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.

AI/ML Overview

The provided document is a 510(k) summary for the Instru-Safe® Instrument Protection System, which is a sterilization tray. This document focuses on demonstrating substantial equivalence to a predicate device (K133015) rather than on presenting a clinical study or performance data of a new AI device. Therefore, many of the requested elements for describing an AI device's acceptance criteria and study proving its performance (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or type of ground truth) are not applicable or cannot be extracted from this document.

The document discusses the performance data in terms of sterilization validation testing for the device's ability to allow sterilization of enclosed medical devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Indications for Use" and the "Sterilization methods and configurations" which specify the conditions under which the device is intended to function effectively for sterilization. The reported performance is that the device has passed "Sterilization validation testing" under these conditions.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	Organize and protect other medical devices sterilized by a healthcare provider. Allow sterilization of enclosed medical devices during a pre-vacuum steam sterilization cycle. Used in conjunction with legally marketed Genesis rigid containers. Not intended on their own to maintain sterility.	The device's indications for use align with this, and its performance is validated through sterilization testing.
Sterilization Parameters	Cycle: Pre-Vacuum	Sterilization validation testing was performed to demonstrate compatibility with a pre-vacuum steam sterilization cycle.
	Temperature: 270°F (132°C)	Sterilization validation testing was performed at 270°F (132°C).
	Minimum Exposure Time: 4 minutes	Sterilization validation testing was performed with a 4-minute exposure time.
	Minimum Dry Time: 30 minutes	Sterilization validation testing was performed with a 30-minute dry time.
Lumen Claims	Specific dimensions for minimum inside diameter, maximum length, and number of lumens for various Summit Cassette Models (e.g., IN-2681: 3mm ID, 200mm length, 1 lumen; IN-0000: 1mm ID, 400mm length, 5 lumens).	The device's performance is demonstrated for the specified lumen claims in the table.
Worst Case Load	IN-2681 tray identified as the worst case validated load by vent-to-volume calculation.	The system is validated for the worst-case load.
Total Weight Limit	Total weight of the container system (container, tray, instrument load) must not exceed 25 lbs.	Not explicitly stated as "met," but implied by the successful sterilization validation. The table for "Estimated Weight - Tray w/ instruments" for various part numbers shows individual tray weights well below 25 lbs, so the cumulative system weight would need to adhere to this.
Material Composition	No changes from predicate device; components made of anodized aluminum, stainless steel, blue silicone, black silicone, polyester, ultem™ 1000.	Confirmed as "No changes from predicate device."
Physical Properties	Includes perforated base, perforated cover, silicone inserts, handles, latches, feet, and optional posts, dividers, and shelves.	Confirmed as identical to the predicate device.
Toxicological Properties	No change from predicate device; biocompatibility, including sterilant residue limits.	Confirmed as "No change."
Shelf Life	Reusable (5-year accelerated shelf life study).	Confirmed as "No change."

Since the provided text is for a traditional medical device (sterilization tray) and not an AI/ML powered device, the following points are largely not applicable. However, I will answer them based on what can be inferred or explicitly stated, noting the limitations.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of cases or patients, as this is a device validation, not a clinical trial evaluating diagnostic or predictive accuracy. The "test" in this context refers to the sterilization validation testing of the physical device models and lumen configurations. For lumen claims, specific models like IN-2681, IN-0000, and IN-6105 with various lumen dimensions were tested. The "worst case validated load" (IN-2681 tray) suggests testing was performed to cover the most challenging scenarios.
- Data Provenance: Not applicable in the context of clinical data. The performance data is derived from laboratory-based sterilization validation testing of the physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The "ground truth" for a sterilization device is whether it effectively sterilizes, which is determined by microbiological and physical testing methods, not expert human interpretation of medical images or pathologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, whereas sterilization effectiveness is assessed objectively through validated protocols (e.g., biological indicators, chemical indicators, physical parameters).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are used for evaluating diagnostic performance of imaging modalities or AI systems that assist human readers. This device is a physical sterilization tray.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI system. Its performance is inherent in its design and its ability to withstand and facilitate sterilization processes.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is the successful completion of sterilization validation testing, typically involving:
  - Biological Indicators: Confirmation of microbial kill (e.g., Geobacillus stearothermophilus spores).
  - Chemical Indicators: Verification of exposure to sterilant.
  - Physical Monitoring: Verification of temperature, pressure, and exposure time within the sterilizer.
  - Dryness Assessment: Ensuring instruments are dry after the cycle.
- The document states "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." This implies the use of standard sterilization validation protocols to confirm efficacy.
The sample size for the training set
- Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.

Summary

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If 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 Model	Minimum Inside Diameter	Maximum Length	Number of Lumens
IN-2681	3mm	200mm	1
IN-2681	1mm	65mm	1
IN-0000	1mm	400mm	5
IN-0000	3mm	400mm	1
IN-0000	5mm	400mm	1
IN-6105	5mm	241mm	1

(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)

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 Number	Maximum # of Instruments	Estimated Weight - Tray w/ instruments (lbs)
IN-1315	30	3.5
IN-2681	13	0.64
IN-2682	13	0.89
IN-2683	13	1.39
IN-2840	36	8.75
IN-2842	24	6.5
IN-2843	36	8.75
IN-2880	56	12.1
IN-2900	22	4.18
IN-2950	12	4.1
IN-3030	34	9.5
IN-4000	20	3.2
IN-4003	30	3.25
IN-4010	10	1.98
IN-5401	6	2
IN-5401-02	2	1
IN-5401-03	2	1
IN-5401-08	8	3.2
IN-5401-12	12	3.25
IN-6103	2	2.15
IN-6105	2	2.15
IN-6110	3	2.15
IN-6203	2	2.75
IN-6205	2	2.75
IN-6210	2	2.75
IN-6240	2	2.75
IN-6303	2	3.28
IN-6305	2	3.28
IN-6310	2	3.28
IN-6403	2	3.28
IN-6405	2	3.28
IN-6410	2	3.28
IN-7010	2	2
IN-7012	1	1.07
IN-7032	2	1.1
IN-7120	45	11.25
IN-7130	45	13.5
IN-7150	8	1.9
IN-7153	6	1.7
IN-7223	10	9.2
IN-7274	30	8
IN-7723	15	7.18
IN-7724	15	7.2
IN-7725	10	9.5
IN-7823	45	14.5
IN-7840	45	13.5
IN-7940	20	13.25
IN-8240	20	13.5
IN-8610	2	6.65
IN-8612	2	6.8
IN-8613	2	6.1
IN-8615	2	5.8
IN-8616	2	5.8
IN-8620	3	7.2
IN-8621	4	7.18
IN-8622	4	7.18
IN-8630	3	6.5
IN-8632	3	6.45
IN-8633	3	6.8
IN-8640	4	5.35
IN-8642	4	5.35
IN-8643	5	5.35
IN-8645	4	5.35
IN-8650	4	5.85
IN-8660	4	5.35
IN-8662	4	5.35
IN-8663	4	5.35
IN-8810	20	13.5
IN-8820	15	8.75
IN-8823	45	14
IN-8830	15	8.75
IN-8833	45	14
IN-8840	20	13.75
IN-8850	15	8.75
IN-8853	45	14
IN-8860	15	8.75
IN-8862	30	10.5
IN-8863	45	14
IN-8880	2	3.28
IN-8882	16	12.1
IN-8883	2	3.28
IN-8884	4	5.35
IN-8885	1	2.25
IN-8886	6	12.1
IN-8889	6	12.1
IN-8891-S	1	2
IN-8891-SI-12-S	1	2
IN-8891-SI-85-S	1	2
IN-8892-01	12	12.1
IN-8893	9	7.5
IN-8894	5	16.1
IN-8897	8	6
IN-8898	10	10.25
IN-8899	7	6.5
IN-8901	1	2.25
IN-8902	22	17
IN-8903	15	13.25
IN-8904	22	17
IN-8907	7	12.5
IN-8931	1	2.4
IN-8932	9	9.5
IN-8933	3	3.75
IN-8936	6	11.5
IN-8937	16	14.5
IN-8938	8	12.5
IN-8939	10	11.6
IN-8940	5	5.18
IN-8942	11	10
IN-8943	1	2.7
IN-8944	6	4.7
IN-8945	2	5.18
IN-8946	9	6.1
IN-8980-01	20	9.5
IN-8982-01	17	9.5
IN-8983-01	16	9.5
IN-8984-01	15	9.5
IN-8986-S	2	6.5
IN-8987-S	2	6.5
IN-8988-S	2	6
IN-8989-S	2	6
IN-9999-160	6	12.1
IN-9999-162-S	2	5.8
IN-9999-168-S	2	5.8
IN-9999-172-S	2	5.8
IN-9999-178-S	2	5.8

Summit Medical, Inc. | 815 Northwest Parkway, Suite 100 | St. Paul, MN 55121 USA 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
Contact	Nicole Dove
Person:	QA/RA Manager
	Tel: (651) 789-3921
	ndove@summitmedicalusa.com
Date Prepared:	December 22, 2014
Subject	Trade 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
Predicate	Tradename: Instru-Safe Instrument Protection System
Device:	510(k) Holder: Summit Medical Inc.
	510(k) #: K133015
Device	Summit 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: arectangular base with latchable cover. The cassettes / trays have perforations toallow sterilant penetration. The cassettes / trays contain silicone inserts in the baseand/or cover to hold, organize and protect the surgical instruments within thecassette / tray.
Intended Use:	Instru-Safe® Instrument Protection System cassettes are used to organize andprotect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization ofthe enclosed medical devices during a pre-vacuum steam sterilization cycle. TheInstru-Safe Instrument Protection System cassettes are intended to be used inconjunction with legally marketed Genesis rigid containers. The Instru-SafeInstrument Protection System cassettes are not intended on their own to maintainsterility.
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 CassetteModel	Minimum InsideDiameter	MaximumLength	Number ofLumens
	IN-2681	3mm	200mm	1
	IN-2681	1mm	65mm	1
	IN-0000	1mm	400mm	5
	IN-0000	3mm	400mm	1
	IN-0000	5mm	400mm	1
	IN-6105	5mm	241mm	1
The intended use of the subject device includes the use of Genesis rigid containersand the intended use of the predicate device includes the use of Aesculap rigidcontainers. The difference in rigid containers is not critical and does not affectsafety and effectiveness of the Instru-Safe Instrument Protection System.
Comparison ofCharacteristicsto PredicateDevice:	Based on a comparison of the design, technology, materials, manufacturing,performance, specifications and methods of use, the Instru-Safe InstrumentProtection System is identical to the identified 510(k) cleared predicate device.
PerformanceData:	Sterilization validation testing was performed to demonstrate Instru-SafeInstrument 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 minutesMinimum 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

CharacteristicIndications	New Device	Predicate Device Instru-SafeInstrument Protection SystemsK133015
Indication forUse	Instru-Safe® Instrument ProtectionSystem cassettes are used to organizeand protect other medical devices thatare sterilized by a healthcare provider.Instru-Safe Instrument ProtectionSystem cassettes are intended to allowsterilization of the enclosed medicaldevices during a pre-vacuum steamsterilization cycle. The Instru-SafeInstrument Protection System cassettesare intended to be used in conjunctionwith legally marketed Genesis rigidcontainer. The Instru-Safe InstrumentProtection System cassettes are notintended on their own to maintainsterility.Sterilization methods and configurations• Autoclave Sterilization Parameter:Cycle: Pre-VacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutes	Instru-Safe Instrument ProtectionSystem cassettes are used toorganize and protect other medicaldevices that are sterilized by ahealthcare provider. Instru-SafeSystem cassettes are intended toallow sterilization of the enclosedmedical devices during a pre-vacuum steam sterilization cycle.The Instru-Safe System cassettes areintended to be used in conjunctionwith central legally marketed wrapor Aesculap rigid container. TheInstru-Safe System cassettes are notintended on their own to maintainsterility.Sterilization methods and configurations• Autoclave Sterilization Parameter:Cycle: Pre-VacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutes
	SummitCassetteModel MinimumInsideDiameter MaximumLength # ofLumens 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 CassetteModel AesculapContainer Model IN-8823-AE JN444 IN-2880 JK444 IN-6105 JN742 Validated by Summit Medical for use insteam pre-vacuum sterilizers ONLYoperating 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.

Element	New Device	Predicate (K133015)
Intended Use	Instru-Safe ® Instrument ProtectionSystem cassettes are used to organizeand protect other medical devices thatare sterilized by a healthcare provider.Instru-Safe Instrument ProtectionSystem cassettes are intended to allowsterilization of the enclosed medicaldevices during a pre-vacuum steamsterilization cycle. The Instru-SafeInstrument Protection System cassettesare intended to be used in conjunctionwith legally marketed Genesis rigidcontainer. The Instru-Safe InstrumentProtection System cassettes are notintended on their own to maintainsterility.	Instru-Safe Instrument ProtectionSystem cassettes are used to organizeand protect other medical devicesthat are sterilized by a healthcareprovider. Instru-Safe InstrumentProtection System cassettes areintended to allow sterilization of theenclosed medical devices during apre-vacuum steam sterilizationcycles. The Instru-Safe InstrumentProtection System cassettes areintended to be used in conjunctionwith a legally marketed wrap orAesculap rigid container. TheInstru-Safe Instrument ProtectionSystem cassettes are not intended ontheir own to maintain sterility.
	Sterilization methods and configurationsAutoclave Sterilization Parameter:Cycle: Pre-VacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutes	Sterilization methods and configurationsAutoclave Sterilization Parameter:Cycle: Pre-vacuumTemperature: : 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutes
	SummitCassetteModel MinimumInsideDiameter MaximumLength # ofLumens 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 CassetteModel AesculapContainer Model IN-8823-AE JN444 IN-2880 JK444 IN-6105 *JN742
	*Validated by Summit Medical for use in steampre-vacuum sterilizers ONLY operating at270°F (132°C) for 4 minutes exposure time.Consult container instructions to ensure thatcontents do not exceed the sterilizationcontainers intended load claims.	*Validated by Summit Medical for use insteam prevacuum sterilizers ONLYoperating at 270°F (132°C) for 4 minutesexposure time. Consult containerinstructions to ensure that contents do notexceed the sterilization containers intendedload 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.

MaterialComposition	No changes from predicate device	The cassette contains componentsmade of anodized aluminum,stainless steel, blue silicone, blacksilicone, polyester, ultemTM 1000
PhysicalProperties	Instru-Safe Instrument ProtectionSystem cassettes include- perforated base- perforated cover- silicone inserts (hold-it / holddown)- Handles- Latches- Feet- Posts (optional)- Divider (optional)- Shelf (optional)	Instru-Safe Instrument ProtectionSystem cassettes include- perforated base- perforated cover- silicone inserts (hold-it / holddown)- Handles- Latches- Feet- Posts (optional)- Divider (optional)- Shelf (optional)
Configurations/Dimensions	Various configurations / dimensions,refer to section 14a	See table located in predicate devicesubmission K133015
Performance	New Device	Predicate (K133015)
SterilantPenetration	Pre-Vacuum SteamNo Change	Pre-Vacuum Steam270°F (132°C), 4 minutes
ToxicologicalProperties(Biocompatibility,includingSterilant ResidueLimits)	No change	Refer to predicate device K133015
Shelf Life	No change	Reusable (5 year accelerated shelflife study)
Drying Time	No change	Autoclave Sterilization Parameter:4 minute 270°C (132°C)Minimum Dry Time:- 30 minute
TechnologicalCharacteristics:	The technological characteristics of the subject devices are equivalent to thepredicate devices. The cassettes / trays are made of standard medical gradematerials and do not incorporate any new technological characteristics.
PerformanceData:	Sterilization validation testing was performed to demonstrate Instru-SafeInstrument 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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Image /page/13/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 in a horizontal row. The logo is simple and modern, and the blue color gives it a professional look.

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

Regulation Number and Section

§ 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).