Instru-Safe Instrument Protection System

K151166 · Summit Medical, Inc. · KCT · Aug 18, 2015 · General Hospital

Device Facts

• Record ID: K151166
• Device Name: Instru-Safe Instrument Protection System
• Applicant: Summit Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Aug 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

InstruSafe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.

Device Story

Device consists of perforated anodized aluminum/stainless steel cassettes/trays with silicone inserts; used to organize/protect surgical instruments during sterilization, storage, and transport. Operated by healthcare staff in clinical settings. Cassettes are placed inside legally marketed sterilization wraps or Aesculap rigid containers; they do not maintain sterility independently. Input: surgical instruments. Output: organized, sterilized instrument set. Benefit: protects instruments from damage and maintains organization during sterilization process. Device does not have direct patient contact.

Clinical Evidence

Bench testing only. Validation performed for Sterrad NX Standard Sterilization Cycle compatibility. Biocompatibility testing (MEM Elution Cytotoxicity per ISO 10993-5) passed; samples were non-cytotoxic.

Technological Characteristics

Materials: Anodized aluminum, stainless steel, blue/black silicone, polyester, Ultem™ 1000. Form factor: Perforated base and latchable cover with internal silicone inserts (hold-it/hold-down), handles, latches, feet, optional posts/dividers/shelves. Sterilization: Sterrad NX Standard Sterilization Cycle. No software or electronic components.

Indications for Use

Indicated for use by healthcare providers to organize and protect medical devices during sterilization cycles, specifically the Sterrad NX Standard Sterilization Cycle, when used with legally marketed sterilization wraps or Aesculap 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

• InstruSafe Instrument Protection System (K133015)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of human profiles facing right, arranged in a way that suggests unity and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central image.

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

August 18, 2015

Summit Medical Inc. Ms. Nicole Dove QA/RA Manager 815 Northwest Parkway, Suite 100 St. Paul, MN 55121

Re: K151166

Trade/Device Name: InstruSafe® Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap containers, trays, cassettes & other accessory Regulatory Class: II Product Code: KCT Dated: July 14, 2015 Received: July 20, 2015

Dear Ms. 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 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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Page 2 - Ms. Dove

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

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

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

Enclosure

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## Indications for Use

510(k) Number (if known) K151166

Device Name Instru-Safe® Instrument Protection System

## Indications for Use (Describe)

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. 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.

Sterilization methods and configurations - Sterrad NX Standard Sterilization Cycle

Lumen claims for Sterrad NX Standard Sterilization Cycle

| Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens |
|-----------------------|-------------------------|----------------|------------------|
| IN-2681 | 1 mm | 65 mm | 1 |
| IN-2681 | 3 mm | 200 mm | 1 |
| IN-8987-S | 1 mm | 500 mm | 5 |
| IN-8615 | 2.3 mm | 210 mm | 5 |
| IN-6105 | 4 mm | 235 mm | 1 |

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

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. 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 diamond shapes, arranged horizontally. The logo is black and white.

| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (lbs |
|-----------------|--------------------------|---------------------------------------------|
| IN-1315 | 30 | 3.5 |
| IN-2006 | 8 | 2 |
| IN-2681 | 13 | 0.64 |
| IN-2682 | 13 | 0.89 |
| IN-2683 | 13 | 1.39 |
| IN-2688 | 15 | 2 |
| IN-2840 | 36 | 8.75 |
| IN-2841 | 38 | 14.5 |
| 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-3006 | 14 | 1.5 |
| IN-3030 | 34 | 9.5 |
| IN-4000 | 20 | 3.2 |
| IN-4003 | 30 | 3.25 |
| IN-4010 | 10 | 1.98 |
| IN-5008 | 10 | 8 |
| IN-5009 | 8 | 5 |
| 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-6220 | 2 | 3 |
| IN-6223 | 2 | 3 |
| IN-6225 | 2 | 3 |
| 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-6500 | 30 | 12.5 |
| IN-7010 | 2 | 2 |
| IN-7012 | 1 | 1.07 |
| IN-7020 | 30 | 8.5 |
| IN-7030 | 30 | 10 |
| IN-7032 | 2 | 1.1 |
| IN-7040 | 25 | 5 |
| IN-7050 | 30 | 12 |
| IN-7073 | 10 | 5 |
| IN-7120 | 45 | 11.25 |
| IN-7123 | 45 | 12 |
| IN-7130 | 45 | 13.5 |
| IN-7140 | 45 | 14.5 |
| IN-7150 | 8 | 1.9 |
| IN-7153 | 6 | 1.7 |
| IN-7213 | 30 | 10 |
| IN-7220 | 30 | 13.5 |
| IN-7223 | 10 | 9.2 |
| IN-7230 | 45 | 14.5 |
| IN-7234 | 45 | 14.5 |
| IN-7240 | 45 | 14.5 |
| IN-7250 | 45 | 14.5 |
| IN-7251 | 30 | 10 |
| IN-7252 | 25 | 8 |
| IN-7253 | 30 | 12 |
| IN-7260 | 45 | 14.5 |
| IN-7273 | 10 | 6 |
| IN-7274 | 30 | 8 |
| IN-7322 | 45 | 14.5 |
| IN-7323 | 45 | 14.5 |
| IN-7343 | 45 | 14.5 |
| IN-7344 | 1 | 4 |
| IN-7360 | 45 | 14.5 |
| IN-7423 | 45 | 14.5 |
| IN-7452 | 10 | 8 |
| IN-7453 | 10 | 8 |
| IN-7540 | 45 | 14.5 |
| IN-7560 | 45 | 14.5 |
| IN-7644 | 45 | 14.5 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| IN-7781 | 45 | 14.5 |
| IN-7823 | 45 | 14.5 |
| IN-7830 | 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 | 3 | 5.5 |
| IN-8700 | 40 | 14 |
| IN-8721 | 1 | 7.5 |
| IN-8771 | 1 | 10.5 |
| 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 | 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-8920 | 1 | 8 |
| IN-8931 | 1 | 2.4 |
| IN-8932 | 0 | 0.5 |
| 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 | 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 |

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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 large, sans-serif font. Below the word "SUMMIT" is the word "medical" in a smaller, sans-serif font. Above the word "SUMMIT" are three black diamonds.

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Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA
www.summitmedicalusa.com Page 2 of 5

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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 stylized font, with three black diamonds above it. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font.

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 large, stylized letters, with three black diamonds arranged horizontally above it. Below the word "SUMMIT" is the word "medical" in smaller, lowercase letters. The logo has a clean and professional design.

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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 black diamonds.

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Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: [phone] | fax: [phone] www.summitmedicalusa.com Page 5 of 5

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Image /page/8/Picture/0 description: The image shows the logo for Summit Medical, which includes three dark blue diamonds above the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font below. Below the logo, the text "510(k) Summary" is displayed, followed by the code "K151166".

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

| Submitter: | Summit Medical Inc.<br>815 Northwest Parkway, Suite 100<br>St. Paul, MN 55121<br>Tel: [phone] |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ER Number: | 3008719017 |
| Contact<br>Person: | Nicole Dove<br>QA/RA Manager<br>Tel: [phone]<br>[e-mail] |
| Date Prepared: | July 14, 2015 |
| Subject<br>Device: | Trade Name(s):<br>InstruSafe® Instrument Protection System<br>Classification Name:<br>Sterilization wrap containers, trays, cassettes & other accessory (21 CFR 880.6850<br>Common Name:<br>Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument Delivery<br>System<br>Device Class:<br>Class II<br>Device Code:<br>KCT<br>Panel:<br>General Hospital |
| Predicate<br>Device: | Tradename: InstruSafe Instrument Protection System<br>510(k) Holder: Summit Medical Inc.<br>510(k) #: K133015 |
| Device<br>Description: | Summit Medical Inc. InstruSafe Instrument Protection System are cassettes / trays<br>used to enclose and hold surgical instruments and instrument accessories in an<br>organized manner during the sterilization process and subsequent storage and<br>transportation. The cassettes / trays do not have direct patient contact. The<br>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

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Image /page/9/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 stylized font, with the word "medical" in a smaller font below it. The logo is simple and modern, with a focus on the company name.

| The cassettes / trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes / trays have perforations to allow sterilant penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassette / tray during the sterilization process and subsequent storage and transportation. | | | | | | | InstruSafe Instrument Protection System cassettes used to organize and protect other medical devices that are sterilized by a healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad NX Standard Sterilization Cycle. The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The InstruSafe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.<br>Sterilization methods and configurations<br>• Sterrad NX Standard Sterilization Cycle<br><br>Lumen claims for Sterrad NX Standard Sterilization Cycle | Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Instru-Safe System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe System cassettes are not intended on their own to maintain 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 | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------------|----------------------------------------------------------------------------------|----------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------|--------------------------|
| Intended Use: | InstruSafe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad NX Standard Sterilization Cycle. The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The InstruSafe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.<br>Sterilization methods and configurations<br>• Sterrad NX Standard Sterilization Cycle | | | | | Summit<br>Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens | Summit<br>Cassette Model | Aesculap Container Model |
| Lumen claims for Sterrad NX Standard Sterilization Cycle | | | | | | IN-2681 | 1mm | 65mm | 1 | IN-8823-AE | *JN444 |
| Summit<br>Cassette Model | Minimum Inside<br>Diameter | Maximum<br>Length | Number of<br>Lumens | IN-2681 | 3mm | 200mm | 1 | IN-2880 | *JK444 | | |
| IN-2681 | 1mm | 65mm | 1 | IN-8987-S | 1mm | 500mm | 5 | IN-6105 | *JN742 | | |
| IN-2681 | 3mm | 200mm | 1 | IN-8615 | 2.3mm | 210mm | 5 | *Validated by Summit Medical for use in steam prevacuum sterilizers ONLY operating at 270°F (132°C) for 4 minutes exposure time. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims. | | | |
| IN-8987-S | 1mm | 500mm | 5 | IN-6105 | 4mm | 235mm | 1 | | | | |
| IN-8615 | 2.3mm | 210mm | 5 | The worst case validated load by vent-to-volume calculation is the IN-2681 tray. | | | | | | | |
| IN-6105 | 4mm | 235mm | 1 | Material<br>Composition | No changes from predicate device | | | The cassette contains components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000 | | | |
| The worst case validated load by vent-to-volume calculation is the IN-2681 tray. | | | | | | Physical<br>Properties | InstruSafe Instrument Protection System cassettes include<br>- perforated base<br>- perforated cover | | | Instru-Safe Instrument Protection System cassettes include<br>- perforated base<br>- perforated cover | |
| The intended use of the subject device includes the Sterrad NX Standard Sterilization Cycle. Performance testing has been performed for the Sterrad NX Standard Sterilization Cycle. This new sterilization cycle does not affect safety and effectiveness of the InstruSafe Instrument Protection System. | | | | | | | | | | | |
| Comparison of<br>Characteristics<br>to Predicate<br>Device: | Based on a comparison of the design, technology, materials, manufacturing, performance, specifications and methods of use, the InstruSafe Instrument Protection System is equivalent to the identified 510(k) cleared predicate device. | | | | | | | | | | |
| Element | New Device | | | Predicate (K133015) | | | | | | | |

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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 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 use of blue gives it a professional and trustworthy feel.

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

www.summitmedicalusa.com

Page 3 of 10

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Image /page/11/Picture/0 description: The image shows the logo for Summit Medical. The logo features 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 has a clean and professional look.

| | - silicone inserts (hold-it / hold down)<br>- Handles<br>- Latches<br>- Feet<br>- Posts (optional)<br>- Divider (optional)<br>- Shelf (optional) | - silicone inserts (hold-it / hold down)<br>- Handles<br>- Latches<br>- Feet<br>- Posts (optional)<br>- Divider (optional)<br>- Shelf (optional) |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemical<br>Properties | Not Applicable | Not Applicable |
| Configurations<br>/ Dimensions | Various configurations / dimensions | See table located in predicate device<br>submission K133015 |
| Air permeance | Not Applicable | Not Applicable |
| Percent of<br>surface<br>performations | Not Applicable | Not Applicable |
| Performance | New Device | Predicate (K133015) |
| Sterilant<br>Penetration | Sterrad NX Standard Sterilization Cycle | Pre-Vacuum Steam<br>Cycle: Pre-vacuum<br>Temperature: 270°F (132°C)<br>Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes |
| Microbial<br>Barrier<br>Properties<br>(Packaging<br>Integrity) | Not Applicable | Not Applicable |
| Material<br>Compatibility | No changes from predicate device | Refer to predicate device K133015 |
| Toxicological<br>Properties<br>(Biocompatibil<br>ity, including<br>Sterilant<br>Residue<br>Limits) | MEM Elution Cytotoxicity (ISO 10993-5)<br>- The test samples meet the USP and<br>ISO 10993-5 requirements for this test.<br>All controls were acceptable and the<br>test considered valid. The test samples<br>PASSED and are considered NON-<br>CYTOTOXIC under the test<br>conditions employed. | Refer to predicate device K133015 |
| Shelf Life | No Change | Reusable (5 year accelerated shelf<br>life study) |
| Drying Time | Not Applicable | Autoclave Sterilization Parameter:<br>Cycle: Pre-Vacuum<br>Temperature: 270°F (132°C) |

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

www.summitmedicalusa.com

Page 4 of 10

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Image /page/12/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 logo is simple and modern, and the blue color gives it a professional look.

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