(135 days)
Not Found
No
The summary describes a simple thermal warmer for enteral nutrition and does not mention any AI or ML components or capabilities.
No
The device warms nutritional feedings but does not directly treat a disease or condition. It facilitates the administration of nutrition.
No
Explanation: The device description states its purpose is to warm nutritional feedings for patients, not to diagnose a condition.
No
The device description explicitly states it is an "electrically powered dry warmer" and an "external dry-heat thermal warmer," indicating it is a hardware device that applies heat. The performance studies also include electrical safety and electromagnetic compatibility testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device's intended use is to warm enteral nutrition feedings for patients being fed via a gastrointestinal tube. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description confirms it's an external dry-heat thermal warmer for warming nutritional feedings.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis, monitoring, or screening.
- Focus on Warming: The core function is purely physical – applying heat to the feeding tube.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
LGZ
Device Description
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.
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
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."
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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 Pine |
| 17745 Metcalf | |
| One Penguin Plaza | |
| Stilwell, KS 66085 | |
| Phone: 760.809.5178 | |
| 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) |
| 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-Line
Warmer | LiFort LT1 Enteral
Nutrition Warmer
(K024373) | Acacia Enteral
Nutrition Warmer
(K122449) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------|
| Overall Technological
Characteristics | Dry-heat, external
thermal warmer. | SAME | SAME |
| Principle of Operation | The gastrointestinal
tubing is fed through the
warming channel of the
warmer, which warms
the nutritional feeding
before entering the
patient. | SAME | SAME |
| Power Requirements | 240V~, 50/60Hz, 60W/hr
100V~, 50/60Hz, 100W/hr | 230V~, 50/60Hz, 60W/hr
115V~, 50/60Hz, 100W/hr | 230V~, 50/60Hz, 60W/hr
115V~, 50/60Hz, 100W/hr |
| Temperature Display | Yes, Celsius and
Fahrenheit, LED | No | No |
| Warming
Temperature | 36-38C | 32-41C | 32C-41C |
| Warming time | 2-3 minutes | 2-3 minutes | Unknown |
| Warming patient
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
F°/C° button (toggles
display) | ON/OFF button | ON/OFF switch |
| Materials of
Construction | Aluminum heating plate | Aluminum heating plate | Heating plate, unknown
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
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
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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.