BIOMEDIX PADNET LAB

K042616 · Biomedix, Inc. · JOM · Oct 12, 2004 · Cardiovascular

Device Facts

• Record ID: K042616
• Device Name: BIOMEDIX PADNET LAB
• Applicant: Biomedix, Inc.
• Product Code: JOM · Cardiovascular
• Decision Date: Oct 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2780
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BioMedix PADnet Lab is a non invasive device used to gauge the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures 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 use on or near non intact skin.

Device Story

Non-invasive cardiovascular blood flow monitor; uses pulse volume recordings and oscillometric segmental systolic blood pressures to assess lower extremity arterial system. Operated by healthcare professionals in hospitals or clinics; requires connection to a Windows-based PC. Device transforms pressure cuff inputs into physiological data and clinical reports; assists physicians in identifying vascular disease. Benefits include early detection of peripheral vascular disease. System includes pressure cuffs, USB cable, and software program.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and adherence to safety standards (EN60601-1, EN60601-1-2, ISO 10993-1).

Technological Characteristics

Non-invasive plethysmograph; uses oscillometric sensors for segmental systolic blood pressure measurement. System components: pressure cuffs, USB interface, PC-based software. Operates on AC power converted to DC. Complies with EN60601-1 (electrical safety), EN60601-1-2 (EMC), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for adult male and female patients for the identification of vascular pathology in the lower extremity arterial system. Not for pediatric or fetal use. Not for 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)

Submission Summary (Full Text)

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K042616
page 1 of 5

# OCT 1 2 2004

# 510(K) Summary of Safety and Effectiveness

# General Information

| Submitter's Name: | BioMedix, Inc. |
|----------------------|-----------------------------------------------|
| Address: | 4205 White Bear Parkway<br>St. Paul, MN 55110 |
| Telephone: | 651-762-4010 |
| Contact Person: | Will Rogers or Dick Magnuson |
| Date Prepared: | July 23, 2004 |
| Registration Number: | 2134492 |

# Device

| Name: | PADnet Lab |
|----------------------|--------------------|
| Trade Name: | PADnet Lab |
| Common Name: | Plethysmograph |
| Classification Name: | Blood Flow Monitor |
| Product Code: | JOM |
| Class: | II |
| Regulation Number: | 870.2780 |

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K042614
page 2 of 5

## Identification of Legally Marketed Devices

Name: Flostat Vascular Lab

K Number: K973644

Date Cleared: December 23, 1997

#### 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 Lab 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 nor 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 t
- 600 MHz Processor or higher .

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# Intended Use Statement

The BioMedix PADnet Lab is a non invasive device used to gauge the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures 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 use on or near non intact skin.

### Components/ Part Numbers

| Description | BioMedix Part Number |
|------------------------------------------------|----------------------|
| 1- USB cable | 100-1600 |
| 1- Cuff kit | 7200 |
| BioMedix PADnet Lab<br>Software Program CD ROM | 400-210 |
| 1-AC Power Cord | 350-215 |
| 1- PADnet Lab Operators Manual | 10650 |

### Table of Comparisons

The following summary table of comparisons compares the new device (PADnet Lab) to the predicate device: Flowstat Vascular Lab.

| # | Area | New Device: PADnet Lab | Predicate Device: Flowstat<br>Vascular Lab | Same | Different |
|----|-----------------------------------|--------------------------|--------------------------------------------|------|-----------|
| 1 | Pulse Volume<br>Recording | Plethysmograph | Plethysmograph | X | |
| 2 | Segmental Pressure<br>flow sensor | Oscillometric | Distal Flow Sensor | | X |
| 3 | Patient Population | Male/Female Adult | Male/Female Adult | X | |
| 4 | Environment | Hospital or Clinic | Hospital or Clinic | X | |
| 5 | Power Source | AC converted to DC | AC converted to DC | X | |
| 6 | Weight | 4 lbs. | 26 lbs. | | X |
| 7 | Data acquisition | Single site | Bilateral | | X |
| 8 | Software Controls | Operator initiated | Operator initiated | X | |
| 9 | Size | 12 1/2"W X 10" D X 3 " H | 20 1/2" W X 17 3/4 " D X 7" H | | X |
| 10 | Cuff Deflation Rate | 3-5 mm Hg/Sec | 3-5 mm Hg/Sec | X | |

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K042616
page 4 of 5

| 11 | Operating Environment | 0 to +40°C 15 - 90% | 0 to +40°C 15 - 90% | X |
|----|------------------------|---------------------|---------------------|---|
| 12 | Storage Environment | -40 to +50° C 5-95% | -40 to +50° C 5-95% | X |
| 3 | Safety Standards | Yes | Yes | X |
| 14 | EMC | Yes | Yes | X |
| 15 | Prescription Device | Yes | Yes | X |
| 16 | Cuff Bladder Deflation | Automatic | Automatic | X |
| 17 | Inflation Method | Automatic | Automatic | X |
| 18 | Cuff Sizes | Multiple | Multiple | X |
| 19 | Clinical Reports | Yes | Yes | X |
| 20 | Printed Reports | Yes | Yes | X |
| 21 | Supplied Non-Sterile | Yes | Yes | X |

#### Discussion of Similarities and Differences

The 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 .
- 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 significantly smaller.

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

- It has the same intended use as the predicate device. .
- It has the same technical characteristics as the predicate device and does not raise . any new types of safety or effectiveness concerns.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.

OCT 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomedix, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K042616

Trade Name: Biomedix PADnet Lab Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: September 22, 2004 Received: September 23, 2004

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for woo bayed in 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 r ou mayy are servisions of the Act include requirements for annual registration, listing 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 may or dayses to 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 -- Ms. Laura Danielson

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/dsma/dsmamain.html

Sincerely yours,

Bhimma for
Drém D. Zuckerman, M.D.

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Biomedix PADnet Lab

Indications for Use:

Callohis for Use.
The BioMedix PADnet Lab is a non invasive device used to record physiological data The DioModix PADmit Larterial system using pulse volume recordings and from the 10wer extremity artitis blood pressures for use by the Physician in the osentification of vascular pathology. It is intended to be used by healthcare identification of vasedial paintees.
professionals in a hospital or clinic environment. The device is not intended for professionals in a nebblished for use on or intended for 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascylar Devices Division omber KO40616

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(Posted November 13, 2003)