Instru-Safe Instrument Protection System

K142630 · Summit Medical, Inc. · KCT · Dec 23, 2014 · General Hospital

Device Facts

• Record ID: K142630
• Device Name: Instru-Safe Instrument Protection System
• Applicant: Summit Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Dec 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.

Device Story

Instru-Safe Instrument Protection System consists of perforated anodized aluminum and stainless steel cassettes/trays with silicone inserts; designed to hold, organize, and protect surgical instruments during sterilization, storage, and transport. Cassettes feature latchable covers and are used within legally marketed Genesis rigid containers. Device does not maintain sterility independently. Healthcare providers place instruments into cassettes; cassettes are placed inside rigid containers; containers undergo pre-vacuum steam sterilization. System ensures sterilant penetration via perforations; protects instruments from damage; facilitates organized instrument delivery to OR. Benefits include improved instrument protection and organized sterilization workflows.

Clinical Evidence

Bench testing only. Sterilization validation testing demonstrated compatibility of the Instru-Safe Instrument Protection System when used in a 4-minute pre-vacuum steam sterilization cycle within a Genesis rigid container.

Technological Characteristics

Materials: anodized aluminum, stainless steel, blue/black silicone, polyester, Ultem 1000. Configuration: perforated base and cover with latch, silicone inserts, handles, feet, optional dividers/shelves. Sterilization: pre-vacuum steam (270°F/132°C, 4 min exposure, 30 min dry). Connectivity: none. Software: none.

Indications for Use

Indicated for use by healthcare providers to organize and protect medical devices during pre-vacuum steam sterilization cycles (270°F/132°C for 4 minutes) when used within Genesis rigid containers.

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

• Instru-Safe Instrument Protection System (K133015)

Submission Summary (Full Text)

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

February 26, 2015

Summit Medical, Inc. Nicole Dove QA/RA Manager 815 Northwest Pkwy, Ste. 100 St. Paul. MN 55121

Re: K142630

Trade/Device Name: Instru-Safe® Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: II Product Code: KCT Dated: November 19, 2014 Received: November 26, 2014

Dear Ms. Nicole Dove:

This letter corrects our substantially equivalent letter of December 23, 2014.

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 vou 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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Image /page/2/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 horizontally. The logo is simple and professional, and the blue color gives it a sense of trust and reliability.

### Indications for Use Statement

Page of

510(k) number: K142630

Device Name: Instru-Safe® Instrument Protection System

Indications for Use:

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

Lumen claims for Four (4) Minute Pre-Vacuum Steam Sterilization Cycle:

| Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens |
|-----------------------|-------------------------|----------------|------------------|
| IN-2681 | 3mm | 200mm | 1 |
| IN-2681 | 1mm | 65mm | 1 |
| IN-0000 | 1mm | 400mm | 5 |
| IN-0000 | 3mm | 400mm | 1 |
| IN-0000 | 5mm | 400mm | 1 |
| IN-6105 | 5mm | 241mm | 1 |

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter X

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: [phone] | fax: [phone] www.summitmedicalusa.com

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Image /page/3/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a large, sans-serif 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 professional, and the blue color gives it a sense of trust and reliability.

# Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

The worst case validated load by vent-to-volume calculation is the IN-2681 tray.

The total weight of the container system (e.g. container, tray and instrument load) must not exceed 25 lbs.

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Image /page/4/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a bold, sans-serif font, with the word "medical" in a smaller font below it. 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.

## Indications for Use Statement

| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (lbs) |
|-----------------|--------------------------|----------------------------------------------|
| IN-1315 | 30 | 3.5 |
| IN-2681 | 13 | 0.64 |
| IN-2682 | 13 | 0.89 |
| IN-2683 | 13 | 1.39 |
| IN-2840 | 36 | 8.75 |
| IN-2842 | 24 | 6.5 |
| IN-2843 | 36 | 8.75 |
| IN-2880 | 56 | 12.1 |
| IN-2900 | 22 | 4.18 |
| IN-2950 | 12 | 4.1 |
| IN-3030 | 34 | 9.5 |
| IN-4000 | 20 | 3.2 |
| IN-4003 | 30 | 3.25 |
| IN-4010 | 10 | 1.98 |
| IN-5401 | 6 | 2 |
| IN-5401-02 | 2 | 1 |
| IN-5401-03 | 2 | 1 |
| IN-5401-08 | 8 | 3.2 |
| IN-5401-12 | 12 | 3.25 |
| IN-6103 | 2 | 2.15 |
| IN-6105 | 2 | 2.15 |
| IN-6110 | 3 | 2.15 |
| IN-6203 | 2 | 2.75 |
| IN-6205 | 2 | 2.75 |
| IN-6210 | 2 | 2.75 |
| IN-6240 | 2 | 2.75 |
| IN-6303 | 2 | 3.28 |
| IN-6305 | 2 | 3.28 |
| IN-6310 | 2 | 3.28 |
| IN-6403 | 2 | 3.28 |
| IN-6405 | 2 | 3.28 |
| IN-6410 | 2 | 3.28 |
| IN-7010 | 2 | 2 |
| IN-7012 | 1 | 1.07 |
| IN-7032 | 2 | 1.1 |
| IN-7120 | 45 | 11.25 |
| IN-7130 | 45 | 13.5 |
| IN-7150 | 8 | 1.9 |
| IN-7153 | 6 | 1.7 |
| IN-7223 | 10 | 9.2 |
| IN-7274 | 30 | 8 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| IN-7823 | 45 | 14.5 |
| IN-7840 | 45 | 13.5 |
| IN-7940 | 20 | 13.25 |
| IN-8240 | 20 | 13.5 |
| IN-8610 | 2 | 6.65 |
| IN-8612 | 2 | 6.8 |
| IN-8613 | 2 | 6.1 |
| IN-8615 | 2 | 5.8 |
| IN-8616 | 2 | 5.8 |
| IN-8620 | 3 | 7.2 |
| IN-8621 | 4 | 7.18 |
| IN-8622 | 4 | 7.18 |
| IN-8630 | 3 | 6.5 |
| IN-8632 | 3 | 6.45 |
| IN-8633 | 3 | 6.8 |
| IN-8640 | 4 | 5.35 |
| IN-8642 | 4 | 5.35 |
| IN-8643 | 5 | 5.35 |
| IN-8645 | 4 | 5.35 |
| IN-8650 | 4 | 5.85 |
| IN-8660 | 4 | 5.35 |
| IN-8662 | 4 | 5.35 |
| IN-8663 | 4 | 5.35 |
| IN-8810 | 20 | 13.5 |
| IN-8820 | 15 | 8.75 |
| IN-8823 | 45 | 14 |
| IN-8830 | 15 | 8.75 |
| IN-8833 | 45 | 14 |
| IN-8840 | 20 | 13.75 |
| IN-8850 | 15 | 8.75 |
| IN-8853 | 45 | 14 |
| IN-8860 | 15 | 8.75 |
| IN-8862 | 30 | 10.5 |
| IN-8863 | 45 | 14 |
| IN-8880 | 2 | 3.28 |
| IN-8882 | 16 | 12.1 |
| IN-8883 | 2 | 3.28 |
| IN-8884 | 4 | 5.35 |
| IN-8885 | 1 | 2.25 |
| IN-8886 | 6 | 12.1 |
| IN-8889 | 6 | 12.1 |
| IN-8891-S | 1 | 2 |
| IN-8891-SI-12-S | 1 | 2 |
| IN-8891-SI-85-S | 1 | 2 |
| IN-8892-01 | 12 | 12.1 |
| IN-8893 | 9 | 7.5 |
| IN-8894 | 5 | 16.1 |
| IN-8897 | 8 | 6 |
| IN-8898 | 10 | 10.25 |
| IN-8899 | 7 | 6.5 |
| IN-8901 | 1 | 2.25 |
| IN-8902 | 22 | 17 |
| IN-8903 | 15 | 13.25 |
| IN-8904 | 22 | 17 |
| IN-8907 | 7 | 12.5 |
| IN-8931 | 1 | 2.4 |
| IN-8932 | 9 | 9.5 |
| IN-8933 | 3 | 3.75 |
| IN-8936 | 6 | 11.5 |
| IN-8937 | 16 | 14.5 |
| IN-8938 | 8 | 12.5 |
| IN-8939 | 10 | 11.6 |
| IN-8940 | 5 | 5.18 |
| IN-8942 | 11 | 10 |
| IN-8943 | 1 | 2.7 |
| IN-8944 | 6 | 4.7 |
| IN-8945 | 2 | 5.18 |
| IN-8946 | 9 | 6.1 |
| IN-8980-01 | 20 | 9.5 |
| IN-8982-01 | 17 | 9.5 |
| IN-8983-01 | 16 | 9.5 |
| IN-8984-01 | 15 | 9.5 |
| IN-8986-S | 2 | 6.5 |
| IN-8987-S | 2 | 6.5 |
| IN-8988-S | 2 | 6 |
| IN-8989-S | 2 | 6 |
| IN-9999-160 | 6 | 12.1 |
| IN-9999-162-S | 2 | 5.8 |
| IN-9999-168-S | 2 | 5.8 |
| IN-9999-172-S | 2 | 5.8 |
| IN-9999-178-S | 2 | 5.8 |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: [phone] | fax: [phone] www.summitmedicalusa.com

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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 large, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds arranged horizontally. The overall design is simple and modern.

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA
www.summitmedicalusa.com

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Image /page/6/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.

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA
www.summitmedicalusa.com

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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 sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

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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 a large, sans-serif 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 use of blue suggests a sense of trust and reliability.

# 510(k) Summary

Following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92

| Submitter: | Summit Medical Inc. |
|----------------|-----------------------------------------------------------------------------------|
| | 815 Northwest Parkway, Suite 100 |
| | St. Paul, MN 55121 |
| | Tel: [phone] |
| ER Number: | 3008719017 |
| Contact | Nicole Dove |
| Person: | QA/RA Manager |
| | Tel: [phone] |
| | [e-mail] |
| Date Prepared: | December 22, 2014 |
| Subject | Trade Name(s): |
| Device: | Instru-Safe® Instrument Protection System |
| | |
| | Classification Name: |
| | Sterilization wrap containers, trays, cassettes & other accessory (21 CFR |
| | 880.6850) |
| | |
| | Common Name: |
| | Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument Delivery |
| | System |
| | |
| | Device Class: |
| | Class II |
| | Device Code: |
| | KCT |
| | |
| | Panel: |
| | General Hospital |
| Predicate | Tradename: Instru-Safe Instrument Protection System |
| Device: | 510(k) Holder: Summit Medical Inc. |
| | 510(k) #: K133015 |
| Device | Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / |
| Description: | trays used to enclose and hold surgical instruments and accessories in an |
| | organized manner during the sterilization process and subsequent storage and |
| | transportation. The cassettes / trays by themselves do not maintain sterility. |
| | |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: [phone] | fax: [phone] www.summitmedicalusa.com

Page 1 of 6

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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 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 use of blue gives it a professional and trustworthy feel.

| The cassettes / trays are different sizes of the same basic configuration: a<br>rectangular base with latchable cover. The cassettes / trays have perforations to<br>allow sterilant penetration. The cassettes / trays contain silicone inserts in the base<br>and/or cover to hold, organize and protect the surgical instruments within the<br>cassette / tray. | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------|---------------------|
| Intended Use: | Instru-Safe® Instrument Protection System cassettes are used to organize and<br>protect other medical devices that are sterilized by a healthcare provider. Instru-<br>Safe Instrument Protection System cassettes are intended to allow sterilization of<br>the enclosed medical devices during a pre-vacuum steam sterilization cycle. The<br>Instru-Safe Instrument Protection System cassettes are intended to be used in<br>conjunction with legally marketed Genesis rigid containers. The Instru-Safe<br>Instrument Protection System cassettes are not intended on their own to maintain<br>sterility. | | | |
| Sterilization methods and configurations | | | | |
| • Autoclave Sterilization Parameter: | | | | |
| Cycle: Pre-Vacuum | | | | |
| Temperature: 270°F (132°C) | | | | |
| Minimum Exposure Time: 4 minutes | | | | |
| Minimum Dry Time: 30 minutes | | | | |
| | Summit Cassette<br>Model | Minimum Inside<br>Diameter | Maximum<br>Length | Number of<br>Lumens |
| | IN-2681 | 3mm | 200mm | 1 |
| | IN-2681 | 1mm | 65mm | 1 |
| | IN-0000 | 1mm | 400mm | 5 |
| | IN-0000 | 3mm | 400mm | 1 |
| | IN-0000 | 5mm | 400mm | 1 |
| | IN-6105 | 5mm | 241mm | 1 |
| The intended use of the subject device includes the use of Genesis rigid containers<br>and the intended use of the predicate device includes the use of Aesculap rigid<br>containers. The difference in rigid containers is not critical and does not affect<br>safety and effectiveness of the Instru-Safe Instrument Protection System. | | | | |
| Comparison of<br>Characteristics<br>to Predicate<br>Device: | Based on a comparison of the design, technology, materials, manufacturing,<br>performance, specifications and methods of use, the Instru-Safe Instrument<br>Protection System is identical to the identified 510(k) cleared predicate device. | | | |
| Performance<br>Data: | Sterilization validation testing was performed to demonstrate Instru-Safe<br>Instrument Protection System compatibility when used in a Four (4) minute pre-<br>vacuum steam sterilization cycle within a Genesis rigid container. | | | |
| Sterilization methods and configurations | | | | |
| • Autoclave Sterilization Parameter: | | | | |
| Cycle: Pre-Vacuum | | | | |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 56121
| Summit Medical, |

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Image /page/10/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 use of blue gives it a professional and trustworthy feel.

| Temperature: | 270°F (132°C)<br>Minimum Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based upon intended use, performance data and technical information provided in this pre-market notification, the Instru-Safe Instrument Protection System described herein are substantially equivalent to current legally marketed predicate devices. |

### Substantial Equivalence - Device Comparisons

| Characteristic<br>Indications | New Device | Predicate Device Instru-Safe<br>Instrument Protection Systems<br>K133015 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Indication for<br>Use | Instru-Safe® Instrument Protection<br>System cassettes are used to organize<br>and protect other medical devices that<br>are sterilized by a healthcare provider.<br>Instru-Safe Instrument Protection<br>System cassettes are intended to allow<br>sterilization of the enclosed medical<br>devices during a pre-vacuum steam<br>sterilization cycle. The Instru-Safe<br>Instrument Protection System cassettes<br>are intended to be used in conjunction<br>with legally marketed Genesis rigid<br>container. The Instru-Safe Instrument<br>Protection System cassettes are not<br>intended on their own to maintain<br>sterility.<br><br>Sterilization methods and configurations<br>• Autoclave Sterilization Parameter:<br>Cycle: Pre-Vacuum<br>Temperature: 270°F (132°C)<br>Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes | Instru-Safe Instrument Protection<br>System cassettes are used to<br>organize and protect other medical<br>devices that are sterilized by a<br>healthcare provider. Instru-Safe<br>System cassettes are intended to<br>allow sterilization of the enclosed<br>medical devices during a pre-<br>vacuum steam sterilization cycle.<br>The Instru-Safe System cassettes are<br>intended to be used in conjunction<br>with central legally marketed wrap<br>or Aesculap rigid container. The<br>Instru-Safe System cassettes are not<br>intended on their own to maintain<br>sterility.<br><br>Sterilization methods and configurations<br>• Autoclave Sterilization Parameter:<br>Cycle: Pre-Vacuum<br>Temperature: 270°F (132°C)<br>Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Summit<br>Cassette<br>Model Minimum<br>Inside<br>Diameter Maximum<br>Length # of<br>Lumens IN-2681 3mm 200mm 1 IN-2681 1mm 65mm 1 IN-0000 1mm 400mm 5 IN-0000 3mm 400mm 4 IN-0000 5mm 400mm 4 IN-6105 5mm 241mm 4 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Summit Cassette<br>Model Aesculap<br>Container Model IN-8823-AE *JN444 IN-2880 *JK444 IN-6105 *JN742 *Validated by Summit Medical for use in<br>steam pre-vacuum sterilizers ONLY<br>operating at 270°F (132°C) for 4 minutes | | | | | | | | | | |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: [phone] | fax: [phone] www.summitmedicalusa.com

Page 3 of 6

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Image /page/11/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 below it. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

| Element | New Device | Predicate (K133015) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Intended Use | Instru-Safe ® Instrument Protection<br>System cassettes are used to organize<br>and protect other medical devices that<br>are sterilized by a healthcare provider.<br>Instru-Safe Instrument Protection<br>System cassettes are intended to allow<br>sterilization of the enclosed medical<br>devices during a pre-vacuum steam<br>sterilization cycle. The Instru-Safe<br>Instrument Protection System cassettes<br>are intended to be used in conjunction<br>with legally marketed Genesis rigid<br>container. The Instru-Safe Instrument<br>Protection System cassettes are not<br>intended on their own to maintain<br>sterility. | Instru-Safe Instrument Protection<br>System cassettes are used to organize<br>and protect other medical devices<br>that are sterilized by a healthcare<br>provider. Instru-Safe Instrument<br>Protection System cassettes are<br>intended to allow sterilization of the<br>enclosed medical devices during a<br>pre-vacuum steam sterilization<br>cycles. The Instru-Safe Instrument<br>Protection System cassettes are<br>intended to be used in conjunction<br>with a legally marketed wrap or<br>Aesculap rigid container. The<br>Instru-Safe Instrument Protection<br>System cassettes are not intended on<br>their own to maintain sterility. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Sterilization methods and configurations<br>Autoclave Sterilization Parameter:<br>Cycle: Pre-Vacuum<br>Temperature: 270°F (132°C)<br>Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes | Sterilization methods and configurations<br>Autoclave Sterilization Parameter:<br>Cycle: Pre-vacuum<br>Temperature: : 270°F (132°C)<br>Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Summit<br>Cassette<br>Model Minimum<br>Inside<br>Diameter Maximum<br>Length # of<br>Lumens IN-2681 3mm 200mm 1 IN-2681 1mm 65mm 1 IN-0000 1mm 400mm 5 IN-0000 3mm 400mm 4 IN-0000 5mm 400mm 4 IN-6105 5mm 241mm 4 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Summit Cassette<br>Model Aesculap<br>Container Model IN-8823-AE *JN444 IN-2880 *JK444 IN-6105 *JN742 | | | | | | | | |
| | *Validated by Summit Medical for use in steam<br>pre-vacuum sterilizers ONLY operating at<br>270°F (132°C) for 4 minutes exposure time.<br>Consult container instructions to ensure that<br>contents do not exceed the sterilization<br>containers intended load claims. | *Validated by Summit Medical for use in<br>steam prevacuum sterilizers ONLY<br>operating at 270°F (132°C) for 4 minutes<br>exposure time. Consult container<br>instructions to ensure that contents do not<br>exceed the sterilization containers intended<br>load claims. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: [phone] | fax: [phone] www.summitmedicalusa.com

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Image /page/12/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of three blue diamonds arranged horizontally above the word "SUMMIT" in a large, sans-serif font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. The color scheme is primarily blue and white.

| Material<br>Composition | No changes from predicate device | The cassette contains components<br>made of anodized aluminum,<br>stainless steel, blue silicone, black<br>silicone, polyester, ultemTM 1000 |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical<br>Properties | Instru-Safe Instrument Protection<br>System cassettes include<br>- perforated base<br>- perforated cover<br>- silicone inserts (hold-it / hold<br>down)<br>- Handles<br>- Latches<br>- Feet<br>- Posts (optional)<br>- Divider (optional)<br>- Shelf (optional) | Instru-Safe Instrument Protection<br>System cassettes include<br>- perforated base<br>- perforated cover<br>- silicone inserts (hold-it / hold<br>down)<br>- Handles<br>- Latches<br>- Feet<br>- Posts (optional)<br>- Divider (optional)<br>- Shelf (optional) |
| Configurations/<br>Dimensions | Various configurations / dimensions,<br>refer to section 14a | See table located in predicate device<br>submission K133015 |
| Performance | New Device | Predicate (K133015) |
| Sterilant<br>Penetration | Pre-Vacuum Steam<br>No Change | Pre-Vacuum Steam<br>270°F (132°C), 4 minutes |
| Toxicological<br>Properties<br>(Biocompatibility,<br>including<br>Sterilant Residue<br>Limits) | No change | Refer to predicate device K133015 |
| Shelf Life | No change | Reusable (5 year accelerated shelf<br>life study) |
| Drying Time | No change | Autoclave Sterilization Parameter:<br>4 minute 270°C (132°C)<br><br>Minimum Dry Time:<br>- 30 minute |
| Technological<br>Characteristics: | The technological characteristics of the subject devices are equivalent to the<br>predicate devices. The cassettes / trays are made of standard medical grade<br>materials and do not incorporate any new technological characteristics. | |
| Performance<br>Data: | Sterilization validation testing was performed to demonstrate Instru-Safe<br>Instrument Protection System compatibility when used in a Four (4) minute pre-<br>vacuum steam sterilization cycle within a Genesis rigid container. | |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA
www.summitmedicalusa.com

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Image /page/13/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a bold, 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.

| Sterilization methods and configurations |
|------------------------------------------|
| Autoclave Sterilization Parameter |
| Cycle: Pre-Vacuum |
| Temperature: 270°F (132°C) |
| Exposure Time: 4 minutes |
| Minimum Dry Time: 30 minutes |