InstruSafe(R) Sterilization Container

K180528 · Summit Medical, Inc. · KCT · Nov 16, 2018 · General Hospital

Device Facts

• Record ID: K180528
• Device Name: InstruSafe(R) Sterilization Container
• Applicant: Summit Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Nov 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The InstruSafe® Sterilization Container is a reusable sterilization container system 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 device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.

Device Story

The InstruSafe® Sterilization Container is a reusable system designed to enclose surgical instruments for sterilization, storage, and transport. It consists of anodized aluminum alloy lids and bottoms, available in various sizes (full, 3/4, 1/2, and XL), used with single-use paper filters. The device is operated by healthcare personnel in clinical settings. Instruments are placed in internal trays or baskets within the container. The system is compatible with pre-vacuum steam sterilization cycles (132°C for 4 minutes, 30-minute minimum dry time). By providing a protective, filtered environment, the container ensures the sterility of the enclosed instruments for up to 180 days, facilitating safe handling and storage of surgical sets.

Clinical Evidence

Bench testing only. Testing included pre-vacuum steam sterilization efficacy and thermal profiling, dry time, maintenance of sterility (180 days), microbial aerosol challenge, biocompatibility (ISO 10993-1), mechanical cleaning, and physical integrity testing (handle, gasket, lid/base, and lock compatibility) per AAMI/ANSI standards (ST77, ST79, TIR12).

Technological Characteristics

Materials: Anodized aluminum alloy, stainless steel, silicone. Design: Perforated/solid containers with single-use paper filters. Sterilization: Pre-vacuum steam (132°C). Biocompatibility: ISO 10993-1 compliant. Standards: AAMI TIR12, ANSI/AAMI ST77, ANSI/AAMI ST79.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices, including metal surgical instruments (forceps, scissors, clamps) and lumened/cannulated instruments, for sterilization in pre-vacuum steam sterilizers and to maintain sterility for 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

• Ermis Medizintechnik Sterilization Container System (K123234)

Reference Devices

• Aesculap SterilContainer System (K112671)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 16, 2018

Summit Medical Inc. Nicole Dove Director of Quality Assurance and Regulatory Affairs 815 Northwest Parkway, Suite 100 St. Paul. Minnesota 55121

Re: K180528

Trade/Device Name: InstruSafe® Sterilization Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 16, 2018 Received: October 17, 2018

Dear Nicole Dove:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

# Clarence W. Murray lii III -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

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## Indications for Use

510(k) Number (if known) K180528

Device Name InstruSafe® Sterilization Container

#### Indications for Use (Describe)

The InstruSafe® Sterilization Container is a reusable sterilization container system 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 device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.

The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated bottoms. All models are intended to be used with single use paper filters.

The container is a reusable device designed to be used with the following sterilization cycle parameters:

Pre-Vacuum Steam Sterilization Cycle: 4 minutes 132oC (270 oF) Drying Time Minimum: 30 minutes

| Model Number | Description | Total Container Loaded<br>Maximum Weight (lbs) | Load Description |
|--------------|--------------------------------------------|------------------------------------------------|-------------------------|
| CS-3XXX | Full 1/1 Perforated Container Lid | Not applicable | Metal (Stainless Steel) |
| CS-3XXX | Full 1/1 Container Bottom | 25 lbs | surgical instruments |
| CS-2XXX | Three quarter 3/4 Perforated Container Lid | Not applicable | like forceps, scissors, |
| CS-2XXX | Three quarter 3/4 Container Bottom | 25 lbs | clamps, etc. including |
| CS-1XXX | One half 1/2 Perforated Container Lid | Not applicable | lumened /cannulated |
| CS-1XXX | One half 1/2 Container Bottom | 18 lbs | instruments. |
| CS-5XXX | XL Perforated Container Lid | Not applicable | |
| CS-5XXX | XL Container Bottom | 25 lbs | |

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)

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Image /page/3/Picture/0 description: The image shows the logo for Summit Medical, which includes three blue diamonds above the word "SUMMIT" in a stylized font, with the word "medical" in smaller letters below. Below the logo, the text "510(k) Summary" is displayed, followed by "K180528".

Following is the 510(k) summary information in accordance with 21 CFR 807.92

| Date Prepared: | October 15, 2018 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Summit Medical, Inc.<br>815 Vikings Parkway, Suite 100<br>St. Paul, MN 55121 USA |
| Official Correspondent: | Nicole Dove<br>Director of Quality Assurance & Regulatory Affairs<br>Tel: [phone] / Fax: [phone]<br>[e-mail] |
| Subject Device | |
| Trade/Device Name: | InstruSafe® Sterilization Container |
| Common or Usual Name: | Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument<br>Delivery System |
| Regulation Number: | 21 CFR 880.6850 |
| Regulation Name: | Sterilization wrap |
| Regulatory Class: | Class II |
| Product Code: | KCT |
| Indications for Use | The InstruSafe® Sterilization Container is a reusable sterilization container<br>system intended to be used to enclose another medical device that is to be<br>sterilized by a healthcare provider. It is intended to allow sterilization of the<br>enclosed device and also maintain sterility for 180 days. The InstruSafe®<br>Sterilization Container includes accessories such as trays, baskets, filters, data<br>cards and tamper proof locks.<br>The InstruSafe® Sterilization Container consists of various models within the<br>validated product line. All models are available with perforated lids and either<br>perforated or non-perforated bottoms. All models are intended to be used with<br>single use paper filter.<br>The container is a reusable device designed to be used with the following<br>sterilization cycle parameters:<br>Pre-Vacuum Steam Sterilization Cycle:<br>4 minutes<br>132°C (270 °F)<br>Drying Time Minimum: 30 minutes |

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Image /page/4/Picture/0 description: The image shows the logo for Summit Medical. The logo has the word "SUMMIT" in a large sans-serif font. Below the word "SUMMIT" is the word "medical" in a smaller sans-serif font. Above the word "SUMMIT" are three blue diamonds.

| | Model | Description | Total Container Loaded | Load Description | | |
|--------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------|--|--|
| | Number | | Maximum Weight (lbs) | | | |
| | CS-3XXX | Full 1/1 Perforated Container Lid | Not applicable | Metal (Stainless | | |
| | CS-3XXX | Full 1/1 Container Bottom | 25 lbs | Steel) surgical | | |
| | CS-2XXX | Three quarter 3/4 Perforated Container Lid | Not applicable | ir struments like | | |
| | CS-2XXX | Three quarter 3/4 Container Bottom | 25 lbs | forceps, scissors, | | |
| | CS-1XXX | One half ½ Perforated Container Lid | Not applicable | clamps, etc. | | |
| | CS-1XXX | One half ½ Container Bottom | 18 lbs | ir cluding | | |
| | CS-5XXX | XL Perforated Container Lid | Not applicable | lı mened/cannulated | | |
| | CS-5XXX | XL Container Bottom | 25 lbs | ii struments. | | |
| | | | | | | |
| | | The InstruSafe® Sterilization Container is a reusable sterilization container system intended | | | | |
| Device Description | | | | | | |
| | | to be used to enclose another medical device that is to be sterilized by a healthcare provider. | | | | |
| | | They consist of various sizes of bottoms and lids that provide an effective packaging method | | | | |
| | | for sterilization, storage and transportation of surgical instruments by healthcare providers. | | | | |
| | | These containers are suitable for use in pre-vacuum Steam Sterilizers with a tray or basket | | | | |
| | | | | | | |
| | | accessory. Metal (Stainless Steel) surgical instruments like forceps, scissors, clamps, etc. | | | | |
| | | including lumened/cannulated instruments are placed in the trays or baskets for sterilization. | | | | |
| | | Note: The maximum number of Lumens/Lumen Configuration is as follow: | | | | |
| | | 2 lumens with ≥ 1mm I.D. x ≤ 200mm and a second lumen ≥ 5mm I.D. x ≤ 400mm | | | | |
| | | | | | | |
| | | | | | | |
| | | The containers are available in different models such as full size (1/1), three-quarter size | | | | |
| | | (3/4), half size (1/2) and XL. | | | | |
| | | InstruSafe® Sterilization Container is manufactured using aluminum alloy, stainless steel, | | | | |
| | | silicone and the surfaces are protected by a layer of anodized aluminum oxide to prevent | | | | |
| | | | | | | |
| | corrosion. | | | | | |
| | The containers must only be used with single use paper filters. | | | | | |
| | | | | | | |
| | | | | | | |
| | | Maximum recommended loading: | | | | |
| | Model | Description | Standard Dimension | Total Container | | |
| | Number | | Outside w/cover | Loaded Maximum | | |
| | | | LxWxH in inches | Weight (lbs) | | |
| | CS-3001 | Full 1/1 Perforated Container Lid | 23 1/8 x 11 x 1 1/4 | Not applicable | | |
| | | | | | | |
| | CS-3002 | Full 1/1 Solid Container Bottom | 23 1/8 x 11 x 4 1/4 | 25 lbs | | |
| | CS-3003 | Full 1/1 Solid Container Bottom<br>Full 1/1 Solid Container Bottom | 23 1/8 x 11 x 6 1/4 | 25 lbs | | |
| | CS-3004 | | 23 1/8 x 11 x 8 1/4 | 25 lbs | | |
| | CS-3005 | Full 1/1 Solid Container Bottom | 23 1/8 x 11x 10 ½ | 25 lbs | | |
| | CS-3012 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11 x 4 1/4 | 25 lbs | | |
| | CS-3013 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11 x 6 1/4 | 25 lbs | | |
| | CS-3014 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11 x 8 1/4 | 25 lbs | | |
| | CS-3015 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11x 10 1/2 | 25 lbs | | |
| | CS-2001 | Three Quarter 3/4 Perforated Container Lid | 18 ¼ x 11 x 1 ¼ | Not applicable | | |
| | CS-2002 | Three Quarter 3/4 Solid Container Bottom | 18 ¼ x 11 x 4 1/4 | 25 lbs | | |
| | CS-2003 | Three Quarter ¾ Solid Container Bottom | 18 ¼ x 11 x 6 ¼ | 25 lbs | | |
| | CS-2012 | Three Quarter ¾ Perforated Container Bottom | 18 ¼ x 11 x 4 1/4 | 25 lbs | | |
| | CS-2013 | Three Quarter ¾ Perforated Container Bottom | 18 ¼ x 11 x 6 ¼ | 25 lbs | | |
| | CS-1001 | One Half 1/2 Perforated Container Lid | 11 ½ x 11 x 1 1/4 | Not applicable | | |
| | CS-1002 | One Half ½ Solid Container Bottom | 11 ½ x 11 x 4 ¼ | 18 lbs | | |
| | CS-1003 | One Half ½ Solid Container Bottom | 11 ½×11×6¼ | 18 lbs | | |
| | CS-1012 | One Half ½ Perforated Container Bottom | 11 ½ x 11 x 4 ¼ | 18 lbs | | |
| | CS-1013 | One Half ½ Perforated Container Bottom | 11 ½ x 11 x 6 ¼ | 18 lbs | | |
| | CS-5000<br>CS-5001 | Extra Large Perforated Container Lid<br>Extra Large Perforated Container Bottom | 30 7/8 x 12 3/4 x 7 1/2<br>30 7/8 x 12 3/4 x 7 1/2 | Not applicable<br>25 lbs | | |

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Image /page/5/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds. The logo is simple and modern, and the blue color gives it a professional look.

| Predicate Device | |
|--------------------------|---------------------------------------------------------------|
| Trade/Device Name/510(k) | Ermis Medizintechnik Sterilization Container System - K123234 |
| Reference Device | |
| Trade/Device Name/510(k) | Aesculap SterilContainer System – K112671 (reference) |

| Comparison of Subject<br>Device to Predicate Devices | Indications for Use | | | | |
|------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|
| | InstruSafe®<br>Sterilization<br>Container | The InstruSafe® Sterilization Container is a reusable sterilization container<br>system intended to be used to enclose another medical device that is to be<br>sterilized by a healthcare provider. It is intended to allow sterilization of the<br>enclosed device and also maintain sterility for 180 days. The InstruSafe®<br>Sterilization Container includes accessories such as trays, baskets, filters,<br>data cards and tamper proof locks.<br>The InstruSafe® Sterilization Container consists of various models within the<br>validated product line. All models are available with perforated lids and<br>either perforated or non-perforated bottoms. All models are intended to be<br>used with single use paper filter.<br><br>The container is a reusable device designed to be used with the following<br>sterilization cycle parameters:<br>Pre-Vacuum Steam Sterilization Cycle:<br>4 minutes<br>132°C (270°F)<br>Drying Time Minimum: 30 minutes | | | |
| | | Model<br>Number | Description | Total Container<br>Loaded<br>Maximum<br>Weight (lbs) | Load<br>Description |
| | | CS-3XXX | Full 1/1 Perforated Container Lid | Not applicable | Metal |
| | | CS-3XXX | Full 1/1 Container Bottom | 25 lbs | (Stainless |
| | | CS-2XXX | Three quarter ¾ Perforated Container<br>Lid | Not applicable | Steel) surgical<br>instruments |
| | | CS-2XXX | Three quarter ¾ Container Bottom | 25 lbs | like forceps, |
| | | CS-1XXX | One half ½ Perforated Container Lid | Not applicable | scissors, |
| | | CS-1XXX | One half ½ Container Bottom | 18 lbs | clamps, etc. |
| | | CS-5XXX<br>CS-5XXX | XL Perforated Container Lid<br>XL Container Bottom | Not applicable<br>25 lbs | including<br>lumened<br>/cannulated<br>instruments. |
| | Reference<br>Device<br>Aesculap<br>SterilContainer<br>System<br>K112671 | The Aesculap SterilContainer System is a reusable sterilization container<br>system intended to be used to enclose another medical device that is to be<br>sterilized by a healthcare provider. It is intended to allow sterilization of the<br>enclosed device and also maintain sterility for 360 days. The<br>SterilContainer System includes accessories such as mats, baskets, trays,<br>holders, organizers, filters, indicator cards and tamper proof locks. | | | |

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| Predicate<br>Device:<br>Ermis<br>Medizintechnik Sterilization<br>Container<br>System<br>K123234 | The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) aluminum bottom and a three-quarter size aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use paper filter (US751, US994), a single use polypropylene filter (MD344) and a reusable PTFE filter (JK090). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.<br>The ERMIS Sterilization Container System is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size,³⁄₄ Size,½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters. | | | | |
|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|------------|--|
| The containers are reusable devices designed to be used with the following sterilization cycle parameters: | | | | | |
| Pre-Vacuum cycle: | | | | | |
| 4 minutes | | | | | |
| | 132°C (270°F) | | | | |
| Drying Time minimum 20 minutes | | | | | |
| 3 minutes | | | | | |
| | 135°C (273°F) | | | | |
| Drying Time minimum 16 minutes | | | | | |
| Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles | | | | | |
| | Maximum recommended loading: | | | | |
| | Maximum Recommended Load in kg (lbs.) incl. Container weight | | | | |
| | Model | Dimension | Instruments | Textiles | |
| | 1/1 Size Container | 580x280x100 | 3.8 (8.3) | 3 (6.6) | |
| | | 580x280x135 | 5.2 (11.4) | 4.1 (9.0) | |
| | | 580x280x150 | 5.8 (12.7) | 4.6 (10.1) | |
| | | 580x280x200 | 7.7 (16.9) | 6.1 (13.4) | |
| | | 580x280x260 | 10 (22.0) | 8 (17.6) | |
| | 3/4 Size Container…