HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33

{0}------------------------------------------------ ## 510(k) SUMMARY K014174 of the roll and be A. Submitter's Name and Address Barnstead/Thermolyne Corp. P.O. Box 797 Dubuque, IA 52004 FEB 2 2 2002 - B. Contact Person Mia M. Ware Regulatory Affairs Specialist 563-556-2241 Ext. 485 Fax: 563-557-0612 C. Establishment Registration Number of Submitter 1950043 Hoch Warry Con - D. Contract Manufacturing Facility Not Applicable - E. Device Name Proprietary Name: Harvey® PV Dry Common Name: Steam Sterilizer Classification Name: Steam Sterilizer - F. Device Classification Class II §880.6880 - G. Action Taken to Comply with Section 514 of the Act The Agency has recognized the ANSVAAMI ST55, Tabletop Steam Sterilizers, and the FDA Guidance on Premarket Notification Submissions for Sterilizers Intended for Use in Health Care Facilities, March 1993, and its addendum, dated September, 1995. Conformance or variance with these standards is described on the following pages. - H. Reason for 510(k) Submission - Initial Product Introduction - New Model for Product-line Extension Initial Import into the USA - Other (Include in Part IV an explanation referenced to Part I. H.) - Predicate Device: Harvey® MC10 Steam Sterilizer, K924955 ﻟﺴﻨﺔ {1}------------------------------------------------ ANAMALA DE or with the Describe Description of the Device: The Harvey® PV Dry is a pre/post-vacuum table top steam sterilizer. Its enclosure Description of the Device. The Harvey - 1 - Dis of pastic. The outside dimensions are 15.5"Hx19"Wx23"D, it weighs 115lbs and the chamber is 10" in diameter. The chamber is made from stainless steel at 45 it weighs 11910s and the enamour is 10 - an Mechanical Engineers (ASME) Pressure Vessel Code. > Intended Use of the Device: The Harvey® PV Dry is a pre/post-vacuum table top steam sterilizer that is micined Ose of the Device. The Harry offices, hospitals, clinics, and other facilities where a variety of designed for use in mealed for sterilization of wrapped or unwrapped instruments, dental handpieces, and linen packs. Technological Characteristics: The Harvey® PV Dry has very similar technological characteristics as the recimented characteriation . In Steam Sterilizer. The Harvey® PV Dry is a table-top autoclave steam predicate uction for the roy - Norto over and sterile post-vacuum drying, similar to larger hospital type units. The Harvey® PV Dry provides superior performance for dental handpieces and difficult to penetrate fabric packs and superior and rand drying for all loads. With sterile vacuum drying, the Harvey® PV Dry is packs and superfor and rapid of the surfere packs, bagged instruments, and wrapped instrument sets, such as surgical kits are stored for later usage. The integral sterile drying in a 30-40 minute cycle, gives sam as salged this and tions of the instruments at the time of delivery to the operatory. Sterile vacuum drying eliminates the need for extended drying cycles using non-sterile air. Some features unique to the Harvey® PV Dry also demonstrate safety as well as the efficiency of the unit. The interlocking device on the door prevents manual opening until the chamber pressure decreases to near I he more corroo on the econologies which help in the convenience and ease of operation of the Harvey® PV Dry include indicator lights to tell the user when the waste tank needs to be emptied, and controls preventing the running of a cycle until it is drained, indicator lights telling the user when the water supply needs to be replenished, and cycle parameter display. In the predicate device comparison matrix in Section II, there are detailed differences and similarities between the Harvey® PV Dry and its predicate device, Harvey MC10 Steam Sterilizer. Non-clinical Testing: Validation studies were conducted by SPS Medical Supply Corporation located at 6789 West Henrietta Road, Rush, NY 14543. Validation testing is in accordance with ANSI/AAMI ST55, ANSVAAMI ST37. Since neither standard specifically addresses handpiece cycle validation, additional handpiece cycle validation testing was performed with the protocol being written in accordance with FDA Draft Guidance Document on Dental Handpieces, 1995, and the Guidance on Premarket Notification Submissions for Sterilizers Intended for Use in Health Care Facilities, 1993. Successful sterilization was achieved in all three validations and the declarations of conformity to the consensus standards are located in Section III. Testing results and raw data are contained in the product's device master record. Conclusion: It is Barnstead/Thermolyne's conclusion that the Harvey® PV Dry is substantially equivalent to its predicate device, the Harvey® MC10 Steam Sterilizer. Based on the validation results and information submitted, the Harvey® PV Dry provides effective sterilization of the indicated medical materials. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 2 2002 Barnstead/Thermolyne Corporation C/O Mr. Reiner Krumme Responsible Third Party TUV Rheinland of North America, Inc 12 Commerce Road Newton, Connecticut 06470 Re: K014174 Trade/Device Name: Harvey PV Dry Sterilizer, Model # ST127325; ST127320 Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: February 12, 2002 Received: February 13, 2002 Dear Ms. Krumme: 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 (1 vir 1) it incan 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 {3}------------------------------------------------ ## Page 2 – Mr. Krumme of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I odelar sates and enginements, including, but not limited to: registration You must comply with an alle Here requires (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), as times (QS) regulation (21 CFR Part 820); and if requirences as set forum in als quality ion 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 This letter will anow you to began marketing your substantial equivalence of your device to 310(k) premailed nourvailed with 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 II you desire specific ad not 10. your for in vitro diagnostic devices), please contact the and additionally 21 OF IC F 21 S 1 4 CL 1 S 94-4618. Additionally, for questions on the FR 1 6 Complia Office of Comphance are, please contact the Office of Compliance at (301) 594-4639. advertising or your are in " Anotification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained from and Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows handwritten text that reads "Attachment" and "02.11.2002". The text is written in black ink on a white background. The word "Attachment" is written on the top left, and the date is written below it. ## INDICATIONS FOR USE STATEMENT 510(k) Number : 014174 Device Name: Harvey® PV Dry ## Indications for Use: The Harvey® PV Dry is a prevacuum and post vacuum drying sterilizer intended to provide sterilization I he Harvey " V Dry is a prevacuall and post ratedial artistication of wrapped or unwrapped or unwrapped meal instruments, surgical devices and other heat stable devices in pouches, surgical packs, dental handpieces, instruments, surgical devices and outer water is required for operation of the Harvey® PV Dry. The sterilizer has four standard cycles: Unwrapped Instruments (135C for 3 minutes); Wrapped I the stellized has four samoure eyeles. One of a (121C for 30 minute); Special, for dental handpieces (5 minutes (155c for 11ve manator), I 2015 (15) 10 11 (15 ) 10 routine testing of the steam penetration capability into packs. The parameters are fixed for each cycle. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) (Optonal Format 3-10-98) ("Tivision Sign-Off) El Vision of Dental, Infection Control, Ceneral Hospital Devices -. .. Privaber _______________________________________________________________________________________________________________________________________________________________