(135 days)
The Penguin In-Line Warmer is an electrically powered dry warmer which supplies external heat to the plastic tubing of enteral nutrition administration sets.
The Penguin In-Line Warmer is an external dry-heat thermal warmer. The Penguin In-Line Warmer warms nutritional feedings for patients being fed via a gastrointestinal tube.
This document describes a 510(k) premarket notification for the "Penguin In-Line Warmer," a device used to warm enteral nutrition. The information provided focuses on the device's technical characteristics and performance testing to demonstrate its substantial equivalence to predicate devices. It does not contain information about studies involving human readers or AI assistance.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document provides a table comparing the technical characteristics of the Penguin In-Line Warmer with its predicate devices. While it lists various characteristics, it doesn't explicitly define "acceptance criteria" in a quantitative sense for each characteristic. Instead, it indicates "SAME" where characteristics are identical to the predicate. For those that differ, the reported performance is simply the characteristic itself.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Penguin In-Line Warmer) |
|---|---|---|
| Overall Technological Characteristics | Dry-heat, external thermal warmer | Dry-heat, external thermal warmer. |
| Principle of Operation | Gastrointestinal tubing fed through warming channel, warming nutritional feeding before entering patient. | The gastrointestinal tubing is fed through the warming channel of the warmer, which warms the nutritional feeding before entering the patient. |
| Power Requirements | 230V~, 50/60Hz, 60W/hr AND 115V~, 50/60Hz, 100W/hr | 240V~, 50/60Hz, 60W/hr AND 100V~, 50/60Hz, 100W/hr |
| Temperature Display | No | Yes, Celsius and Fahrenheit, LED |
| Warming Temperature | 32-41C | 36-38C |
| Warming Time | 2-3 minutes | 2-3 minutes |
| Warming patient proximity | At point of care | At point of care |
| Temperature control | Pre-Set at manufacturer | Pre-Set at manufacturer |
| Number of heaters | One (for one predicate, unknown for other) | One |
| User controls | ON/OFF button OR ON/OFF switch | ON/OFF button, F°/C° button (toggles display) |
| Materials of Construction | Aluminum heating plate (for one predicate, unknown for other) | Aluminum heating plate |
| Heating channel | "S" shaped OR Exaggerated "S" Shape | Multi-"S" shaped |
| Tube compatibility | 4.1-5.0 dia mm OR 2.4mm | 2.0-3.0 dia mm |
| Flow rate | 0-7ml/min | 0.25-1 ml/min |
| Thermal cut-off | Fuse | Fuse |
| Operating Condition | 0-40C | 0-40C |
| Water resistant case/housing | Yes (for one predicate, unknown for other) | Yes |
| Fluid Path Contact | No | No |
| Direct Patient Contact | No | No |
| How provided | Non-sterile | Non-sterile |
| Reusable | Yes | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states "All necessary verification and validation testing has been performed," but does not detail the sample sizes, test setup (e.g., specific number of tests run for temperature verification), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided. The device is an enteral nutrition warmer, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The testing mentioned (cleaning/disinfection, temperature verification, electrical safety, EMC, software validation) would be performed by engineers and technicians against established technical standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation (e.g., by radiologists) is required to establish ground truth for a diagnostic device. The device in question is a medical warmer, and its performance is evaluated against objective technical standards, not subjective human interpretations.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers (e.g., radiologists, pathologists) and AI assistance. The Penguin In-Line Warmer is a physical device that warms fluids, and its evaluation does not involve human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical warmer, not an algorithm, so a "standalone algorithm only" performance evaluation is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the verification and validation testing mentioned, the "ground truth" would be established by:
- Established industry standards and regulatory requirements: For electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).
- Engineering specifications and design documents: For temperature verification (e.g., ensuring the device warms to a specific range), cleaning/disinfection effectiveness, and software functionality.
- Physical measurements and observations: For parameters like warming temperature accuracy, warming time, flow rate, and tube compatibility.
This is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set and associated ground truth establishment.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
Creche Innovations c/o Ms. Rebecca K. Pine Vice President 17745 Metcalf One Penguin Plaza Stilwell, Kansas 66085
Re: K150484
Trade/Device Name: Penguin In-Line Warmer Regulation Number: Unclassified, Preamendment Regulation Name: Thermal Infusion Fluid Warmer Regulatory Class: Unclassified, Preamendment Product Code: LGZ Dated: April 7, 2015 Received: April 10, 2015
Dear Ms. Pine:
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150484
Device Name Penguin In-Line Warmer
Indications for Use (Describe)
The Penguin In-Line Warmer is an electrically powered dry warmer which supplies external heat to the plastic tubing of enteral nutrition administration sets.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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6. 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510K NUMBER: | K150484 |
|---|---|
| APPLICANT: | Creche Innovations |
| DATE PREPARED: | July 9, 2015 |
| CONTACT PERSON: | Rebecca K Pine17745 MetcalfOne Penguin PlazaStilwell, KS 66085Phone: 760.809.5178Fax: 760.290.3216 |
| TRADE NAME: | Penguin In-Line Warmer |
| COMMON NAME: | Thermal Infusion Fluid Warmer |
| CLASSIFICATION NAME: | Unclassified, preamendment |
| DEVICE CLASSIFICATION: | None |
| PRODUCT CODE | LGZ |
| PREDICATE DEVICES: | LiFort LT1 Enteral Nutrition Warmer (K024373)Acacia Enteral Nutrition Warmer (K122449) |
Substantially Equivalent To:
The Penguin In-Line Warmer is substantially equivalent in intended use, principal of operation and technological characteristics to the LiFort LT1 Enteral Nutrition Warmer (K024373) and Acacia Enteral Nutrition Warmer (K122449).
Description of the Device Subject to Premarket Notification:
The Penguin In-Line Warmer is an external dry-heat thermal warmer. The Penguin In-Line Warmer warms nutritional feedings for patients being fed via a gastrointestinal tube.
Indication for Use:
The Penguin In-Line Warmer is an electrically powered dry warmer which supplies external heat to the plastic tubing of enteral nutrition administration sets.
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Technical Characteristics:
The Penguin In-Line Warmer has similar physical and technical characteristics to the predicate device. The table below illustrates the similarities and differences of the devices.
| Penguin In-LineWarmer | LiFort LT1 EnteralNutrition Warmer(K024373) | Acacia EnteralNutrition Warmer(K122449) | |
|---|---|---|---|
| Overall TechnologicalCharacteristics | Dry-heat, externalthermal warmer. | SAME | SAME |
| Principle of Operation | The gastrointestinaltubing is fed through thewarming channel of thewarmer, which warmsthe nutritional feedingbefore entering thepatient. | SAME | SAME |
| Power Requirements | 240V~, 50/60Hz, 60W/hr100V~, 50/60Hz, 100W/hr | 230V~, 50/60Hz, 60W/hr115V~, 50/60Hz, 100W/hr | 230V~, 50/60Hz, 60W/hr115V~, 50/60Hz, 100W/hr |
| Temperature Display | Yes, Celsius andFahrenheit, LED | No | No |
| WarmingTemperature | 36-38C | 32-41C | 32C-41C |
| Warming time | 2-3 minutes | 2-3 minutes | Unknown |
| Warming patientproximity | At point of care | SAME | SAME |
| Temperature control | Pre-Set at manufacturer | SAME | SAME |
| Number of heaters | One | Unknown | One |
| User controls | ON/OFF buttonF°/C° button (togglesdisplay) | ON/OFF button | ON/OFF switch |
| Materials ofConstruction | Aluminum heating plate | Aluminum heating plate | Heating plate, unknownmaterial(s) |
| Heating channel | Multi-"S" shaped | "S" shaped | Exaggerated "S" Shape |
| Tube compatibility | 2.0-3.0 dia mm | 4.1-5.0 dia mm | 2.4mm |
| Flow rate | 0.25-1 ml/min | 0-7ml/min | 0-7ml/min |
| Thermal cut-off | Fuse | Fuse | Fuse |
| Operating Condition | 0-40C | 0-40C | 0-40C |
| Water resistantcase/housing | Yes | Yes | Unknown |
| Fluid Path Contact | No | SAME | SAME |
| Direct Patient Contact | No | SAME | SAME |
| How provided | Non-sterile | SAME | SAME |
| Reusable | Yes | SAME | SAME |
The minor differences in indications for use statements between the Penguin In- line Warmer and that of the predicate devices have no bearing on the safety or effectiveness of the device when used as labeled, as these differences are merely a functional description (such as flow rate and different diameter range of catheters the device can accommodate) and have no effect on the fundamental intended use. All devices share intended use, namely, to provide external electrical heat to enteral feeding tubes for the purpose of warming the
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nutrition solution.
Performance Data:
All necessary verification and validation testing has been performed for the Penguin In-Line Warmer to assure substantial equivalence to the predicate device. The testing included:
- . cleaning/disinfection
- temperature verification ●
- . electrical safety (IEC 60601-1)
- electromagnetic compatibility (IEC 60601-1-2) ●
- software validation ●
Basis for Determination of Substantial Equivalence:
Based on the comparable intended use, principle of operation, overall technological characteristics and the performance data provided, the Penguin In-Line Warmer is as safe and effective as the cited predicate devices and is therefore substantially equivalent.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).