(78 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Insulated Strap:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (510(k) Summary for K130867) does not list specific numerical acceptance criteria or performance metrics for the enFlow IV Fluid Warmer Insulated Strap. Instead, it focuses on qualitative compliance and equivalence.
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Material Biocompatibility | Meets biocompatibility requirements per ISO 10993. |
| Design & Performance Verification | Verified that the enFlow IV Fluid Warmer IV System meets the defined specifications. Includes functional, packaging, and labeling evaluations. |
| Risk Analysis | Risk Management employed throughout development and implementation. |
| User Validation Testing | User testing performed to validate the enFlow IV Fluid Warmer Insulated Strap against its intended use. |
| Equivalence to Predicate Device | Equivalent in performance to the predicate strap, but introduces new materials in the insulating element and mounting plate. |
| Safety and Effectiveness | Considered as safe, as effective, and to perform in a substantially equivalent manner to the current enFlow IV Fluid Warmer System and the predicate device. |
| Compliance with Voluntary Standards | Accessories comply with voluntary standards. |
| Clinical Studies | Did not require clinical studies. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "User Validation Testing" and "Design & Performance Verification Testing" but does not quantify the number of units or tests involved.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission from a US company (GE Healthcare, Totowa, NJ), the testing was likely conducted in the US, but this is not confirmed. The testing appears to be retrospective in the sense that it's evaluating a developed accessory against established standards and a predicate device, rather than a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
- Number of Experts: Not explicitly stated. The section mentions "User Validation Testing" but does not specify how many users were involved or if they were considered "experts" for establishing ground truth, and if so, their qualifications. The other tests (biocompatibility, design/performance verification, risk analysis) would involve qualified engineers and scientists, but these are not referred to as "experts establishing ground truth" in the context of clinical or diagnostic performance.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. For non-clinical tests like material biocompatibility, functional verification, and risk analysis, formal adjudication methods like 2+1 or 3+1 are typically not applied in the same way they would be for expert review of images in a diagnostic AI study. Decisions would be based on test results meeting predefined specifications or standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No. The document explicitly states: "The subject of this premarket submission, enFlow IV Fluid Warmer Insulated Strap, did not require clinical studies to support substantial equivalence." This means no comparative effectiveness study with human readers was conducted, as the device is an IV fluid warmer accessory, not a diagnostic imaging device.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as there was no MRMC study or AI component in this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done? Not applicable. This device is an IV fluid warmer accessory and does not involve an algorithm or AI for diagnostic or predictive purposes. Its performance is related to warming fluids and material properties.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus for disease presence or absence) is not directly applicable here. For this device, the "ground truth" or reference for evaluating its performance comes from:
- Defined Specifications: For functional, packaging, and labeling evaluations.
- Voluntary Standards: For overall compliance.
- ISO 10993: For biocompatibility requirements.
- Intended Use: For user validation testing.
- Predicate Device Performance: For establishing substantial equivalence.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a hardware accessory and does not involve a "training set" in the context of machine learning or AI models.
- How Ground Truth for Training Set was Established: Not applicable.
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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
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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 ContactPerson: | 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 InsulatedStrap |
| 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 FluidWarmer which is used to secure the warmer component of theenFlow IV Fluid Warmer System to the patient during transport.The Insulated strap consists of a silicone strap, an insulatingelement and a mounting plate, into which the user can securethe enFlow IV Fluid Warmer. |
| Intended Use: | The enFlow IV Fluid Warmer System is indicated for warmingblood, blood products and intravenous solutions prior toadministration. It is intended to be used by healthcareprofessionals in hospital, clinical and field environments to helpprevent hypothermia. |
| Technology: | The enFlow IV Fluid Warmer with Insulated Strap accessorydoes not change the fundamental scientific technology of theenFlow IV Fluid Warmer with Strap, its predicate device.The Insulated Strap is equivalent in performance to thepredicate strap, but introduces new materials which composethe insulating element and the mounting plate. |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The enFlow IV Fluid Warmer with Insulated Strap and itsaccessories comply with voluntary standards. The followingquality assurance measures were applied to the developmentof the system:Risk Analysis - Risk Management was employed throughoutthe development and implementation of the enFlow IV FluidWarmer System. Design & Performance Verification Testing includingfunctional, packaging and labeling evaluations - verifiedthat the enFlow Fluid Warmer IV System meets the definedspecifications. Biocompatibility testing - The materials used in theInsulated strap meet the biocompatibility requirements perISO 10993. User Validation Testing - User testing was performed to'validate the enFlow IV Fluid Warmer Insulated Strap againstits intended use. Summary of Clinical Tests:The subject of this premarket submission, enFlow IV FluidWarmer Insulated Strap, did not require clinical studies tosupport substantial equivalence. |
| Conclusion: | GE Healthcare considers the enFlow IV Fluid Warmer Systemwith the Insulated Strap to be as safe, as effective, and toperform in a substantially equivalent manner to the currentenFlow IV Fluid Warmer System, and to the predicate deviceenFlow IV Fluid Warmer Strap. |
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GE Healthcare
510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission
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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.
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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
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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: _
§ 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).