STERILUCENT STERILIZATION CONTAINER SYSTEM

K142109 · Sterilucent, Inc. · KCT · Jan 20, 2015 · General Hospital

Device Facts

• Record ID: K142109
• Device Name: STERILUCENT STERILIZATION CONTAINER SYSTEM
• Applicant: Sterilucent, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jan 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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. 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 and egress 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 Sterilucent VHP sterilization process.

Device Story

Rigid, reusable, stackable container system; houses surgical instrumentation in baskets during sterilization, transport, and storage. Input: medical devices placed inside container; container processed in Sterilucent PSD-85 Hydrogen Peroxide Sterilizer. Transformation: container design allows sterilant ingress/egress via filter media while maintaining microbial barrier; tamper-evident arrows and process indicators provide visual confirmation of sterilization exposure. Output: sterilized, protected medical devices. Used in clinical settings by healthcare staff. Benefits: ensures sterility maintenance of instruments for up to 180 days post-processing; provides organized, secure transport and storage.

Clinical Evidence

No clinical data. Bench testing only: 12-log reduction and SAL of 10^-6 achieved via BI overkill method; 180-day shelf-life validation; aerosol microbial challenge (1x10^6 CFU Bacillus atrophaeus) confirmed barrier integrity.

Technological Characteristics

Materials: 5000/1100 series anodized aluminum, 300/400 series stainless steel, silicone elastomer gaskets/mats, SMS polypropylene filters, HDPE data cards. Principle: Rigid container with filter-based gas exchange for VHP sterilization. Dimensions: Various sizes (Mini to Full Length). Connectivity: None. Sterilization: Vaporized Hydrogen Peroxide (VHP).

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (Lumen and Non-Lumen cycles) and to maintain sterility of the enclosed devices for up to 180 days.

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

• Genesis™ Reusable Rigid Container System (K112535)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

(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 # | | Lumen<br>Cycle | Non-Lumen<br>Cycle |
| 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) or<br>shorter | YES<br>Qty. 10 | NO |
| SL070 | SL016 | | | |
| SL071 | SL017 | | | |
| SL072 | SL018 | | | |
| SL073 | SL019 | Lumen: 2mm (ID) or larger x 250mm (L) or<br>shorter | YES<br>Qty. 10 | NO |
| SL074 | SL020 | | | |
| SL075 | SL021 | | | |
| SL076 | SL022 | | | |
| SL076 | SL023 | Lumen: 3mm (ID) or larger x 350mm (L) or<br>shorter | YES<br>Qty. 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 | SL082<br>SL083<br>SL084 | SL082<br>SL083<br>SL084 |
| 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<br>(4.5 kg) | 25 lbs<br>(11.3 kg) |
| SL098 | SL050 | | | |

## Container and Accessory Device Challenges

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| Catalog<br>Code | Container Description | External Dimensions | Total Container Plus Load<br>Weight | |
|-----------------|-----------------------|----------------------|-------------------------------------|---------------------|
| | | | Lumen Cycle¹ | Non-Lumen² |
| SL065 | Mini | 10.2" x 7.2" x 3.2" | 5 lbs<br>(2.3 kg) | 5 lbs<br>(2.3 kg) |
| SL066 | Quarter Length | 9.5" x 12.4" x 3.8" | 8 lbs<br>(3.3 kg) | 8 lbs<br>(3.3 kg) |
| SL067 | Half Length, 4" Deep | 11.8" x 12.4" x 4.5" | 10 lbs<br>(4.5 kg) | 12 lbs³<br>(5.4 kg) |
| SL068 | Half Length, 5" Deep | 11.8" x 12.4" x 5.3" | 10 lbs<br>(4.5 kg) | 12 lbs³<br>(5.4 kg) |
| SL069 | Half Length, 6" Deep | 11.8" x 12.4" x 6.1" | 10 lbs<br>(4.5 kg) | 12 lbs³<br>(5.4 kg) |
| SL070 | Mid Length, 4" Deep | 19.2" x 12.4" x 4.5" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL071 | Mid Length, 5" Deep | 19.2" x 12.4" x 5.3" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL098 | Mid Length, 6" Deep | 19.2" x 12.4" x 6.1" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL072 | Mid Length, 8" Deep | 19.2" x 12.4" x 7.8" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL073 | Full Length, 4" Deep | 23.1" x 12.4" x 4.5" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3kg) |
| SL074 | Full Length, 5" Deep | 23.1" x 12.4" x 5.3" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3 kg) |
| SL075 | Full Length, 6" Deep | 23.1" x 12.4" x 6.1" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3kg) |
| SL076 | Full Length, 7" Deep | 23.1" x 12.4" x 7.0" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3kg) |
| SL077 | Small Narrow, 3" Deep | 20.8" x 7.3" x 3.9" | 10 lbs<br>(4.5 kg) | 10 lbs<br>(4.5 kg) |
| SL078 | Small Narrow, 5" Deep | 20.8" x 7.3" x 5.2" | 10 lbs<br>(4.5 kg) | 10 lbs<br>(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 & Other<br>Accessories |
| Product Code: | KCT (21 CFR 880.6850) |
| Class: | II |

## 2. Predicate Device

Genesis™ Reusable Rigid Container System (K112535)

## 3. 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.

## 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.

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 and egress 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

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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 സ്കാരം<br>SLOE6 | SL011<br>SL012 | Baskets | YES | YES | |
| SL067<br>SL068 | SL013<br>SL014 | Stacking Baskets | YES | YES | |
| SLO69<br>SL070<br>SL071 | SL015<br>SL016<br>SL017 | Lumen: 1mm (ID) or larger x 60mm (L) or<br>shorter | YES<br>Qty. 10 | NO | |
| SL072<br>SL073 | SL018<br>SL019<br>SL020 | Lumen: 2mm (ID) or larger x 250mm (L) or<br>shorter | YES<br>Qty. 10 | NO | |
| SL074<br>SL075<br>SL076 | SL021<br>SL022<br>SL023 | Lumen: 3mm (ID) or larger x 350mm (L) or<br>shorter | YES<br>Qty. 10 | NO | |
| SL077<br>SL078 | SL024<br>SL025 | Occluded/Mated Challenge | YES | YES | |
| SL098 | SL026<br>SL027 | Silicone Support Bars | YES | YES | |
| | SL028<br>SL029 | Dividers | YES | YES | |
| | SL030<br>SL031 | Brackets | YES | YES | |
| | SL032<br>SL033 | Silicone Mat | YES | YES | |
| | SL034<br>SL035<br>SL036<br>SL037 | Filter | SL082<br>SL083<br>SL084 | SL082<br>SL083<br>SL084 | |
| | SL038<br>SL039 | Data Card | SL081 | SL081 | |
| | SL040<br>SL041<br>SL042<br>SL043<br>SL044<br>SL045<br>SL046<br>SL047<br>SL048<br>SL049<br>SL050 | 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<br>(4.5 kg) | 25 lbs<br>(11.3 kg) | |

# Container and Accessory Device Challenges

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| Catalog<br>Code | Container Description | External Dimensions | Total Container Plus Load<br>Weight | |
|-----------------|-----------------------|----------------------|-------------------------------------|---------------------|
| | | | Lumen Cycle¹ | Non-Lumen² |
| SL065 | Mini | 10.2" x 7.2" x 3.2" | 5 lbs<br>(2.3 kg) | 5 lbs<br>(2.3 kg) |
| SL066 | Quarter Length | 9.5" x 12.4" x 3.8" | 8 lbs<br>(3.3 kg) | 8 lbs<br>(3.3 kg) |
| SL067 | Half Length, 4" Deep | 11.8" x 12.4" x 4.5" | 10 lbs<br>(4.5 kg) | 12 lbs³<br>(5.4 kg) |
| SL068 | Half Length, 5" Deep | 11.8" x 12.4" x 5.3" | 10 lbs<br>(4.5 kg) | 12 lbs³<br>(5.4 kg) |
| SL069 | Half Length, 6" Deep | 11.8" x 12.4" x 6.1" | 10 lbs<br>(4.5 kg) | 12 lbs³<br>(5.4 kg) |
| SL070 | Mid Length, 4" Deep | 19.2" x 12.4" x 4.5" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL071 | Mid Length, 5" Deep | 19.2" x 12.4" x 5.3" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL098 | Mid Length, 6" Deep | 19.2" x 12.4" x 6.1" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL072 | Mid Length, 8" Deep | 19.2" x 12.4" x 7.8" | 10 lbs<br>(4.5 kg) | 20 lbs<br>(9.1 kg) |
| SL073 | Full Length, 4" Deep | 23.1" x 12.4" x 4.5" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3 kg) |
| SL074 | Full Length, 5" Deep | 23.1" x 12.4" x 5.3" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3 kg) |
| SL075 | Full Length, 6" Deep | 23.1" x 12.4" x 6.1" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3 kg) |
| SL076 | Full Length, 7" Deep | 23.1" x 12.4" x 7.0" | 10 lbs<br>(4.5 kg) | 25 lbs<br>(11.3 kg) |
| SL077 | Small Narrow, 3" Deep | 20.8" x 7.3" x 3.9" | 10 lbs<br>(4.5 kg) | 10 lbs<br>(4.5 kg) |
| SL078 | Small Narrow, 5" Deep | 20.8" x 7.3" x 5.2" | 10 lbs<br>(4.5 kg) | 10 lbs<br>(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 Device<br>Sterilucent Sterilization<br>Container System<br>K142109 | Predicate Device<br>Genesis™ Reusable Rigid<br>Container System<br>K112535 |
| Container | 5000 and 1100 Series Anodized<br>Aluminum;<br>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 Reactive<br>Ink | Same |
| Sterilization Modality | Vaporized Hydrogen Peroxide (VHP) | Same (some models also<br>approved for steam and<br>ETO) |
| Indications for Use | The Sterilucent Sterilization Container<br>System is a device intended to be used to<br>enclose another medical device that is to<br>be sterilized by a healthcare provider. It<br>is intended to allow sterilization of the<br>enclosed medical device and also to<br>maintain sterility of the enclosed device<br>until used. The container system is<br>intended to be used in the Sterilucent<br>PSD-85 Hydrogen Peroxide Sterilizer<br>Lumen and Non-Lumen Cycles.<br>Reusable baskets and accessory items<br>(clips, posts, pins, dividers, brackets, bars<br>and mats) are intended to organize and<br>secure enclosed medical devices during<br>sterilization, transport, and storage of the<br>container. | The Genesis Reusable<br>Rigid Sterilization<br>Container System is a<br>device intended to be used<br>to enclose another medical<br>device that is to be<br>sterilized by a healthcare<br>provider. It allows<br>sterilization of the<br>enclosed medical device<br>and maintains sterility of<br>the enclosed device until<br>used for a maximum of<br>180 days.<br>Containers are suitable for<br>dynamic air removal (pre-<br>vacuum) steam |
| | | |
| Consumable accessory items (e.g. filter<br>media, data card and tamper evident<br>arrows) provide a range of functions and<br>are indicated as single-use devices. Filter<br>media allows ingress and egress of<br>sterilant while providing a microbial<br>barrier. Data cards are used to record<br>information regarding a specific<br>sterilization process load. Tamper evident<br>arrows provide a visual indication that<br>the container system has not been<br>inadvertently opened prior to use. Each<br>arrow contains an external process<br>indicator that serves as a visual indication<br>that the system has been exposed to the<br>Sterilucent VHP sterilization process. | use pre-vacuum steam<br>sterilization and 100%<br>ethylene oxide sterilization<br>when used as described in<br>the instructions for use.<br>Reusable baskets and<br>accessory items (pins,<br>dividers, mats, etc) are<br>intended to organize and<br>secure enclosed medical<br>devices during<br>sterilization, transport, and<br>storage of the container.<br>Data cards are used to<br>record information<br>regarding a specific<br>sterilization process load.<br>Filter media allows ingress<br>and egress of sterilant<br>while providing a<br>microbial barrier. Tamper<br>evident arrows provide a<br>visual indication that the<br>container system has not<br>been inadvertently opened<br>prior to use. Each arrow<br>contains a modality-<br>specific external process<br>indicator that serves as a | |
| | visual indication that the<br>system has been exposed<br>to a specific sterilization<br>parameter. Data cards,<br>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.