PADNET 2.0

K122281 · Biomedix, Inc. · JOM · Aug 29, 2012 · Cardiovascular

Device Facts

• Record ID: K122281
• Device Name: PADNET 2.0
• Applicant: Biomedix, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Aug 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Intended 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.

Device Story

Non-invasive vascular assessment system; used in hospital/clinic by healthcare professionals. Inputs: pressure changes in inflated blood pressure cuffs (pneumo-plethysmography) and optical volume changes (photo-plethysmography). System performs pulse volume recording, arterial pulse contour analysis, segmental systolic/diastolic blood pressure measurements (oscillometry), venous refilling time, and venous outflow rate. Device transforms pressure/optical signals into waveform morphology and amplitude data. Output: clinical reports for physician review to assist in diagnosing arterial insufficiency, venous reflux, and venous obstruction. Benefits: non-invasive identification of vascular disease.

Clinical Evidence

Bench testing only. Device tested against product and software requirements specifications. Compliance verified for electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2). No clinical data provided.

Technological Characteristics

Pneumo-plethysmograph and photo-plethysmograph; oscillometric blood pressure measurement. Powered by AC to DC conversion. Dimensions: 12.5"W x 10"D x 3"H. Weight: 5 lbs. Operates 0°C to +40°C. Supplied non-sterile. Software-controlled via operator-initiated commands. Complies with IEC/EN 60601-1-1 and IEC/EN 60601-2-2.

Indications for Use

Indicated for adult male/female patients requiring assessment of lower and upper extremity arterial and venous circulatory systems to identify vascular disease. Contraindicated for pediatric/fetal use and use on or near non-intact skin.

Regulatory Classification

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.

Predicate Devices

• PADnet+ (K073146)

Submission Summary (Full Text)

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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: [phone] Facsimile: 651-762-4014

Contact: Greg Hocking Phone: [phone] Facsimile: 651-762-4014 e-mail: [e-mail]

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 of<br>Predicate | Manufacturer | Use | 510(k) | Date<br>Cleared |
|----------------------|--------------|----------------|---------|-----------------|
| PADnet+ | BioMedix | Plethysmograph | K073146 | 11/21/2007 |

### 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.

AUG 2 9 2012

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## 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.

## 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 Device<br>PADnet 2.0 | Previously Cleared<br>Device: 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 or<br>Prescription | Prescription | Prescrption | × | |
| | Testing | | | | |
| 4 | Pulse Volume<br>Recording | Pneumo-Plethysmograph<br>(Air Plethysmograph) | Pneumo-Plethysmograph<br>(Air Plethysmograph) | × | |
| 5 | Segmental<br>Pressure<br>Measurement<br>System | Oscillometric | Oscillometric | × | |
| 6 | Venous Tests | Pneumo-Plethysmograph<br>& Photo-<br>Plethysmography | Photo-Plethysmography | | × |
| | Contraindications | | | | |
| 7 | Contraindications | No contraindications | No contraindications | × | |
| | Sterility/Expiration Dating | | | | |
| 8 | Supplied Non-<br>sterile | Yes | Yes | × | |
| Energy Supplied | | | | | |
| 9 | Power Source | AC to DC Conversion | AC to DC Conversion | × | |
| | Environmental Specifications | | | | |
| 10 | Operating<br>Temperature | 0°C to +40°C | 0°C to +40°C | × | |
| 11 | Operating Relative<br>Humidity | 15-90% RH | 15-90% RH | × | |
| 12 | Storage<br>Temperature | -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 |
| | <b>Software/Firmware</b> | | | | |
| 16 | Data acquisition | Single Site | Single Site | | X |
| 17 | Software Controls | Operator Initiated | Operator Initiated | | X |
| | <b>Standards</b> | | | | |
| 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 |
| | <b>Cuffs</b> | | | | |
| 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 |
| | <b>Reports</b> | | | | |
| 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

C

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