SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER
Device Facts
| Record ID | K132439 |
|---|---|
| Device Name | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER |
| Applicant | Sakura Seiki Co., Ltd. |
| Product Code | FLE · General Hospital |
| Decision Date | Jan 6, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6880 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
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.
Device Story
Steam sterilizer for healthcare facilities; utilizes high-pressure steam to process non-porous and porous, heat/moisture-stable items. Input: user-selected sterilization cycles (Flash, Prevacuum, Gravity, Liquid). Operation: microprocessor-controlled; monitors cycle phases (time, pressure, temperature); provides visual/audible status updates; includes impact printer for cycle documentation. Safety: automated safeguards abort cycles and trigger alerts upon malfunction; requires 4-digit access code for operation/parameter changes. Output: sterilized medical instruments/materials. Benefit: ensures sterility assurance level (SAL) of at least 10^-6. Used by healthcare staff in sterile processing departments.
Clinical Evidence
Bench testing only. Validation performed per ANSI/AAMI ST8:2008 standards. Efficacy demonstrated by biological indicator kill and SAL of at least 10^-6. Software validation conducted per FDA moderate level of concern guidance. No clinical data.
Technological Characteristics
Chamber: SUS 316L stainless steel. Jacket: SUS SA-240 type 304L. Insulation: 25mm glass wool. Air filtration: Polypropylene main filter, cellulose pre-filter (efficiency >99.9999% for 0.3 micron particles). Energy: House steam. Control: Microprocessor-based with color LCD touch-panel. Connectivity: Impact printer for data recording. Standards: ASME Section VIII Div 1, IEC 60601-1-2, IEC 61010-1.
Indications for Use
Indicated for sterilization of non-porous and porous, heat and moisture-stable items and materials in healthcare facilities. Includes immediate-use (flash) cycles for unwrapped instruments and standard cycles for wrapped instrument trays and fabric packs. Liquid cycle for non-patient contacting devices only.
Regulatory Classification
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.
Predicate Devices
- Sakura Steam Sterilizer ASSV-AB09, 09E (K120149)
- Skytron Integrity 215, 215 SG Steam Sterilizer (K120149)
Related Devices
- K100622 — BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 · Belimed Sauter AG · Aug 27, 2010
- K130172 — BELIMED STEAM STERILIZER MST-V · Belimed, Inc. · Sep 23, 2013
- K103841 — BELIMED STEAM STERILIZER MST-V · Sauter AG · Mar 15, 2011
- K120149 — SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA · Sakura Seiki Co., Ltd. · May 8, 2012
- K020747 — AMSCO CENTURY MEDIUM STERILIZER 26 X 26 · STERIS Corporation · May 17, 2002
Submission Summary (Full Text)
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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 -----------
- 1. 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
#### 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 | Sterilize<br>Temp | Sterilize<br>Time | Dry Time |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|------------|
| Flash 1<br>(IU 1) | One unwrapped,<br>nonporous instrument no<br>heavier than 0.22 lbs. (100<br>gram) | 270 F (132 C) | 3 minutes | 1 minute |
| Flash 2<br>(IU 2) | Maximum of sixteen (16)<br>unwrapped instrument | 270 F (132 C) | 4 minutes | 1 minute |
| | | | | |
| | trays, maximum weight 25<br>pound (11.3 kg) each.<br>The maximum of three (3)<br>2 mm inside diameter<br>(minimum) and 400 mm<br>long (maximum) lumen<br>instruments per cycle load. | | | |
| Prevacuum<br>270 | Maximum of sixteen (16)<br>double-wrapped<br>instrument trays,<br>maximum weight 25<br> | 270 F (132 C) | 4 minutes | 30 minutes |
| Prevacuum<br>275 | Maximum of sixteen (16)<br>double-wrapped<br>instrument trays,<br>maximum weight 25<br>pound (11.3 kg) each.<br>The maximum of three (3)<br>2 mm inside diameter<br>(minimum) and 400 mm<br>long (maximum) lumen<br>instruments per cycle load. | 275 F (135 C) | 3 minutes | 30 minutes |
| Express<br>Prevacuum<br>(IU 3) | Maximum of sixteen (16)<br>single wrapped instrument<br>trays, maximum weight 25<br>pound (11.3 kg) each.<br>The maximum of three (3)<br>2 mm inside diameter<br>(minimum) and 400 mm<br>long (maximum) lumen<br>instruments per cycle load.<br>This cycle is intended for<br>immediate use and the<br>wrap used for this cycle is<br>not intended to be a sterile<br>barrier. | 270 F (132 C) | 4 minutes | 3 minutes |
| Gravity 1 | Maximum of thirty-two (32)<br>-fabric packs. | 250 F (121 C) | 30 minutes | 15 minutes |
| Gravity 2 | Maximum of sixteen (16)<br>double-wrapped<br>instrument trays,<br>maximum weight 25<br>pound (11.3 kg) each. | 270 F (132 C) | 15 minutes | 30 minutes |
| Liquid | Three (3) 1,000 mill-liter<br>containers with vented | 250 F (121 C) | 45 minutes | 0 minutes |
| | closures. This cycle is<br>intended for non-patient<br>contacting devices only. | | | |
| Leak Test | Empty Chamber, test time<br>of 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 Steam<br>Sterilizer ASSR-<br>AO12, -AO12W, -<br>AO12P, -<br>AO12PW /<br>Skytron Integrity<br>270, 270 VP<br>Steam Sterilizer | Predicate<br>Product<br>(Sakura Steam<br>Sterilizer<br>ASSV-AB09,<br>09E<br>Skytron<br>Integrity 215,<br>215 SG Steam<br>Sterilizer,<br>K120149) | Substantially<br>Equivalent or<br>Different | | | | | | |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication for Use | Sakura Steam<br>Sterilizer / Skytron<br>Integrity Steam<br>Sterilizer is<br>designed and<br>optimized for use<br>in health care<br>facilities. Sakura<br>Steam Sterilizer /<br>Skytron Integrity<br>Steam Sterilizer<br>incorporates high-<br>pressure steam to<br>sterilize non-<br>porous and<br>porous, heat and<br>moisture-stable<br>items and<br>materials used in | Sakura Steam<br>Sterilizer /<br>Skytron Integrity<br>Steam Sterilizer<br>is designed and<br>optimized for<br>use in health<br>care facilities.<br>Sakura Steam<br>Sterilizer /<br>Skytron Integrity<br>Steam Sterilizer<br>incorporates<br>high-pressure<br>steam to<br>sterilize non-<br>porous and<br>porous, heat<br>and moisture-stable | Same | | | | | | |
| | the health care<br>facilities. | stable items and<br>materials used<br>in the health care facilities. | | | | | | | |
| | Single Phase,<br>120VAC, 60Hz | Single Phase,<br>120VAC, 60Hz | Same | | | | | | |
| Electrical | 3 Phases,<br>208VAC, 60 Hz,<br>15 Amps.<br>Or, 3 Phase,<br>480VAC, 60 Hz, 7<br>Amps.<br>(For Vacuum<br>Pump option) | No Vacuum<br>Pump | Different | | | | | | |
| Frame | Carbon steel | Carbon steel | Same | | | | | | |
| Chamber | SUS 316L | SUS 316L | Same | | | | | | |
| Chamber Size &<br>Volume | 26.5 in x 37.5 in x<br>53 in | 21.5 in x 21.5 in<br>x 38 in | Substantially<br>Equivalent | | | | | | |
| | 32.3 ft3 | 11.1 ft3 | | | | | | | |
| System Weight -<br>Dry (no utilities,<br>no cabinet) | For Integrity 270:<br>Single Door -<br>1,516 kg / 3,335<br>lbs.<br>Double Door -<br>1,714 kg / 3,771<br>lbs. | For integrity<br>215: 760kg /<br>1675 lbs. For<br>Integrity 215<br>SG:<br>830 kg / 1830<br>lbs. | Substantially<br>Equivalent | | | | | | |
| | SUS SA-240 type<br>304L | SUS SA-240<br>type 304L | Same | | | | | | |
| Jacket | ASME section VIII,<br>Div. 1 | ASME section<br>VIII, Div. 1 | Same | | | | | | |
| Door | SUS 316L,<br>emergency<br>manual door<br>opening system | SUS 316L,<br>emergency<br>manual door<br>opening system | Same | | | | | | |
| Door | Single or double<br>door (pass<br>through) | Single Door | Substantially<br>Equivalent | | | | | | |
| Door Opening<br>Method | Manual Swing<br>type (open/close)<br>with power lock-up<br>by elevation of<br>door. | Automated<br>vertical sliding<br>door with foot<br>pedal | Substantially<br>Equivalent. | | | | | | |
| Door Seal | Steam activated<br>door seal | Steam activated<br>door seal | Same | | | | | | |
| Insulation | The entire exterior<br>surface of vessel | The entire<br>exterior surface | Same | | | | | | |
| | | | | | | | | | |
| | is insulated with<br>glass wool<br>insulation<br>materials.<br>Thickness: 25mm<br>Specific gravity:<br>24kg/m³ | of vessel is<br>insulated with<br>glass wool<br>insulation<br>materials.<br>Thickness:<br>25mm<br>Specific gravity:<br>24kg/m³ | | | | | | | |
| | Industrial grade<br>brass or SUS | Industrial grade<br>brass or SUS | Same | | | | | | |
| Control Valve | Actuated by<br>electric solenoid or<br>motor or manual<br>shutoff valves. | Actuated by<br>electric solenoid<br>or motor or<br>manual shutoff<br>valves. | Same | | | | | | |
| Piping | Stainless Steel<br>(SUS 304) or<br>flared copper | Stainless Steel<br>(SUS 304) or<br>flared copper | Same | | | | | | |
| Safety (pressure<br>relief) valves | ASME approved. | ASME<br>approved. | Same | | | | | | |
| Steam Source | House steam | House steam or<br>integrated<br>steam<br>generator. | Same | | | | | | |
| Steam Capacity<br>Requirement<br>(from house<br>steam) | 220 lbs./Hour | 100 lbs./Hour | Substantially<br>Equivalent. | | | | | | |
| Vacuum System | Water ejector as<br>standard<br>specification, and<br>the vacuum pump<br>option is available. | Water ejector as<br>standard<br>specification. | Substantially<br>Equivalent | | | | | | |
| Air Filtration | Cellulose-medium<br>type.<br>Main filter element<br>Material:<br>Polypropylene<br>Pre-filter element<br>Material: Cellulose<br>with phenol<br>impregnated.<br>Two filters are<br>used consisting of<br>one pre-filter and<br>the main filter:<br>Pre-filter: Fuji 6R- | Cellulose-<br>medium type.<br>Main filter<br>element<br>Material:<br>Polypropylene<br>Pre-filter<br>element<br>Material:<br>Cellulose with<br>phenol<br>impregnated.<br>Two filters are<br>used consisting<br>of one pre-filter | Same | | | | | | |
| | PALL (R1F070)<br>with the efficiency<br>of greater than<br>99.9999% for 0.3<br>micron particles.<br>(Refer to Exhibit<br>19 "Filter<br>Information - Pall<br>and Fuji "and<br>Exhibit 21 "Air<br>Filter<br>Replacement<br>Information") | filter:<br>Pre-filter: Fuji<br>6R-60<br>Main Filter:<br>PALL (R1F070)<br>with the<br>efficiency of<br>greater than<br>99.9999% for<br>0.3 micron<br>particles.<br>(Refer to Exhibit<br>19 "Filter<br>Information -<br>Pall and Fuji<br>"and Exhibit 21<br>"Air Filter<br>Replacement<br>Information") | | | | | | | |
| Control | Automatic<br>operation through<br>all phases of<br>sterilization cycle. | Automatic<br>operation<br>through all<br>phases of<br>sterilization<br>cycle. | Same | | | | | | |
| | Cycle parameters<br>can be selected<br>and programmed<br>by operator. | Cycle<br>parameters can<br>be selected and<br>programmed by<br>operator. | Same | | | | | | |
| | All cycle phases<br>are monitored<br>visually. | All cycle phases<br>are monitored<br>visually. | Same | | | | | | |
| | Cycle completion<br>indications are<br>monitored both<br>audibly and<br>visually. | Cycle<br>completion<br>indications are<br>monitored both<br>audibly and<br>visually. | Same | | | | | | |
| | Color liquid crystal<br>touch-panel<br>display. | Color liquid<br>crystal touch-<br>panel display. | Same | | | | | | |
| | Cycle progress<br>and information on<br>time, pressure and<br>temperature,<br>including any fault<br>statements, are<br>indicated on the<br>40-character | Cycle progress<br>and information<br>on time,<br>pressure and<br>temperature,<br>including any<br>fault statements,<br>are indicated on | Same | | | | | |…
