InstruSafe Instrument Protection System

K210836 · Summitt Medical, LLC · KCT · Nov 30, 2021 · General Hospital

Device Facts

• Record ID: K210836
• Device Name: InstruSafe Instrument Protection System
• Applicant: Summitt Medical, LLC
• Product Code: KCT · General Hospital
• Decision Date: Nov 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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 casettes are not intended on their own to maintain sterility.

Device Story

InstruSafe Instrument Protection System consists of perforated, latchable cassettes/trays made of anodized aluminum, stainless steel, silicone, polyester, and Ultem 1000. Used by healthcare providers in clinical settings to organize and protect surgical instruments during sterilization, storage, and transport. Cassettes feature silicone inserts to secure instruments. Device is placed inside a legally marketed sterilization wrap or Aesculap rigid container before processing in a STERIZONE VP4 sterilizer (Cycle 1). Perforations allow sterilant (vapor hydrogen peroxide and ozone) penetration. Output is a sterilized, organized instrument set. Benefits include protection of delicate instruments and maintenance of organization during the sterilization workflow. Does not maintain sterility on its own.

Clinical Evidence

Bench testing only. Validated sterilization efficacy using half-cycle overkill approach (ANSI/AAMI/ISO 14937:2009) with biological indicators (10^6 CFU/BI). Additional testing included cleaning validation (AAMI TIR30:2011), sterility maintenance/shelf-life (ANSI/AAMI/ISO 11607:2019), microbial aerosol challenge, residual hydrogen peroxide testing, biocompatibility (ISO 10993-5), and mechanical handle performance (100-lb load). All tests passed.

Technological Characteristics

Materials: Anodized aluminum, stainless steel, silicone, polyester, Ultem 1000. Design: Perforated base/cover, silicone inserts, handles, latches. Sterilization: Vapor hydrogen peroxide and ozone (STERIZONE VP4). Reusable. No software or electronic components.

Indications for Use

Indicated for organizing and protecting medical devices during sterilization by healthcare providers. Compatible with STERIZONE VP4 sterilization Cycle 1. Used with legally marketed wraps or Aesculap rigid containers. Not for maintaining sterility independently. Validated for general instruments, rigid/semi-rigid instruments with lumens, and flexible endoscopes.

Regulatory Classification

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.

Predicate Devices

• Instru-Safe Instrument Protection System (K150540)

Reference Devices

• K133015
• K141163 (TS03 Sterizone Sterilizer)
• K190260 (STERIZONE VP4 Sterilizer)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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.

Table - Description of InstruSafe Instrument Protect System Loads.

| Representative of<br>STERIZONE®<br>VP4 Sterilizer<br>Validation Load<br>No.<br>(K190260) | Summit Medical Validation Load Description | Total Load Weight<br>(excludes the 25-lbs.<br>loading rack) |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 4 | Load 4a: Consisted of the load limit for rigid and semi-rigid channeled<br>instruments:<br>Three (3) double channel semi-rigid endoscopes<br>(ureteroscope - 0.7 mm × 500 mm and 1.1 mm × 500 mm)<br>were packaged, one (1) per cassette, in three (3) IN-7323-R<br>cassettes. Additional rigid channel instruments were added to reach a<br>total of 15 channels. Each cassette included appropriate silicone instrument holders and was<br>wrapped. | Load 4a =<br>5 lbs/cassette,<br>15 lbs total |
| | Load 4b: Consisted of the load limit for rigid and semi-rigid channeled<br>instruments:<br>Three (3) double channel semi-rigid endoscopes<br>(ureteroscope - 0.7 mm × 400 mm and 1.1 mm × 400 mm)<br>were packaged, one (1) per cassette, in three (3) IN-0007-TF<br>cassettes. Additional rigid channeled instruments were added to reach a<br>total of 15 channels. Each cassette included appropriate silicone instrument holders and was<br>placed in an Aesculap JM440 rigid container. | Load 4b =<br>11 lbs/cassette,<br>33 lbs total |

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| Representative of<br>STERIZONE®<br>VP4 Sterilizer<br>Validation Load<br>No.<br>(K190260) | Summit Medical Validation Load Description | Total Load Weight<br>(excludes the 25-lbs.<br>loading rack) |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 7 | Summit Medical Validation Load 7a: Consisted of the load weight<br>limit for general medical instruments representing the following<br>geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments were spread across three (3) IN-7323-R<br>cassettes with appropriate silicone holders, each weighing 25 lbs. The<br>cassettes were wrapped. | Load 7a =<br>25 lbs/cassette<br>75 lbs total |
| | Summit Medical Validation Load 7b: Consisted of the load weight<br>limit for general medical instruments representing the following<br>geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments were spread across three (3) IN-0006-TF<br>cassettes with appropriate silicone holders. Cassettes were placed in<br>Aesculap JM440 containers, each weighing 25 lbs. | Load 7b =<br>25 lbs/cassette<br>75 lbs total |
| 8 | Summit Medical Validation Load 8a: Consisted of the load limit of<br>five (5) total flexible endoscope channels in wrapped cassettes:<br>• Two (2) double-channel flexible endoscopes (ureteroscopes –<br>1 mm x 850 mm and 1 mm x 989 mm) were packaged, one (1) per cassette, in IN-0003-R cassettes.<br>• One (1) single-channel flexible endoscope (ureteroscope – 1<br>mm x 850 mm) was packaged in an IN-0004-R cassette.<br>Cassettes included appropriate silicone holders and were wrapped.<br><br>Summit Medical Validation Load 8b: Consisted of the load limit of<br>four (4) total flexible endoscope channels in cassettes packaged in<br>rigid containers:<br>• Two (2) double channel flexible endoscopes (ureteroscope –<br>1 mm x 850 mm and 1 mm x 989 mm) were packaged, one (1)<br>per cassette, in IN-0003-TF cassettes with appropriate silicone<br>holders.<br>Each cassette was placed inside an Aesculap JM442 container. | Load 8a =<br>4.3 lbs/cassette,<br>13 lbs total<br><br>Load 8b =<br>8.3 lbs/cassette,<br>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: [phone] |
| Official<br>Correspondent: | Debra Kridner |
| | President Debra J Kridner Consulting, LLC |
| | Regulatory Affairs |
| | Email: [e-mail] |
| Subject Device | |
| Trade/Device Name: | InstruSafe® Instrument Protection Systems |
| Common or<br>Usual Name: | Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument Delivery<br>System |
| Device Classification<br>Regulation Number | 21 CFR 880.6850 |
| Classification<br>Name: | Sterilization wrap containers, trays, cassettes and other accessories |
| Regulatory<br>Class: | Class II |
| Product Code: | KCT |
| Predicate Device Details | |
| Predicate Device: | K150540 - Instru-Safe Instrument Protection System – SUMMIT MEDICAL, INC.<br>21 CFR 880.6850 - KCT |

### 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

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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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| Representative<br>of<br>STERIZONE®<br>VP4 Sterilizer<br>Validation<br>Load No.<br>(K190260) | Summit Medical Validation Load Description | Total Load<br>Weight<br>(excludes the 25-<br>lbs. loading<br>rack) |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 4 | Load 4a: Consisted of the load limit for rigid and<br>semi-rigid channeled instruments:<br>Three (3) double channel semi-rigid<br>endoscopes (ureteroscope – $0.7 mm × 500 mm$<br>and $1.1 mm × 500 mm$ ) were packaged,<br>one (1) per cassette, in three (3) IN-7323-R<br>cassettes. Additional rigid channel instruments were<br>added to reach a total of 15 channels.<br>Each cassette included appropriate silicone<br>instrument holders and was wrapped. | Load 4a =<br>5 lbs/cassette,<br>15 lbs total |
| | Load 4b: Consisted of the load limit for rigid and<br>semi-rigid channeled instruments:<br>Three (3) double channel semi-rigid<br>endoscopes (ureteroscope – $0.7 mm × 400 mm$<br>and $1.1 mm × 400 mm$ ) were packaged,<br>one (1) per cassette, in three (3) IN-0007-TF<br>cassettes. Additional rigid channeled instruments were<br>added to reach a total of 15 channels.<br>Each cassette included appropriate silicone<br>instrument holders and was placed in an Aesculap<br>JM440 rigid container. | Load 4b =<br>11 lbs/cassette,<br>33 lbs total |

### Table – Description of InstruSafe Instrument Protect System Loads.

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| Representative<br>of<br>STERIZONE®<br>VP4 Sterilizer<br>Validation<br>Load No.<br>(K190260) | Summit Medical Validation Load Description | Total Load<br>Weight<br>(excludes the 25-<br>lbs. loading<br>rack) |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 7 | Summit Medical Validation Load 7a: Consisted of<br>the load weight limit for general medical instruments<br>representing the following geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments were spread across<br>three (3) IN-7323-R cassettes with appropriate<br>silicone holders, each weighing 25 lbs. The cassettes<br>were wrapped. | Load 7a =<br>25 lbs/cassette<br>75 lbs total |
| | Summit Medical Validation Load 7b: Consisted of<br>the load weight limit for general medical instruments<br>representing the following geometries:<br>• Box-lock hinge<br>• Pivot hinge<br>• Luer-lock<br>General medical instruments were spread across<br>three (3) IN-0006-TF cassettes with appropriate<br>silicone holders. Cassettes were placed in Aesculap<br>JM440 containers, each weighing 25 lbs. | Load 7b =<br>25 lbs/cassette<br>75 lbs total |

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| Representative<br>of<br>STERIZONE®<br>VP4 Sterilizer<br>Validation<br>Load No.<br>(K190260) | Summit Medical Validation Load Description | Total Load<br>Weight<br>(excludes the 25-<br>lbs. loading<br>rack) |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 8 | Summit Medical Validation Load 8a: Consisted of<br>the load limit of five (5) total flexible endoscope<br>channels in wrapped cassettes:<br>Two (2) double-channel flexible endoscopes<br>(ureteroscopes – 1 mm x 850 mm and 1 mm x<br>989 mm) were packaged, one (1) per cassette,<br>in IN-0003-R cassettes. One (1) single-channel flexible endoscope<br>(ureteroscope – 1 mm x 850 mm) was<br>packaged in an IN-0004-R cassette. Cassettes included appropriate silicone holders and<br>were wrapped. | Load 8a =<br>4.3 lbs/cassette,<br>13 lbs total |
| | Summit Medical Validation Load 8b: Consisted of<br>the load limit of four (4) total flexible endoscope<br>channels in cassettes packaged in rigid containers:<br>Two (2) double channel flexible endoscopes<br>(ureteroscope – 1 mm x 850 mm and 1 mm x<br>989 mm) were packaged, one (1) per cassette,<br>in IN-0003-TF cassettes with appropriate<br>silicone holders. Each cassette was placed inside an Aesculap JM442<br>container | Load 8b =<br>8.3 lbs/cassette,<br>25 lbs total |

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# Technological Characteristic Comparison Table

| Comparison of Subject<br>Device to Predicate<br>Device | Subject Device<br>InstruSafe® Instrument<br>Protection Systems<br>(K210836) | Predicate Device<br>InstruSafe® Instrument<br>Protection Systems<br>(K150540) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Trade/Device Name | InstruSafe® Instrument Protection<br>Systems | InstruSafe® Instrument Protection<br>Systems | Same |
| Common or<br>Usual Name | Instrument Tray, Sterilization<br>Tray, Sterilization Cassettes,<br>Instrument Delivery System | Instrument Tray, Sterilization<br>Tray, Sterilization Cassettes,<br>Instrument Delivery System | Same |
| Device Classification<br>Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Classification<br>Name: | Sterilization wrap containers,<br>trays, cassettes and other<br>accessories | Sterilization wrap containers,<br>trays, cassettes and other<br>accessories | Same |
| Regulatory<br>Class: | II | II | Same |
| Product Code: | KCT | KCT | Same |
| Indications for Use | InstruSafe® Instrument Protection System<br>cassettes (trays) are used to organize and<br>protect other medical devices that are<br>sterilized by a healthcare provider.<br>InstruSafe Instrument Protection System<br>cassettes are intended to allow sterilization<br>of the enclosed medical devices during<br>STERIZONE VP4 sterilization Cycle 1.<br><br>The InstruSafe Instrument Protection<br>System cassettes are intended to be used in<br>conjunction with a legally marketed wrap<br>or Aesculap rigid container. The InstruSafe<br>Instrument Protection System cassettes are<br>not intended on their own to maintain<br>sterility.<br><br>Summit Medical has validated the use of<br>the InstruSafe Instrument Protection<br>System cassettes in Cycle 1 of the<br>STERIZONE VP4 sterilizer through<br>demonstrations of sterilization efficacy<br>using representative samples of medical<br>devices including general instruments,<br>rigid and semi-rigid instruments with<br>lumens, and flexible endoscopes. The<br>validation provided information that has<br>been used to establish design limits that are<br>applied across the range of InstruSafe<br>Instrument Protection System cassettes to<br>ensure that all models fall within the<br>validated limits for cassette ventilation,<br>internal shelving, and weight: | Instru-Safe® Instrument<br>Protection System cassettes are<br>used to organize and protect other<br>medical devices that are sterilized<br>by a healthcare provider. Instru-Safe Instrument Protection<br>System cassettes are intended to<br>allow sterilization of the enclosed<br>medical devices during Amsco V-PRO Low Temperature<br>Sterilization Cycles. The Instru-Safe Instrument Protection<br>System cassettes are intended to<br>be used in conjunction with<br>legally marketed wrap or<br>Aesculap rigid container. The<br>Instru-Safe Instrument Protection<br>System cassettes are not intended<br>on 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. | | | |
| Technological<br>Characteristics/<br>Performance<br>Comparison of<br>Subject Device to<br>Predicate Device | Subject Device<br>InstruSafe® Instrument Protection<br>Systems<br>(K210836) | Predicate Device<br>InstruSafe® Instrument Protection<br>Systems<br>(K150540) | Comparison |
| Material Composition | No changes from predicate device | The cassette contains components made of<br>anodized aluminum, stainless steel, blue silicone,<br>black silicone, polyester, ultem™ 1000 | Same |
| Physical<br>Properties | InstruSafe Instrument Protection System<br>cassettes include<br>- Perforated cassette base<br>- Perforated cassette cover<br>- Silicone inserts (hold-it /<br>hold down)<br>- Handles<br>- Feet<br>- Latches<br>- Divider (optional)<br>- Locating Post (optional)<br>- Module (optional) | Instru-Safe Instrument Protection System<br>cassettes include<br>- Perforated cassette base<br>- Perforated cassette cover<br>- Silicone inserts (hold-it / hold<br>down)<br>- Handles<br>- Feet<br>- Latches<br>- Divider (optional)<br>- Locating Post (optional)<br>- Module (optional) | Same |
| Chemical Properties | Not Applicable | Not Applicable | - |
| Configurations/<br>Dimensions | Various configurations / dimensions | Various configurations / dimensions | Same |
| Air permeance | Not Applicable | Not Applicable | - |
| Percent of surface<br>perforations | Not Applicable | Not Applicable | - |
| Sterilant Penetration | Sterizone VP4 sterilizer with vapor<br>hydrogen peroxide and ozone dual<br>sterilant | Amsco V-PRO Low Temperature Sterilization<br>Systems with vapor hydrogen peroxide<br>sterilant | Similar<br>Hydrogen<br>peroxide base<br>sterilants |
| Microbial Barrier<br>Properties<br>(Packaging<br>Integrity) | Not Applicable…