CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER

{0}------------------------------------------------ K041833 10/25/04 Consolidated Machine Corporation FDA Abbreviated 510(k) - Consolidated SR and SSR MC-Series Steam Sterilizers # APPENDIX 7 510(k) Summary DEC 1 0 2004 Consolidated Machine Corp. 76 Ashford St. Boston, Ma. 02134 Tel: 617-782-6072 Fax: 617-787-5865 ### 510K Summary of Safety and Effectiveness June 4, 2004 Consolidated SSR and SR Series Steam Sterilizers #### 1. Sponsor Name Consolidated Machine Corp. 76 Ashford St. Boston, Ma. 02134 #### Device Name 2. Proprietary Name: Consolidated SSR Series and SR Series Sterilizers Models: SSR-2A, SSR-3A, and SR-24E Common Name: Steam Sterilizer or Autoclave Classification Name: Steam Sterilizer #### Identification of Legally Marketed Device 3. Getinge/Castle , "Castle Series 100HC", K994314 #### র্ব-Device Description The Consolidated SR and SSR Series Sterilizers are for general purpose gravity or vacuum steam sterilization of heat and moisture-stabile goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 16 cycles can be easily accessed and are password protected. All cycle phases are sequenced and monitored by the Mark V control system, providing both audible and visual notification of deviation from certain operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of pressure or come equipped with an integral, electrically heated steam generator. #### ડ. Intended Use Consolidated SSR/SR Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam. {1}------------------------------------------------ Consolidated Machine Corporation #### Comparison of Technological Characteristics 6. The Consolidated SR and SSR Series Steam Sterilizers are substantially equivalent in design, materials, construction and intended use as those of the predicates identified above. Since the Consolidated SR and SSR Series Steam Sterilizers are the same in intended use and technological characteristics as the predicate devices, they do not raise any new safety and efficacy concerns when compared to these similar legally marketed devices. #### 7. Performance Testing Biological and physical testing was conducted to determine device functionality and conformance to design input requirements. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines representing the branches of government. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Arthur Trapotsis Director, R & D Consolidated Machine Corporation P.O. Box 297 76 Ashford Street Boston, Massachusetts 02134 DEC | 0 2004 Re: K041833 Trade/Device Name: Consolidated SSR and SR MC-Series Steam Sterilizer, Models: SSR-2A, SSR-3A, SR-24E Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: October 26, 2004 Received: October 27, 2004 Dear Mr. Trapotsis: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ Page 2 - Mr. Trapotsis 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 Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 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 labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Susan Runner Chiu-Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDIICATION FOR USE STATEMENT 12041833 510(k) Number (if known): This submission Consolidated SSR and SR MC-Series Steam Sterilizer Device Name: Models: SSR-2A, SSR-3A, SR-24E Indications For Use: Consolidated SSR and SR MC-Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam. See attached for Load Specifications and Cycle Parameters. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Smphain Oms 12-10-04 (Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices Page 1 of / 510(k) Number