K Number
K180528
Device Name
InstruSafe(R) Sterilization Container
Date Cleared
2018-11-16

(261 days)

Product Code
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated or non-perforated bottoms. All models are intended to be used with single use paper filter. The container is a reusable device designed to be used with the following sterilization cycle parameters: Pre-Vacuum Steam Sterilization Cycle: 4 minutes 132°C (270 °F) Drying Time Minimum: 30 minutes
Device Description
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. 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.
More Information

No
The device description and performance studies focus on the physical properties and sterilization efficacy of a reusable container, with no mention of AI or ML capabilities.

No.

The device is a sterilization container used to enclose other medical devices for sterilization and maintain their sterility; it does not directly treat or diagnose a disease or condition.

No.
The device is a sterilization container intended to enclose other medical devices for sterilization and maintain their sterility, rather than diagnose a medical condition.

No

The device is a physical sterilization container system made of aluminum alloy, stainless steel, and silicone, with accessories like trays, baskets, and filters. It is clearly a hardware device.

Based on the provided text, the InstruSafe® Sterilization Container is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to enclose another medical device for sterilization and maintain sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body.
  • Device Description: The description focuses on the physical characteristics of the container and its use in sterilizing surgical instruments. There is no mention of analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing human specimens (blood, urine, tissue, etc.)
    • Providing information for diagnosis, monitoring, or screening
    • Using reagents or assays

The device is clearly intended for the sterilization and storage of other medical devices used in healthcare settings.

N/A

Intended Use / Indications for 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.

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

The container is a reusable device designed to be used with the following sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
132°C (270 °F)
Drying Time Minimum: 30 minutes

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

KCT

Device Description

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. 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.

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

healthcare 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)

Non-Clinical Testing: The InstruSafe® Sterilization Container proved to be successful in all the non-clinical tests conducted. The non-clinical tests conducted included the tests listed below:

  • Pre-Vacuum Steam Efficacy and Thermal Profile
  • Dry Time
  • Maintenance of sterility (180 days)
  • Microbial Aerosol Challenge
  • Biocompatibility
  • Cleaning/reusability (AAMI TIR12)
  • Handle Testing
  • Gasket Testing
  • Lid/Base Compatibility Testing
  • Locking Tag/Label Compatibility Testing

Non-Clinical Testing Summary: The following Non-Clinical Testing was conducted using current standards and FDA guidance.

  • Pre-Vacuum Steam Efficacy and Thermal Profile, and Dry Time per AAMI TIR12:2010, ANSI/AAMI ST77:2013 and ANSI/AAMI ST79:2013/A4:2013
  • Shelf Life and Microbial Aerosol Challenge per AAMI TIR12:2010, ANSI/AAMI ST77:2013 and ANSI/AAMI ST79:2010/A3:2012
  • Biocompatibility per FDA Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", ANSI/AAMI/ISO 10993-5:2009 and ANSI/AAMI/ISO 10993-12:2012
  • Mechanical Cleaning per AAMI TIR12:2010, AAMI TIR30:2011 and ANSI/AAMI ST81:2004(R)2010
  • Handle Testing, Gasket Testing, Lid/Base Compatibility Testing and Locking Tag/Label Compatibility Testing per ANSI/AAMI ST77:2013

Conclusion: In summary, the non-clinical testing demonstrates that the InstruSafe® Sterilization Container is as safe, as effective and performs as well as or better than the legally marketed predicate device (Ermis Medizintechnik Sterilization Container System K123234).

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.

Ermis Medizintechnik Sterilization Container System - K123234

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.

Aesculap SterilContainer System – K112671 (reference)

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

§ 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).

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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
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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3

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.
815 Vikings Parkway, Suite 100
St. Paul, MN 55121 USA
Official Correspondent:Nicole Dove
Director of Quality Assurance & Regulatory Affairs
Tel: (651) 789-3921 / Fax: (651) 789-3961
ndove@innoviamedical.com
Subject Device
Trade/Device Name:InstruSafe® Sterilization Container
Common or Usual Name:Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument
Delivery System
Regulation Number:21 CFR 880.6850
Regulation Name:Sterilization wrap
Regulatory Class:Class II
Product Code:KCT
Indications for UseThe 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 or non-perforated bottoms. All models are intended to be used with
single use paper filter.
The container is a reusable device designed to be used with the following
sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
132°C (270 °F)
Drying Time Minimum: 30 minutes

4

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.

ModelDescriptionTotal Container LoadedLoad Description
NumberMaximum Weight (lbs)
CS-3XXXFull 1/1 Perforated Container LidNot applicableMetal (Stainless
CS-3XXXFull 1/1 Container Bottom25 lbsSteel) surgical
CS-2XXXThree quarter 3/4 Perforated Container LidNot applicableir struments like
CS-2XXXThree quarter 3/4 Container Bottom25 lbsforceps, scissors,
CS-1XXXOne half ½ Perforated Container LidNot applicableclamps, etc.
CS-1XXXOne half ½ Container Bottom18 lbsir cluding
CS-5XXXXL Perforated Container LidNot applicablelı mened/cannulated
CS-5XXXXL Container Bottom25 lbsii 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:
ModelDescriptionStandard DimensionTotal Container
NumberOutside w/coverLoaded Maximum
LxWxH in inchesWeight (lbs)
CS-3001Full 1/1 Perforated Container Lid23 1/8 x 11 x 1 1/4Not applicable
CS-3002Full 1/1 Solid Container Bottom23 1/8 x 11 x 4 1/425 lbs
CS-3003Full 1/1 Solid Container Bottom
Full 1/1 Solid Container Bottom23 1/8 x 11 x 6 1/425 lbs
CS-300423 1/8 x 11 x 8 1/425 lbs
CS-3005Full 1/1 Solid Container Bottom23 1/8 x 11x 10 ½25 lbs
CS-3012Full 1/1 Perforated Container Bottom23 1/8 x 11 x 4 1/425 lbs
CS-3013Full 1/1 Perforated Container Bottom23 1/8 x 11 x 6 1/425 lbs
CS-3014Full 1/1 Perforated Container Bottom23 1/8 x 11 x 8 1/425 lbs
CS-3015Full 1/1 Perforated Container Bottom23 1/8 x 11x 10 1/225 lbs
CS-2001Three Quarter 3/4 Perforated Container Lid18 ¼ x 11 x 1 ¼Not applicable
CS-2002Three Quarter 3/4 Solid Container Bottom18 ¼ x 11 x 4 1/425 lbs
CS-2003Three Quarter ¾ Solid Container Bottom18 ¼ x 11 x 6 ¼25 lbs
CS-2012Three Quarter ¾ Perforated Container Bottom18 ¼ x 11 x 4 1/425 lbs
CS-2013Three Quarter ¾ Perforated Container Bottom18 ¼ x 11 x 6 ¼25 lbs
CS-1001One Half 1/2 Perforated Container Lid11 ½ x 11 x 1 1/4Not applicable
CS-1002One Half ½ Solid Container Bottom11 ½ x 11 x 4 ¼18 lbs
CS-1003One Half ½ Solid Container Bottom11 ½×11×6¼18 lbs
CS-1012One Half ½ Perforated Container Bottom11 ½ x 11 x 4 ¼18 lbs
CS-1013One Half ½ Perforated Container Bottom11 ½ x 11 x 6 ¼18 lbs
CS-5000
CS-5001Extra Large Perforated Container Lid
Extra Large Perforated Container Bottom30 7/8 x 12 3/4 x 7 1/2
30 7/8 x 12 3/4 x 7 1/2Not applicable
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

Device to Predicate DevicesIndications for Use
InstruSafe®
Sterilization
ContainerThe 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 or non-perforated bottoms. All models are intended to be
used with single use paper filter.

The container is a reusable device designed to be used with the following
sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
132°C (270°F)
Drying Time Minimum: 30 minutes | | | |
| | | Model
Number | Description | Total Container
Loaded
Maximum
Weight (lbs) | Load
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
Lid | Not applicable | Steel) surgical
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
CS-5XXX | XL Perforated Container Lid
XL Container Bottom | Not applicable
25 lbs | including
lumened
/cannulated
instruments. |
| | Reference
Device
Aesculap
SterilContainer
System
K112671 | The Aesculap SterilContainer System 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 360 days. The
SterilContainer System includes accessories such as mats, baskets, trays,
holders, organizers, filters, indicator cards and tamper proof locks. | | | |

6

| Predicate
Device:
Ermis
Medizintechnik Sterilization
Container
System
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.
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 | 465x280x100 | 3.1 (6.8) | 2.5 (5.5) | |
| | | 465x280x135 | 4.2 (9.2) | 3.3 (7.2) | |
| | | 465x280x150 | 4.6 (10.1) | 3.7 (8.1) | |
| | 1/2 Size Container | 285x280x100 | 1.9 (4.1) | 1.5 (3.3) | |
| | | 285x280x135 | 2.6 (5.7) | 2 (4.4) | |
| | | 285x280x150 | 2.8 (6.1) | 2.2 (4.8) | |

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Image /page/7/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the blue color gives it a professional look.

285x280x2003.8 (8.3)3 (6.6)
285x280x2604.9 (10.8)3.9 (8.5)
Mini Container300x140x400.4 (0.8)0.3 (0.6)
300x140x700.7 (1.5)0.5(1.1)
300x140x1001 (2.2)0.8 (1.7)
Dental
Container310x190x400.6(1.3)0.5(1.1)
310x190x650.9 (1.9)0.7 (1.5)
310x190x801.2 (2.6)0.9 (1.9)
310x190x1001.5 (3.3)1.2 (2.6)
310x190x1301.8 (3.9)1.4 (3.0)

| Technological
Characteristics/Performance
Comparison of Subject
Device to Predicate Device | InstruSafe® Sterilization
Container
(K180528) | Reference Device:
Aesculap
SterilContainer
System K112671 | Predicate Device:
Ermis
Medizintechnik
Sterilization
Container K123234 | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Materials | Anodized Aluminum Alloy,
Stainless Steel, Silicone | Anodized Aluminum
Alloy/Radel R | Anodized Aluminum
Alloy, Stainless Steel,
Silicone | |
| Properties | | | | |
| - Instruments to be sterilized in
vacuum steam sterilizers | Yes | Yes | Yes | |
| - Reusable | Yes | Yes | Yes | |
| - Closed System | Yes | Yes | Yes | |
| - Sealed | Yes | Yes | Yes | |
| - Filtered to Permit Entry of
Sterilant | Yes | Yes | Yes | |
| - Filtered to Prevent Microbial
Migration during Transport | Yes | Yes | Yes | |
| - Incorporates security lid to
prevent damage/contamination
of filter unit during transport | No | No | Yes | |
| Performance | | | | |
| - Load Weight | Up to 25 lbs | Up to 25 lbs | Up to 22 lbs | |
| - Lumened/ cannulated
instruments | Yes | Yes | No | |
| - Stainless steel medical
devices | Yes | Yes | Yes | |
| Shelf life | 180 Days | 360 Days | 90 Days | |
| Biocompatibility | meets requirements of
ISO 10993-1 | meets requirements of
ISO 10993-1 | meets requirements of
ISO 10993-1 | |
| Discussion on Technological /
Performance Characteristic
Differences | There are four technological/performance characteristic differences between the predicate devices and the subject device (Reference Table above). These are: 1) Incorporates security lid to prevent damage/contamination of filter unit during transport,
2) Load weight
3) Lumened/cannulated instruments
4) Shelf life
Scientific methods (bench testing) and sterilization standards, exist for evaluating different technical characteristics.
Specifically:

  1. Incorporates security lid to prevent damage/contamination of filter unit during transport a. The sterilization containers were tested without a security lid during sterilization efficacy, dry time, microbial aerosol challenge and shelf life testing and were found to have no failures that were caused by damage or contamination of the filter unit. The subject device functions as intended.
  2. Load weight a. The sterilization containers were tested to the load weight claimed in the indications for use in the sterilization efficacy and dry time testing. The subject device functions as intended
  3. Lumened/Cannulated instruments a. The sterilization containers were tested with lumened/cannulated instruments during sterilization efficacy testing.
  4. Shelf life a. The sterilization containers were tested to the shelf life claimed in the indications for use during the sterilization efficacy testing. | | | |
    | Non-Clinical Testing | The InstruSafe®
    Sterilization Container
    proved to be successful in
    all the non-clinical tests
    conducted. The non-clinical
    tests conducted included the
    tests listed below: | The Aesculap
    SterilContainer System
    conducted the
    following non-clinical
    tests:
  • Reprocessing
    Validation &
    Verification | The Ermis
    Sterilization
    Container System
    conducted the
    following non-
    clinical tests:
  • Pre-Vacuum
    Steam Efficacy | |
    | | - Pre-Vacuum Steam
    Efficacy and Thermal
    Profile
  • Dry Time
  • Maintenance of
    sterility (180 days)
  • Microbial Aerosol
    Challenge
  • Biocompatibility
  • Cleaning/reusability
    (AAMI TIR12)
  • Handle Testing
  • Gasket Testing
  • Lid/Base Compatibility
    Testing
  • Locking Tag/Label
    Compatibility Testing | - Sterilization Efficacy
  • Sterility
  • Maintenance | and Thermal
    Profile
  • Dry Time
  • Shelf Life
  • Microbial Aerosol
    Challenge
  • Biocompatibility
  • Mechanical
    Cleaning
  • Reusability
    (repetitive
    exposure)
  • Handle Testing
  • Lock Testing | |
    | Non-Clinical Testing
    Summary | The following Non-Clinical Testing was conducted using current standards
    and FDA guidance.
  • Pre-Vacuum Steam Efficacy and Thermal Profile, and Dry Time per
    AAMI TIR12:2010, ANSI/AAMI ST77:2013 and ANSI/AAMI
    ST79:2013/A4:2013
  • Shelf Life and Microbial Aerosol Challenge per AAMI TIR12:2010,
    ANSI/AAMI ST77:2013 and ANSI/AAMI ST79:2010/A3:2012
  • Biocompatibility per FDA Use of International Standard ISO 10993-1,
    "Biological evaluation of medical devices – Part 1: Evaluation and testing
    within a risk management process", ANSI/AAMI/ISO 10993-5:2009 and
    ANSI/AAMI/ISO 10993-12:2012
  • Mechanical Cleaning per AAMI TIR12:2010, AAMI TIR30:2011 and
    ANSI/AAMI ST81:2004(R)2010
  • Handle Testing, Gasket Testing, Lid/Base Compatibility Testing and
    Locking Tag/Label Compatibility Testing per ANSI/AAMI ST77:2013 | | | |
    | Conclusion: | In summary, the non-clinical testing demonstrates that the InstruSafe®
    Sterilization Container is as safe, as effective and performs as well as or
    better than the legally marketed predicate device (Ermis Medizintechnik
    Sterilization Container System K123234). | | | |

510(k) Premarket Notification - InstruSafe® Sterilization Container Summit Medical, Inc.
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Image /page/8/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in large, bold, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three dark blue diamonds arranged horizontally.

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Image /page/9/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, arranged in a horizontal row. The logo is simple and modern, and the blue color gives it a professional look.