(72 days)
Not Found
Not Found
No
The description details a standard fluid warming cabinet with electrothermal heating and temperature control, lacking any mention of AI or ML algorithms for operation, control, or analysis.
No.
The device's sole purpose is to store and warm fluids; it does not directly treat a patient's condition or provide a therapeutic effect.
No
The device is a fluid warming cabinet, used to heat irrigation or injection fluids to a specific temperature. It does not diagnose any medical condition.
No
The device description clearly states it is a "stainless steel fluid warming cabinet" that utilizes an "electrothermal cable array" for heating, indicating it is a physical hardware device.
Based on the provided information, the Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to safely store and warm irrigation fluids or injection fluids. This is a physical process applied to fluids before they are used in or on a patient.
- Device Description: The device is a warming cabinet that uses heating elements to raise the temperature of fluids. It does not perform any diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body. The EC-7701 warms fluids that will be used in vivo (inside the living body) or on the body.
N/A
Intended Use / Indications for Use
The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
Product codes (comma separated list FDA assigned to the subject device)
LHC, LGZ, LDO
Device Description
The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
JAN 2 0 2000
Appendix C
510(k) Summary Enthermics Medical Systems EC-7701 Fluid Warming Cabinet
- I. General Information on Submitter:
| Name: | Enthermics Medical Systems |
|---|---|
| Address: | W164 N9221 Water Street |
| Menomonee Falls, WI 53052-0450 | |
| Telephone: | (262) 251-8356 |
| Fax: | (262) 251-7067 |
| Name of Contact Person: | Mr. Mark Suszkowski |
| Date Summary Prepared: | November 5, 1999 |
- II. General Information on the Device
| Name: | EC-770I Fluid Warming Cabinet |
|---|---|
| Classification Name: | LHC, Warmer, Irrigation Solution |
| LGZ, Warmer, Thermal, Infusion Fluid |
- III. Predicate Devices: TempO II™ Warming Cabinet Castle® 5500 Series Warming Cabinets AMSCO Warming Cabinets
IV. Description of the Device:
The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.
- V. Intended Use:
The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
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Technological Characteristics of Device Compared to Predicate Device: VI.
The EC-770l is nearly identical to the three predicate devices in all material respects. All four devices use the same basic technology (nonelectromagnetic heating) and utilize similar over-temperature alarm systems (audible and visual indicators). The only material difference between the EC-7701 and the predicate devices is the selectable modes of operation (irrigation or injection) on the EC-7701. The selectable modes, however, do not raise additional questions of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping wing shapes, creating a sense of movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 2000
Emalee G. Murphy, Esquire McKenna & Cuneo, L.L.P. Attorneys at Law 1900 K Street N.W. Washington, D.C. 20006-1108
Re : K993797 Enthermics Medical Systems EC-7701 Fluid Trade Name: Warming Cabinet Regulatory Class: I Product Code: LDO Dated: November 8, 1999 Received: November 9, 1999
Dear Ms. Murphy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Murphy
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
EC-7701 Fluid Warming Cabinet Device Name:
Indications For Use:
The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 C.F.R. § 801.109) Over-The-Counter Use _
Patrice Ciaccanti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number