PADNET+

K073146 · Biomedix, Inc. · JOM · Nov 21, 2007 · Cardiovascular

Device Facts

• Record ID: K073146
• Device Name: PADNET+
• Applicant: Biomedix, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2780
• Device Class: Class 2

Intended Use

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 Story

Non-invasive cardiovascular blood flow monitor; utilizes pulse volume recording, oscillometric segmental systolic blood pressure, and photoplethysmography (PPG) to assess lower extremity arterial/venous systems. Operated by healthcare professionals in hospitals or clinics; requires connection to a Windows-based PC. Device transforms physiological signals into clinical reports to assist in vascular disease identification. Benefits include early detection of peripheral vascular disease. System components include pressure cuffs, USB cable, and software.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing to standards including EN60601-1 (electrical safety), EN60601-1-2 (EMC), and ISO 10993-1 (biological evaluation).

Technological Characteristics

Non-invasive plethysmograph; utilizes pressure cuffs for oscillometric segmental systolic blood pressure and pulse volume recording, plus photoplethysmography. Operates via PC connection (Windows 2000+, 128MB RAM, 600MHz processor). Supplied non-sterile. Complies with EN60601-1, EN60601-1-2, and ISO 10993-1.

Indications for Use

Indicated for adult male and female patients for the assessment of lower extremity arterial and venous systems to assist in identifying vascular disease. Contraindicated for pediatric or 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

• Flostat Vascular Lab (K973644)
• PADnet Lab (K042616)

Submission Summary (Full Text)

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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: | [phone] | |
| 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 .

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 .

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#### Intended 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.

#### 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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