Penguin In-Line Warmer

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 Pine<br>17745 Metcalf<br>One Penguin Plaza<br>Stilwell, KS 66085<br>Phone: 760.809.5178<br>Fax: 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)<br>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. {4}------------------------------------------------ # 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-Line<br>Warmer | LiFort LT1 Enteral<br>Nutrition Warmer<br>(K024373) | Acacia Enteral<br>Nutrition Warmer<br>(K122449) | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------| | Overall Technological<br>Characteristics | Dry-heat, external<br>thermal warmer. | SAME | SAME | | Principle of Operation | The gastrointestinal<br>tubing is fed through the<br>warming channel of the<br>warmer, which warms<br>the nutritional feeding<br>before entering the<br>patient. | SAME | SAME | | Power Requirements | 240V~, 50/60Hz, 60W/hr<br>100V~, 50/60Hz, 100W/hr | 230V~, 50/60Hz, 60W/hr<br>115V~, 50/60Hz, 100W/hr | 230V~, 50/60Hz, 60W/hr<br>115V~, 50/60Hz, 100W/hr | | Temperature Display | Yes, Celsius and<br>Fahrenheit, LED | No | No | | Warming<br>Temperature | 36-38C | 32-41C | 32C-41C | | Warming time | 2-3 minutes | 2-3 minutes | Unknown | | Warming patient<br>proximity | At point of care | SAME | SAME | | Temperature control | Pre-Set at manufacturer | SAME | SAME | | Number of heaters | One | Unknown | One | | User controls | ON/OFF button<br>F°/C° button (toggles<br>display) | ON/OFF button | ON/OFF switch | | Materials of<br>Construction | Aluminum heating plate | Aluminum heating plate | Heating plate, unknown<br>material(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 resistant<br>case/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 {5}------------------------------------------------ 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.