InstruSafe® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterlization Cycle 1. The Instrusate Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instrument Protection System casettes are not intended on their own to maintain sterility.

Summit Medical has validated the use of the Instrument Protection System cassettes in Cycle 1 of the STERIZONE VP4 sterilizer through demonstrations of sterilization efficacy using representative samples including general instruments, rigid and semi-rigid instruments with lumens, and flexible endoscopes. The validation provided information that has been used to establish design limits that are applied across the range of Instrument Protection System cassettes to ensure that all models fall within the validated limits for cassette ventilation, internal shelving, and weight:

Minimum ventilation-to-volume ratio, general instruments: 0.073
Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263
Maximum number of internal shelves: Two (2)
Maximum cassette weight (including contents): 25 lbs/cassette

Refer to Table for the validated loads using Instrument Protection System cassettes. Refer to the sterilizer manufacturer's instructions for use to ensure that loads do not exceed the claimed limits for the sterilizer.

Device Description

Summit Medical LLC InstruSafe Instrument Protection Systems are cassettes/trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays do not have direct patient contact. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize, and protect the surgical instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the InstruSafe Instrument Protection System, details the device's acceptance criteria and the studies conducted to demonstrate that it meets these criteria. This device is a medical accessory, specifically sterilization wrap, and the performance data focuses on its efficacy in the sterilization process, not on diagnostic accuracy of an AI/ML algorithm. Therefore, many of the standard questions regarding AI/ML device validation (e.g., sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable in this context.

However, I can extract the relevant acceptance criteria and the performance results for this device, which are based on non-clinical testing for sterilization efficacy and device integrity.

Acceptance Criteria and Reported Device Performance

The device's performance was validated through a series of nonclinical tests designed to ensure its safety and effectiveness in the sterilization process. The acceptance criteria and the reported performance are summarized in the table below.

Test Methodology	Purpose	Acceptance Criteria	Results
Cleaning Validations (Manual, Mechanical, and Ultrasonic) FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Issued March 2015) AAMI TIR30:2011	To validate the effectiveness of manual, mechanical, and ultrasonic cleaning procedures specified in the Instructions for Use using the worst-case cassette in terms of product geometry, worst-case (coldest) processing temperatures, and artificial soil.	Micro BCA Protein Assay: Residual protein level $\leq$ 6.4 µg/cm²Total Organic Carbon assay: TOC $\leq$ 2.2 µg/cm²	Pass
Sterilization Efficacy Validation: Half-Cycle Overkill Approach ANSI/AAMI/ISO 14937:2009	To demonstrate delivery of a minimum sterility assurance level (SAL) of 10^-6 to biological indicators (BIs) at difficult to sterilize locations in medical devices when validation loads are processed in the InstruSafe Instrument Protection System cassettes. Both wraps and rigid containers were used as sterile barriers.	Three (3) consecutive half cycles in which all biological indicators (BIs) are inactivated.Minimum BI population: 1 x 10^6 CFU/BI	Pass
Sterility maintenance via simulated use and shelf-life testing using coupon sterility tests at end of shelf life. ANSI/AAMI/ISO 11607:2019 ANSI/AAMI ST77:2013/(R)2018	To demonstrate maintenance of sterility over the stated shelf life using simulated handling conditions when sterilization wrap is used as the sterile barrier for the worst-case cassette in terms of weight.	Sterility tests of coupons that were sterilized and stored in the wrapped cassettes shall be negative for growth after 366 days of simulated storage and handling.	Pass
Microbial Aerosol Challenge for Sterile Barrier Package Integrity	To demonstrate the integrity of sterilization wrap as a sterile barrier after exposure to Cycle 1 using a microbial aerosol challenge of $\geq$ 800 CFU/cm².	Sterility tests of coupons that were sterilized in Cycle 1 and then subjected to the microbial aerosol challenge in the wrapped cassette shall be negative.	Pass
Residual hydrogen peroxide testing ANSI/AAMI ST77:2013 ANSI/AAMI/ISO 11607-1:2019 ISO 10993-12:2012	To demonstrate that levels of residual hydrogen peroxide on cassette materials were below safe levels after a worst-case exposure of three (3) consecutive iterations of Cycle 1.	The extracted residual hydrogen peroxide on device materials shall not exceed 997 ± 142 µg/cm², which was established as a safe level in K141163.	Pass
Biocompatibility of Subject Device (by cytotoxicity testing) ANSI/AAMI/ISO 10993-5 ANSI/AAMI/ISO 10993-12	To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.	Non-cytotoxic, a reactivity grade of $\leq$ 1 is scored based on histological interpretation of the test system.	Pass
Life Cycle / Simulated Use Life Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)	To validate the service life of the trays as stated in the Instructions for Use.	Visual inspection, component dimensional fit verification, functional closure/latch verification for 100 use cycles.	Pass
Cassette handle safety test. ANSI/AAMI ST77:2013	To demonstrate that the handles on the InstruSafe cassettes could withstand a 100-lb load without deforming or failing.	No evidence of damage, deformation, or cracking of the handle after a 100-lb load is applied for 1 minute.	Pass

Study Information (Relevant to Device Validation)

Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in the context of an AI/ML algorithm. Instead, the testing involved representative samples of instruments and cassettes under various loading conditions. These conditions are detailed in the "Description of InstruSafe Instrument Protect System Loads" table (pages 2-3 and 6-8 of the original document). For instance:
- Load 4a: Three (3) IN-7323-R cassettes.
- Load 4b: Three (3) IN-0007-TF cassettes.
- Load 7a: Three (3) IN-7323-R cassettes.
- Load 7b: Three (3) IN-0006-TF cassettes.
- Load 8a: Three (3) cassettes (two IN-0003-R, one IN-0004-R).
- Load 8b: Two (2) IN-0003-TF cassettes.
  The provenance of this data is from the manufacturer's internal validation studies, not from patient data, and it is prospective in nature as it involves planned experimental testing. The country of origin is not explicitly stated for the testing, but the applicant (Summit Medical LLC) is based in St. Paul, Minnesota, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The device is a physical product (instrument protection system), not an AI/ML diagnostic tool. Ground truth is established through physical and chemical performance metrics (e.g., microbial inactivation, protein residue levels, structural integrity), not expert human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This question is not applicable as there is no human interpretation or labeling involved. The "ground truth" is determined by objective laboratory measurements and standardized test protocols.
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:
This question is not applicable as the device is not an AI/ML diagnostic tool and does not involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is not an AI/ML algorithm. The performance established is the "standalone" performance of the physical device in meeting its intended function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is established through physical and biological measurements based on recognized standards (e.g., ANSI/AAMI/ISO standards, FDA guidance). Examples include:
- Biological indicators (BIs): Used to confirm sterility assurance level (SAL).
- Chemical assays: Micro BCA Protein Assay and Total Organic Carbon (TOC) assay for cleaning validation.
- Physical inspection and load testing: For life cycle, handling, and structural integrity.
- Microbial challenge: For sterile barrier integrity.
- Cytotoxicity testing: To evaluate biocompatibility.
The sample size for the training set:
This question is not applicable as there is no "training set" in the context of an AI/ML algorithm.
How the ground truth for the training set was established:
This question is not applicable as there is no "training set" or AI/ML algorithm.

Summary

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November 30, 2021

Summitt Medical LLC Debra Kridner President Debra J Kridner Consulting LLC 815 Vikings Pkwy, Suite 100 St. Paul, Minnesota 55121

Re: K210836

Trade/Device Name: InstruSafe Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 28, 2021 Received: October 29, 2021

Dear Debra Kridner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210836

Device Name

InstruSafe® Instrument Protection System

Indications for Use (Describe)

Instrusate® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterlization Cycle 1. The Instrusate Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instrument Protection System casettes are not intended on their own to maintain sterility.

Minimum ventilation-to-volume ratio, general instruments: 0.073
Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263
Maximum number of internal shelves: Two (2)
Maximum cassette weight (including contents): 25 lbs/cassette

Table - Description of InstruSafe Instrument Protect System Loads.

Representative ofSTERIZONE®VP4 SterilizerValidation LoadNo.(K190260)	Summit Medical Validation Load Description	Total Load Weight(excludes the 25-lbs.loading rack)
4	Load 4a: Consisted of the load limit for rigid and semi-rigid channeledinstruments:Three (3) double channel semi-rigid endoscopes(ureteroscope - 0.7 mm × 500 mm and 1.1 mm × 500 mm)were packaged, one (1) per cassette, in three (3) IN-7323-Rcassettes. Additional rigid channel instruments were added to reach atotal of 15 channels. Each cassette included appropriate silicone instrument holders and waswrapped.	Load 4a =5 lbs/cassette,15 lbs total
	Load 4b: Consisted of the load limit for rigid and semi-rigid channeledinstruments:Three (3) double channel semi-rigid endoscopes(ureteroscope - 0.7 mm × 400 mm and 1.1 mm × 400 mm)were packaged, one (1) per cassette, in three (3) IN-0007-TFcassettes. Additional rigid channeled instruments were added to reach atotal of 15 channels. Each cassette included appropriate silicone instrument holders and wasplaced in an Aesculap JM440 rigid container.	Load 4b =11 lbs/cassette,33 lbs total

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Representative ofSTERIZONE®VP4 SterilizerValidation LoadNo.(K190260)	Summit Medical Validation Load Description	Total Load Weight(excludes the 25-lbs.loading rack)
7	Summit Medical Validation Load 7a: Consisted of the load weightlimit for general medical instruments representing the followinggeometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments were spread across three (3) IN-7323-Rcassettes with appropriate silicone holders, each weighing 25 lbs. Thecassettes were wrapped.	Load 7a =25 lbs/cassette75 lbs total
	Summit Medical Validation Load 7b: Consisted of the load weightlimit for general medical instruments representing the followinggeometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments were spread across three (3) IN-0006-TFcassettes with appropriate silicone holders. Cassettes were placed inAesculap JM440 containers, each weighing 25 lbs.	Load 7b =25 lbs/cassette75 lbs total
8	Summit Medical Validation Load 8a: Consisted of the load limit offive (5) total flexible endoscope channels in wrapped cassettes:• Two (2) double-channel flexible endoscopes (ureteroscopes –1 mm x 850 mm and 1 mm x 989 mm) were packaged, one (1) per cassette, in IN-0003-R cassettes.• One (1) single-channel flexible endoscope (ureteroscope – 1mm x 850 mm) was packaged in an IN-0004-R cassette.Cassettes included appropriate silicone holders and were wrapped.Summit Medical Validation Load 8b: Consisted of the load limit offour (4) total flexible endoscope channels in cassettes packaged inrigid containers:• Two (2) double channel flexible endoscopes (ureteroscope –1 mm x 850 mm and 1 mm x 989 mm) were packaged, one (1)per cassette, in IN-0003-TF cassettes with appropriate siliconeholders.Each cassette was placed inside an Aesculap JM442 container.	Load 8a =4.3 lbs/cassette,13 lbs totalLoad 8b =8.3 lbs/cassette,25 lbs total

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY- K210836

Following is a summary of 510(k) is in accordance with 21 CFR 807.92

Date Prepared:	November 24, 2021
Applicant:	Summit Medical LLC
	815 Vikings Parkway, Suite 100
	St. Paul, MN 55121 USA
	Ph: (651) 789-3966
OfficialCorrespondent:	Debra Kridner
	President Debra J Kridner Consulting, LLC
	Regulatory Affairs
	Email: dkridner@comcast.net
Subject Device
Trade/Device Name:	InstruSafe® Instrument Protection Systems
Common orUsual Name:	Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument DeliverySystem
Device ClassificationRegulation Number	21 CFR 880.6850
ClassificationName:	Sterilization wrap containers, trays, cassettes and other accessories
RegulatoryClass:	Class II
Product Code:	KCT
Predicate Device Details
Predicate Device:	K150540 - Instru-Safe Instrument Protection System – SUMMIT MEDICAL, INC.21 CFR 880.6850 - KCT

Device Description:

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cover to hold, organize, and protect the surgical instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.

Indications for Use:

InstruSafe® Instrument Protection System cassettes (trays) 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 STERIZONE VP4 sterilization Cycle 1. The Instrusafe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instrument Protection System cassettes are not intended on their own to maintain sterility. Summit Medical has validated the use of the Instrument Protection System cassettes in Cycle 1 of the STERIZONE VP4 sterilizer through demonstrations of sterilization efficacy using representative samples of medical devices including general instruments, rigid and semi- rigid instruments with lumens, and flexible endoscopes. The validation provided information that has been used to establish design limits that are applied across the range of Instrument Protection System cassettes to ensure that all models fall within the validated limits for cassette ventilation,

internal shelving, and weight:

Minimum ventilation-to-volume ratio, general instruments: 0.073 ●
Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263 ●
Maximum number of internal shelves: Two (2) .
. Maximum cassette weight (including contents): 25 lbs/cassette

Refer to the table below for the validated loads using Instrument Protection System cassettes. Refer to the sterilizer manufacturer's instructions for use to ensure that loads do not exceed the claimed limits for the sterilizer.

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RepresentativeofSTERIZONE®VP4 SterilizerValidationLoad No.(K190260)	Summit Medical Validation Load Description	Total LoadWeight(excludes the 25-lbs. loadingrack)
4	Load 4a: Consisted of the load limit for rigid andsemi-rigid channeled instruments:Three (3) double channel semi-rigidendoscopes (ureteroscope – $0.7 mm × 500 mm$and $1.1 mm × 500 mm$ ) were packaged,one (1) per cassette, in three (3) IN-7323-Rcassettes. Additional rigid channel instruments wereadded to reach a total of 15 channels.Each cassette included appropriate siliconeinstrument holders and was wrapped.	Load 4a =5 lbs/cassette,15 lbs total
	Load 4b: Consisted of the load limit for rigid andsemi-rigid channeled instruments:Three (3) double channel semi-rigidendoscopes (ureteroscope – $0.7 mm × 400 mm$and $1.1 mm × 400 mm$ ) were packaged,one (1) per cassette, in three (3) IN-0007-TFcassettes. Additional rigid channeled instruments wereadded to reach a total of 15 channels.Each cassette included appropriate siliconeinstrument holders and was placed in an AesculapJM440 rigid container.	Load 4b =11 lbs/cassette,33 lbs total

Table – Description of InstruSafe Instrument Protect System Loads.

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RepresentativeofSTERIZONE®VP4 SterilizerValidationLoad No.(K190260)	Summit Medical Validation Load Description	Total LoadWeight(excludes the 25-lbs. loadingrack)
7	Summit Medical Validation Load 7a: Consisted ofthe load weight limit for general medical instrumentsrepresenting the following geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments were spread acrossthree (3) IN-7323-R cassettes with appropriatesilicone holders, each weighing 25 lbs. The cassetteswere wrapped.	Load 7a =25 lbs/cassette75 lbs total
	Summit Medical Validation Load 7b: Consisted ofthe load weight limit for general medical instrumentsrepresenting the following geometries:• Box-lock hinge• Pivot hinge• Luer-lockGeneral medical instruments were spread acrossthree (3) IN-0006-TF cassettes with appropriatesilicone holders. Cassettes were placed in AesculapJM440 containers, each weighing 25 lbs.	Load 7b =25 lbs/cassette75 lbs total

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RepresentativeofSTERIZONE®VP4 SterilizerValidationLoad No.(K190260)	Summit Medical Validation Load Description	Total LoadWeight(excludes the 25-lbs. loadingrack)
8	Summit Medical Validation Load 8a: Consisted ofthe load limit of five (5) total flexible endoscopechannels in wrapped cassettes:Two (2) double-channel flexible endoscopes(ureteroscopes – 1 mm x 850 mm and 1 mm x989 mm) were packaged, one (1) per cassette,in IN-0003-R cassettes. One (1) single-channel flexible endoscope(ureteroscope – 1 mm x 850 mm) waspackaged in an IN-0004-R cassette. Cassettes included appropriate silicone holders andwere wrapped.	Load 8a =4.3 lbs/cassette,13 lbs total
	Summit Medical Validation Load 8b: Consisted ofthe load limit of four (4) total flexible endoscopechannels in cassettes packaged in rigid containers:Two (2) double channel flexible endoscopes(ureteroscope – 1 mm x 850 mm and 1 mm x989 mm) were packaged, one (1) per cassette,in IN-0003-TF cassettes with appropriatesilicone holders. Each cassette was placed inside an Aesculap JM442container	Load 8b =8.3 lbs/cassette,25 lbs total

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Technological Characteristic Comparison Table

Comparison of SubjectDevice to PredicateDevice	Subject DeviceInstruSafe® InstrumentProtection Systems(K210836)	Predicate DeviceInstruSafe® InstrumentProtection Systems(K150540)	Comparison
Trade/Device Name	InstruSafe® Instrument ProtectionSystems	InstruSafe® Instrument ProtectionSystems	Same
Common orUsual Name	Instrument Tray, SterilizationTray, Sterilization Cassettes,Instrument Delivery System	Instrument Tray, SterilizationTray, Sterilization Cassettes,Instrument Delivery System	Same
Device ClassificationRegulation Number	21 CFR 880.6850	21 CFR 880.6850	Same
ClassificationName:	Sterilization wrap containers,trays, cassettes and otheraccessories	Sterilization wrap containers,trays, cassettes and otheraccessories	Same
RegulatoryClass:	II	II	Same
Product Code:	KCT	KCT	Same
Indications for Use	InstruSafe® Instrument Protection Systemcassettes (trays) are used to organize andprotect other medical devices that aresterilized by a healthcare provider.InstruSafe Instrument Protection Systemcassettes are intended to allow sterilizationof the enclosed medical devices duringSTERIZONE VP4 sterilization Cycle 1.The InstruSafe Instrument ProtectionSystem cassettes are intended to be used inconjunction with a legally marketed wrapor Aesculap rigid container. The InstruSafeInstrument Protection System cassettes arenot intended on their own to maintainsterility.Summit Medical has validated the use ofthe InstruSafe Instrument ProtectionSystem cassettes in Cycle 1 of theSTERIZONE VP4 sterilizer throughdemonstrations of sterilization efficacyusing representative samples of medicaldevices including general instruments,rigid and semi-rigid instruments withlumens, and flexible endoscopes. Thevalidation provided information that hasbeen used to establish design limits that areapplied across the range of InstruSafeInstrument Protection System cassettes toensure that all models fall within thevalidated limits for cassette ventilation,internal shelving, and weight:	Instru-Safe® InstrumentProtection System cassettes areused to organize and protect othermedical devices that are sterilizedby a healthcare provider. Instru-Safe Instrument ProtectionSystem cassettes are intended toallow sterilization of the enclosedmedical devices during Amsco V-PRO Low TemperatureSterilization Cycles. The Instru-Safe Instrument ProtectionSystem cassettes are intended tobe used in conjunction withlegally marketed wrap orAesculap rigid container. TheInstru-Safe Instrument ProtectionSystem cassettes are not intendedon their own to maintain sterility.	Similar
•	volume ratio, general instruments: 0.073
•	Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263
•	Maximum number of internal shelves: Two (2)
•	Maximum cassette weight (including contents): 25 lbs/cassette
Refer to the table located under the indications for use section for the validated loads using InstruSafe Instrument Protection System cassettes. Refer to the sterilizer manufacturer's instructions for use to ensure that loads do not exceed the claimed limits for the sterilizer.
TechnologicalCharacteristics/PerformanceComparison ofSubject Device toPredicate Device	Subject DeviceInstruSafe® Instrument ProtectionSystems(K210836)	Predicate DeviceInstruSafe® Instrument ProtectionSystems(K150540)	Comparison
Material Composition	No changes from predicate device	The cassette contains components made ofanodized aluminum, stainless steel, blue silicone,black silicone, polyester, ultem™ 1000	Same
PhysicalProperties	InstruSafe Instrument Protection Systemcassettes include- Perforated cassette base- Perforated cassette cover- Silicone inserts (hold-it /hold down)- Handles- Feet- Latches- Divider (optional)- Locating Post (optional)- Module (optional)	Instru-Safe Instrument Protection Systemcassettes include- Perforated cassette base- Perforated cassette cover- Silicone inserts (hold-it / holddown)- Handles- Feet- Latches- Divider (optional)- Locating Post (optional)- Module (optional)	Same
Chemical Properties	Not Applicable	Not Applicable	-
Configurations/Dimensions	Various configurations / dimensions	Various configurations / dimensions	Same
Air permeance	Not Applicable	Not Applicable	-
Percent of surfaceperforations	Not Applicable	Not Applicable	-
Sterilant Penetration	Sterizone VP4 sterilizer with vaporhydrogen peroxide and ozone dualsterilant	Amsco V-PRO Low Temperature SterilizationSystems with vapor hydrogen peroxidesterilant	SimilarHydrogenperoxide basesterilants
Microbial BarrierProperties(PackagingIntegrity)	Not Applicable	Not Applicable	–
MaterialCompatibility	No changes from predicate device	No changes from reference device (K133015)	Same
ToxicologicalProperties(Biocompatibility,including SterilantResidue Limits)	MEM Elution Cytotoxicity (ISO 10993-5)Levels of residual hydrogen peroxide onmaterials met the limit for safetyestablished by the sterilizer manufacturer(The limit for safety was provided inK141163 -TS03 Sterizone Sterilizer)	MEM Elution Cytotoxicity (ISO 10993-5)NA	Same
Shelf Life	Reusable (5 year accelerated shelf-lifestudy)	Reusable (5 year accelerated shelf-life study)	Same
Test Methodology	Purpose	Acceptance Criteria	Results
Cleaning Validations (Manual,Mechanical, and Ultrasonic) FDAGuidance Reprocessing MedicalDevices in Health CareSettings:Validation Methods and Labeling(Issued March 2015) AAMITIR30:2011	The purpose of this study was to validatethe effectiveness of manual, mechanical,and ultrasonic cleaning proceduresspecified in the Instructions for Use usingthe worst-case cassette in terms of productgeometry, worst-case (coldest) processingtemperatures, and artificial soil.	Micro BCA Protein Assay: Residual proteinlevel $≤$ 6.4 µg/cm²Total Organic Carbon assay: TOC $≤$ 2.2µg/cm²	Pass
Sterilization Efficacy Validation:Half-Cycle Overkill ApproachANSI/AAMI/ISO 14937:2009	The purpose of the study was todemonstrate delivery of a minimumsterility assurance level (SAL) of 10-6 tobiological indicators (BIs) at difficult tosterilize locations in medical devices whenvalidation loads are processed in theInstruSafe Instrument Protection Systemcassettes. Both wraps and rigid containerswere used as sterile barriers.	Three (3) consecutive half cycles in which allbiological indicators (BIs) are inactivated.Minimum BI population: 1 x 106 CFU/BI	Pass
Sterility maintenance via simulateduse and shelf-life testing using couponsterility tests at end of shelf life.ANSI/AAMI/ISO 11607:2019ANSI/AAMI ST77:2013/(R)2018	The purpose of the study was todemonstrate maintenance of sterility overthe stated shelf life using simulatedhandling conditions when sterilizationwrap is used as the sterile barrier for theworst-case cassette in terms of weight.	Sterility tests of coupons that weresterilized and stored in the wrappedcassettes shall be negative for growthafter 366 days of simulated storage andhandling.	Pass
Microbial Aerosol Challenge forSterile Barrier Package Integrity	The purpose of the test was todemonstrate the integrity of sterilizationwrap as a sterile barrier after exposure toCycle 1 using a microbial aerosolchallenge of $≥$ 800 CFU/cm².	Sterility tests of coupons that weresterilized in Cycle 1 and then subjected tothe microbial aerosol challenge in thewrapped cassette shall be negative.	Pass
Residual hydrogen peroxide testingANSI/AAMI ST77:2013ANSI/AAMI/ISO 11607-1:2019ISO 10993-12:2012	The purpose of the test was todemonstrate that levels of residualhydrogen peroxide on cassette materialswere below safe levels after a worst-caseexposure of three (3) consecutiveiterations of Cycle 1.	The extracted residual hydrogen peroxideon device materials shall not exceed 997 ±142 µg/cm², which was established as asafe level in K141163.	Pass
Biocompatibility of Subject Device(by cytotoxicity testing)ANSI/AAMI/ISO 10993-5ANSI/AAMI/ISO 10993-12	The purpose of this test is toevaluate thecytotoxicity potential of the test articleusing an in vitro cell cultureassay.	Acceptance criterion:Non-cytotoxic a reactivity grade of $≤$ 1 isscored based on histological interpretationof the test system.	Pass
Life Cycle / Simulated Use LifeValidation FDA GuidanceReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling (issuedMarch 2015)	The purpose of this test is to validate theservice life of the trays as stated in theInstructions for Use.	Acceptance criteria:Visual inspection, component dimensional fitverification, functional closure/latchverification for 100 use cycles	Pass
Cassette handle safety test.ANSI/AAMI ST77:2013	The purpose of this test was todemonstrate that the handles on theInstruSafe cassettes could withstand a100-lb load without deforming or failing.	No evidence of damage, deformation, orcracking of the handle after a 100-lb load isapplied for 1 minute.	Pass

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Technological Characteristics Comparison Table

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Technological Characteristics:

The technological characteristics of the subject device are identical to the predicate device. The cassettes / trays are made of identical materials and do not incorporate any new technological characteristics. The only change from the predicate to the subject device is in the sterilizer and the sterilant.

Performance Data:

All necessary testing has been performed for the InstruSafe® Instrument Protection System to demonstrate the device performs as intended and met the standards and test methodology listed below.

The InstruSafe® Instrument Protection System using the Sterizone sterilizer was qualified through the following tests:

Sterilization efficacy with sterilization wraps and rigid containers ●
Sterility maintenance ●
Microbial aerosol challenge
Sterilant Residual study ●
Biocompatibility study
Reusability study
InstruSafe tray handle performance testing ●
Cleaning validations (manual, mechanical, and ultrasonic) ●

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Summary of Nonclinical Testing:

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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).