INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM

K140289 · Summit Medical, Inc. · KCT · Jun 27, 2014 · General Hospital

Device Facts

• Record ID: K140289
• Device Name: INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
• Applicant: Summit Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jun 27, 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. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

Device Story

Instru-Safe Instrument Protection System consists of specialized cassettes designed to organize and protect surgical instruments during sterilization. Cassettes are placed inside legally marketed sterilization wraps or Aesculap rigid containers; then processed through Sterrad 100S or 100NX Standard sterilization cycles. System facilitates sterilization of enclosed medical devices, including specific stainless steel lumen configurations. Used in clinical settings by healthcare personnel responsible for instrument reprocessing. Device does not maintain sterility independently; relies on external packaging/containers. Benefits include organized instrument handling and protection during the sterilization process.

Clinical Evidence

Bench testing only. Validation performed for Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. Testing confirmed compatibility with specific lumen configurations (e.g., 3mm ID x 400mm length) and validated the use of specific Summit cassette models within designated Aesculap rigid containers.

Technological Characteristics

Cassette-based instrument organization system. Materials: Not specified (metal/polymer construction implied). Sensing/Actuation: None. Energy Source: None (passive). Connectivity: None. Sterilization: Compatible with Sterrad 100S and 100NX Standard cycles (hydrogen peroxide gas plasma). Form factor: Various tray dimensions and configurations (see Table 1). Software: None.

Indications for Use

Indicated for use by healthcare providers to organize and protect medical devices during Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. Used in conjunction 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.

Reference Devices

• Aesculap rigid container

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct, curved lines forming its body and wings. The bird is positioned within a circular border. Encircling the bird within the border is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 27, 2014

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

Re: K140289

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: May 29, 2014 Received: June 2, 2014

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely vours.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

Tejashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH FFOR

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 stylized font, with three black 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 use of black and white gives it a professional look.

## Indications for Use Statement

**Page** 1 of 4

510(k) number: K140289

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 Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.

The following sterilization trays were validated with the corresponding rigid containers:

- . Sterrad 100S Standard Cycle

| 1<br>Continued on the compared<br>assette Model<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Comment country of consider con from the drive and the cases of the cases of the cases of the cases of the cases of the cases of the cases of the cases of the cases of the ca<br>ontainer Model | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| -------------------------<br>IN_2872 | MAAA | | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>INTE INS<br>A LENGLES A<br>MALES OFF E------------------------------------------------------------------------------------------------------------------------------------------------------------------- | 1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>* INAAAC<br> | | |

- Sterrad 100NX Standard Cycle �

| Summit Cassette Model | Aesculap Container Model |
|-----------------------|--------------------------|
| IN-8823-AE | *JM444 |
| IN-6105 | *JM440 |

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

Lumen claims for Sterrad 100S Standard and Sterrad 100NX Standard Cycles:

OR

| 4 Stainless steel lumens with 3mm inner diameter × 400mm length | All appropriate sized models listed in Table 1 with the exception of IN-2681 |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|
| 2 Stainless steel lumens with 3mm inner diameter × 200mm length | |
| 1 Stainless steel lumens with 3mm inner diameter × 200mm length | IN-2681 |
| 1 Stainless steel lumens with 1mm inner diameter × 65mm length | |

Prescription Use: (Per 21 CFR 801.109)

| Over-The-Counter | X |
|------------------|---|
|------------------|---|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Sreekanth

Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=20005404 90, cn=Sreekanth Gutala -S Date: 2014.06.25 15:35:48 -04'00'

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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 bold, sans-serif font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three black diamonds arranged horizontally. The logo is simple and modern, and the use of black and white gives it a professional look.

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

| Part Number | Maximum # of Instruments | Estimated Weight - Tray w/ instruments (Ibs) | | | |
|-------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| 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 | રેણ | 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 | б | 2 | | | |
| IN-5401-02 | 2 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | |
| IN-5401-03 | 2 | l | | | |
| 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-7012 | l | 1.07 | | | |
| IN-7032 | 2 | 1.1 | | | |
| IN-7150 | 8 | 1.9 | | | |
| IN-7153 | б | 1.7 | | | |
| IN-7223 | 10 | 9.2 | | | |

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

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Image /page/4/Picture/1 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 the word "SUMMIT" is the word "medical" in a smaller, sans-serif font. The logo is simple and modern, and the use of black and white gives it a professional look.

| IN-7224 | 15 | 7.2 |
|-----------------|----|-------|
| IN-7225 | 10 | 9.5 |
| IN-7723 | 15 | 7.18 |
| IN-7724 | 15 | 7.2 |
| IN-7725 | 10 | 9.5 |
| IN-7823 | 18 | 4 |
| IN-7940 | 20 | 13.25 |
| IN-8240 | 20 | 13.5 |
| IN-8420 | 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-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-8863 | 30 | 10.5 |
| IN-8880 | 45 | 14 |
| IN-8882 | 2 | 3.28 |
| IN-8883 | 16 | 12.1 |
| IN-8884 | 2 | 3.28 |
| IN-8885 | 1 | 2.25 |
| IN-8886 | 6 | 12.1 |
| IN-8889 | 6 | 12.1 |
| IN-8891-S | 1 | 2 |
| IN-8891-S1-12-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-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
| 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 large, bold letters, with three black diamonds above it. Below the word "SUMMIT" is the word "medical" in smaller letters.

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

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