(78 days)
No
The document describes a simple accessory (an insulated strap) for a fluid warmer and contains no mention of AI or ML technology.
No
The device is an accessory (Insulated Strap) to an IV fluid warmer, which is used to prevent hypothermia by warming fluids prior to administration, not to directly treat a disease or condition in a patient.
No.
The device is an IV fluid warmer system intended for warming blood and intravenous solutions, which is a therapeutic function, not diagnostic. It does not provide any information about the patient's health status or condition.
No
The device description clearly outlines hardware components (silicone strap, insulating element, mounting plate) and the summary of performance studies includes testing related to these physical components (biocompatibility, functional testing).
Based on the provided information, the enFlow IV Fluid Warmer System and its accessory, the Insulated Strap, are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and intravenous solutions prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device description focuses on the physical components and how they are used to secure and insulate the warmer. There is no mention of analyzing samples from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
The device is clearly intended for use on the patient (warming fluids before they enter the body) and is used by healthcare professionals in a clinical setting. This aligns with the definition of a medical device used for treatment or support, not diagnosis.
N/A
Intended Use / Indications for Use
The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Product codes
LGZ
Device Description
The Insulated Strap is an accessory to the enFlow IV Fluid Warmer which is used to secure the warmer component of the enFlow IV Fluid Warmer System to the patient during transport. The Insulated strap consists of a silicone strap, an insulating element and a mounting plate, into which the user can secure the enFlow IV Fluid Warmer.
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
healthcare professionals in hospital, clinical and field environments
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)
Summary of Non-Clinical Tests:
The enFlow IV Fluid Warmer with Insulated Strap and its accessories comply with voluntary standards. The following quality assurance measures were applied to the development of the system:
Risk Analysis - Risk Management was employed throughout the development and implementation of the enFlow IV Fluid Warmer System. Design & Performance Verification Testing including functional, packaging and labeling evaluations - verified that the enFlow Fluid Warmer IV System meets the defined specifications. Biocompatibility testing - The materials used in the Insulated strap meet the biocompatibility requirements per ISO 10993. User Validation Testing - User testing was performed to 'validate the enFlow IV Fluid Warmer Insulated Strap against its intended use.
Summary of Clinical Tests:
The subject of this premarket submission, enFlow IV Fluid Warmer Insulated Strap, did not require clinical studies to support substantial equivalence.
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).
0
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '130867'. The characters are written in a simple, clear style, and they appear to be on a white background.
GE Healthcare
510(k) Premarket Notification Submission
Image /page/0/Picture/3 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white, with the letters and border appearing in white against a black background.
JUN 1 4 2013
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 26, 2013 |
|---|---|
| Submitter: | Vital Signs Inc., A GE Healthcare Company |
| 20 Campus Road | |
| Totowa, NJ 07512 | |
| Telephone: (973) 597-1800 | |
| Primary Contact Person: | Stacie Geffner-Atiya |
| Regulatory Affairs Manager | |
| Vital Signs Inc., A GE Healthcare Company | |
| Telephone: (973) 956-5491 | |
| Fax: (973) 956-5442 | |
| Email: stacie.geffner-atiya@ge.com | |
| Secondary Contact | |
| Person: | Trishia Dwyer |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Telephone: (608) 221-1551 x500-3074 | |
| Fax: (608) 646-6488 | |
| Email: trishia.l.dwyer@ge.com | |
| Device Trade Name: | enFlow IV Fluid Warmer, enFlow IV Fluid Warmer Insulated |
| Strap | |
| Common/Usual Name: | enFlow, Insulated strap, i-strap |
| Classification Names: | Warmer, Thermal, Infusion Fluid |
| Product Code: | LGZ |
| BSB - 21 CFR 864.9205 | |
| Predicate Device(s): | K121775, enFlow IV Fluid Warmer Strap |
| Device Description: | The Insulated Strap is an accessory to the enFlow IV Fluid |
| Warmer which is used to secure the warmer component of the | |
| enFlow IV Fluid Warmer System to the patient during transport. | |
| The Insulated strap consists of a silicone strap, an insulating | |
| element and a mounting plate, into which the user can secure | |
| the enFlow IV Fluid Warmer. | |
| Intended Use: | The enFlow IV Fluid Warmer System is indicated for warming |
| blood, blood products and intravenous solutions prior to | |
| administration. It is intended to be used by healthcare | |
| professionals in hospital, clinical and field environments to help | |
| prevent hypothermia. | |
| Technology: | The enFlow IV Fluid Warmer with Insulated Strap accessory |
| does not change the fundamental scientific technology of the | |
| enFlow IV Fluid Warmer with Strap, its predicate device. | |
| The Insulated Strap is equivalent in performance to the | |
| predicate strap, but introduces new materials which compose | |
| the insulating element and the mounting plate. | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The enFlow IV Fluid Warmer with Insulated Strap and its | |
| accessories comply with voluntary standards. The following | |
| quality assurance measures were applied to the development | |
| of the system: | |
| Risk Analysis - Risk Management was employed throughout | |
| the development and implementation of the enFlow IV Fluid | |
| Warmer System. Design & Performance Verification Testing including | |
| functional, packaging and labeling evaluations - verified | |
| that the enFlow Fluid Warmer IV System meets the defined | |
| specifications. Biocompatibility testing - The materials used in the | |
| Insulated strap meet the biocompatibility requirements per | |
| ISO 10993. User Validation Testing - User testing was performed to | |
| 'validate the enFlow IV Fluid Warmer Insulated Strap against | |
| its intended use. Summary of Clinical Tests: | |
| The subject of this premarket submission, enFlow IV Fluid | |
| Warmer Insulated Strap, did not require clinical studies to | |
| support substantial equivalence. | |
| Conclusion: | GE Healthcare considers the enFlow IV Fluid Warmer System |
| with the Insulated Strap to be as safe, as effective, and to | |
| perform in a substantially equivalent manner to the current | |
| enFlow IV Fluid Warmer System, and to the predicate device | |
| enFlow IV Fluid Warmer Strap. |
33
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GE Healthcare
510(k) Premarket Notification Submission
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are solid black, creating a strong contrast against the white background.
GE Healthcare 510(k) Premarket Notification Submission
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
Vital Signs, Incorporated, A GE Healthcare Company Ms. Stacie Geffner-Atiya Regulatory Affairs Manager 20 Campus Road TOTOWA NJ 07512-1210
Re: K130867
Trade/Device Name: enFlow IV Fluid Warmer Regulation Number: 21 CFR 864.9205 Regulation Name: Blood and Plasma Warming Device Regulatory Class: Unclassified Product Code: LGZ Dated: May 24, 2013 Received: May 29, 2013
Dear Ms. Geffner-Atiya:
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.
4
Page 2 - Ms. Geffner-Atiya
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mary-S.
Susan Runner DDS, MA Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name:
enFlow IV Fluid Warmer
Indications for Use:
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
| Prescription Use | x |
|---|---|
| ------------------ | --- |
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subport C)
(Part 21 CFR 801 Sub part D)
(PLEASE DO NOT-WRITE BELOW THIS LINE - CONTINUE ON AÑOTHER PAGE IF NEEDED)
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Richard C. Chapman 2013.06.14 11:32:3.1 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
130867 510(k) Number: _