(102 days)
Not Found
No
The summary describes a warming cabinet with standard digital controls and temperature regulation, with no mention of AI or ML features.
No
The device is a warming cabinet for irrigation solutions, which are used in medical procedures, but the device itself does not directly treat or diagnose a disease or condition. It is a support device for medical procedures.
No
Explanation: The device is a warming cabinet designed to store and warm irrigation solutions. It does not analyze patient data, diagnose conditions, or provide information about a patient's health status. Its function is to prepare solutions for medical use, not to diagnose.
No
The device description explicitly states it is a "120 or 220 V Ac powered warming cabinet," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "store, warm, and maintain the recommended temperature of irrigation solutions prior to use." This describes a device used to prepare a substance for use in a medical procedure, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics and functionality of a warming cabinet. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, this device falls under the category of a medical device used for preparing materials for patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These warming cabinets are designed to store, warm, and maintain the recommended temperature of irrigation solutions prior to use.
Product codes (comma separated list FDA assigned to the subject device)
LHC
Device Description
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.
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
Not Found
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)
The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
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.
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.
Not Found
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).
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§ 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.
0
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
1
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
2
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
3
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
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- 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
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- Equivalent legally marketed devices: K993797, Enthermics Medical Systems Fluid Warming Cabinet
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- 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.
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- 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.
4
14080609
6. Substantial Equivalence Chart
| Characteristic | K993797,
Enthermics
Medical Systems
Fluid Warming
Cabinet | SWC/DWC
(Various Models)
Warming Cabinets |
|----------------|-----------------------------------------------------------------------|-------------------------------------------------|
| Intended Use: | Warming Irrigation
Solutions | 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.