LogoFDA 510(k) Search
K Number
K151166
Device Name
Instru-Safe Instrument Protection System
Manufacturer
Summit Medical Inc.
Date Cleared
2015-08-18

(109 days)

Product Code
KCT
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
Summit Medical Inc. InstruSafe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays do not have direct patient contact. The cassettes / trays by themselves do not maintain sterility. 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 include - perforated base - perforated cover - silicone inserts (hold-it / hold down) - Handles - Latches - Feet - Posts (optional) - Divider (optional) - Shelf (optional) The cassette contains components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000
More Information

K133015

Not Found

No
The device description and intended use clearly describe a physical instrument protection system (cassettes/trays) used for organizing and sterilizing surgical instruments. There is no mention of software, algorithms, data processing, or any components that would suggest the use of AI or ML.

No
The device is described as an "Instrument Protection System" which are cassettes/trays used to organize and protect other medical devices during sterilization, storage, and transportation, and are not intended for direct patient contact or to maintain sterility on their own. This indicates it is an accessory for other medical devices, rather than a device that provides therapeutic benefit itself.

No

The device is an instrument protection system (cassettes/trays) used to organize and protect other medical devices during sterilization, storage, and transportation. It does not perform any diagnostic function.

No

The device is described as physical cassettes/trays made of materials like aluminum, stainless steel, and silicone, used to hold and protect surgical instruments during sterilization. There is no mention of software components.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used to "organize and protect other medical devices that are sterilized by a healthcare provider." It facilitates the sterilization process of other instruments.
  • Device Description: The description details a system of cassettes/trays designed to hold and protect surgical instruments during sterilization, storage, and transportation.
  • Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with human specimens or provide diagnostic information.

The device's function is related to the sterilization and handling of surgical instruments, which are used in vivo (within the body), but the device itself is not an IVD.

N/A

Intended Use / Indications for Use

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 ModelMinimum Inside DiameterMaximum LengthNumber of Lumens
IN-26811 mm65 mm1
IN-26813 mm200 mm1
IN-8987-S1 mm500 mm5
IN-86152.3 mm210 mm5
IN-61054 mm235 mm1

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

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

Summit Medical Inc. InstruSafe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes / trays do not have direct patient contact. The cassettes / trays by themselves do not maintain sterility. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Sterilization validation testing was performed to demonstrate InstruSafe Instrument Protection System compatibility when used in a Sterrad NX Standard Sterilization Cycle with a legally marketed wrap or Aesculap rigid container.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133015

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).

0

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.

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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 ModelMinimum Inside DiameterMaximum LengthNumber of Lumens
IN-26811 mm65 mm1
IN-26813 mm200 mm1
IN-8987-S1 mm500 mm5
IN-86152.3 mm210 mm5
IN-61054 mm235 mm1

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 NumberMaximum # of InstrumentsEstimated Weight - Tray w/ instruments (lbs
IN-1315303.5
IN-200682
IN-2681130.64
IN-2682130.89
IN-2683131.39
IN-2688152
IN-2840368.75
IN-28413814.5
IN-2842246.5
IN-2843368.75
IN-28805612.1
IN-2900224.18
IN-2950124.1
IN-3006141.5
IN-3030349.5
IN-4000203.2
IN-4003303.25
IN-4010101.98
IN-5008108
IN-500985
IN-540162
IN-5401-0221
IN-5401-0321
IN-5401-0883.2
IN-5401-12123.25
IN-610322.15
IN-610522.15
IN-611032.15
IN-620322.75
IN-620522.75
IN-621022.75
IN-622023
IN-622323
IN-622523
IN-624022.75
IN-630323.28
IN-630523.28
IN-631023.28
IN-640323.28
IN-640523.28
IN-641023.28
IN-65003012.5
IN-701022
IN-701211.07
IN-7020308.5
IN-70303010
IN-703221.1
IN-7040255
IN-70503012
IN-7073105
IN-71204511.25
IN-71234512
IN-71304513.5
IN-71404514.5
IN-715081.9
IN-715361.7
IN-72133010
IN-72203013.5
IN-7223109.2
IN-72304514.5
IN-72344514.5
IN-72404514.5
IN-72504514.5
IN-72513010
IN-7252258
IN-72533012
IN-72604514.5
IN-7273106
IN-7274308
IN-73224514.5
IN-73234514.5
IN-73434514.5
IN-734414
IN-73604514.5
IN-74234514.5
IN-7452108
IN-7453108
IN-75404514.5
IN-75604514.5
IN-76444514.5
IN-7723157.18
IN-7724157.2
IN-7725109.5
IN-77814514.5
IN-78234514.5
IN-78304514.5
IN-78404513.5
IN-79402013.25
IN-82402013.5
IN-861026.65
IN-861226.8
IN-861326.1
IN-861525.8
IN-861625.8
IN-862037.2
IN-862147.18
IN-862247.18
IN-863036.5
IN-863236.45
IN-863336.8
IN-864045.35
IN-864245.35
IN-864355.35
IN-864545.35
IN-865045.85
IN-866045.35
IN-866245.35
IN-866335.5
IN-87004014
IN-872117.5
IN-8771110.5
IN-88102013.5
IN-8820158.75
IN-88234514
IN-8830158.75
IN-88334514
IN-88402013.75
IN-8850158.75
IN-88534514
IN-8860158.75
IN-88623010.5
IN-88634514
IN-888023.28
IN-88821612.1
IN-888323.28
IN-888445.35
IN-888512.25
IN-8886612.1
IN-8889612.1
IN-8891-S12
IN-8891-SI-12-S12
IN-8891-SI-85-S12
IN-88921212.1
IN-889397.5
IN-8894516.1
IN-889786
IN-88981010.25
IN-889976.5
IN-890112.25
IN-89022217
IN-89031513.25
IN-89042217
IN-8907712.5
IN-892018
IN-893112.4
IN-893200.5
IN-893333.75
IN-8936611.5
IN-89371614.5
IN-8938812.5
IN-89391011.6
IN-894055.18
IN-89421110
IN-894312.7
IN-894464.7
IN-894525.18
IN-894696.1
IN-8980209.5
IN-8982-01179.5
IN-8983-01169.5
IN-8984-01159.5
IN-8986-S26.5
IN-8987-S26.5
IN-8988-S26
IN-8989-S26
IN-9999-160612.1
IN-9999-162-S25.8
IN-9999-168-S25.8
IN-9999-172-S25.8
IN-9999-178-S25.8

్ స్టే

4

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.

,我们的人都是一

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

જ

网

5

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

Page 3 of 5

6

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.

Page 4 of 5

:

7

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.

2

:

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com Page 5 of 5

8

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.
815 Northwest Parkway, Suite 100
St. Paul, MN 55121
Tel: (651) 789-3939 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ER Number: | 3008719017 |
| Contact
Person: | Nicole Dove
QA/RA Manager
Tel: (651) 789-3921
ndove@summitmedicalusa.com |
| Date Prepared: | July 14, 2015 |
| Subject
Device: | Trade Name(s):
InstruSafe® 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
Device: | Tradename: InstruSafe Instrument Protection System
510(k) Holder: Summit Medical Inc.
510(k) #: K133015 |
| Device
Description: | Summit Medical Inc. InstruSafe Instrument Protection System are cassettes / trays
used to enclose and hold surgical instruments and instrument accessories in an
organized manner during the sterilization process and subsequent storage and
transportation. The cassettes / trays do not have direct patient contact. The
cassettes / trays by themselves do not maintain sterility. |

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979

www.summitmedicalusa.com

9

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.
Sterilization methods and configurations
• Sterrad NX Standard Sterilization Cycle

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.

Sterilization methods and configurations
• Autoclave Sterilization Parameter:
Cycle: Pre-vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
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.
Sterilization methods and configurations
• Sterrad NX Standard Sterilization Cycle | | | | | Summit
Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens | Summit
Cassette Model | Aesculap Container Model |
| Lumen claims for Sterrad NX Standard Sterilization Cycle | | | | | | IN-2681 | 1mm | 65mm | 1 | IN-8823-AE | *JN444 |
| Summit
Cassette Model | Minimum Inside
Diameter | Maximum
Length | Number of
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
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
Properties | InstruSafe Instrument Protection System cassettes include

  • perforated base
  • perforated cover | | | Instru-Safe Instrument Protection System cassettes include
  • perforated base
  • 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
    Characteristics
    to Predicate
    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) | | | | | | | |

Page 2 of 10

10

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: 651.789.3939 | fax: 651.789.3979

www.summitmedicalusa.com

Page 3 of 10

11

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)

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

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA phone: 651.789.3939 | fax: 651.789.3979

www.summitmedicalusa.com

Page 4 of 10

12

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.

Minimum Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Aeration TimeNot ApplicableNot Applicable
Technological
Characteristics:The technological characteristics of the subject devices are equivalent to the
predicate devices. The cassettes / trays are made of standard medical grade
materials and do not incorporate any new technological characteristics.
Performance
Data:Sterilization validation testing was performed to demonstrate InstruSafe Instrument
Protection System compatibility when used in a Sterrad NX Standard Sterilization
Cycle with a legally marketed wrap or Aesculap rigid container.
Conclusion:Based upon intended use, performance data and technical information provided in
this pre-market notification, the InstruSafe Instrument Protection System described
herein are substantially equivalent to the predicate device [InstruSafe Instrument
Protection System (K133015)]

13

Image /page/13/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, with a clean design.

Part NumberMaximum # of InstrumentsEstimated Weight - Tray w/ instruments (lbs)
IN-1315303.5
IN-200682
IN-2681130.64
IN-2682130.89
IN-2683131.39
IN-2688152
IN-2840368.75
IN-28413814.5
IN-2842246.5
IN-2843368.75
IN-28805612.1
IN-2900224.18
IN-2950124.1
IN-3006141.5
IN-3030349.5
IN-4000203.2
IN-4003303.25
IN-4010101.98
IN-5008108
IN-500985
IN-540162
IN-5401-0221
IN-5401-0321
IN-5401-0883.2
IN-5401-12123.25
IN-610322.15
IN-610522.15
IN-611032.15
IN-620322.75
IN-620522.75
IN-621022.75
IN-622023
IN-622323
IN-622523

Page 6 of 10

14

Image /page/14/Picture/0 description: The image shows the logo for Summit Medical. The logo features the word "SUMMIT" in a bold, sans-serif font, with the "U" stylized to resemble a mountain range. Above the word "SUMMIT" are three blue diamonds arranged in a horizontal line. Below the word "SUMMIT" is the word "medical" in a smaller, sans-serif font.

IN-630323.28
IN-630523.28
IN-631023.28
IN-640323.28
IN-640523.28
IN-641023.28
IN-65003012.5
IN-701022
IN-701211.07
IN-7020308.5
IN-70303010
IN-703221.1
IN-7040255
IN-70503012
IN-7073105
IN-71204511.25
IN-71234512
IN-71304513.5
IN-71404514.5
IN-715081.9
IN-715361.7
IN-72133010
IN-72203013.5
IN-7223109.2
IN-72304514.5
IN-72344514.5
IN-72404514.5
IN-72504514.5
IN-72513010
IN-7252258
IN-72533012
IN-72604514.5
IN-7273106
IN-7274308
IN-73224514.5
IN-73234514.5
IN-73434514.5

Page 7 of 10

15

Image /page/15/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 blue diamonds, arranged in a horizontal line. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

IN-734414
IN-73604514.5
IN-74234514.5
IN-7452108
IN-7453108
IN-75404514.5
IN-75604514.5
IN-76444514.5
IN-7723157.18
IN-7724157.2
IN-7725109.5
IN-77814514.5
IN-78234514.5
IN-78304514.5
IN-78404513.5
IN-79402013.25
IN-82402013.5
IN-861026.65
IN-861226.8
IN-861326.1
IN-861525.8
IN-861625.8
IN-862037.2
IN-862147.18
IN-862247.18
IN-863036.5
IN-863236.45
IN-863336.8
IN-864045.35
IN-864245.35
IN-864355.35
IN-864545.35
IN-865045.85
IN-866045.35
IN-866245.35
IN-866335.5
IN-87004014

Page 8 of 10

16

Image /page/16/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.

IN-872117.5
IN-8771110.5
IN-88102013.5
IN-8820158.75
IN-88234514
IN-8830158.75
IN-88334514
IN-88402013.75
IN-8850158.75
IN-88534514
IN-8860158.75
IN-88623010.5
IN-88634514
IN-888023.28
IN-88821612.1
IN-888323.28
IN-888445.35
IN-888512.25
IN-8886612.1
IN-8889612.1
IN-8891-S12
IN-8891-SI-12-S12
IN-8891-SI-85-S12
IN-88921212.1
IN-889397.5
IN-8894516.1
IN-889786
IN-88981010.25
IN-889976.5
IN-890112.25
IN-89022217
IN-89031513.25
IN-89042217
IN-8907712.5
IN-892018
IN-893112.4
IN-893299.5

Page 9 of 10

17

Image /page/17/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.

IN-893333.75
IN-8936611.5
IN-89371614.5
IN-8938812.5
IN-89391011.6
IN-894055.18
IN-89421110
IN-894312.7
IN-894464.7
IN-894525.18
IN-894696.1
IN-8980209.5
IN-8982-01179.5
IN-8983-01169.5
IN-8984-01159.5
IN-8986-S26.5
IN-8987-S26.5
IN-8988-S26
IN-8989-S26
IN-9999-160612.1
IN-9999-162-S25.8
IN-9999-168-S25.8
IN-9999-172-S25.8
IN-9999-178-S25.8