(196 days)
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.
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.
The provided text describes the 510(k) summary for the EZ-IV Medical Pad Warming Unit, Model 1000. It is a device 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.
However, the provided document does not contain the acceptance criteria for device performance, nor does it detail a study that explicitly proves the device meets such criteria in a quantitative manner typical of performance studies for diagnostic or AI-based medical devices. The "Efficacy" and "Safety" sections describe studies related to the benefits of using warmed pads and the safety of the warming unit itself, rather than performance of the device against predefined quantitative metrics suitable for a table of acceptance criteria.
The device in question is a simple warming unit, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC. Therefore, many of the questions regarding AI-specific criteria (like ground truth, expert consensus, MRMC studies, etc.) are not applicable to this submission.
Given the nature of the device and the provided document, I will answer the applicable questions based on the information available and note where information is not present or not relevant.
1. Table of Acceptance Criteria and Reported Device Performance
As no explicit acceptance criteria for device performance are stated in the provided 510(k) summary, I cannot populate a table in the typical format of a diagnostic device. However, I can infer the "performance" demonstrated by the efficacy and safety studies mentioned.
| Performance Aspect (Inferred) | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Efficacy | Reduction in Venous Access Attempts | Statistically significant reduction in needle sticks. |
| Reduction in Time for Venous Access | Significant decrease in time required for venous access. | |
| Microbial Equivalence | Equivalent to room temperature pads in reducing microbial load. | |
| Safety | Chemical Integrity of Pads | No effect on chemical composition of alcohol/betadine pads when warmed at 58° C for 96 hours and 80° C for 24 hours. |
| Sterility of Pads | No adverse effect on sterility when warmed at 58° C for 96 hours. | |
| Electrical Safety | Underwriters Laboratories (UL) certification indicates no electrical safety issues. | |
| Temperature | Pre-set Maximum Temperature | Pre-set maximum temperature of 55° C. |
| Warming Target Temperature | Alcohol pads warmed to 40° C (for clinical study). |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Clinical Efficacy Studies: The summary mentions "pediatric patients" for the first clinical study and "warmed alcohol and povidone iodine pads" for the second clinical evaluation. However, the specific sample sizes (number of patients or number of procedures) for these clinical studies are not provided in the document.
- Chemical and Sterility Studies: The sample size for pads used in infrared spectrometer analyses and sterility studies is implied but not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the clinical studies. The clinical studies appear to be prospective as they describe "a clinical study was conducted" and "a second clinical evaluation showed." The chemical and sterility tests are laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable as the device is a warming unit, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The clinical studies likely used objective measures (number of needle sticks, time to venous access) and microbial culture results.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This question is not applicable. Adjudication methods are typically used for evaluating human-expert disagreement on diagnostic tasks. The clinical and laboratory studies reported for this device would have objective outcomes (e.g., counts, time measurements, laboratory analyses) rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The EZ-IV Medical Pad Warming Unit is not an AI device, and therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to its assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The EZ-IV Medical Pad Warming Unit is not an algorithm or AI device. Its performance is related to its physical function (warming) and its impact on clinical procedures, not an algorithm's standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the efficacy studies:
- Clinical Outcomes Data: The ground truth for the efficacy studies appears to be clinical outcomes data, specifically:
- "statistically significant reduction in the number of venous access attempts (needle sticks)"
- "significant decrease in time required for venous access"
- The "microbial analysis" likely used standard microbiological culture results or similar laboratory methods to determine microbial load reduction.
For the safety studies:
- Laboratory Analysis Results: For chemical composition, the ground truth would be based on infrared spectrometer analyses. For sterility, it would be based on standard sterility testing methods.
8. The Sample Size for the Training Set
This question is not applicable. The EZ-IV Medical Pad Warming Unit is a hardware device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as the device does not involve a training set.
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SEP 14 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Marda Medical, Inc. |
|---|---|
| Contact: | Howard SchrayerRegulatory Affairs Consultant |
| Address: | 895 NE Dixie HighwaySuite 201Jensen 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 IRQ21 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 medicalprep pads (alcohol and povidone iodine), with a pre-set maximumtemperature of 55° C. A lid covers the unit to minimize any heatloss from the medical pads. Inside the unit are four individualcompartments, in which the sealed pads are placed. Eachcompartment has it's own, inner lid. The front of the device has amembrane keypad to control the device function. |
| Intended Use:(Indications) | The EZ-IV Medical Pad Warming Unit is intended to warm alcoholand povidone iodine skin cleansing pads for use in gaining venousaccess during intravenous fluid and / or medication administrationand to facilitate phlebotomy procedures. |
| SE: | The EZ-IV Medical Pad Warming Unit, is a medical device, andMarda Medical, Inc. believes it falls within the same FederalRegulation Number 21 CFR 890.5950, as the predicate device.Marda Medical believes the EZ-IV Medical Pad Warming Unit hasthe same technological characteristics, and is substantiallyequivalent to the predicate device. It differs in that the Thermalatorwarms it's contents with a water bath, while the EZ-IV Medical PadWarming Unit employs simple radiant heating. |
| Efficacy: | A clinical study was conducted during which alcohol pads werewarmed to a temperature of 40° C before being used to facilitateintravenous access in pediatric patients. The results showed astatistically significant reduction in the number of venous accessattempts (needle sticks) when warmed alcohol pads were used,compared with the use of non-warmed, room temperature alcoholpads. A second clinical evaluation showed a significant decreasein time required for venous access when warmed alcohol andpovidone iodine pads were used compared to room temperaturepads. A microbial analysis demonstrated that heated pads areequivalent to room temperature pads in their ability to reducemicrobial load on the patient's skin. |
| Safety: | Infrared spectrometer analyses showed the device does not affectthe chemical composition of the alcohol and betadine pads whenwarmed at 58° C for 96 hours and 80° C for 24 hours. Additionalstudies showed the device does not adversely affect the sterility ofthe alcohol and povidone iodine pads when warmed at 58° C for96 hours. Underwriters Laboratories certification shows there areno electrical safety issues. |
| Conclusions: | Marda Medical Inc. believes that the information providedestablishes that the EZ-IV Medical Pad Warming Unit performs asimilar function to that of other, legally marketed, devices, namelythe warming of patient contact materials to provide patient benefit.The devices intended for distribution by Marda Medical have beentested 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 (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
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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
§ 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.