EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000

K050524 · Marda Medical, Inc. · IRQ · Sep 14, 2005 · Physical Medicine

Device Facts

• Record ID: K050524
• Device Name: EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
• Applicant: Marda Medical, Inc.
• Product Code: IRQ · Physical Medicine
• Decision Date: Sep 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5950
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone iodine skin cleansing pads for use in gaining venous access during intravenous fluid and / or medication administration and to facilitate phlebotomy procedures.

Device Story

Compact, portable, tabletop warming unit for factory-sealed alcohol and povidone iodine prep pads. Device features four individual compartments with inner lids and a main outer lid to minimize heat loss. User interface consists of a membrane keypad to control device function. Operates via radiant heating to a pre-set maximum temperature of 55°C. Used in clinical settings to warm pads prior to application on patient skin. Warmed pads reduce the number of venous access attempts (needle sticks) and decrease time required for venous access procedures. Benefits include improved efficiency and patient comfort during phlebotomy or IV placement. Safety testing confirms no adverse effects on pad chemical composition or sterility when heated.

Clinical Evidence

Clinical study in pediatric patients showed a statistically significant reduction in venous access attempts (needle sticks) using warmed alcohol pads versus room temperature pads. A second evaluation showed a significant decrease in time required for venous access using warmed alcohol and povidone iodine pads. Microbial analysis demonstrated that heated pads are equivalent to room temperature pads in reducing microbial load on patient skin.

Technological Characteristics

Compact, portable tabletop unit; radiant heating element; pre-set maximum temperature 55°C; membrane keypad control; four-compartment design with individual lids; electrical safety certified by Underwriters Laboratories.

Indications for Use

Indicated for warming alcohol and povidone iodine skin cleansing pads to facilitate venous access and phlebotomy procedures in patients requiring intravenous fluid or medication administration.

Regulatory Classification

Identification

A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

Predicate Devices

• Thermalator (Models T-4-S, T-8-S, etc)

Submission Summary (Full Text)

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SEP 14 2005

K050524

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

## General Company Information

| Name: | Marda Medical, Inc. |
|------------|-------------------------------------------------------------|
| Contact: | Howard Schrayer<br>Regulatory Affairs Consultant |
| Address: | 895 NE Dixie Highway<br>Suite 201<br>Jensen Beach, FL 34957 |
| Telephone: | [phone] |

- Date Prepared: August 20, 2005
## General Device Information

| Device Name: | EZ-IV Medical Pad Warming Unit, Model 1000 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Powered Heating Unit |
| Classification: | Class I - Product Code IRQ<br>21 CFR 890.5950 |
| Predicate Device: | Thermalator. Models T-4-S, T-8-S, etc |
| Description: | The EZ-IV Medical Pad Warming Unit, is a compact, portable,<br>tabletop size medical device, used to warm factory sealed medical<br>prep pads (alcohol and povidone iodine), with a pre-set maximum<br>temperature of 55° C. A lid covers the unit to minimize any heat<br>loss from the medical pads. Inside the unit are four individual<br>compartments, in which the sealed pads are placed. Each<br>compartment has it's own, inner lid. The front of the device has a<br>membrane keypad to control the device function. |
| Intended Use:<br>(Indications) | The EZ-IV Medical Pad Warming Unit is intended to warm alcohol<br>and povidone iodine skin cleansing pads for use in gaining venous<br>access during intravenous fluid and / or medication administration<br>and to facilitate phlebotomy procedures. |
| SE: | The EZ-IV Medical Pad Warming Unit, is a medical device, and<br>Marda Medical, Inc. believes it falls within the same Federal<br>Regulation Number 21 CFR 890.5950, as the predicate device.<br>Marda Medical believes the EZ-IV Medical Pad Warming Unit has<br>the same technological characteristics, and is substantially<br>equivalent to the predicate device. It differs in that the Thermalator<br>warms it's contents with a water bath, while the EZ-IV Medical Pad<br>Warming Unit employs simple radiant heating. |
| Efficacy: | A clinical study was conducted during which alcohol pads were<br>warmed to a temperature of 40° C before being used to facilitate<br>intravenous access in pediatric patients. The results showed a<br>statistically significant reduction in the number of venous access<br>attempts (needle sticks) when warmed alcohol pads were used,<br>compared with the use of non-warmed, room temperature alcohol<br>pads. A second clinical evaluation showed a significant decrease<br>in time required for venous access when warmed alcohol and<br>povidone iodine pads were used compared to room temperature<br>pads. A microbial analysis demonstrated that heated pads are<br>equivalent to room temperature pads in their ability to reduce<br>microbial load on the patient's skin. |
| Safety: | Infrared spectrometer analyses showed the device does not affect<br>the chemical composition of the alcohol and betadine pads when<br>warmed at 58° C for 96 hours and 80° C for 24 hours. Additional<br>studies showed the device does not adversely affect the sterility of<br>the alcohol and povidone iodine pads when warmed at 58° C for<br>96 hours. Underwriters Laboratories certification shows there are<br>no electrical safety issues. |
| Conclusions: | Marda Medical Inc. believes that the information provided<br>establishes that the EZ-IV Medical Pad Warming Unit performs a<br>similar function to that of other, legally marketed, devices, namely<br>the warming of patient contact materials to provide patient benefit.<br>The devices intended for distribution by Marda Medical have been<br>tested to assure compliance with requirements. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol on the right side. On the left side, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howard Schrayer Marda Medical, Inc. 895 NE Nixie Highway, Suite 201 Jensen Beach, Florida 34957

Re: K050524

Trade/Device Name: EZ-IV Medical Pad Warming Unit, Model 1000 Regulation Number: 21 CFR 890.5950 Regulation Name: Powered heating unit Regulatory Class: I Product Code: IRQ Dated: August 24, 2005 Received: August 25, 2005

Dear Mr. Schrayer:

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 received a cor 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.

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 (1 wr 1), it a 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. Schrayer

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 meall that I DA nas made a deceminary and regulations administered by other Federal agencies. of the Act of ally I edelar statues and systements, including, but not limited to: registration 1 ou must comply with and are are are are 801); good manufacturing practice and listing (21 CF RT Far 007), abality systems (QS) regulation (21 CFR Part 820); and if requirents as sectionic 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) This letter will anow you to ocean finding of substantial equivalence of your device to a premits in the cation. - The PDF 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), If you desire specific at not tee for your ce 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 may other generation of Small Manufacturers, International and Consumer Assistance at its toll-free Division of 01638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE

510(k) Number (if known): K050524

Device Name: EZ-IV Medical Pad Warming Unit

Indications For Use:

The EZ-IV Medical Pad Warming Unit is intended to warm alcohol and povidone The EZ-TV Medical I ad Warming United in gaining venous access during intravenous iodine skin cleansing paus for use in gaming vehicus as a low
fluid and / or medication administration and to facilitate phlebotomy procedures.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rill C. Chapman for Min 9/10/01

(Division Sign-Off) (Civision Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K050524