These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.

AI/ML Overview

The provided document is a 510(k) summary for warming cabinets (SWC/DWC Various Models) and does not contain information about acceptance criteria for a device evaluated with a study (like an AI/ML device). Instead, it's a notification to the FDA to market a medical device, demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, as the document does not describe such a study or criteria for this type of medical device (warming cabinets).

The document focuses on:

Device Name: SWC/DWC (Various Models) Warming Cabinets
Regulation Number and Name: 21 CFR 890.5950, Powered Heating Unit
Product Code: LHC
Indications for Use: To store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
Predicate Device: K993797, Enthermics Medical Systems Fluid Warming Cabinet
Conclusion: Based on bench and standards testing, the device is deemed as safe and effective as the predicate device, with few technological differences and no new indications for use, thus substantially equivalent.

There is no mention of an algorithm or AI component, nor any study involving a test set, ground truth, or expert review, as would be relevant for an AI/ML device. The "testing" referred to is "bench and standards testing," which typically involves engineering and performance validation against industry standards for warming cabinets, not a clinical or AI performance study.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, with three wavy lines representing the services provided by the department.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mac Medical C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

JAN 1 0 2017

Re: K080609

Trade/Device Name: SWC/DWC Warming Cabinets Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: May 30, 2008 Received: June 2, 2008

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of June 13, 2008.

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.

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

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Page 2 - Mr. Daniel Kamm

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); 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 Parts 801 and 809), 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 yours.

Erin I. Keith -S

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

510(k) Number (if known): A 08060 G

Device Name: SWC/DWC (Various Models) Warming Cabinets

Indications For Use:

These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __X . (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Srutty H. Micham Omd

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080609

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510(k) Summary K080609

JUN 18 2008

MAC Medical 820 S Mulberry St. Millstadt, IL 62260 Phone (618) 476-3550 Fax (618) 476-3337 Date prepared: Mav 25, 2008 Contact: Dennis Cooper

1. Identification of the Device: Proprietary-Trade Name: SWC/DWC (Various Models) Warming Cabinets Classification Name: Warmer, irrigation-solution colution colution colorner Product Code 140 LD Common/Usual Name: Intigation Warmer
1. Equivalent legally marketed devices: K993797, Enthermics Medical Systems Fluid Warming Cabinet
1. Indications for Use (intended use) These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.

Description of the Devices: These devices are 120 or 220 V Ac powered warming cabinets designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use. The particular cabinet configuration can be deduced from its model number: SWC = Single Warming Cabinet. DWC = Dual Warming Cabinet. G = Glass Door The temperature ranges and capacities vary according to model but all have: Adjustable Temperature Range Digital Control Dual Display Push Button Operation Rapid Warm Time High Accuracy.

1. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

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14080609

6. Substantial Equivalence Chart

Characteristic	K993797,EnthermicsMedical SystemsFluid WarmingCabinet	SWC/DWC(Various Models)Warming Cabinets
Intended Use:	Warming IrrigationSolutions	SAME
User Interface	Digital Display	SAME
Power Source	AC Line	SAME
Door opening	Left or right hand	SAME
Door style	Glass	Glass or Stainless
Construction	Stainless Steel	SAME
Safety	UL Listed	SAME

7. Conclusion

After analyzing bench and standards testing data, it is the conclusion of MAC Mcdical that the SWC/DWC (Various Models) Warming Cabinets are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the prodicate devices.

Regulation Number and Section

§ 890.5950 Powered heating unit.

(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.