(154 days)
Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-A012PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012. ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities.
The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer, are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. The Sakura Steam Sterilizer ASSR-A012. Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P. Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.
The Sakura Steam Sterilizer models ASSR-A012, ASSR-A012W, ASSR-A012P, ASSR-A012PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer are assessed for safety and effectiveness through non-clinical testing and comparison to a predicate device.
1. A table of acceptance criteria and the reported device performance:
The acceptance criterion for sterilization efficacy is a Sterility Assurance Level (SAL) of <10^-6, meaning less than one in one million probability of a viable microorganism after sterilization. The devices were validated according to the ANSI/AAMI ST8: 2008 standard.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy (SAL): <10^-6 SAL based on ANSI/AAMI ST8: 2008 Section 5.5.2.5-a) | Met: <10^-6 SAL |
| Factory-Programmed Cycles | Met: All factory-programmed cycles were validated according to ANSI/AAMI ST8: 2008. |
| Safety Standards Compliance | Met: Complies with IEC 60601-1-2:2007, IEC61010-1, IEC61010-2-040: 2005, CISPR11: 2009, IEC61000-3-2:2005, IEC61000-3-3:2008, IEC61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-4: 2004, IEC61000-4-5: 2005, IEC61000-4-6: 2003, IEC61000-4-8: 2009, IEC61000-4-11: 2004, and ASME Boiler and Pressure Vessel Code Section VIII Division 1 2010 Edition. |
| Software Validation | Met: Software validation for cycle operation performed according to FDA's moderate level of concern recommendations ("Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)"). |
2. Sample size used for the test set and the data provenance:
The document describes "complete kill of biological indicators" but does not specify the sample size for the biological indicator tests. The data provenance is primarily from non-clinical verification, validation, and testing activities conducted by Sakura Seiki Co., Ltd. The context suggests these are prospective tests performed on the manufactured devices. The manufacturer is based in Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the summary. The ground truth for sterilization efficacy is established by verifying the complete kill of biological indicators and achieving an SAL of <10^-6, which typically relies on microbiological testing rather than expert consensus on individual cases.
4. Adjudication method for the test set:
This information is not applicable for this type of device and study. The validation process involves laboratory testing with biological indicators against a predefined standard (ANSI/AAMI ST8: 2008), not human adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a steam sterilizer, a medical device for sterilization, not an AI-assisted diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of AI algorithms. However, in the context of device performance, the sterilizer's function is standalone, performing sterilization cycles autonomously. Its efficacy is assessed independently of human intervention during the sterilization process itself, once programmed and initiated.
7. The type of ground truth used:
The ground truth for the effectiveness of the sterilization process is established by:
- Complete kill of biological indicators: This is a direct microbiological measure of sterilization efficacy.
- Sterility Assurance Level (SAL) of <10^-6: This is a universally accepted standard for sterilization, verified through biological indicator testing.
- Compliance with ANSI/AAMI ST8: 2008: This industry standard dictates the methodologies and criteria for validating steam sterilization cycles.
8. The sample size for the training set:
This is not applicable. The device is a steam sterilizer, not a machine learning model. There is no concept of a "training set" for such a device.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above. The device does not utilize a training set in the machine learning sense. The ground truth for its performance is established through rigorous validation and testing against pre-defined industry standards and performance requirements using biological indicators.
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JAN - 6 2014
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: K132439 -----------
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- Submitter's Identification: Sakura Seiki Co., Ltd. 46-1, Shinden Chikuma, Nagano 387-0018 Japan Phone: 81-26-273-3583 Fax: 81-26-273-2584
Date Summary Prepared: January 3, 2014
- Submitter's Identification: Sakura Seiki Co., Ltd. 46-1, Shinden Chikuma, Nagano 387-0018 Japan Phone: 81-26-273-3583 Fax: 81-26-273-2584
2. Name of the Device:
Proprietary name: Sakura Steam Sterilizer ASSR-A012 Sakura Steam Sterilizer ASSR-A012W Sakura Steam Sterilizer ASSR-A012P Sakura Steam Sterilizer ASSR-A012PW Skytron Integrity 270 Steam Sterilizer Skytron Integrity 270 VP Steam Sterilizer
Common Name: Steam Sterilizer Regulation: 21CFR Part 880.6880, Class II Product Code: FLE
3. Common or Usual Name:
Common name: Steam Sterilizer Classification name: Sterilizer, Steam
4. Predicate Device Information:
Skytron Integrity 215 Steam Sterilizer, Skytron Integrity 215 SG Steam Sterilizer, K120149
5. Description:
The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-
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AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer, are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities.
The Sakura Steam Sterilizer ASSR-A012. Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P. Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.
6. Intended Use:
Sakura Steam Sterilizer ASSR-A012. ASSR-A012W. ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012, ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities. Sakura Steam Sterilizer ASSR-A012, ASSR-A012W, ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are available in the following configuration.
26.5" x 37.5" x 53" chamber size, Single or Double Door Prevacuum and Gravity Sakura Steam Sterilizer ASSR-AO12 is a single door.
Sakura Steam Sterilizer ASSR-AO12W is a double door (pass through).
Sakura Steam Sterilizer ASSR-AO12P is a single door with vacuum pump. Sakura Steam Sterilizer ASSR-AO12PW is a double door (pass through) with vacuum pump.
Skytron Integrity 270 Steam Sterilizer is a single or double door (pass through). Skytron 270 VP Steam Sterilizer is a single or double door (pass through) with vacuum pump.
Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-AQ12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are equipped with the following factory-programmed sterilization cycle values. The following factory-programmed cycles are validated according to ANSI/AAMI ST8: 2008.
| Cycle | Validated Loads | SterilizeTemp | SterilizeTime | Dry Time |
|---|---|---|---|---|
| Flash 1(IU 1) | One unwrapped,nonporous instrument noheavier than 0.22 lbs. (100gram) | 270 F (132 C) | 3 minutes | 1 minute |
| Flash 2(IU 2) | Maximum of sixteen (16)unwrapped instrument | 270 F (132 C) | 4 minutes | 1 minute |
| trays, maximum weight 25pound (11.3 kg) each.The maximum of three (3)2 mm inside diameter(minimum) and 400 mmlong (maximum) lumeninstruments per cycle load. | ||||
| Prevacuum270 | Maximum of sixteen (16)double-wrappedinstrument trays,maximum weight 25 | 270 F (132 C) | 4 minutes | 30 minutes |
| Prevacuum275 | Maximum of sixteen (16)double-wrappedinstrument trays,maximum weight 25pound (11.3 kg) each.The maximum of three (3)2 mm inside diameter(minimum) and 400 mmlong (maximum) lumeninstruments per cycle load. | 275 F (135 C) | 3 minutes | 30 minutes |
| ExpressPrevacuum(IU 3) | Maximum of sixteen (16)single wrapped instrumenttrays, maximum weight 25pound (11.3 kg) each.The maximum of three (3)2 mm inside diameter(minimum) and 400 mmlong (maximum) lumeninstruments per cycle load.This cycle is intended forimmediate use and thewrap used for this cycle isnot intended to be a sterilebarrier. | 270 F (132 C) | 4 minutes | 3 minutes |
| Gravity 1 | Maximum of thirty-two (32)-fabric packs. | 250 F (121 C) | 30 minutes | 15 minutes |
| Gravity 2 | Maximum of sixteen (16)double-wrappedinstrument trays,maximum weight 25pound (11.3 kg) each. | 270 F (132 C) | 15 minutes | 30 minutes |
| Liquid | Three (3) 1,000 mill-litercontainers with vented | 250 F (121 C) | 45 minutes | 0 minutes |
| closures. This cycle isintended for non-patientcontacting devices only. | ||||
| Leak Test | Empty Chamber, test timeof 15 minutes. | N/A | N/A | N/A |
| Warm Up | Empty Chamber | 270 F (132C) | 4 minutes | 3 minutes |
| Bowie-Dick Test | Bowie-Dick Test Pack | 273 F (134 C) | 3.5 minutes | 2 minutes |
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Note:
"IU" means "Immediate Use" cycle. 产
ン Liquid cycle is for non-patient contact use only.
7. Technological Characteristics
Comparison to Predicate Device
Sakura Steam Sterilizer Comparison to Legally Marketed Predicate
| Item Description | Sakura SteamSterilizer ASSR-AO12, -AO12W, -AO12P, -AO12PW /Skytron Integrity270, 270 VPSteam Sterilizer | PredicateProduct(Sakura SteamSterilizerASSV-AB09,09ESkytronIntegrity 215,215 SG SteamSterilizer,K120149) | SubstantiallyEquivalent orDifferent | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Indication for Use | Sakura SteamSterilizer / SkytronIntegrity SteamSterilizer isdesigned andoptimized for usein health carefacilities. SakuraSteam Sterilizer /Skytron IntegritySteam Sterilizerincorporates high-pressure steam tosterilize non-porous andporous, heat andmoisture-stableitems andmaterials used in | Sakura SteamSterilizer /Skytron IntegritySteam Sterilizeris designed andoptimized foruse in healthcare facilities.Sakura SteamSterilizer /Skytron IntegritySteam Sterilizerincorporateshigh-pressuresteam tosterilize non-porous andporous, heatand moisture-stable | Same | ||||||
| the health carefacilities. | stable items andmaterials usedin the health care facilities. | ||||||||
| Single Phase,120VAC, 60Hz | Single Phase,120VAC, 60Hz | Same | |||||||
| Electrical | 3 Phases,208VAC, 60 Hz,15 Amps.Or, 3 Phase,480VAC, 60 Hz, 7Amps.(For VacuumPump option) | No VacuumPump | Different | ||||||
| Frame | Carbon steel | Carbon steel | Same | ||||||
| Chamber | SUS 316L | SUS 316L | Same | ||||||
| Chamber Size &Volume | 26.5 in x 37.5 in x53 in | 21.5 in x 21.5 inx 38 in | SubstantiallyEquivalent | ||||||
| 32.3 ft3 | 11.1 ft3 | ||||||||
| System Weight -Dry (no utilities,no cabinet) | For Integrity 270:Single Door -1,516 kg / 3,335lbs.Double Door -1,714 kg / 3,771lbs. | For integrity215: 760kg /1675 lbs. ForIntegrity 215SG:830 kg / 1830lbs. | SubstantiallyEquivalent | ||||||
| SUS SA-240 type304L | SUS SA-240type 304L | Same | |||||||
| Jacket | ASME section VIII,Div. 1 | ASME sectionVIII, Div. 1 | Same | ||||||
| Door | SUS 316L,emergencymanual dooropening system | SUS 316L,emergencymanual dooropening system | Same | ||||||
| Door | Single or doubledoor (passthrough) | Single Door | SubstantiallyEquivalent | ||||||
| Door OpeningMethod | Manual Swingtype (open/close)with power lock-upby elevation ofdoor. | Automatedvertical slidingdoor with footpedal | SubstantiallyEquivalent. | ||||||
| Door Seal | Steam activateddoor seal | Steam activateddoor seal | Same | ||||||
| Insulation | The entire exteriorsurface of vessel | The entireexterior surface | Same | ||||||
| is insulated withglass woolinsulationmaterials.Thickness: 25mmSpecific gravity:24kg/m³ | of vessel isinsulated withglass woolinsulationmaterials.Thickness:25mmSpecific gravity:24kg/m³ | ||||||||
| Industrial gradebrass or SUS | Industrial gradebrass or SUS | Same | |||||||
| Control Valve | Actuated byelectric solenoid ormotor or manualshutoff valves. | Actuated byelectric solenoidor motor ormanual shutoffvalves. | Same | ||||||
| Piping | Stainless Steel(SUS 304) orflared copper | Stainless Steel(SUS 304) orflared copper | Same | ||||||
| Safety (pressurerelief) valves | ASME approved. | ASMEapproved. | Same | ||||||
| Steam Source | House steam | House steam orintegratedsteamgenerator. | Same | ||||||
| Steam CapacityRequirement(from housesteam) | 220 lbs./Hour | 100 lbs./Hour | SubstantiallyEquivalent. | ||||||
| Vacuum System | Water ejector asstandardspecification, andthe vacuum pumpoption is available. | Water ejector asstandardspecification. | SubstantiallyEquivalent | ||||||
| Air Filtration | Cellulose-mediumtype.Main filter elementMaterial:PolypropylenePre-filter elementMaterial: Cellulosewith phenolimpregnated.Two filters areused consisting ofone pre-filter andthe main filter:Pre-filter: Fuji 6R- | Cellulose-medium type.Main filterelementMaterial:PolypropylenePre-filterelementMaterial:Cellulose withphenolimpregnated.Two filters areused consistingof one pre-filter | Same | ||||||
| PALL (R1F070)with the efficiencyof greater than99.9999% for 0.3micron particles.(Refer to Exhibit19 "FilterInformation - Palland Fuji "andExhibit 21 "AirFilterReplacementInformation") | filter:Pre-filter: Fuji6R-60Main Filter:PALL (R1F070)with theefficiency ofgreater than99.9999% for0.3 micronparticles.(Refer to Exhibit19 "FilterInformation -Pall and Fuji"and Exhibit 21"Air FilterReplacementInformation") | ||||||||
| Control | Automaticoperation throughall phases ofsterilization cycle. | Automaticoperationthrough allphases ofsterilizationcycle. | Same | ||||||
| Cycle parameterscan be selectedand programmedby operator. | Cycleparameters canbe selected andprogrammed byoperator. | Same | |||||||
| All cycle phasesare monitoredvisually. | All cycle phasesare monitoredvisually. | Same | |||||||
| Cycle completionindications aremonitored bothaudibly andvisually. | Cyclecompletionindications aremonitored bothaudibly andvisually. | Same | |||||||
| Color liquid crystaltouch-paneldisplay. | Color liquidcrystal touch-panel display. | Same | |||||||
| Cycle progressand information ontime, pressure andtemperature,including any faultstatements, areindicated on the40-character | Cycle progressand informationon time,pressure andtemperature,including anyfault statements,are indicated on | Same | |||||||
| impact printer. | the 40-characterimpact printer. | ||||||||
| Factoryprogrammedoperation cyclesare provided asstandardizedsterilizing cycles. | Factoryprogrammedoperation cyclesare provided asstandardizedsterilizingcycles. | Same | |||||||
| Access (security)Code | Requires entry ofa 4-digit accesscode to operatesterilizer and/orchange the cyclevalues. | Requires entryof a 4-digitaccess code tooperate sterilizerand/or changethe cycle values. | Same | ||||||
| Temperaturereadouts are bothin Fahrenheit orCentigrade. | Temperaturereadouts areboth inFahrenheit orCentigrade. | Same | |||||||
| Temperature | Impact printerprovides recordingof time,temperature,pressure, cyclenumber, sterilizernumber and datefor each cycle. | Impact printerprovidesrecording oftime,temperature,pressure, cyclenumber,sterilizer numberand date foreach cycle. | Same | ||||||
| Printer Device | Included asstandard. Printedon all pertinentcycle data on 21/4 inch widepaper. | Included asstandard.Printed on allpertinent cycledata on 2 1/4inch wide paper. | Same | ||||||
| Integrated Waterrecirculationsystem | Stainless Steelreservoir with abrass-recirculatingpump, provided asstandard. | Stainless Steelreservoir with abrass-recirculatingpump, providedas standard. | Same | ||||||
| FactoryProgrammedCycle #s(Including Liquidcycle as Option) | 8 | 8 | Same | ||||||
| Factory-Programmed Sterilization Cycle - Prevacuum Configuration | |||||||||
| Flash 1(IU 1) | 270 F. (132 C)degree sterilize | 270 F. (132 C)degree sterilize | Same | ||||||
| Flash 2(IU 2) | temp., 3 min.sterilize time, 1min. dry time.Unwrappednonporous, asingle instrument. | temp., 3 min.sterilize time, 1min. dry time.Unwrappednonporous, asingle instrument. | SubstantiallyEquivalent | ||||||
| 270 F. (132 C)degree sterilizetemp., 4 min.sterilize time, 1min. dry time.Maximum ofsixteen (16)unwrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | 270 F. (132 C)degree sterilizetemp., 4 min.sterilize time, 1min. dry time.Maximum of six(6) unwrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | ||||||||
| Prevacuum 270 | 270 F. (132 C)degree sterilizetemp., 4 min.sterilize time, 30min. dry time.Maximum ofsixteen (16)double wrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | 270 F. (132 C)degree sterilizetemp., 4 min.sterilize time, 30min. dry time.Maximum of six(6) doublewrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | SubstantiallyEquivalent | ||||||
| Prevacuum 275 | 275 F. (135 C)degree sterilizetemp., 3 min.sterilize time 30 | 275 F. (135 C)degree sterilizetemp., 3 min.sterilize time 30 | SubstantiallyEquivalent | ||||||
| min. dry time.Maximum ofsixteen (16)double wrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | min. dry time.Maximum of six(6) doublewrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | ||||||||
| ExpressPrevacuum(IU 3) | 270 F. (132 C)degree sterilizetemp., 4 min.sterilize time, 3min. dry time.Maximum ofsixteen (16) singlewrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | 270 F. (132 C)degree sterilizetemp., 4 min.sterilize time, 3min. dry time.Maximum of six(6) singlewrappedinstrument trays,maximum weight25 pound (11.3kg) each. Themaximum of three(3) 2 mm insidediameter(minimum) and400 mm long(maximum) lumeninstrument percycle load. | SubstantiallyEquivalent | ||||||
| Factory-Programmed Sterilization Cycle - Gravity Configuration | |||||||||
| Gravity 1 | 250 F (121 C)degree sterilizetemp. 30 min.sterilize time, 15min. dry time.Maximum of thirty-two (32) -fabricpacks. | 250 F (121 C)degree sterilizetemp. 30 min.sterilize time, 15min. dry time.Maximum oftwelve (12) -fabricpacks. | SubstantiallyEquivalent | ||||||
| Gravity 2 | 270 F (132 C)degree sterilizetemp., 15 min.sterilize time, 30 | 270 F (132 C)degree sterilizetemp., 15 min.sterilize time, 30 | SubstantiallyEquivalent | ||||||
| min. dry time.Maximum ofsixteen (16)double wrappedinstruments,maximum weight25 pounds (11.3 | min. dry time.Maximum of six(6) doublewrappedinstruments,maximum weight25 pounds (11.3 | ||||||||
| Liquid Cycle(Option) | kg) per tray.250 F (121 C)degree sterilizetemp., 45 min.sterilize time.Maximum of three(3) 1,000 mill-litercontainers. | kg) per tray.250 F (121 C)degree sterilizetemp., 45 min.sterilize time.Maximum of three(3) 1,000 mill-litercontainers. | Same | ||||||
| SAL LEVELBased onANSI/AAMIST8: 2008Section 5.5.2.5-a) | <10-6 SAL | <10-6 SAL | Same |
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Discussion of Similarities and Differences
The previously cleared devices and these larger devices utilize the same technology (software) and materials. The only differences are the size of the sterilizers, chamber door (single or double doors) and its opening mechanism, and vacuum system (vacuum system is option). The larger size option is being offered to facilities that need to sterilize a larger quantity of instruments at once. The larger sizes of these models with door and vacuum system differences do not affect the safety and effectiveness of the device.
EFFECTIVENESS:
Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10 ° reduction. Sakura Seiki Co., Ltd. validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI). Prior to release, the sterilizers were validated to meet the requirements of AAMIIANSI ST8: 2008.
The software validation for the cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document
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"Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005).
SAFETY:
The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards.
The Sakura Steam Sterilizer ASSR-AO12, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizercomplies with the following safety standards:
IEC 60601-1-2:2007 IEC61010-1 (2nd Edition) 2008 / CSA C22.2 No.61010-1 IEC61010-2-040: 2005 CISPR11: 2009 ED5.0: AMENDMENT1: 2010 IEC61000-3-2:2005 ED3.0: AMENDMENT1:2010 IEC61000-3-3:2008 ED2.0 (EMC) - PART 3-3 IEC61000-4-2: 2008 ED2.0 (EMC) - PART 4-2 IEC61000-4-3: 2006 ED3.0 +AMENDMENT1: 2007+AMENDMENT2:2010 (EMC) IEC61000-4-4: 2004 ED2.0 +AMENDMENT1:2010 IEC61000-4-5: 2005 ED2.0 IEC61000-4-6: 2003 ED2.0+AMENDMENT1:2004+AMENDMENT1:2006 IEC61000-4-8: 2009 ED2.0 IEC61000-4-11: 2004 ED2.0 American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code Section VIII Division 1 2010 Edition: Rules for the Construction of Pressure Vessels.
HAZARDS-FAILURE OF PERFORMANCES
Failure of the sterilization process can lead to incidence of cross contamination, the transmission of potentially infectious organisms from one infected person to another who was not otherwise infected prior to the incident.
To avoid failure, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the manufacturer's instructions for use are followed, that the cycle to be used for each type of sterilizer load has been validated, that the sterilizer has been maintained in accordance with the sterilizer's manufacturer's maintenance schedule and is operating properly, and that each sterilizer load is monitored with available and validated biological and chemical sterilization process indicators.
Today, there are many steam sterilizers in daily use in hospitals throughout the United States. The incident of sterilizer malfunction or sterilization process failure is relatively rare considering the wide spread use of steam sterilizers. Further,
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there are no reports in the literature of patient infection that have resulted from steam sterilizer failure.
The technology designed in the The Sakura Steam Sterilizer ASSR-AO12, Sakura Steam Sterilizer ASSR-AQ12W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-A012PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide microprocessor controller safequards that abort the cycle and give appropriate signals, alerts and warnings when required conditions have not been met or when a malfunction occurs.
USER INFORMATION
Sakura Seiki Co., Ltd. provides information to the user that is intended to insure safe and effective use of steam sterilization in its detailed User's Manual and other labeling.
Sakura Seiki Co., Ltd. also recommends the use and periodic review of the AAMI steam sterilization standards to ensure further assurance of the safe and effective use of steam sterilization equipment in health care facilities.
8. Performance Data:
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer. The device passed all of the tests based on pre-determined Pass/Fail criteria.
ഗ് Conclusions:
The data from consensus standard testing and comparison to the predicate device show that the The Sakura Steam Sterilizer ASSR-AO12, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-AO12P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizerare as safe and effective as the legally marketed predicate device.
Therefore Sakura Seiki Co., Ltd. conclude that the each of the sterilizers included under this submission are substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
Sakura Seiki Co., Ltd C/O Ms. Maria F. Griffin Official Correspondent 55 NORTHERN BLVD SUITE 200 GREAT NECK NY 11021
Re: K132439
Trade/Device Name: Sakura Steam Sterilizer ASSR-A012, ASSR-A012W, ASSR-A012P, ASSR-A012PW, Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Sterilizer Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 19, 2013 Received: December 23, 2013
Dear Ms. Griffin:
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.
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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 (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin DKeith
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit 3
Indications for Use Statement
Page _ 1 of 3
510(k) Number (if known): K132439
Device Name:
Sakura Steam Sterilizer ASSR-A012 Sakura Steam Sterilizer ASSR-A012W Sakura Steam Sterilizer ASSR-A012P Sakura Steam Sterilizer ASSR-A012PW Skytron Integrity 270 Steam Sterilizer Skytron Integrity 270 VP Steam Sterilizer
Indications For Use:
Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-A012PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012. ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities. Sakura Sterilizer ASSR-A012. ASSR-A012W. ASSR-A012W. ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are available in the following configuration.
26.5" x 37.5" x 53" chamber size, Single or Double Door Prevacuum and Gravity
| Prescription Use | Over-The Counter Use X | |
|---|---|---|
| (Per 21 CFR 801 Subpart D) | OR | (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)
Elizabeth F. Claverie -S 2014.01.06 13:55:25 -05'00'
Page 1 of 3
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Note:
Sakura Steam Sterilizer ASSR-AO12 is a single door.
Sakura Steam Sterilizer ASSR-AO12W.is a double door (pass through).
Sakura Steam Sterilizer ASSR-AO12P is a single door with vacuum pump. Sakura Steam Sterilizer ASSR-AO12PW is a double door (pass through) with
vacuum pump.
Skytron Integrity 270 Steam Sterilizer is a single or double door (pass through). Skytron 270 VP Steam Sterilizer is a single or double door (pass through) with vacuum pump.
Sakura Steam Sterilizer ASSR-A012, ASSR-A012W, ASSR-A012P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are equipped with the following factory-programmed sterilization cycle values. The following factory-programmed cycles are validated according to ANSI/AAMI ST8: 2008.
| Cycle | Validated Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---|---|---|---|---|
| Flash 1(IU 1) | One unwrapped, nonporous instrument no heavier than 0.22 lbs. (100 gram) | 270 F (132 C) | 3 minutes | 1 minute |
| Flash 2(IU 2) | Maximum of sixteen (16) unwrapped instrument trays, maximum weight 25 pound (11.3 kg) each. The maximum of three (3) 2 mm inside diameter (minimum) and 400 mm long (maximum) lumen instruments per cycle load. | 270 F (132 C) | 4 minutes | 1 minute |
| Prevacuum270 | Maximum of sixteen (16) double-wrapped instrument trays, maximum weight 25 pound (11.3 kg) each. The maximum of three (3) 2 mm inside diameter (minimum) and 400 mm long (maximum) lumen instruments per cycle load. | 270 F (132 C) | 4 minutes | 30 minutes |
| Prevacuum275 | Maximum of sixteen (16) double-wrapped instrument trays, maximum weight 25 pound (11.3 kg) each. The maximum of three (3) 2 mm inside diameter (minimum) and 400 mm long (maximum) lumen instruments per cycle load. | 275 F (135 C) | 3 minutes | 30 minutes |
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Exhibit 3
| instruments per cycle load. | ||||
|---|---|---|---|---|
| ExpressPrevacuum(IU 3) | Maximum of sixteen (16)single wrapped instrumenttrays, maximum weight 25pound (11.3 kg) each.The maximum of three (3)2 mm inside diameter(minimum) and 400 mmlong (maximum) lumeninstruments per cycle load.This cycle is intended forimmediate use and thewrap used for this cycle isnot intended to be a sterilebarrier. | 270 F (132 C) | 4 minutes | 3 minutes |
| Gravity 1 | Maximum of thirty-two (32)-fabric packs. | 250 F (121 C) | 30 minutes | 15 minutes |
| Gravity 2 | Maximum of thirty-two (32)double-wrappedinstrument trays,maximum weight 25pound (11.3 kg) each. | 270 F (132 C) | 15 minutes | 30 minutes |
| Liquid | Three (3) 1,000 mill-litercontainers with ventedclosures. This cycle isintended for non-patientcontacting devices only. | 250 F (121 C) | 45 minutes | 0 minutes |
| Leak Test | Empty Chamber, test timeof 15 minutes. | N/A | N/A | N/A |
| Warm Up | Empty Chamber | 270 F (132C) | 4 minutes | 3 minutes |
| Bowie-DickTest | Bowie-Dick Test Pack | 273 F (134 C) | 3.5 minutes | 2 minutes |
Note:
♪ Prevacuum 270 - Adjusting the Dry Time to be 15 minutes allows the sterilization of thirty-two (32) fabric packs (maximum).
Gravity 2 - Adjusting the Steam Purge Time to 10 minutes, the Sterilize Time to ア Gravity 2 - Aujuoting the Time to 15 minutes allows the sterilization of thirty-two (32) fabric packs (maximum).
"IU" means "Immediate Use" cycle.
V V Liquid cycle is for non-patient contact use only.
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§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).