The Sterilucent Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days.

Reusable baskets and accessory items (clips, posts, pins, dividers, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container.

Consumable accessory items (filter media, data card and tamper evident arrows) provide a range of functions and are indicated as single-use devices. Filter media allows ingress of sterilant while providing a microbial barrier. Data cards are used to record information regarding a specific sterilization process load. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilization process.

Device Description

The Sterilucent Sterilization Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of those devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.

The container system houses reusable baskets of varying depths and organizing accessory items that are used to organize and secure surgical instrumentation and/or other medical devices.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the Sterilucent Sterilization Container System (K142109) through non-clinical studies.

Here's the breakdown of the information you requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Sterilization Performance (Sterilization Container System):

Demonstrate a 12 log reduction in microbial load.
Achieve a Sterility Assurance Level (SAL) of 10^-6.
Demonstrate sterility maintenance for a period of up to 180 days.
Maintain appropriate microbial barrier properties following exposure to hydrogen peroxide sterilization processes under worst-case conditions.

Reported Device Performance:

Sterilization efficacy testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10^-6.
Real-time event-related shelf-life studies demonstrated sterility maintenance for a 180-day time period.
Whole package microbial challenge testing demonstrated appropriate microbial barrier properties following exposure to the Sterilucent hydrogen peroxide sterilization processes under worst-case conditions.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" in terms of number of devices or iterations for the efficacy and sterility maintenance tests. It refers to "studies" and "testing" without quantifying the number of units tested.

Sample size for test set: Not explicitly stated (e.g., "three containers were tested" or "n=X runs"). The document refers to "studies" and "testing."
Data provenance: Prospective non-clinical studies. The country of origin of the data is not specified, but the device is submitted for FDA clearance in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. Non-clinical studies for sterilization effectiveness typically rely on laboratory assays and established microbiological standards, rather than expert human interpretation of results in the way, for example, a radiology AI model would.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical (laboratory-based microbiological and physical testing), not involving human readers or interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, not for sterilization container systems.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical sterilization container system, not an algorithm or AI model. The performance described is that of the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the non-clinical studies was established using microbiological assays, specifically:

Biological indicator (BI) overkill method: For sterilization efficacy (demonstrating a 12 log reduction and SAL of 10^-6).
Microbial challenge testing: For evaluating microbial barrier properties, using a specified quantity of Bacillus atrophaeus colony forming units (CFU).
Real-time event-related shelf-life studies: To determine sterility maintenance over time.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (a sterilization container system), not a software or AI model that requires a training set. The studies described are validation and performance tests, not training data for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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

January 20, 2015

Sterilucent, Inc. Peter Kalkbrenner Director of Engineering 1400 Marshall Street NE Minneapolis, MN 55413

Re: K142109

Trade/Device Name: Sterilucent Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Container Regulatory Class: II Product Code: KCT Dated: December 19, 2014 Received: December 22, 2014

Dear Mr. Kalkbrenner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142109

Device Name Sterilucent Sterilization Container System

Indications for Use (Describe)

(Continued on separate page.)

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Indications for Use Continuation page (Form FDA 3881 (1/14)

Container	Basket	Contents/Configuration	Sterilization Cycle
Catalog #	Catalog #		LumenCycle	Non-LumenCycle
SL065	SL011	Baskets	YES	YES
SL066	SL012
SL067	SL013
SL068	SL014	Stacking Baskets	YES	YES
SL069	SL015	Lumen: 1mm (ID) or larger x 60mm (L) orshorter	YESQty. 10	NO
SL070	SL016
SL071	SL017
SL072	SL018
SL073	SL019	Lumen: 2mm (ID) or larger x 250mm (L) orshorter	YESQty. 10	NO
SL074	SL020
SL075	SL021
SL076	SL022
SL076	SL023	Lumen: 3mm (ID) or larger x 350mm (L) orshorter	YESQty. 10	NO
SL076	SL023
SL077	SL024	Occluded/Mated Challenge	YES	YES
SL078	SL025
SL098	SL026
SL098	SL027	Silicone Support Bars	YES	YES
SL098	SL028	Dividers	YES	YES
SL098	SL029
SL098	SL030
SL098	SL031	Brackets	YES	YES
SL098	SL032
SL098	SL033
SL098	SL034	Silicone Mat	YES	YES
SL098	SL035
SL098	SL036
SL098	SL037	Filter	SL082SL083SL084	SL082SL083SL084
SL098	SL038
SL098	SL039
SL098	SL040	Data Card	SL081	SL081
SL098	SL041
SL098	SL042
SL098	SL043	Tamper-Evident Arrow	SL085	SL085
SL098	SL044
SL098	SL045
SL098	SL046	Stack Height	NO STACKING	NO STACKING
SL098	SL047
SL098	SL048
SL098	SL049	Max. Total Container System Weight	10 lbs(4.5 kg)	25 lbs(11.3 kg)
SL098	SL050

Container and Accessory Device Challenges

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CatalogCode	Container Description	External Dimensions	Total Container Plus LoadWeight
			Lumen Cycle¹	Non-Lumen²
SL065	Mini	10.2" x 7.2" x 3.2"	5 lbs(2.3 kg)	5 lbs(2.3 kg)
SL066	Quarter Length	9.5" x 12.4" x 3.8"	8 lbs(3.3 kg)	8 lbs(3.3 kg)
SL067	Half Length, 4" Deep	11.8" x 12.4" x 4.5"	10 lbs(4.5 kg)	12 lbs³(5.4 kg)
SL068	Half Length, 5" Deep	11.8" x 12.4" x 5.3"	10 lbs(4.5 kg)	12 lbs³(5.4 kg)
SL069	Half Length, 6" Deep	11.8" x 12.4" x 6.1"	10 lbs(4.5 kg)	12 lbs³(5.4 kg)
SL070	Mid Length, 4" Deep	19.2" x 12.4" x 4.5"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL071	Mid Length, 5" Deep	19.2" x 12.4" x 5.3"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL098	Mid Length, 6" Deep	19.2" x 12.4" x 6.1"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL072	Mid Length, 8" Deep	19.2" x 12.4" x 7.8"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL073	Full Length, 4" Deep	23.1" x 12.4" x 4.5"	10 lbs(4.5 kg)	25 lbs(11.3kg)
SL074	Full Length, 5" Deep	23.1" x 12.4" x 5.3"	10 lbs(4.5 kg)	25 lbs(11.3 kg)
SL075	Full Length, 6" Deep	23.1" x 12.4" x 6.1"	10 lbs(4.5 kg)	25 lbs(11.3kg)
SL076	Full Length, 7" Deep	23.1" x 12.4" x 7.0"	10 lbs(4.5 kg)	25 lbs(11.3kg)
SL077	Small Narrow, 3" Deep	20.8" x 7.3" x 3.9"	10 lbs(4.5 kg)	10 lbs(4.5 kg)
SL078	Small Narrow, 5" Deep	20.8" x 7.3" x 5.2"	10 lbs(4.5 kg)	10 lbs(4.5 kg)

Maximum Container Loads

1 The Lumen Cycle validation testing was conducted using a maximum of ten (10) lumens per load. The validation studies were performed using the following device models and weights:

Model	SL065	SL066	SL069	SL072	SL076	SL078
Validation Load Weight (lbs.)	5.1	8.0	10.3	14.0	17.1	10.1

2 The Non-Lumen Cycle validation studies were performed using the following device models and weights:

	Model	SL065	SL066	SL069	SL072	SL076	SL078
Validation Load Weight (lbs.)	5.0	8.0	12.1	20.1	25.1	10.1

3 Two (2) containers, each containing 12 lbs. (5.4 kg), for a total chamber load weight of 24 lbs. (10.8 kg), has also been validated for use in the PSD-85 Non-Lumen Cycle.

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Image /page/6/Picture/0 description: The image shows the logo for Sterilucent. The logo consists of a blue abstract symbol to the left of the word "sterilucent" in blue, sans-serif font. Below the word "sterilucent" is the phrase "scientific sterilization solutions" in a smaller, blue, sans-serif font. The background of the image is light blue.

510(k) Summary for the Sterilucent Sterilization Container System K142109

Owner:
Address:

Telephone:

Sterilucent, Inc. 1400 Marshall Street NE Minneapolis, MN 55413 612-767-3260 612-767-3261

Contact:

Fax:

Peter R. Kalkbrenner Director of Engineering

612-767-3253

612-767-3261

Telephone: Fax:

Summary Date: 16 January 2015

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1. Device Name and Classification

Trade Name:	Sterilucent Sterilization Container System
Common/Usual Name:	Sterilization Container
Classification Name:	Sterilization Wrap, Containers, Trays, Cassettes & OtherAccessories
Product Code:	KCT (21 CFR 880.6850)
Class:	II

2. Predicate Device

Genesis™ Reusable Rigid Container System (K112535)

3. Device Description

The container system houses reusable baskets of varying depths and organizing accessory items that are used to organize and secure surgical instrumentation and/or other medical devices.

4. Statement of Intended Use:

The Sterilucent Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days.

Reusable baskets and accessory items (clips, posts, pins, dividers, brackets, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container.

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visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilucent VHP sterilization process.

Container	Basket		Sterilization Cycle
Catalog #	Catalog #	Contents/Configuration	Lumen	Non-Lumen
			Cycle	Cycle
ട് സ്കാരംSLOE6	SL011SL012	Baskets	YES	YES
SL067SL068	SL013SL014	Stacking Baskets	YES	YES
SLO69SL070SL071	SL015SL016SL017	Lumen: 1mm (ID) or larger x 60mm (L) orshorter	YESQty. 10	NO
SL072SL073	SL018SL019SL020	Lumen: 2mm (ID) or larger x 250mm (L) orshorter	YESQty. 10	NO
SL074SL075SL076	SL021SL022SL023	Lumen: 3mm (ID) or larger x 350mm (L) orshorter	YESQty. 10	NO
SL077SL078	SL024SL025	Occluded/Mated Challenge	YES	YES
SL098	SL026SL027	Silicone Support Bars	YES	YES
	SL028SL029	Dividers	YES	YES
	SL030SL031	Brackets	YES	YES
	SL032SL033	Silicone Mat	YES	YES
	SL034SL035SL036SL037	Filter	SL082SL083SL084	SL082SL083SL084
	SL038SL039	Data Card	SL081	SL081
	SL040SL041SL042SL043SL044SL045SL046SL047SL048SL049SL050	Tamper-Evident Arrow	ട് സ്റ്റാറ്റ് ട്രോഗ്യമായി സ്റ്റാമിക്കുന്നു. അവലംബം കോട്ടിക്കുന്നു വിവ്യാവിക്കുന്നു. അവലംബം കേരള	ട് സ്റ്റാറ്റ് ട്രോഗ്യമായി സ്റ്റാമിക്കുന്നു. അവലംബം കോട്ടിക്കുന്നു കേരള
		Stack Height	NO STACKING	NO STACKING
		Max. Total Container System Weight	10 lbs(4.5 kg)	25 lbs(11.3 kg)

Container and Accessory Device Challenges

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CatalogCode	Container Description	External Dimensions	Total Container Plus LoadWeight
			Lumen Cycle¹	Non-Lumen²
SL065	Mini	10.2" x 7.2" x 3.2"	5 lbs(2.3 kg)	5 lbs(2.3 kg)
SL066	Quarter Length	9.5" x 12.4" x 3.8"	8 lbs(3.3 kg)	8 lbs(3.3 kg)
SL067	Half Length, 4" Deep	11.8" x 12.4" x 4.5"	10 lbs(4.5 kg)	12 lbs³(5.4 kg)
SL068	Half Length, 5" Deep	11.8" x 12.4" x 5.3"	10 lbs(4.5 kg)	12 lbs³(5.4 kg)
SL069	Half Length, 6" Deep	11.8" x 12.4" x 6.1"	10 lbs(4.5 kg)	12 lbs³(5.4 kg)
SL070	Mid Length, 4" Deep	19.2" x 12.4" x 4.5"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL071	Mid Length, 5" Deep	19.2" x 12.4" x 5.3"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL098	Mid Length, 6" Deep	19.2" x 12.4" x 6.1"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL072	Mid Length, 8" Deep	19.2" x 12.4" x 7.8"	10 lbs(4.5 kg)	20 lbs(9.1 kg)
SL073	Full Length, 4" Deep	23.1" x 12.4" x 4.5"	10 lbs(4.5 kg)	25 lbs(11.3 kg)
SL074	Full Length, 5" Deep	23.1" x 12.4" x 5.3"	10 lbs(4.5 kg)	25 lbs(11.3 kg)
SL075	Full Length, 6" Deep	23.1" x 12.4" x 6.1"	10 lbs(4.5 kg)	25 lbs(11.3 kg)
SL076	Full Length, 7" Deep	23.1" x 12.4" x 7.0"	10 lbs(4.5 kg)	25 lbs(11.3 kg)
SL077	Small Narrow, 3" Deep	20.8" x 7.3" x 3.9"	10 lbs(4.5 kg)	10 lbs(4.5 kg)
SL078	Small Narrow, 5" Deep	20.8" x 7.3" x 5.2"	10 lbs(4.5 kg)	10 lbs(4.5 kg)

Maximum Container Loads

1 The Lumen Cycle validation testing was conducted using a maximum of ten (10) lumens per load. The validation studies were performed using the following device models and weights:

Model	SL065	SL066	SL069	SL072	SL076	SL078
Validation Load Weight (lbs.)	5.1	8.0	10.3	14.0	17.1	10.1

2 The Non-Lumen Cycle validation studies were performed using the following device models and weights:

Model	SL065	SL066	SL069	SL072	SL076	SL078
Validation Load Weight (lbs.)	5.0	8.0	12.1	20.1	25.1	10.1

3 Two (2) containers, each containing 12 lbs. (5.4 kg), for a total chamber load weight of 24 lbs. (10.8 kg), has also been validated for use in the PSD-85 Non-Lumen Cycle.

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5. Technological Characteristics Summary Comparison

The Sterilucent Sterilization Container System has similar technological characteristics as the predicate device:

Summary of Technological Characteristics of the Device Compared to the
Predicate Device
Characteristic	New DeviceSterilucent SterilizationContainer SystemK142109	Predicate DeviceGenesis™ Reusable RigidContainer SystemK112535
Container	5000 and 1100 Series AnodizedAluminum;300 Series Stainless Steel	Same
Container Gasket	Closed Cell Silicone Foam	Same
Reusable Baskets	304 Electropolished Stainless Steel	Same
Clips, Posts, Pins	300 and 400 Series Stainless Steel	Same
Dividers, Brackets	5000 Series Aluminum	Same
Bars, Mats	Silicone Elastomer	Same
Filter Material	SMS Polypropylene	Same
Data Card	High-Density Polyethylene (Tyvek®)	Same
Tamper Evident Arrow	Polypropylene	Same
Arrow Process Indicator	Synthetic Substrate printed with ReactiveInk	Same
Sterilization Modality	Vaporized Hydrogen Peroxide (VHP)	Same (some models alsoapproved for steam andETO)
Indications for Use	The Sterilucent Sterilization ContainerSystem is a device intended to be used toenclose another medical device that is tobe sterilized by a healthcare provider. Itis intended to allow sterilization of theenclosed medical device and also tomaintain sterility of the enclosed deviceuntil used. The container system isintended to be used in the SterilucentPSD-85 Hydrogen Peroxide SterilizerLumen and Non-Lumen Cycles.Reusable baskets and accessory items(clips, posts, pins, dividers, brackets, barsand mats) are intended to organize andsecure enclosed medical devices duringsterilization, transport, and storage of thecontainer.	The Genesis ReusableRigid SterilizationContainer System is adevice intended to be usedto enclose another medicaldevice that is to besterilized by a healthcareprovider. It allowssterilization of theenclosed medical deviceand maintains sterility ofthe enclosed device untilused for a maximum of180 days.Containers are suitable fordynamic air removal (pre-vacuum) steam

Consumable accessory items (e.g. filtermedia, data card and tamper evidentarrows) provide a range of functions andare indicated as single-use devices. Filtermedia allows ingress and egress ofsterilant while providing a microbialbarrier. Data cards are used to recordinformation regarding a specificsterilization process load. Tamper evidentarrows provide a visual indication thatthe container system has not beeninadvertently opened prior to use. Eacharrow contains an external processindicator that serves as a visual indicationthat the system has been exposed to theSterilucent VHP sterilization process.	use pre-vacuum steamsterilization and 100%ethylene oxide sterilizationwhen used as described inthe instructions for use.Reusable baskets andaccessory items (pins,dividers, mats, etc) areintended to organize andsecure enclosed medicaldevices duringsterilization, transport, andstorage of the container.Data cards are used torecord informationregarding a specificsterilization process load.Filter media allows ingressand egress of sterilantwhile providing amicrobial barrier. Tamperevident arrows provide avisual indication that thecontainer system has notbeen inadvertently openedprior to use. Each arrowcontains a modality-specific external processindicator that serves as a
	visual indication that thesystem has been exposedto a specific sterilizationparameter. Data cards,filters and tamper evident
	arrows are single use only.

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6. Summary of Non-Clinical Performance Data

Sterilization performance studies were conducted for the Sterilization Container System and all acceptance criteria were met. Sterilization efficacy testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10 ° using the biological indicator (BI) overkill method and half-cycle validation under worst case conditions. Real time event related shelf life studies demonstrated sterility maintenance for a 180 day time period. Whole

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package microbial challenge testing, exposing a container to a minimum of 1 x 106 Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge, demonstrated appropriate microbial barrier properties following exposure to the Sterilucent hydrogen peroxide sterilization processes under worst case conditions.

7. Summary of Clinical Performance Data

N/A - No clinical tests were conducted for this submission.

8. Overall Performance Conclusion Statement

The non-clinical studies demonstrated that the Sterilization Container System is as safe, as effective, and performs as well as the predicate device for the sterilization of the enclosed medical devices and maintains sterility of those devices for a period of up to 180 days. The proposed device and the predicate device are composed of the same designs, materials, and manufacturing characteristics. The proposed device is substantially equivalent to the predicate device.

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).