Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define a physical sterilization tray system, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is a sterilization wrap system used to enclose and protect medical devices for sterilization, not to provide therapeutic treatment itself.

Diagnostic

No
The device, "SteriZign Signatur Device Protection System," is described as cassettes/trays used to organize, transport, store, and protect surgical and other medical devices during sterilization and subsequent storage/transportation. Its function is to allow sterilization and protect instruments, not to diagnose medical conditions or analyze data from a patient.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical cassette/tray system used to enclose and hold surgical instruments, which are hardware components.

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 clearly states that the device is a "sterilization wrap (pack, sterilization wrapper, bag, or accessories)" and a "cassette/tray" used to "enclose another medical device that is to be sterilized by a health care provider." Its purpose is to facilitate sterilization and maintain sterility (in conjunction with sterilization wrap).
IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnostic, monitoring, or screening purposes.
Lack of Diagnostic Function: The description of the SteriZign Signatur Device Protection System does not involve the analysis of human specimens or provide any diagnostic information. Its function is purely related to the sterilization and handling of other medical devices.

Therefore, the SteriZign Signatur Device Protection System falls under the category of devices used in the sterilization process of other medical devices, not as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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

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.

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

KCT

Device 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.

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 provider

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)

The purpose of this study was to verify that the SteriZign Signatur Device Protection System allows for sufficient sterilant penetration when exposed to a pre-vacuum steam 132°C two (2) minute sterilization, half cycle with no BI growth.

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.

K133015

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

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
74 Orion Street
Brunswick, ME 04011
888-234-3074 |
|-----------------|-------------------------------------------------------------------------------------------------|
| II. Contact: | Sonia Lutarewych
President
(206) 510-3650 |
| Date : | January 31, 2018 |
| Device Name: | SteriZign Signatur Device Protection System |
| Common Name: | Sterilization cassette/trays |
| Classification: | Sterilization Wrap Containers, Cassettes/trays , Cassettes & Accessories.
(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 Volume
Ratio |
|---------------------|----------------------|------- | 102010-3 | 9.86"X20.46"X3.58" | 122010-3 | 10"X20"X3" | 121610-3 | 10"X16"X3" | 121410-3 | 10"X14"X3" | 120910-3 | 10"X9.3"X3" | 122010-4 | 10"X20"X4" | 121610-4 | 10"X16"X4" | 121410-4 | 10"X14"X4" | 120910-4 | 10"X9.3"X4" | 122010-5 | 10"X20"X5" | 121610-5 | 10"X16"X5" | 121410-5 | 10"X14"X5" | 120910-5 | 10"X9.3"X5" | 112410-3 | 10"X24"X3" | 112010-3 | 10"X20"X3" | 111610-3 | 10"X16"X3" | 111410-3 | 10"X14"X3" | 110910-3 | 10"X9.3"X3" | 112410-4 | 10"X24"X4" | 112010-4 | 10"X20"X4" | 111610-4 | 10"X16"X4" | 111410-4 | 10"X14"X4" | 110910-4 | 10"X9.3"X4" | 112410-5 | 10"X24"X5" | 112010-5 | 10"X20"X5" | 111610-5 | 10"X16"X5" | 111410-5 | 10"X14"X5" | 110910-5 | 10"X9.3"X5" | 202557-190 | 25"X5.75"X1.9" | 202535-190 | 25"X3.5"X1.9" | 202057-190 | 20"X5.75"X1.9" | 202035-190 | 20"X3.5"X1.9" | 201757-190 | 17.6"X5.75"X1.9" | 201757-190 | 17.6"X3.5"X1.9" | 201457-190 | 14"X5.75"X1.9" | 201435-190 | 14"X3.5""X1.9" | 201157-190 | 11"X5.75""X1.9" | 201135-190 | 11"X3.5""X1.9" | 301610-630 | 16"X10"X6.3" | | | | 302210-630 | 22.6"X10"X6.3" | 302610-630 | 26"X10"X6.3" | 401510-166 | 15.61"X10.44"X1.66" | 401006-166 | 10.61"X6.44"X1.66" | 400606-166 | 6.61"X6.44"X1.66" | 400603-166 | 6.61"X3.44"X1.66" | ACCESSORIES | Inner Trays | | 902309-250 | 23.24"X9.4"2.5" | 902309-200 | 23.24"X9.4"2.0" | 902309-125 | 23.24"X9.4"1.25" | 901909-250 | 19.24"X9.4"2.5" | 901909-200 | 19.24"X9.4"2.0" | 901909-125 | 19.24"X9.4"1.25" | 901509-250 | 15.24"X9.4"2.5" | 901509-200 | 15.24"X9.4"2.0" | 901509-125 | 15.24"X9.4"1.25" | 901309-250 | 13.24"X9.4"2.5" | 901309-200 | 13.24"X9.4"2.0" | 901309-125 | 13.24"X9.4"1.25" | 900809-250 | 8.54"X9.4"2.5" | 900909-200 | 8.54"X9.4"2.0" | 900909-125 | 8.54"X9.4"1.25" | 912309-250 | 23.24"X9.4"2.5" | 912309-200 | 23.24"X9.4"2.0" | 912309-125 | 23.24"X9.4"1.25" | 911909-250 | 19.24"X9.4"2.5" | 911909-200 | 19.24"X9.4"2.0" | 911909-125 | 19.24"X9.4"1.25" | 911509-250 | 15.24"X9.4"2.5" | 911509-200 | 15.24"X9.4"2.0" | 911509-125 | 15.24"X9.4"1.25" | 911309-250 | 13.24"X9.4"2.5" | 911309-200 | 13.24"X9.4"2.0" | 911309-125 | 13.24"X9.4"1.25" | 910909-250 | 8.54"X9.4"2.5" | 910909-200 | 8.54"X9.4"2.0" | 910909-125 | 8.54"X9.4"1.25" | Vent to
---------------------|
| 0.075 |
| 0.231 |
| 0.225 |
| 0.232 |
| 0.228 |
| 0.197 |
| 0.195 |
| 0.203 |
| 0.184 |
| 0.173 |
| 0.172 |
| 0.172 |
| 0.165 |
| 0.158 |
| 0.152 |
| 0.152 |
| 0.146 |
| 0.139 |
| 0.128 |
| 0.123 |
| 0.124 |
| 0.121 |
| 0.117 |
| 0.11 |
| 0.107 |
| 0.105 |
| 0.105 |
| 0.103 |
| 0.522 |
| 0.561 |
| 0.514 |
| 0.563 |
| 0.508 |
| 0.543 |
| 0.504 |
| 0.548 |
| 0.491 |
| 0.543 |
| 0.156 |
|
| 0.131 |
| 0.132 |
| 0.428 |
| 0.413 |
| 0.423 |
| 0.345 |
|
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |
| NA |

5

6

Comparative Chart VII

| Company | SteriZign | Substantially
Equivalent
(Y/N) | Summit Medical Instru-Safe |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | SteriZign Signatur Device Protection
System | Y | Instru-Safe® Instrument Protection System |
| FDA 510K # | K171520 | - | K133015 |
| 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 | Y | Instru -Safe Instrument Protection System cassettes are used
to organize and protect other medical devices that are
sterilized by a healthcare provider. Instru -Safe Instrument
Protection System cassettes are intend to allow sterilization
of the enclosed medical devices during a pre-vacuum steam
sterilization cycles. Instru -Safe Instrument Protection System
cassettes are intended to be used in conjunction with legally
marketed wrap or Aesculap rigid container. Instru -Safe
Instrument Protection System cassettes are not intended on
their own to maintain sterility.

Autoclave Sterilization Parameter Cycle: Pre-Vacuum
Temperature: 270 degrees F (132 degrees C)
Exposure Time: 4 minutes Minimum Dry Time: 30 minutes |
| Lumen Claims | Lumen Inner Diameter (ID) x Length
1 mm 76 mm
1 mm 400 mm
2 mm 300 mm
3 mm 400 mm
5 mm 400 mm | Y | Lumen Inner Diameter (ID) x Length
1 mm x 76 mm
1mm x 65mm
1 mm x 400 mm
2 mm x 300 mm
3 mm x 177 mm
3 mm x 200mm
3 mm x 400 mm
5 mm x 241 mm |
| Max Weight | The total weight of the container system (e.g. container,
tray and instrument load) must not exceed 25 lbs. | Y | 17 lbs. |
| Classification
Monograph | | Y | |
| Regulation
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
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 | Y | Instru-Safe Instrument Protection System cassettes include

perforated base
perforated cover
silicone inserts (hold-it / hold down)
handles
-latches
feet
posts (optional)
divider (optional)
Shelf (optional) |
| Material
Composition | Base: Aluminum Anodized
Insert: Aluminum Anodized
Lid: Aluminum Anodized
Latch: 300 Series SS Passivated
Handle: 300 Series SS Passivated
Shelf Bracket: 300 Series SS Passivated
Mat(s): Silicone
Brackets: Polypropylene | Y | Anodized Aluminum lid and base
silicone brackets
Stainless Steel latch
Stainless Steel handles
Anodized aluminum bar holders
Polypropylene feet
Silicone dividers
Silicone mats
Stainless steel brackets
Locating post - High performance plastic (Radel or
Delrin)
Accessory box- High performance plastic Delrin or
Radel |
| Sterilization
parameters | Sterilant (steam) penetration through perforations in tray
PreVacuum, 132 degrees C/270 Degrees F, 4 minute cycle
with 30 dry time | Y | From Summit Medical 510K 133015
"*Validated by Summit Medical for use in steam prevacuum
sterilizers ONLY operating at 270°F (132°C) for 4 minutes
exposure time. Consult container instructions to ensure that
contents do not exceed the sterilization containers load
claims." |
| Microbial
Barrier
Properties | SteriZign Signatur Device Protection System is
intended to be used in conjunction with a legally
marketed wrap. The SteriZign Signatur Device
Protection System are not intended on their own to
maintain sterility | Y | The Instru-Safe Instrument Protection System cassettes are
intended to be used in conjunction with a legally marketed
wrap. The Instru-Safe Instrument Protection System cassettes
are not intended on their own to
maintain sterility. |
| Air Permeance | Yes | N/A | Not Indicated |
| Material
Compatibility | Materials of construction are compatible with steam
sterilization. | Y | Not Indicated |
| SteriZign Precision Technologies, LLC | | | |
| Toxicological
Properties
(Biocompatibility including
sterilant
residual limits | MEM Elution Cytotoxicity (ISO 10993-5) The test samples
meet the USP and ISO 10993-5 requirements for this test.
All controls were acceptable and the test considered valid.
The test samples PASSED and are considered NON-
CYTOTOXIC under the test conditions employed. | | |
| Aeration Time | N/A | - | Not Indicated |
| Technical
Characteristics | The technological characteristics of the subject devices are
equivalent to the predicate devices. The cassettes / trays
are made of standard medical grade materials and do not
incorporate any new technological characteristics. | Y | Not Indicated |
| Sterilant
Penetration
Performance
Data | The purpose of this study was to verify that the
SteriZign Signatur Device Protection System
allows for sufficient sterilant penetration when
exposed to a pre-vacuum steam 132°C two (2)
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.