Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard steam sterilizer and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No
The device is a steam sterilizer for medical instruments, not a device that treats a disease or condition in a patient.

Diagnostic

No

The device is a steam sterilizer designed to sterilize medical items, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Steam Sterilizer" and describes its function as using "high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials". This indicates a physical hardware device, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to sterilize medical items using high-pressure steam in healthcare facilities. This is a process applied to medical devices and materials, not a test performed on biological samples to diagnose a condition.
Device Description: The device is described as a Class II medical device (Product Code FLE) used for steam sterilization and drying. This classification and function are consistent with sterilization equipment, not IVD devices.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays

The device's purpose is to ensure the sterility of instruments and materials used in healthcare, which is a crucial part of infection control, but it does not perform diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers 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 ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are available in the following configuration.

17.5" x 17.5" x 26.5" chamber size, Single Door Prevacuum and Gravity.

Note: Sakura Steam Sterilizer ASSV-AH06E / SKYTRON Integrity 175 SG Steam Sterilizers equip the integrated steam generator.
Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are equipped with the following factory-programmed sterilization cycle values. The following factory-programmed cycles are validated according to ANSI/AAMI ST8: 2008.

Flash 1 (IU 1): One unwrapped, nonporous instrument no heavier than 0.22 lbs. (100 gram), Sterilize Temp 270 F (132 C), Sterilize Time 3 minutes, Dry Time 1 minute.
Flash 2 (IU 2): Maximum of two (2) 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., Sterilize Temp 270 F (132 C), Sterilize Time 4 minutes, Dry Time 1 minute.
Prevaccum 270: Maximum of two (2) double-wrapped instrument trays, maximum weight 25 pound (11.3kg) each. The maximum of three (3) 2 mm inside diameter (minimum) and 400 mm long (maximum) lumen instruments per cycle load., Sterilize Temp 270 F (132 C), Sterilize Time 4 minutes, Dry Time 30 minutes.
Prevaccum 275: Maximum of two (2) 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., Sterilize Temp 275 F (135 C), Sterilize Time 3 minutes, Dry Time 30 minutes.
Express Prevaccum (IU 3): Maximum of two (2) single 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. This cycle is intended for immediate use and the wrap used for this cycle is not intended to be a sterile barrier., Sterilize Temp 270 F (132 C), Sterilize Time 4 minutes, Dry Time 3 minutes.
Gravity 1: Maximum of four (4) - fabric packs., Sterilize Temp 250 F (121 C), Sterilize Time 30 minutes, Dry Time 15 minutes.
Gravity 2: Maximum of two (2) double-wrapped instrument trays, maximum weight 25 pound (11.3 kg) each., Sterilize Temp 270 F (132 C), Sterilize Time 15 minutes, Dry Time 30 minutes.
Liquid: Maximum of three (3) 1,000 mill-liter containers with vented closures. This cycle is intended for non-patient contacting devices only., Sterilize Temp 250 F (121 C), Sterilize Time 45 minutes, Dry Time 0 minutes.
Leak Test: Empty Chamber, test time of 15 minutes., Sterilize Temp N/A, Sterilize Time N/A, Dry Time N/A.
Warm Up: Empty Chamber, Sterilize Temp 270 F (132C), Sterilize Time 4 minutes, Dry Time 3 minutes.
Bowie-Dick Test: Bowie-Dick Test Pack, Sterilize Temp 273 F (134 C), Sterilize Time 3.5 minutes, Dry Time 2 minutes.

Product codes (comma separated list FDA assigned to the subject device)

FLE

Device Description

Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizer. The device passed all of the tests based on predetermined Pass/Fail criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120149

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

Document 004

MAY 0 9 2013

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K122774

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: December 5, 2012

2. Name of the Device:

Proprietary name: Sakura Steam Sterilizer ASSV-AH06 SKYTRON Integrity 175 Steam Sterilizer Sakura Steam Sterilizer ASSV-AH06E SKYTRON Integrity 175 SG 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:

Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam

1

Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers 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.

છં Intended Use:

Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer. Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers 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 ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are available in the following configuration.

17.5" x 17.5" x 26.5" chamber size, Single Door Prevacuum and Gravity.

Note: Sakura Steam Sterilizer ASSV-AH06E / SKYTRON Integrity 175 SG Steam Sterilizer equip the integrated steam generator.

Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are equipped with the following factory-programmed sterilization cycle values. The following factory-programmed cycles are validated according to ANSI/AAMI ST8: 2008.

| Cycle | Maximum 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 two (2)
unwrapped instrument
trays, maximum weight 25
pound (11.3 kg) each.
The maximum of three (3)
2 mm inside diameter
(minimum) and 400 mm | 270 F (132 C) | 4 minutes | 1 minute |
| | long (maximum) lumen
instruments per cycle load. | | | |
| Prevacuum
270 | Maximum of two (2)
double-wrapped
instrument trays,
maximum weight 25
pound (11.3kg) 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 |
| Prevacuum
275 | Maximum of two (2)
double-wrapped
instrument trays,
maximum weight 25
pound (11.3 kg) each.
The maximum of three (3)
2 mm inside diameter
| 275 F (135 C) | 3 minutes | 30 minutes |
| Express
Prevacuum
(IU 3) | Maximum of two (2) single
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.
This cycle is intended for
immediate use and the
wrap used for this cycle is
not intended to be a sterile
barrier. | 270 F (132 C) | 4 minutes | 3 minutes |
| Gravity 1 | Maximum of four (4) -
fabric packs. | 250 F (121 C) | 30 minutes | 15 minutes |
| Gravity 2 | Maximum of two (2)
double-wrapped
instrument trays.
maximum weight 25
pound (11.3 kg) each. | 270 F (132 C) | 15 minutes | 30 minutes |
| Liquid | Maximum of three (3) | 250 F (121 C) | 45 minutes | 0 minutes |
| | with vented closures. This
cycle is intended for non-patient contacting devices
only. | | | |
| Leak Test | Empty Chamber, test time 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 |

2

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Note:

"IU" means "Immediate Use Steam Sterilization" cvcle.

Liquid cycle is for non-patient contact use only.

Technological Characteristics 7.

Comparison to Predicate Device

The proposed sterilizers offered within this submission are equipped with the same options offered under the predicate device, in design and construction. The only difference between the predicate and the subject device is the size of the models being offered and less number of sterilization cycles. The subject device has different chamber dimensions and different load configulations and less sterilization cycles compared to the predicate device. The predicate devices are larger in size to fit more instruments in one sterilization cycle. This difference has no effect 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 Seikl 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 "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005).

SAFETY:

Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam

4

Sterilizers have been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers comply with the following safety standards:

IEC 60601-1-2:2007 IEC61010-1 (200 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 cvcle 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, there are no reports in the literature of patient infection that have resulted from steam sterilizer failure.

The technology designed in Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers 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.

5

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 Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizer. The device passed all of the tests based on predetermined Pass/Fail criteria.

9. Conclusions:

The data from consensus standard testing and comparison to the predicate device show that Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers are 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.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like extensions.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 09, 2013

Sakura Seiki Company, Limited C/O Ms. Swapna Chirala Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Hwy 8 NW, Suite 104 NEW BRIGHTON, MN 55112-1891

Re: K122774

Trade/Device Name: Sakura Sterilizer ASSV-AH06, Skytron Integrity 175 Steam Sterilizer, Sakura Sterilizer ASSV-AH06E Skytron Integrity 175 SG Steam Sterilizer

Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: April 4, 2013 Received: April 26, 2013

Dear Ms. Chirala:

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.

7

Page 2 – Ms. Chirala

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 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,

for

Ruth
urot.u.s.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

Indications for Use Statement

Page 1 of 3

510(k) Number (if known): 长122774

Device Name:

Sakura Steam Sterilizer ASSV-AH06 Skytron Integrity 175 Steam Sterilizer Sakura Steam Sterilizer ASSV-AH06E Skytron Integrity 175 SG Steam Sterilizer

Indications For Use:

Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers 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 ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are available in the following configuration.

17.5" x 17.5" x 26.5" chamber size, Single Door Prevacuum and Gravity.

Note: Sakura Steam Sterilizer ASSV-AH06E / SKYTRON Integrity 175 SG Steam Sterilizers equip the integrated steam generator.

Prescription Use
(Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use	X
(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)
ed by Elizabeth F. Claverie
Elizabeth=
Claverie
(Division Sign-Off)
ിvision of Anesthesiology, General Hospital
ifection Control, Dental Devices
510/k) Number: K \22774	rage

of 3

9

Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are equipped with the following factory-programmed sterilization cycle values. The following factory-programmed cycles are validated according to ANSI/AAMI ST8: 2008.

Cycle	Maximum 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 two (2) 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
Prevacuum 270	Maximum of two (2) double-wrapped instrument trays, maximum weight 25 pound (11.3kg) 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
Prevacuum 275	Maximum of two (2) 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
Express Prevacuum
(IU 3)	Maximum of two (2) single 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	3 minutes
	This cycle is intended for
immediate use and the
wrap used for this cycle is
not intended to be a sterile
barrier.
Gravity 1	Maximum of four (4) -
fabric packs.	250 F (121 C)	30 minutes	15 minutes
Gravity 2	Maximum of two (2)
double-wrapped
instrument trays,
maximum weight 25
pound (11.3 kg) each.	270 F (132 C)	15 minutes	30 minutes
Liquid	Maximum of three (3)
1,000 mill-liter containers
with vented closures. This
cycle is intended for non-
patient contacting devices
only.	250 F (121 C)	45 minutes	0 minutes
Leak Test	Empty Chamber, test time
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

Page 2 of 3

10

Note:

、

・

. . . . . .

: ・

V V "IU" means "Immediate Use Steam Sterilization" cycle.

Liquid cycle is for non-patient contact use only.

.

. .

. . . . .

1 4. "

.