INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM

K141513 · Summit Medical, Inc. · KCT · Dec 15, 2014 · General Hospital

Device Facts

• Record ID: K141513
• Device Name: INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
• Applicant: Summit Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Dec 15, 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® 100NX Express Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. The Instru-Safe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.

Device Story

Instru-Safe® Instrument Protection System consists of specialized cassettes designed to organize and protect medical instruments during sterilization. Cassettes are loaded with instruments by healthcare staff; then wrapped in a legally marketed sterilization wrap. The system is compatible with the Sterrad® 100NX Express Cycle. The device does not maintain sterility independently; it functions as a protective container within the sterilization process. By organizing instruments, the system facilitates efficient sterilization workflows and protects delicate devices from damage during handling and processing. No lumen claims are made for this cycle.

Clinical Evidence

Bench testing only. Validation performed using vent-to-volume calculations and load testing (number of instruments and estimated weight) to confirm compatibility with the Sterrad® 100NX Express Cycle.

Technological Characteristics

Instrument protection cassettes; metallic/polymer construction (specific materials not detailed); designed for use with Sterrad® 100NX Express Cycle; non-sterile; requires external sterilization wrap; no lumen claims.

Indications for Use

Indicated for use by healthcare providers to organize and protect medical devices during sterilization in a Sterrad® 100NX Express Cycle. Used in conjunction with a legally marketed wrap. No specific patient population or contraindications defined.

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.

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

December 15, 2014

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

Re: K141513

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: October 24, 2014 Received: October 30, 2014

Dear Mrs. Nicole Dove:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You 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 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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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 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.

Indications for Use Statement

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510(k) number: K141513

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® 100NX Express Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. The Instru-Safe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter X

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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 below it. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The overall design is simple and modern.

Indications for Use Statement

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The worst case validated load by vent-to-volume calculation is the IN-2681 tray. The worst case validated load by number of instruments and estimated weight is the IN-8823-CF tray.

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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 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-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-7012 | 1 | 1.07 |
| IN-7032 | 2 | 1.1 |
| IN-7150 | 8 | 1.9 |
| IN-7223 | 10 | 9.2 |
| 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 | 25 | 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-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-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 |

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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, blue letters, with the word "medical" in smaller, red letters underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue and red gives it a professional look.

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