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K Number
K142630
Device Name
Instru-Safe Instrument Protection System
Manufacturer
Summit Medical Inc.
Date Cleared
2014-12-23

(97 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 sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility.
Device Description
Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. 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.
More Information

K133015

Not Found

No
The device description and intended use clearly define the device as a physical cassette for organizing and protecting instruments during sterilization, with no mention of software, algorithms, or AI/ML capabilities.

No
The device is described as an instrument protection system (cassettes/trays) used to organize and protect other medical devices during sterilization, storage, and transportation. It does not perform any therapeutic function itself.

No
The device, Instru-Safe® Instrument Protection System, is described as cassettes/trays used to organize, hold, and protect other medical devices during sterilization, storage, and transportation. Its function is to facilitate the sterilization process of other instruments, not to diagnose a condition or disease in a patient.

No

The device description explicitly states it is a system of "cassettes / trays" which are physical hardware components used to hold and organize surgical instruments.

Based on the provided information, 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" and to "allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle." This describes a device used in the process of sterilizing surgical instruments, not a device used to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease.
  • Device Description: The description reinforces this by stating the cassettes/trays are used to "enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation."
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely related to the handling and sterilization of other medical instruments.

Therefore, the Instru-Safe® Instrument Protection System cassettes fall under the category of devices used in the sterilization and handling of medical instruments, not as an in vitro diagnostic device.

N/A

Intended Use / 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 pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. 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.

Product codes

KCT

Device Description

Summit Medical Inc. Instru-Safe Instrument Protection System are cassettes / trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. 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.

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

healthcare provider

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 Instru-Safe Instrument Protection System compatibility when used in a Four (4) minute pre-vacuum steam sterilization cycle within a Genesis rigid container.

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

Not Found

Predicate Device(s)

K133015

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 U.S. Department of Health and Human Services. The seal features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

February 26, 2015

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

Re: K142630

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: November 19, 2014 Received: November 26, 2014

Dear Ms. Nicole Dove:

This letter corrects our substantially equivalent letter of December 23, 2014.

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

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 vou 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

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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 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 professional, and the blue color gives it a sense of trust and reliability.

Indications for Use Statement

Page of

510(k) number: K142630

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 pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. 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.

Lumen claims for Four (4) Minute Pre-Vacuum Steam Sterilization Cycle:

Summit Cassette ModelMinimum Inside DiameterMaximum LengthNumber of Lumens
IN-26813mm200mm1
IN-26811mm65mm1
IN-00001mm400mm5
IN-00003mm400mm1
IN-00005mm400mm1
IN-61055mm241mm1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter X

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

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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 underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and professional, and the blue color gives it a sense of trust and reliability.

Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

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

The total weight of the container system (e.g. container, tray and instrument load) must not exceed 25 lbs.

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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 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 blue color gives it a professional look.

Indications for Use Statement

Part NumberMaximum # of InstrumentsEstimated Weight - Tray w/ instruments (lbs)
IN-1315303.5
IN-2681130.64
IN-2682130.89
IN-2683131.39
IN-2840368.75
IN-2842246.5
IN-2843368.75
IN-28805612.1
IN-2900224.18
IN-2950124.1
IN-3030349.5
IN-4000203.2
IN-4003303.25
IN-4010101.98
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-624022.75
IN-630323.28
IN-630523.28
IN-631023.28
IN-640323.28
IN-640523.28
IN-641023.28
IN-701022
IN-701211.07
IN-703221.1
IN-71204511.25
IN-71304513.5
IN-715081.9
IN-715361.7
IN-7223109.2
IN-7274308
IN-7723157.18
IN-7724157.2
IN-7725109.5
IN-78234514.5
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-866345.35
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-8892-011212.1
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-893112.4
IN-893299.5
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-8980-01209.5
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

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

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

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Image /page/6/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in 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 blue color gives it a professional look.

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

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Image /page/7/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a 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.

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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 underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue suggests a sense of trust and reliability.

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.
815 Northwest Parkway, Suite 100
St. Paul, MN 55121
Tel: (651) 789-3939
ER Number:3008719017
ContactNicole Dove
Person:QA/RA Manager
Tel: (651) 789-3921
ndove@summitmedicalusa.com
Date Prepared:December 22, 2014
SubjectTrade Name(s):
Device:Instru-Safe® 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
PredicateTradename: Instru-Safe Instrument Protection System
Device:510(k) Holder: Summit Medical Inc.
510(k) #: K133015
DeviceSummit Medical Inc. Instru-Safe Instrument Protection System are cassettes /
Description:trays used to enclose and hold surgical instruments and accessories in an
organized manner during the sterilization process and subsequent storage and
transportation. 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

Page 1 of 6

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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.

| 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.
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 pre-vacuum steam sterilization cycle. The
Instru-Safe Instrument Protection System cassettes are intended to be used in
conjunction with legally marketed Genesis rigid containers. The Instru-Safe
Instrument Protection 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)
Minimum Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Summit Cassette
ModelMinimum Inside
DiameterMaximum
LengthNumber of
Lumens
IN-26813mm200mm1
IN-26811mm65mm1
IN-00001mm400mm5
IN-00003mm400mm1
IN-00005mm400mm1
IN-61055mm241mm1
The intended use of the subject device includes the use of Genesis rigid containers
and the intended use of the predicate device includes the use of Aesculap rigid
containers. The difference in rigid containers is not critical and does not affect
safety and effectiveness of the Instru-Safe 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 Instru-Safe Instrument
Protection System is identical to the identified 510(k) cleared predicate device.
Performance
Data:Sterilization validation testing was performed to demonstrate Instru-Safe
Instrument Protection System compatibility when used in a Four (4) minute pre-
vacuum steam sterilization cycle within a Genesis rigid container.
Sterilization methods and configurations
• Autoclave Sterilization Parameter:
Cycle: Pre-Vacuum

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 56121
| Summit Medical, |

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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 sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds, arranged in a horizontal row. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

| Temperature: | 270°F (132°C)
Minimum Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based upon intended use, performance data and technical information provided in this pre-market notification, the Instru-Safe Instrument Protection System described herein are substantially equivalent to current legally marketed predicate devices. |

Substantial Equivalence - Device Comparisons

| Characteristic
Indications | New Device | Predicate Device Instru-Safe
Instrument Protection Systems
K133015 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Indication for
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 pre-vacuum steam
sterilization cycle. The Instru-Safe
Instrument Protection System cassettes
are intended to be used in conjunction
with legally marketed Genesis rigid
container. The Instru-Safe Instrument
Protection 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 | 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 central 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Summit
Cassette
Model Minimum
Inside
Diameter Maximum
Length # of
Lumens IN-2681 3mm 200mm 1 IN-2681 1mm 65mm 1 IN-0000 1mm 400mm 5 IN-0000 3mm 400mm 4 IN-0000 5mm 400mm 4 IN-6105 5mm 241mm 4 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Summit Cassette
Model Aesculap
Container Model IN-8823-AE *JN444 IN-2880 *JK444 IN-6105 *JN742 *Validated by Summit Medical for use in
steam pre-vacuum sterilizers ONLY
operating at 270°F (132°C) for 4 minutes | | | | | | | | | | |

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 6

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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 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 use of blue gives it a professional and trustworthy feel.

ElementNew DevicePredicate (K133015)
Intended UseInstru-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 pre-vacuum steam
sterilization cycle. The Instru-Safe
Instrument Protection System cassettes
are intended to be used in conjunction
with legally marketed Genesis rigid
container. The Instru-Safe Instrument
Protection System cassettes are not
intended on their own to maintain
sterility.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
pre-vacuum steam sterilization
cycles. 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.
Sterilization methods and configurations
Autoclave Sterilization Parameter:
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutesSterilization methods and configurations
Autoclave Sterilization Parameter:
Cycle: Pre-vacuum
Temperature: : 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Summit
Cassette
Model Minimum
Inside
Diameter Maximum
Length # of
Lumens IN-2681 3mm 200mm 1 IN-2681 1mm 65mm 1 IN-0000 1mm 400mm 5 IN-0000 3mm 400mm 4 IN-0000 5mm 400mm 4 IN-6105 5mm 241mm 4Summit Cassette
Model Aesculap
Container Model IN-8823-AE *JN444 IN-2880 *JK444 IN-6105 *JN742
*Validated by Summit Medical for use in steam
pre-vacuum 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.*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.

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

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Image /page/12/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 large, sans-serif font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. The color scheme is primarily blue and white.

| Material
Composition | No changes from predicate device | The cassette contains components
made of anodized aluminum,
stainless steel, blue silicone, black
silicone, polyester, ultemTM 1000 |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
Properties | Instru-Safe Instrument Protection
System cassettes include

  • perforated base
  • perforated cover
  • silicone inserts (hold-it / hold
    down)
  • Handles
  • Latches
  • Feet
  • Posts (optional)
  • Divider (optional)
  • Shelf (optional) | Instru-Safe Instrument Protection
    System cassettes include
  • perforated base
  • perforated cover
  • silicone inserts (hold-it / hold
    down)
  • Handles
  • Latches
  • Feet
  • Posts (optional)
  • Divider (optional)
  • Shelf (optional) |
    | Configurations/
    Dimensions | Various configurations / dimensions,
    refer to section 14a | See table located in predicate device
    submission K133015 |
    | Performance | New Device | Predicate (K133015) |
    | Sterilant
    Penetration | Pre-Vacuum Steam
    No Change | Pre-Vacuum Steam
    270°F (132°C), 4 minutes |
    | Toxicological
    Properties
    (Biocompatibility,
    including
    Sterilant Residue
    Limits) | No change | Refer to predicate device K133015 |
    | Shelf Life | No change | Reusable (5 year accelerated shelf
    life study) |
    | Drying Time | No change | Autoclave Sterilization Parameter:
    4 minute 270°C (132°C)

Minimum Dry Time:

  • 30 minute |
    | 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 Instru-Safe
    Instrument Protection System compatibility when used in a Four (4) minute pre-
    vacuum steam sterilization cycle within a Genesis rigid container. | |

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

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Sterilization methods and configurations
Autoclave Sterilization Parameter
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes