(196 days)
Not Found
Not Found
No
The device description and performance studies focus on a simple heating mechanism and its clinical impact, with no mention of AI or ML technologies.
No
The device warms medical pads to facilitate venous access and phlebotomy procedures, which are supportive actions rather than direct therapeutic interventions.
No
The device's function is to warm medical pads, which aids in procedures like gaining venous access and phlebotomy by reducing attempts and time. It does not analyze patient data or provide diagnostic information about a medical condition.
No
The device description clearly outlines a physical, portable, tabletop medical device with hardware components such as a heating unit, lid, compartments, and a membrane keypad. It is not solely software.
Based on the provided information, the EZ-IV Medical Pad Warming Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to warm skin cleansing pads for use in gaining venous access and facilitating phlebotomy. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device warms pads used for skin preparation. It does not analyze biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, tissue, urine, etc.) to provide information for diagnostic, monitoring, or screening purposes. The EZ-IV Medical Pad Warming Unit's function is to prepare the skin for a medical procedure, not to analyze a biological sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IRQ
Device Description
The EZ-IV Medical Pad Warming Unit, is a compact, portable, tabletop size medical device, used to warm factory sealed medical prep pads (alcohol and povidone iodine), with a pre-set maximum temperature of 55° C. A lid covers the unit to minimize any heat loss from the medical pads. Inside the unit are four individual compartments, in which the sealed pads are placed. Each compartment has it's own, inner lid. The front of the device has a membrane keypad to control the device function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted during which alcohol pads were warmed to a temperature of 40° C before being used to facilitate intravenous access in pediatric patients. The results showed a statistically significant reduction in the number of venous access attempts (needle sticks) when warmed alcohol pads were used, compared with the use of non-warmed, room temperature alcohol pads. A second clinical evaluation showed a significant decrease in time required for venous access when warmed alcohol and povidone iodine pads were used compared to room temperature pads. A microbial analysis demonstrated that heated pads are equivalent to room temperature pads in their ability to reduce microbial load on the patient's skin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Thermalator. Models T-4-S, T-8-S, etc
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5950 Powered heating unit.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
0
SEP 14 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Marda Medical, Inc. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 895 NE Dixie Highway |
| Suite 201 | |
| Jensen Beach, FL 34957 | |
| Telephone: | (772) 225-3111 |
- 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 |
| 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, |
| tabletop size medical device, used to warm factory sealed medical | |
| prep pads (alcohol and povidone iodine), with a pre-set maximum | |
| temperature of 55° C. A lid covers the unit to minimize any heat | |
| loss from the medical pads. Inside the unit are four individual | |
| compartments, in which the sealed pads are placed. Each | |
| compartment has it's own, inner lid. The front of the device has a | |
| membrane keypad to control the device function. | |
| Intended Use: | |
| (Indications) | 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. | |
| SE: | The EZ-IV Medical Pad Warming Unit, is a medical device, and |
| Marda Medical, Inc. believes it falls within the same Federal | |
| Regulation Number 21 CFR 890.5950, as the predicate device. | |
| Marda Medical believes the EZ-IV Medical Pad Warming Unit has | |
| the same technological characteristics, and is substantially | |
| equivalent to the predicate device. It differs in that the Thermalator | |
| warms it's contents with a water bath, while the EZ-IV Medical Pad | |
| Warming Unit employs simple radiant heating. | |
| Efficacy: | A clinical study was conducted during which alcohol pads were |
| warmed to a temperature of 40° C before being used to facilitate | |
| intravenous access in pediatric patients. The results showed a | |
| statistically significant reduction in the number of venous access | |
| attempts (needle sticks) when warmed alcohol pads were used, | |
| compared with the use of non-warmed, room temperature alcohol | |
| pads. A second clinical evaluation showed a significant decrease | |
| in time required for venous access when warmed alcohol and | |
| povidone iodine pads were used compared to room temperature | |
| pads. A microbial analysis demonstrated that heated pads are | |
| equivalent to room temperature pads in their ability to reduce | |
| microbial load on the patient's skin. | |
| Safety: | Infrared spectrometer analyses showed the device does not affect |
| the chemical composition of the alcohol and betadine pads when | |
| warmed at 58° C for 96 hours and 80° C for 24 hours. Additional | |
| studies showed the device does not adversely affect the sterility of | |
| the alcohol and povidone iodine pads when warmed at 58° C for | |
| 96 hours. Underwriters Laboratories certification shows there are | |
| no electrical safety issues. | |
| Conclusions: | Marda Medical Inc. believes that the information provided |
| establishes that the EZ-IV Medical Pad Warming Unit performs a | |
| similar function to that of other, legally marketed, devices, namely | |
| the warming of patient contact materials to provide patient benefit. | |
| The devices intended for distribution by Marda Medical have been | |
| 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.
3
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 (240) 276-0115. 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 (301) 443-6597 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
4
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