DECOMAT 228

K920406 · Getinge International, Inc. · MDZ · Apr 5, 1994 · General Hospital

Device Facts

• Record ID: K920406
• Device Name: DECOMAT 228
• Applicant: Getinge International, Inc.
• Product Code: MDZ · General Hospital
• Decision Date: Apr 5, 1994
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6992
• Device Class: Class 2

Device Story

The Decomat 228 Washer/Disinfector is a medical device designed for the cleaning and disinfection of medical instruments. It functions as an automated system to process reusable medical devices, reducing bioburden through washing and disinfection cycles. It is intended for use in healthcare facilities, such as hospitals or clinics, and is operated by trained personnel (e.g., sterile processing technicians). The device automates the cleaning process, ensuring consistent instrument preparation for subsequent sterilization, thereby supporting infection control protocols and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical washer/disinfector; automated cleaning and disinfection system; intended for processing reusable medical instruments; classified as Class II under 21 CFR 880.6992 (Product Code: MDZ).

Regulatory Classification

Identification

A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”(1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices. (2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue

Document Control Center – WO66-G609

Silver Spring, MD 20993-0002

Mr. Paul Rodriguez

Quality Assurance Manager

Getinge International, Inc.

1100 Towbin Avenue

Lakewood, New Jersey 08701

JAN - 5 2017

Re: K920406

Trade/Device Name: Decomat 228 Washer/Disinfector

Regulation Number: 21 CFR 880.6992

Regulation Name: Medical Washer/Disinfector

Regulatory Class: Class II

Product Code: MDZ

Dated: April 7, 1993

Received: April 27, 1993

Dear Mr. Rodriguez:

This letter corrects our substantially equivalent letter of April 5, 1994.

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 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

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Page 2 – Mr. Paul Rodriguez

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Tina Kiang

Tina Kiang, Ph.D.

Acting Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health