concerns.
It has combined the PPG from the Flowstat Vascular Lab with the original design of the . PADnet Lab. Both products are predicate devices for the PADnet+.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2007

BioMedix, Inc. c/o Mr. Will Rogers Chief Technology Officer 4215 White Bear Parkway St. Paul, MN 55110

Re: K073146

PADnet+ Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM and JAF Dated: November 02, 2007 Received: November 08, 2007

Dear Mr. Rogers:

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 Fedral Food, Dr 10 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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Will Rogers

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mesazhy
C.R.B.Z. Inc. M.P.

D. Zuckerma 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):

Device Name: PADnet+

Indications for Use:

User Profile:

Patient Population: Male/Female, Adults Environment of Use: Hospitals or Clinics

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(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 IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

Moseley for BDZ

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K011146

Page _ of _

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).