SteriZign Signatur Device Protection System

K171520 · Sterizign Precision Technologies, LLC · KCT · Feb 7, 2018 · General Hospital

Device Facts

• Record ID: K171520
• Device Name: SteriZign Signatur Device Protection System
• Applicant: Sterizign Precision Technologies, LLC
• Product Code: KCT · General Hospital
• Decision Date: Feb 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Identification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. SteriZign Signatur Device Protection System are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Protection System are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Protection System are not intended on their own to maintain sterility. The SteriZign Signatur Device Protection System have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap. Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs. Validated sizes of stainless steel instrument lumens include: 1 each 1mm x 76 mm 1 each 1mm x 400 mm 1 each 2mm x 400 mm 1 each 3mm x 400 mm 1 each 5mm x 400 mm

Device Story

SteriZign Signatur Device Protection System consists of perforated anodized aluminum cassettes/trays with silicone inserts; used by healthcare providers in clinical settings to organize, transport, and protect surgical instruments during pre-vacuum steam sterilization. Devices are placed inside the cassette, which is then enclosed in a validated, FDA-cleared sterilization wrap. The system allows steam penetration through perforations during the autoclave cycle (270°F/132°C for 4 minutes). The system does not maintain sterility independently; it relies on the external wrap. By organizing instruments, the system facilitates efficient sterilization workflows and protects instruments from damage during handling and transport.

Clinical Evidence

Bench testing only. Studies included sterilant penetration verification using a pre-vacuum steam cycle (132°C, 2-minute half-cycle) with no biological indicator growth. Biocompatibility testing (MEM Elution Cytotoxicity per ISO 10993-5) confirmed the device is non-cytotoxic.

Technological Characteristics

Materials: Anodized aluminum (base, insert, lid), 300 series passivated stainless steel (latches, handles, brackets), silicone (mats, dividers), and polypropylene (brackets). Sensing/Actuation: None (passive). Energy: Steam sterilization (autoclave). Form factor: Rectangular cassettes/trays with perforations for steam penetration. Connectivity: None. Sterilization: Pre-vacuum steam (270°F/132°C).

Indications for Use

Indicated for healthcare providers to organize, transport, store, and protect surgical and medical instruments during pre-vacuum steam sterilization. Used in conjunction with FDA-cleared sterilization wrap. Not for maintaining sterility independently. Max weight 25 lbs. Validated for specific stainless steel lumen sizes (1mm-5mm diameter).

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Summit Medical, Instrument Protection System (K133015)

Submission Summary (Full Text)

{0}------------------------------------------------

February 7, 2018

SteriZign Precision Technologies, LLC % Robert Dean President Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, New York 14209

Re: K171520

Trade/Device Name: SteriZign Signatur Device Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 8, 2018 Received: January 12, 2018

Dear Robert Dean:

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.

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 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);

{1}------------------------------------------------

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: 0MB No. 0910-0120

Expiration Date:January 31, 2017

510(k) Number (if known) K171520

### Device Name

SteriZign Signatur Device Protection System

Indications for Use (Describe)

Identification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

SteriZign Signatur Device Cassette and Trays are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Cassette and Trays are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Cassette and Trays are not intended on their own to maintain sterility. SteriZign Signatur Device Cassette and Trays have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.

> Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes

The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 Ibs.

Validated sizes of stainless steel instrument lumens include:

- 1 each 1mm x 76 mm 1 each 1mm x 400 mm
- 1 each 2mm x 400 mm
- 1 each 3mm x 400 mm
- 1 each 5mm x 400 mm
-

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) x |Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. -

The burden time for this collection of information isestimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintainthe data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, inciuding suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| I. Company: | SteriZign Precision Technologies, LLC<br>74 Orion Street<br>Brunswick, ME 04011<br>888-234-3074 |
|-----------------|-------------------------------------------------------------------------------------------------|
| II. Contact: | Sonia Lutarewych<br>President<br>[phone] |
| Date : | January 31, 2018 |
| Device Name: | SteriZign Signatur Device Protection System |
| Common Name: | Sterilization cassette/trays |
| Classification: | Sterilization Wrap Containers, Cassettes/trays , Cassettes & Accessories.<br>(21 CFR 880.6850) |
| Class: | II |

Product Code: KCT

III. Predicate Devices: Cassettes/trays - K133015 Summit Medical, Instrument Protection System.

- IV. Description:
SteriZign Signatur Device Protection System are cassettes/trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with a cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassettes/trays .

- V. Indications for Use:
ldentification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

SteriZign Signatur Device Protection System are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Protection System are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Protection System are not intended on their own to maintain sterility. The SteriZign Signatur Device Protections and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.

> Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes

The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs.

{4}------------------------------------------------

Validated sizes of stainless steel instrument lumens include:

1 each 1mm x 76 mm 1 each 1mm x 400 mm 1 each 2mm x 400 mm 1 each 3mm x 400 mm 1 each 5mm x 400 mm

#### VI. Device List

| CATALOG PART NUMBER | Cassette - Tray Size | Vent to<br>Volume<br>Ratio |
|---------------------|----------------------|----------------------------|
| 102010-3 | 9.86"X20.46"X3.58" | 0.075 |
| 122010-3 | 10"X20"X3" | 0.231 |
| 121610-3 | 10"X16"X3" | 0.225 |
| 121410-3 | 10"X14"X3" | 0.232 |
| 120910-3 | 10"X9.3"X3" | 0.228 |
| 122010-4 | 10"X20"X4" | 0.197 |
| 121610-4 | 10"X16"X4" | 0.195 |
| 121410-4 | 10"X14"X4" | 0.203 |
| 120910-4 | 10"X9.3"X4" | 0.184 |
| 122010-5 | 10"X20"X5" | 0.173 |
| 121610-5 | 10"X16"X5" | 0.172 |
| 121410-5 | 10"X14"X5" | 0.172 |
| 120910-5 | 10"X9.3"X5" | 0.165 |
| 112410-3 | 10"X24"X3" | 0.158 |
| 112010-3 | 10"X20"X3" | 0.152 |
| 111610-3 | 10"X16"X3" | 0.152 |
| 111410-3 | 10"X14"X3" | 0.146 |
| 110910-3 | 10"X9.3"X3" | 0.139 |
| 112410-4 | 10"X24"X4" | 0.128 |
| 112010-4 | 10"X20"X4" | 0.123 |
| 111610-4 | 10"X16"X4" | 0.124 |
| 111410-4 | 10"X14"X4" | 0.121 |
| 110910-4 | 10"X9.3"X4" | 0.117 |
| 112410-5 | 10"X24"X5" | 0.11 |
| 112010-5 | 10"X20"X5" | 0.107 |
| 111610-5 | 10"X16"X5" | 0.105 |
| 111410-5 | 10"X14"X5" | 0.105 |
| 110910-5 | 10"X9.3"X5" | 0.103 |
| 202557-190 | 25"X5.75"X1.9" | 0.522 |
| 202535-190 | 25"X3.5"X1.9" | 0.561 |
| 202057-190 | 20"X5.75"X1.9" | 0.514 |
| 202035-190 | 20"X3.5"X1.9" | 0.563 |
| 201757-190 | 17.6"X5.75"X1.9" | 0.508 |
| 201757-190 | 17.6"X3.5"X1.9" | 0.543 |
| 201457-190 | 14"X5.75"X1.9" | 0.504 |
| 201435-190 | 14"X3.5""X1.9" | 0.548 |
| 201157-190 | 11"X5.75""X1.9" | 0.491 |
| 201135-190 | 11"X3.5""X1.9" | 0.543 |
| 301610-630 | 16"X10"X6.3" | 0.156 |
| | | |
| 302210-630 | 22.6"X10"X6.3" | 0.131 |
| 302610-630 | 26"X10"X6.3" | 0.132 |
| 401510-166 | 15.61"X10.44"X1.66" | 0.428 |
| 401006-166 | 10.61"X6.44"X1.66" | 0.413 |
| 400606-166 | 6.61"X6.44"X1.66" | 0.423 |
| 400603-166 | 6.61"X3.44"X1.66" | 0.345 |
| ACCESSORIES | Inner Trays | |
| 902309-250 | 23.24"X9.4"2.5" | NA |
| 902309-200 | 23.24"X9.4"2.0" | NA |
| 902309-125 | 23.24"X9.4"1.25" | NA |
| 901909-250 | 19.24"X9.4"2.5" | NA |
| 901909-200 | 19.24"X9.4"2.0" | NA |
| 901909-125 | 19.24"X9.4"1.25" | NA |
| 901509-250 | 15.24"X9.4"2.5" | NA |
| 901509-200 | 15.24"X9.4"2.0" | NA |
| 901509-125 | 15.24"X9.4"1.25" | NA |
| 901309-250 | 13.24"X9.4"2.5" | NA |
| 901309-200 | 13.24"X9.4"2.0" | NA |
| 901309-125 | 13.24"X9.4"1.25" | NA |
| 900809-250 | 8.54"X9.4"2.5" | NA |
| 900909-200 | 8.54"X9.4"2.0" | NA |
| 900909-125 | 8.54"X9.4"1.25" | NA |
| 912309-250 | 23.24"X9.4"2.5" | NA |
| 912309-200 | 23.24"X9.4"2.0" | NA |
| 912309-125 | 23.24"X9.4"1.25" | NA |
| 911909-250 | 19.24"X9.4"2.5" | NA |
| 911909-200 | 19.24"X9.4"2.0" | NA |
| 911909-125 | 19.24"X9.4"1.25" | NA |
| 911509-250 | 15.24"X9.4"2.5" | NA |
| 911509-200 | 15.24"X9.4"2.0" | NA |
| 911509-125 | 15.24"X9.4"1.25" | NA |
| 911309-250 | 13.24"X9.4"2.5" | NA |
| 911309-200 | 13.24"X9.4"2.0" | NA |
| 911309-125 | 13.24"X9.4"1.25" | NA |
| 910909-250 | 8.54"X9.4"2.5" | NA |
| 910909-200 | 8.54"X9.4"2.0" | NA |
| 910909-125 | 8.54"X9.4"1.25" | NA |

{5}------------------------------------------------

{6}------------------------------------------------

Comparative Chart VII

| Company | SteriZign | Substantially<br>Equivalent<br>(Y/N) | Summit Medical Instru-Safe |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | SteriZign Signatur Device Protection<br>System | Y | Instru-Safe® Instrument Protection System |
| FDA 510K # | K171520 | - | K133015 |
| Intended Use | Identification: A sterilization wrap (pack,<br>sterilization wrapper, bag, or accessories, is a<br>device intended to be used to enclose another<br>medical device that is to be sterilized by a health<br>care provider. It is intended to allow sterilization of<br>the enclosed medical device and also to maintain<br>sterility of the enclosed device until used.<br><br>SteriZign Signatur Device Protection System are<br>used to organize, transport, store and protect<br>between uses of surgical and other medical<br>devices that are sterilized by a healthcare<br>provider. SteriZign Signatur Device Protection<br>System are intended to allow sterilization of the<br>enclosed medical devices during a pre-vacuum<br>steam sterilization cycles. The SteriZign Signatur<br>Device Protection System are not intended on<br>their own to maintain sterility. The SteriZign<br>Signatur Device Protection System have<br>perforations and intended to be used in<br>conjunction with legally marketed, validated FDA<br>cleared sterilization wrap.<br><br>Autoclave Sterilization Parameter Cycle:<br>Pre-vacuum<br>Temperature: 270°F (132°C)<br>Exposure Time: 4 minutes<br>Dry Time: 30 minutes<br><br>The total weight of a tray (e.g. tray, insert and<br>instruments) should never exceed 25 lbs.<br><br>Validated sizes of stainless steel instrument lumens<br>include:<br>1 each 1mm x 76 mm<br>1 each 1mm x 400 mm<br>1 each 2mm x 400 mm<br>1 each 3mm x 400 mm<br>1 each 5mm x 400 mm | Y | Instru -Safe Instrument Protection System cassettes are used<br>to organize and protect other medical devices that are<br>sterilized by a healthcare provider. Instru -Safe Instrument<br>Protection System cassettes are intend to allow sterilization<br>of the enclosed medical devices during a pre-vacuum steam<br>sterilization cycles. Instru -Safe Instrument Protection System<br>cassettes are intended to be used in conjunction with legally<br>marketed wrap or Aesculap rigid container. Instru -Safe<br>Instrument Protection System cassettes are not intended on<br>their own to maintain sterility.<br><br>Autoclave Sterilization Parameter Cycle: Pre-Vacuum<br>Temperature: 270 degrees F (132 degrees C)<br>Exposure Time: 4 minutes Minimum Dry Time: 30 minutes |
| Lumen Claims | Lumen Inner Diameter (ID) x Length<br>1 mm 76 mm<br>1 mm 400 mm<br>2 mm 300 mm<br>3 mm 400 mm<br>5 mm 400 mm | Y | Lumen Inner Diameter (ID) x Length<br>1 mm x 76 mm<br>1mm x 65mm<br>1 mm x 400 mm<br>2 mm x 300 mm<br>3 mm x 177 mm<br>3 mm x 200mm<br>3 mm x 400 mm<br>5 mm x 241 mm |
| Max Weight | The total weight of the container system (e.g. container,<br>tray and instrument load) must not exceed 25 lbs. | Y | 17 lbs. |
| Classification<br>Monograph | | Y | |
| Regulation<br>Name | Sterilization Wrap | Y | Sterilization Wrap |
| Class | 2 | Y | 2 |
| Class Code | KCT | Y | KCT |
| Predicate 510K | Summit K133015 | N/A | Not Indicated in 510k Statement |
| Description | SteriZign Signatur Device Protection System are<br>cassettes/ trays used to enclose and hold surgical<br>instruments and accessories in an organized manner<br>during the sterilization process and subsequent<br>storage and transportation. The cassettes / trays by<br>themselves do not maintain sterility | Y | Instru-Safe Instrument Protection System cassettes include<br>- perforated base<br>- perforated cover<br>- silicone inserts (hold-it / hold down)<br>- handles<br>-latches<br>- feet<br>- posts (optional)<br>- divider (optional)<br>- Shelf (optional) |
| Material<br>Composition | Base: Aluminum Anodized<br>Insert: Aluminum Anodized<br>Lid: Aluminum Anodized<br>Latch: 300 Series SS Passivated<br>Handle: 300 Series SS Passivated<br>Shelf Bracket: 300 Series SS Passivated<br>Mat(s): Silicone<br>Brackets: Polypropylene | Y | Anodized Aluminum lid and base<br>silicone brackets<br>Stainless Steel latch<br>Stainless Steel handles<br>Anodized aluminum bar holders<br>Polypropylene feet<br>Silicone dividers<br>Silicone mats<br>Stainless steel brackets<br>Locating post - High performance plastic (Radel or<br>Delrin)<br>Accessory box- High performance plastic Delrin or<br>Radel |
| Sterilization<br>parameters | Sterilant (steam) penetration through perforations in tray<br>PreVacuum, 132 degrees C/270 Degrees F, 4 minute cycle<br>with 30 dry time | Y | From Summit Medical 510K 133015<br>"*Validated by Summit Medical for use in steam prevacuum<br>sterilizers ONLY operating at 270°F (132°C) for 4 minutes<br>exposure time. Consult container instructions to ensure that<br>contents do not exceed the sterilization containers load<br>claims." |
| Microbial<br>Barrier<br>Properties | SteriZign Signatur Device Protection System is<br>intended to be used in conjunction with a legally<br>marketed wrap. The SteriZign Signatur Device<br>Protection System are not intended on their own to<br>maintain sterility | Y | The Instru-Safe Instrument Protection System cassettes are<br>intended to be used in conjunction with a legally marketed<br>wrap. The Instru-Safe Instrument Protection System cassettes<br>are not intended on their own to<br>maintain sterility. |
| Air Permeance | Yes | N/A | Not Indicated |
| Material<br>Compatibility | Materials of construction are compatible with steam<br>sterilization. | Y | Not Indicated |
| SteriZign Precision Technologies, LLC | | | |
| Toxicological<br>Properties<br>(Biocompatibility including<br>sterilant<br>residual limits | MEM Elution Cytotoxicity (ISO 10993-5) The test samples<br>meet the USP and ISO 10993-5 requirements for this test.<br>All controls were acceptable and the test considered valid.<br>The test samples PASSED and are considered NON-<br>CYTOTOXIC under the test conditions employed. | | |
| Aeration Time | N/A | - | Not Indicated |
| Technical<br>Characteristics | The technological characteristics of the subject devices are<br>equivalent to the predicate devices. The cassettes / trays<br>are made of standard medical grade materials and do not<br>incorporate any new technological characteristics. | Y | Not Indicated |
| Sterilant<br>Penetration<br>Performance<br>Data | The purpose of this study was to verify that the<br>SteriZign Signatur Device Protection System<br>allows for sufficient sterilant penetration when<br>exposed to a pre-vacuum steam 132°C two (2)<br>minute sterilization, half cycle with no BI growth. | Y | Not Indicated |
| Drying Time | 30 minutes | Y | 30 minutes |

{7}------------------------------------------------

{8}------------------------------------------------

#### 510(k) Summary K171520 ・・・ icion 1 .

### VIII. Conclusion

The subject device is substantially equivalent to the legally marketed predicate device.