(72 days)
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.
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.
This document, K993797 pertains to the Enthermics Medical Systems EC-7701 Fluid Warming Cabinet. As a submission for a 510(k) premarket notification, it focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This type of information is typically found in submissions for novel devices requiring clinical trials, not for devices demonstrating substantial equivalence to already marketed products.
The document states:
- "The EC-770l is nearly identical to the three predicate devices in all material respects."
- "All four devices use the same basic technology (non-electromagnetic 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."
This indicates that the FDA's clearance of this device is based on its similarity to existing, legally marketed devices, not on a new study demonstrating its efficacy against specific pre-defined acceptance criteria.
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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 StreetMenomonee 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 SolutionLGZ, 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.
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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
N/A