← Product Code [KMH](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH) · K094026 # STERI-DENT, STERI-SURE (K094026) _Cpac, Inc. · KMH · Jul 12, 2011 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K094026 ## Device Facts - **Applicant:** Cpac, Inc. - **Product Code:** [KMH](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH.md) - **Decision Date:** Jul 12, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6870 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). The Model 2100 and 3100 are identical in operation and only differ in instrument capacity. The Model 2100 is provided with two (2) trays and the Model 3100 is provided with three (3) trays that are slightly larger in size than the Model 2100 trays. The maximum recommended load for each tray for the Model 2100 is 1.3 lbs including the weight of the tray. For the Model 3100, the maximum recommended load for each tray is 1.4 lbs including the weight of the tray. ## Device Story Steri-Dent Model 2100/3100 are table-top natural convective dry heat sterilizers; used in healthcare facilities for metal instruments and glassware. Device inputs: electrical power (115 VAC); user-selected cycle parameters. Operation: electric heating element heats chamber to 160°C for 60 minutes; thermocouple monitors temperature; embedded PCB controls cycle. Output: sterilized instruments; LED display shows temperature and remaining time; audible alarms; printer output for documentation. Healthcare providers load instruments onto trays; monitor cycle via LED display; retrieve sterilized items after cycle completion. Benefits: ensures sterility of instruments (10^-6 SAL) via 12-log reduction of Bacillus atrophaeus spores; prevents cross-contamination. ## Clinical Evidence Bench testing only. Thermal profile and sterile efficacy studies performed per AAMI ST50. Testing demonstrated 12-log reduction of Bacillus atrophaeus spores and 10^-6 Sterility Assurance Level (SAL). Half-cycle overkill method (30 minutes) confirmed Fu values exceeded minimum requirements. 84 test samples (including lumen devices and biological indicators) were negative for growth; positive controls were positive. ## Technological Characteristics Natural convective (static air) dry heat sterilizer. Electric heating element (500W for Model 2100; 735W for Model 3100). Thermocouple temperature sensing with electronic control. LED digital display. Embedded PCB for cycle control and error detection. 115 VAC power. Compliance with ANSI/UL 61010-1, CAN/CSA C22.2 No. 61010-1, and IEC 61010-2-040. ## Regulatory Identification A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat. ## Predicate Devices - Steri-Dent Model 200 ([K771070](/device/K771070.md)) - Steri-Dent Model 300 ([K771070](/device/K771070.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K094026 page 1 of 5 # Section 5 - 510(k) Summary ## JUL 1 2 2011 Device Owner and Manufacturer CPAC, Inc 2364 Leicester Rd Leicester, NY 14481 : : ______________________________________________________________________________________________________________________________________________________________________________ . . . . . #### Contact person Jeffrey Crane 2364 Leicester Rd Leicester, NY 14481 Phone: 585-382-3223 Fax: 585-382-3736 Summary prepared on December 23, 2009 {1}------------------------------------------------ ### Device | Trade name: | Steri-Dent Model 2100/3100 | Page 2 of 5 | |----------------------|----------------------------------------------------------|-------------| | Common-name: | Table Top Dry Heat Sterilizer | | | Classification name: | Sterilizer, Dry Heat (21 CFR 880.6870, Product Code KMH) | | K094026 ### Predicate Device The Steri-Dent Model 2100 and 3100 are substantially equivalent to the Steri-Dent Model 200 and 300 both of which are table top dry heat sterilizers currently manufactured by CPAC, Inc and legally marketed under 510(k) K771070. #### Device Description The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments and glassware. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). Items to be sterilized are placed horizontally on the removable trays inside the chamber. Both models are plug-in units designed to run on standard 115 VAC household current. A thermocouple is used to measure the chamber temperature. All functions of the sterilizer are controlled by an embedded PCB. Access to the heating chamber is through a hinged door on the front of unit. A LED digital display located on the front of the unit indicates chamber temperature and remaining cycle time. #### Indications for Use The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments and glassware. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). The Model 2100 and 3100 are identical in operation and only differ in instrument capacity. The Model 2100 is provided with two (2) trays and the Model 3100 is provided with three (3) trays that are slightly larger in size than the Model 2100 trays. The maximum recommended load for each tray for the Model 2100 is 1.3 lbs including the weight of the tray. For the Model 3100, the maximum recommended load for each trav is 1.4 lbs including the weight of the tray. The indications for use are the same for the predicate device. {2}------------------------------------------------ ## Technological Characteristics Comparison Below is a comparison of the technological characteristics of the two (2) tray sterilizers, Models 200 and 2100, and also the three (3) tray sterilizers, Models 300 and 3100. | Characteristic | Predicate Device - Model 200 | Device - Model 2100 | |--------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Method of Organism Destruction | Dry heat (static air) | Dry heat (static air) | | Method of heating | Electric element | Electric element | | Sterilizing temperature | 320°F | 320°F | | Sterilizing cycle time | 60 minutes | 60 minutes | | Chamber Size | 12-1/4" x 7-15/16" x 5-3/8" | 12-1/4" x 7-15/16" x 5-3/8" | | Tray Capacity | (2) 9-1/2" x 6-3/8" x 1/2" Trays | (2) 9-1/2" x 6-3/8" x 1/2" Trays | | Total Heater Wattage | 500W | 500W | | Load capacity | 1.3 pounds per tray (including
weight of tray) | 1.3 pounds per tray (including
weight of tray) | | Timer | Mechanical | Digital | | Temperature Control | Bi-Metal Thermostat | Thermocouple with Electronic
Control | | Temperature monitoring | Spirit-filled thermometer | LED display | | Process error detection | No | Yes, software monitors all
cycle parameters and provides
diagnostic error codes and
audible alarm | | User Option Interface | No | Yes, options such as unit of
measure and use of audible
alarm can be set by the user | | Printer output | No | Yes | 1. {3}------------------------------------------------ K094026 page 4 of 5 ## Technological Characteristics Comparison(cont) | Characteristic | Predicate Device - Model 300 Device - Model 3100 | | |--------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Method of Organism Destruction | Dry heat (static air) | Dry heat (static air) | | Method of heating | Electric element | Electric element | | Sterilizing temperature | 320°F | 320°F | | Sterilizing cycle time | 60 minutes | 60 minutes | | Chamber Size | 14-7/8" x 9-1/16" x 7-3/8" | 14-7/8" x 9-1/16" x 7-3/8" | | Tray Capacity | (3) 12" x 7-3/8" x ½" Trays | (3) 12" x 7-3/8" x ½" Trays | | Total Heater Wattage | 735W | 735W | | Load capacity | 1.4 pounds per tray (including
weight of tray) | 1.4 pounds per tray (including
weight of tray) | | Timer | Mechanical | Digital | | Temperature Control | Bi-Metal Thermostat | Thermocouple with Electronic
Control | | Temperature monitoring | Spirit-filled thermometer | LED display | | Process error detection | No | Yes, software monitors all
cycle parameters and
provides diagnostic error
codes and audible alarm | | User Option Interface | No | Yes, options such as unit of
measure and use of audible
alarm can be set by the user | | Printer output | No | Yes | | | | | | | | | ## Non-Clinical Performance Data #### Safety Models 2100 and 3100 (115V only) have been tested, investigated and found to comply with the following standards: - ANSI/UL 61010-1: Electrical Equipment for Measurement, Control, and . Laboratory Use; Part 1 - General Requirements - CAN/CSA C22.2 No. 61010-1: Electrical Equipment for Measurement, Control, . and Laboratory Use; Part 1 - General Requirements - IEC 61010-2-040: Particular Requirements for Sterilizers and Washer-. Disinfectors Used to Treat Medical Materials {4}------------------------------------------------ #### Effectiveness --- Thermal profile and sterile efficacy studies, following AAMI ST50 were performed by SPS Medical on the Model 2100 and 3100 sterilizers. These tests conclude that each sterilizer consistently provide a 12-log reduction of the Bacillus atrophaeus spores and produce a 10-6 SAL (Sterility Assurance Level). The thermal profile tests for each sterilizer were run three times using a small load and three times using a full load in order to demonstrate that each sterilizer was able to consistently achieve and maintain the proper temperature inside the chamber. The thermal profiles revealed that the top tray of both sterilizers was the cold spot. The sterile efficacy studies for the Model 2100 and 3100 sterilizers used the halfcycle overkill method to prove that the sterilizers recommended full cycle (160°C for 60 minutes) has a 10 6 SAL (Sterility Assurance Level) as required by AAMI ST50. Three full load half-cycle (30 minute) tests were run on each model. Testing demonstrated that the Fu values exceed the minimum of 30 minutes as required in AAMI ST50 for all test cycles. As outlined in AAMI ST50, multiple inoculated instruments including lumen devices and Bl (biological indicator) strips were challenged in the sterilizers' cold spot. All 84 test samples were negative for growth and the positive controls were positive for growth. The performance testing validates the Model 2100 and 3100 are safe and effective sterilizers. #### Test Results Conclusions The Model 2100 and 3100 were found to comply with the latest safety standards which are the same standards that the predicate device has been found to comply. The tests to ensure effectiveness of the Model 2100 and 3100 sterilizers were based on the latest AAMI ST50 standard and so were more stringent than those conducted on the predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Jeffery Crane CPAC, Incorporated 2364 Leicester Road P.O. Box 175 Leicester. New York 14481-0175 JUL 1 2 2011 Re: K094026 Trade/Device Name: Steri-Dent Model 2100 and 3100 Regulation Number: 21 CFR 880.6870 Regulation Name: Dry-Heat Sterilizer Regulatory Class: II Product Code: KMH Dated: July 5, 2011 Received: July 6, 2011 Dear Mr. Crane: 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. {6}------------------------------------------------ #### Page 2 - Mr. Crane 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); 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reporta Problem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthony O. muller Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Section 4 - Indications for Use Statement K094026 501(k) Number: Steri-Dent Model 2100 and 3100 Device Name: #### Indications for Use The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). The Model 2100 and 3100 are identical in operation and only differ in instrument capacity. The Model 2100 is provided with two (2) trays and the Model 3100 is provided with three (3) trays that are slightly larger in size than the Model 2100 trays. The maximum recommended load for each tray for the Model 2100 is 1.3 Ibs including the weight of the tray. For the Model 3100, the maximum recommended load for each tray is 1.4 lbs including the weight of the tray. - Prescription Use (Part 21 CFR 801 Subpart D) AND/OR XX Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY), iangalia (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) ്ട് Sion of Anesthesiology, General Hospital tection Control, Dental Devices Sec. 4 -1 Confidential Document CPAC, Inc. η(k) Number: 14941026 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K094026](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMH/K094026) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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