LogoFDA 510(k) Search
K Number
K150540
Device Name
Instru-Safe Instrument Protection System
Manufacturer
SUMMIT MEDICAL, INC.
Date Cleared
2015-06-22

(111 days)

Product Code
KCT
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Amsco V-PRO Low Temperature 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. A full list of device models is provided in table 1.
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 data processing.

No
The device is described as an instrument protection system, used to organize and protect other medical devices during sterilization, storage, and transportation. It does not exert any therapeutic effect on a patient.

No
The document describes the device as cassettes/trays used to organize and protect medical devices during sterilization, storage, and transportation. It does not perform any diagnostic function.

No

The device description clearly states it is a physical cassette/tray system used to hold and organize surgical instruments, which are hardware 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" and to "allow sterilization of the enclosed medical devices". This describes a device used in the sterilization process of other medical instruments.
  • Device Description: The description reinforces this by stating they 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."
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

Therefore, the Instru-Safe® Instrument Protection System is a device used in the sterilization and handling of other medical instruments, not 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. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during Amsco V-PRO Low Temperature Sterilization Cycles. The 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.

Amsco V-PRO Low Temperature Sterilization Cycles:
Sterilizer: V-PRO 1, Standard Cycle: X, LumenCycle: N/A, Non Lumen Cycle: N/A
Sterilizer: V-PRO 1 Plus, Standard Cycle: N/A, LumenCycle: X, Non Lumen Cycle: X
Sterilizer: V-PRO maX, Standard Cycle: N/A, LumenCycle: X, Non Lumen Cycle: X

Summit Cassette Model: IN-8823, Aesculap Container Model: *JM444
Summit Cassette Model: IN-6105, Aesculap Container Model: *JM742

  • Validated by Summit Medical for use in Amso V-PRO Low Temperature Sterilization systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.

Lumen size of instrumentation validated includes:
Summit Cassette Model: IN-8823, Minimum Inside Diameter: 3 mm, Maximum Length: 400 mm, Number of Lumens: 2
Summit Cassette Model: IN-6105, Minimum Inside Diameter: 3 mm, Maximum Length: 200 mm, Number of Lumens: 1
Summit Cassette Model: IN-2681, Minimum Inside Diameter: 1 mm, Maximum Length: 64 mm, Number of Lumens: 1

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. 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 an Amsco V-PRO Low Temperature Sterilization Systems 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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other.

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

June 22, 2015

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

Re: K150540

Trade/Device Name: Instru-Safe® Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 20, 2015 Received: May 22, 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) K150540

Device Name

Instru-Safe® Instrument Protection System

Indications for Use (Describe)

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during Amsco V-PRO Low Temperature Sterilization Cycles. The 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.

Amsco V-PRO Low Temperature Sterilization Cycles:
-------------------------------------------------------------

| Sterilizer | Standard
Cycle | Lumen
Cycle | Non Lumen
Cycle |
|--------------|-------------------|----------------|--------------------|
| V-PRO 1 | X | N/A | N/A |
| V-PRO 1 Plus | N/A | X | X |
| V-PRO maX | N/A | X | X |

Summit Cassette ModelAesculap Container Model
IN-8823*JM444
IN-6105*JM742
  • Validated by Summit Medical for use in Amso V-PRO Low Temperature Sterilization systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.
Lumen size of instrumentation validated includes:
Summit Cassette ModelMinimum Inside DiameterMaximum LengthNumber of Lumens
IN-88233 mm400 mm2
IN-61053 mm200 mm1
IN-26811 mm64 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)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

Image /page/4/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, sans-serif font underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo has a clean and modern design.

Indications for Use Statement

Table 1 – Device Models
Part NumberMaximum # of InstrumentsEstimated Weight - Tray w/ instruments (lbs)
IN-1315303.5
IN-200682
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-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-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-7073105
IN-71204511.25
IN-71234512
IN-71304513.5
IN-71404514.5
IN-715081.9
IN-715361.7
IN-72204514.5
IN-7223109.2
IN-72304514.5
IN-72344514.5
IN-72404514.5
IN-72504514.5
IN-7252258
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-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-8902-G22217
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-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

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

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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.

7

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 blue color gives it a professional look.

8

Image /page/8/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/9/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 suggests 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 |
| Contact
Person: | Nicole Dove
QA/RA Manager Tel: (651)
789-3921
ndove@summitmedicalusa.com |
| Date Prepared: | June 22, 2015 |
| Subject
Device: | Trade Name(s):
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 |
| Predicate
Device: | Tradename: Instru-Safe Instrument Protection System
510(k) Holder: Summit Medical Inc.
510(k) #: K133015 |
| 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. |

Page 1 of 11

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Image /page/10/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. Below "SUMMIT" is the word "medical" in a smaller, sans-serif font. The overall design is clean and professional, suggesting a healthcare or medical-related organization.

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 Amsco V-PRO Low Temperature Sterilization Cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
Amsco V-PRO Low Temperature Sterilization Systems
SterilizerStandard CycleLumen CycleNon Lumen Cycle
V-PRO 1XN/AN/A
V-PRO 1 PlusN/AXX
V-PRO maXN/AXX
Summit Cassette ModelAesculap Container Model
IN-8823*JM444
IN-6105*JM742
*Validated by Summit Medical for use in Amsco V-PRO Low Temperature Sterilization Systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.
Lumen size of instrumentation validated includes:
Summit Cassette ModelMinimum Inside DiameterMaximum LengthNumber of Lumens
IN-88233mm400mm2
IN-61053mm200mm1
IN-26811mm64mm1
The worst case validated load by vent-to-volume calculation is the IN-2681 tray. The intended use of the subject device includes the Amsco V-PRO Low Temperature Sterilization Systems. Performance testing has been completed for the Amsco V-PRO Low Temperature Sterilization Systems. These new sterilization cycles do 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 equivalent to the identified 510(k) cleared predicate device.
ElementNew DevicePredicate (K133015)

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 2 of 11

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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. The logo is simple and modern, and the use of blue gives it a professional look.

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 Amsco V-PRO Low Temperature Sterilization Cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in table 1.
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 configurationsSterilization methods and configurations
Amsco V-PRO Low Temperature Sterilization Systems• Autoclave Sterilization Parameter:
Cycle: Pre-vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
SterilizerStandard CycleLumen CycleNon Lumen Cycle
V-PRO 1XN/AN/A
V-PRO 1 PlusN/AXX
V-PRO MAXN/AXX
Summit Cassette ModelAesculap Container Model
IN-8823-AE*JN444
IN-2880*JK444
IN-6105*JN742
IN-8823*JM444
IN-6105*JM742
*Validated by Summit Medical for use in Amsco V-PRO Low Temperature Sterilization Systems ONLY. When using the Aesculap container as a sterile barrier, the load (Summit tray and contents), should not exceed the load claims for the container in weight or load type.*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 container intended load claims.

Page 3 of 11

12

Lumen size of instrumentation validated includes:
Summit
Cassette
ModelMinimum
Inside
DiameterMaximum
LengthNumber of
Lumens
IN-88233mm400mm2
IN-61053mm200mm1
IN-26811mm64mm1
The worst case validated load by vent-to- volume calculation
is the IN-2681 tray.
Material
CompositionNo changes from predicate deviceThe cassette contains
components made
of anodized aluminum,
stainless steel, blue
Physical
PropertiesInstru-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 |
    | Chemical
    Properties | Not Applicable | | Not Applicable |
    | Configurations
    / Dimensions | Various configurations / dimensions | | See table located in
    predicate device |
    | Air permeance | Not Applicable | | Not Applicable |

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 11

13

| Percent of
surface

performationsNot ApplicableNot Applicable
PerformanceNew DevicePredicate
SterilantAmsco V-PRO Low TemperaturePre-Vacuum Steam
PenetrationSterilization Systems.Cycle: Pre-
vacuum
Temperature:
270°F (132°C)
MicrobialNot ApplicableNot Applicable
Barrier
Properties
(Packaging
Integrity)
MaterialNo changes from predicate deviceRefer to predicate device
CompatibilityK133015
ToxicologicalMEM Elution Cytotoxicity (ISORefer to predicate device
Properties10993-5)K133015
(BiocompatibilThe test samples meet the USP and
  • | |
    | ity, including | ISO 10993-5 requirements for this | |

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Image /page/14/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a large, 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 and trustworthy look.

| Sterilant
Residue
Limits) | test. All controls were acceptable
and the test considered valid. The
test samples PASSED and are
considered NON-CYTOTOXIC
under the test conditions employed. | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) Minimum Exposure
Time: 4 minutes Minimum Dry Time:
30 minutes |
| Aeration Time | Not Applicable | Not 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 Instru-Safe
Instrument Protection System compatibility when used in an Amsco V-PRO Low
Temperature Sterilization Systems 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 Instru-Safe Instrument Protection System
described herein is substantially equivalent to the predicate device [Instru-Safe
Instrument Protection System (K133015)]. | |

15

Image /page/15/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.

Table 1 – Device Models
Part NumberMaximum # of InstrumentsEstimated Weight - Tray w/ instruments (lbs)
IN-1315303.5
IN-200682
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-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-624022.75
IN-630323.28
IN-630523.28
IN-631023.28
IN-640323.28
IN-640523.28
IN-641023.28

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 7 of 11

16

Image /page/16/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized, 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, with a clean and professional look.

IN-65003012.5
IN-701022
IN-701211.07
IN-7020308.5
IN-70303010
IN-703221.1
IN-7073105
IN-71204511.25
IN-71234512
IN-71304513.5
IN-71404514.5
IN-715081.9
IN-715361.7
IN-72204514.5
IN-7223109.2
IN-72304514.5
IN-72344514.5
IN-72404514.5
IN-72504514.5
IN-7252258
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

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

phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com

17

Image /page/17/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.

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-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

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

phone: 651.789.3939 | fax: 651.789.3979 www.summitmedicalusa.com

summermedicalusa.com
Page 0 of 11

Page 9 of 11

18

Image /page/18/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 blue font. Below "SUMMIT" is the word "medical" in a smaller, sans-serif blue font.

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-8902-G22217
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-8980209.5
IN-8982-01179.5
IN-8983-01169.5

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 10 of 11

19

Image /page/19/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-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