Instru-Safe Instrument Protection System

K142768 · Summit Medical, Inc. · KCT · May 29, 2015 · General Hospital

Device Facts

• Record ID: K142768
• Device Name: Instru-Safe Instrument Protection System
• Applicant: Summit Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: May 29, 2015
• 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. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex 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

Instru-Safe Instrument Protection System consists of perforated, latchable aluminum/stainless steel cassettes with silicone inserts; used to organize/protect surgical instruments during sterilization, storage, and transport. Cassettes are placed inside legally marketed sterilization wraps or Aesculap rigid containers; they do not maintain sterility independently. Operated by healthcare staff in clinical settings. Device facilitates sterilization via Sterrad 100NX Flex cycle; perforations allow sterilant penetration. Benefits include organized instrument handling and protection during sterilization cycles.

Clinical Evidence

Bench testing only. Sterilization validation testing performed to demonstrate compatibility of the Instru-Safe Instrument Protection System with the Sterrad 100NX Flex Sterilization Cycle using worst-case load configurations (vent-to-volume calculations). Biocompatibility testing (MEM Elution Cytotoxicity per ISO 10993-5) confirmed samples are non-toxic.

Technological Characteristics

Materials: Anodized aluminum, stainless steel, blue/black silicone, polyester, Ultem™ 1000. Design: Perforated base and cover with latching mechanism, silicone inserts, handles, feet, and optional dividers/posts. Connectivity: None. Energy: None. Sterilization: Validated for Sterrad 100NX Flex cycle.

Indications for Use

Indicated for use by healthcare providers to organize and protect medical devices during sterilization in a Sterrad 100NX Flex Sterilization Cycle. Used with legally marketed wrap 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

• Instru-Safe Instrument Protection System (K133015)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

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

May 29, 2015

Summit Medical Inc. Ms. Nicole Dove Quality Assurance/Regulatory Affairs Manager 815 Northwest Pkwy, Suite 100 St. Paul, MN 55121

Re: K142768

Trade/Device Name: Instru-Safe® Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 29, 2015 Received: May 1, 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/ResourcesforYou/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) K142768

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 sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100NX Flex 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.

Sterrad 100NX Flex Sterilization Cycle

| Summit Cassette Model | Aesculap Container Model |
|-----------------------|--------------------------|
| IN-0000 | *JM444 |
| IN-6105 | *JM440 |

* Validated by Summit Medical for use in Sterrad 100NX Flex Sterilization Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims.

#### Lumen claims for Sterrad 100NX Flex Sterilization Cycle

| Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens | Wrap / Rigid Container |
|-----------------------|-------------------------|----------------|------------------|--------------------------|
| IN-0000 | 1 mm | 850 mm | 1 | Wrap and Rigid Container |
| IN-8823 | 1 mm | 850 mm | 1 | Wrap and Rigid Container |
| IN-7344 | 1 mm | 850 mm | 1 | Wrap |
| IN-6105 | 4 mm | 235 mm | 1 | Wrap and Rigid Container |

The worst case validated load by vent-to-volume calculation is the IN-0000 tray. Note: The IN-0000 tray is for testing purposes only.

| 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 large, stylized letters, with three diamond shapes above it. Below the word "SUMMIT" is the word "medical" in smaller letters.

# Indications for Use Statement

Table 1 - Device Models

.

| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (lbs) |
|-------------|--------------------------|----------------------------------------------|
| IN-1315 | 30 | 3.5 |
| 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-3030 | 34 | 9.5 |
| IN-5401-12 | 12 | 3.25 |
| IN-7120 | 45 | 11.25 |
| IN-7130 | 45 | 13.5 |
| IN-7223 | 10 | 9.2 |
| IN-7344 | 1 | 4 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| 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-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-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-8882 | 16 | 12.1 |
| 4 | 5.35 | |
| 6 | 12.1 | |
| 6 | 12.1 | |
| 12 | 12.1 | |
| 9 | 7.5 | |
| 5 | 16.1 | |
| 10 | 10.25 | |
| 7 | 6.5 | |
| 22 | 17 | |
| 15 | 13.25 | |
| 22 | 17 | |
| 7 | 12.5 | |
| 16 | 14.5 | |
| 8 | 12.5 | |
| 10 | 11.6 | |
| 11 | 10 | |
| 1 | 2.7 | |
| 6 | 4.7 | |
| 20 | 9.5 | |
| 17 | 9.5 | |
| 16 | 9.5 | |
| ાર | 9.5 | |
| 2 | 6.5 | |
| 2 | 6.5 | |
| 2 | 6 | |
| 2 | 6 | |
| 6 | 12.1 | |
| | | |

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

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Image /page/4/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of three diamonds arranged horizontally above the word "SUMMIT" in a stylized font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. The diamonds and text are all in a dark color, possibly gray or black.

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 sans-serif font, with three blue diamonds above it. Below the word "SUMMIT" is the word "medical" in a smaller, sans-serif font. The logo is simple and modern, and the blue color gives it a professional look.

# 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.<br>815 Northwest Parkway, Suite 100<br>St. Paul, MN 55121<br>Tel: [phone] | | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| ER Number: | 3008719017 | | |
| Contact Person: | Nicole Dove<br>QA/RA Manager<br>Tel: [phone]<br>[e-mail] | | |
| Date Prepared: | May 26, 2015 | | |
| Subject Device: | Trade Name(s):<br>Instru-Safe® Instrument Protection System<br><br>Classification Name:<br>Sterilization wrap containers, trays, cassettes & other accessory (21 CFR 880.6850<br><br>Common Name:<br>Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument Delivery System<br><br>Device Class:<br>Class II<br><br>Device Code:<br>KCT<br><br>Panel:<br>General Hospital | | |
| Predicate Device: | Tradename: Instru-Safe Instrument Protection System<br>510(k) Holder: Summit Medical Inc.<br>510(k) #: K133015 | | |
| Device Description: | Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used<br>to enclose and hold surgical instruments and accessories in an organized manner during<br>the sterilization process and subsequent storage and transportation. The cassettes / trays<br>by themselves do not maintain sterility.<br><br>The cassettes / trays are different sizes of the same basic configuration: a rectangular<br>base with latchable cover. The cassettes / trays have perforations to allow sterilant<br>penetration. The cassettes / trays contain silicone inserts in the base and/or cover to hold, | | |

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

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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 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.

| organize and protect the surgical instruments within the cassette / tray. | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------|---------------------|--------------------------|
| 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 Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with 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. | | | | |
| Sterrad 100NX Flex Sterilization Cycle | | | | | |
| | Summit Cassette Model | | Aesculap Container Model | | |
| | IN-0000 | | *JM444 | | |
| | IN-6105 | | *JM440 | | |
| *Validated by Summit Medical for use in Sterrad 100NX Flex Sterilization Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims. | | | | | |
| Lumen claims for Sterrad 100NX Flex Sterilization Cycle | | | | | |
| | Summit<br>Cassette Model | Minimum<br>Inside Diameter | Maximum<br>Length | Number<br>of Lumens | Wrap / Rigid Container |
| | IN-0000 | 1 mm | 850 mm | 1 | Wrap and Rigid Container |
| | IN-8823 | 1 mm | 850 mm | 1 | Wrap and Rigid Container |
| | IN-7344 | 1 mm | 850 mm | 1 | Wrap |
| | IN-6105 | 4 mm | 235 mm | 1 | Wrap and Rigid Container |
| The worst case validated load by vent-to-volume calculation is the IN-0000 tray.<br>Note: The IN-0000 tray is for testing purposes only. | | | | | |
| The intended use of the subject device includes the Sterrad 100NX Flex Sterilization Cycle. Performance testing has been performed for the Sterrad 100NX Flex Sterilization Cycle. This new sterilization cycle does not affect 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, performance, specifications and methods of use, the Instru-Safe Instrument Protection System is equivalent to the identified 510(k) cleared predicate device. | | | | |
| | Element | | New Device | | Predicate (K133015) |

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Image /page/7/Picture/0 description: The image shows the logo for Summit Medical. The logo features the word "SUMMIT" in a stylized font, with the letters connected at the top. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. Above the word "SUMMIT" are three dark blue diamonds arranged horizontally.

| Intended Use | Instru-Safe Instrument Protection System cassettes 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 Sterrad 100NX Flex Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.<br>Sterilization methods and configurations<br>• Sterrad 100NX Flex Sterilization Cycle<br>Summit Cassette Model Aesculap Container Model IN-0000 *JM444 IN-6105 *JM440 *Validated by Summit Medical for use in Sterrad 100NX Flex Sterilization Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers intended load claims. | | | | | | | 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>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<br>Summit Cassette Model Aesculap Container Model IN-8823-AE *JN444 IN-2880 *JK444 IN-6105 *JN742 *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. | | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Material Composition | No changes from predicate device | The cassette contains components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000 | | | | | | | | | | | | | | |
| Physical Properties | Instru-Safe Instrument Protection System cassettes include<br>- perforated base<br>- perforated cover | Instru-Safe Instrument Protection System cassettes include<br>- perforated base<br>- perforated cover | | | | | | | | | | | | | | |

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/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 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.

| Chemical<br>Properties | - silicone inserts (hold-it / hold down)<br>- Handles<br>- Latches<br>- Feet<br>- Posts (optional)<br>- Divider (optional)<br>- Shelf (optional)<br>Not Applicable | - silicone inserts (hold-it / hold down)<br>- Handles<br>- Latches<br>- Feet<br>- Posts (optional)<br>- Divider (optional)<br>- Shelf (optional)<br>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 100NX Flex 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>(Biocompatibili<br>ty, including<br>Sterilant<br>Residue Limits) | MEM Elution Cytotoxicity (ISO 10993-5)<br>- The test samples meet the USP and ISO<br>10993-5 requirements for this test. All<br>controls were acceptable and the test<br>considered valid. The test samples<br>PASSED and are considered NON-<br>TOXIC under the test conditions<br>employed. | Refer to predicate device K133015 |
| Shelf Life | No Change | Reusable (5 year accelerated shelf life<br>study) |
| Drying Time | Not Applicable | Autoclave Sterilization Parameter:<br>Cycle: Pre-Vacuum<br>Temperature: 270°F (132°C)<br>Minimum Exposure Time: 4 minutes |
| | | Minimum Dry Time: 30 minutes |
| Aeration Time | Not Applicable | Not Applicable |
| Technological<br>Characteristics: | The technological characteristics of the subject devices are equivalent to the predicate<br>devices. The cassettes / trays are made of standard medical grade materials and do not<br>incorporate any new technological characteristics. | |
| Performance<br>Data: | Sterilization validation testing was performed to demonstrate Instru-Safe Instrument<br>Protection System compatibility when used in a Sterrad 100NX Flex Sterilization Cycle<br>with a legally marketed wrap or Aesculap rigid container. | |
| Conclusion: | Based upon intended use, performance data and technical information provided in this<br>pre-market notification, the Instru-Safe® Instrument Protection System described herein<br>is substantially equivalent to the predicate device [Instru-Safe® Instrument Protection<br>System (K133015)]. | |

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 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.

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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 stylized font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three blue diamonds arranged in a row. The logo is simple and modern, and the blue color gives it a professional look.

| Table 1 - Device Models | | | | | | | |
|-------------------------|--|--|--|--|--|--|--|
|-------------------------|--|--|--|--|--|--|--|

| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (lbs) |
|-------------|--------------------------|----------------------------------------------|
| IN-1315 | 30 | 3.5 |
| 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-3030 | 34 | 9.5 |
| IN-5401-12 | 12 | 3.25 |
| IN-7120 | 45 | 11.25 |
| IN-7130 | 45 | 13.5 |
| IN-7223 | 10 | 9.2 |
| IN-7344 | 1 | 4 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| 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-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-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-8882 | 16 | 12.1 |
| IN-8884 | 4 | 5.35 |
| IN-8886 | 6 | 12.1 |
| IN-8889 | 6 | 12.1 |
| IN-8892-01 | 12 | 12.1 |
| IN-8893 | 9 | 7.5 |
| IN-8894 | 5 | 16.1 |
| IN-8898 | 10 | 10.25 |
| IN-8899 | 7 | 6.5 |
| IN-8902 | 22 | 17 |
| IN-8903 | 15 | 13.25 |
| IN-8904 | 22 | 17 |
| IN-8907 | 7 | 12.5 |
| IN-8937 | 16 | 14.5 |
| IN-8938 | 8 | 12.5 |
| IN-8939 | 10 | 11.6 |
| IN-8942 | 11 | 10 |
| IN-8943 | 1 | 2.7 |
| IN-8944 | 6 | 4.7 |
| 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 |

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/11/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. 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

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