(253 days)
Not Found
No
The document describes a medical device (instrument protection cassettes) used for organizing and protecting instruments during sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as cassettes/trays used to organize, protect, and allow sterilization of other medical devices. It does not exert a therapeutic effect on a patient.
No
Explanation: The device is described as cassettes/trays used to organize and protect other medical devices during sterilization, storage, and transportation. Its function is to facilitate the sterilization process and protect instruments, not to diagnose a medical condition or disease.
No
The device is described as physical cassettes/trays used to hold and organize surgical instruments, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "organize and protect other medical devices that are sterilized by a healthcare provider." It facilitates the sterilization process of other instruments.
- Device Description: The description reinforces this by stating the cassettes/trays "enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation."
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. IVDs are specifically designed for this purpose.
- Focus on Sterilization and Protection: The entire document focuses on the device's role in the sterilization process and protecting the instruments within.
Therefore, the InstruSafe Instrument Protection System cassettes are considered medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
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 cover to hold, organize, and protect the surgical instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Cleaning Validations (Manual, Mechanical, and Ultrasonic) FDA Guidance Reprocessing Medical Devices in Health CareSettings: Validation Methods and Labeling (Issued March 2015) AAMI TIR30:2011. Purpose: The purpose of this study was 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. Results: Pass.
- Sterilization Efficacy Validation: Half-Cycle Overkill Approach ANSI/AAMI/ISO 14937:2009. Purpose: The purpose of the study was 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. Results: 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. Purpose: The purpose of the study was 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. Results: Pass.
- Microbial Aerosol Challenge for Sterile Barrier Package Integrity. Purpose: The purpose of the test was to demonstrate the integrity of sterilization wrap as a sterile barrier after exposure to Cycle 1 using a microbial aerosol challenge of ≥ 800 CFU/cm². Results: Pass.
- Residual hydrogen peroxide testing ANSI/AAMI ST77:2013 ANSI/AAMI/ISO 11607-1:2019 ISO 10993-12:2012. Purpose: The purpose of the test was 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. Results: Pass.
- Biocompatibility of Subject Device (by cytotoxicity testing) ANSI/AAMI/ISO 10993-5 ANSI/AAMI/ISO 10993-12. Purpose: The purpose of this test is toevaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. Results: Pass.
- Life Cycle / Simulated Use Life Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015). Purpose: The purpose of this test is to validate the service life of the trays as stated in the Instructions for Use. Results: Pass.
- Cassette handle safety test. ANSI/AAMI ST77:2013. Purpose: The purpose of this test was to demonstrate that the handles on the InstruSafe cassettes could withstand a 100-lb load without deforming or failing. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Micro BCA Protein Assay: Residual protein level ≤ 6.4 µg/cm²
Total Organic Carbon assay: TOC ≤ 2.2 µg/cm²
Sterility Assurance Level (SAL) of 10-6
Minimum BI population: 1 x 10^6 CFU/BI
Microbial aerosol challenge of ≥ 800 CFU/cm²
Residual hydrogen peroxide on device materials shall not exceed 997 ± 142 µg/cm²
Non-cytotoxic a reactivity grade of ≤ 1
Cassette handles must withstand a 100-lb load without damage, deformation, or cracking.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known)
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
STERIZONE®
VP4 Sterilizer
Validation Load
No.
(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 channeled
instruments:
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-R
cassettes. Additional rigid channel instruments were added to reach a
total of 15 channels. Each cassette included appropriate silicone instrument holders and was
wrapped. | Load 4a =
5 lbs/cassette,
15 lbs total |
| | Load 4b: Consisted of the load limit for rigid and semi-rigid channeled
instruments:
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-TF
cassettes. Additional rigid channeled instruments were added to reach a
total of 15 channels. Each cassette included appropriate silicone instrument holders and was
placed in an Aesculap JM440 rigid container. | Load 4b =
11 lbs/cassette,
33 lbs total |
3
| Representative of
STERIZONE®
VP4 Sterilizer
Validation Load
No.
(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 weight
limit for general medical instruments representing the following
geometries:
• Box-lock hinge
• Pivot hinge
• Luer-lock
General medical instruments were spread across three (3) IN-7323-R
cassettes with appropriate silicone holders, each weighing 25 lbs. The
cassettes were wrapped. | Load 7a =
25 lbs/cassette
75 lbs total |
| | Summit Medical Validation Load 7b: Consisted of the load weight
limit for general medical instruments representing the following
geometries:
• Box-lock hinge
• Pivot hinge
• Luer-lock
General medical instruments were spread across three (3) IN-0006-TF
cassettes with appropriate silicone holders. Cassettes were placed in
Aesculap JM440 containers, each weighing 25 lbs. | Load 7b =
25 lbs/cassette
75 lbs total |
| 8 | Summit Medical Validation Load 8a: Consisted of the load limit of
five (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 – 1
mm 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 of
four (4) total flexible endoscope channels in cassettes packaged in
rigid 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 silicone
holders.
Each cassette was placed inside an Aesculap JM442 container. | Load 8a =
4.3 lbs/cassette,
13 lbs total
Load 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 | |
| Official | |
| Correspondent: | Debra Kridner |
| President Debra J Kridner Consulting, LLC | |
| Regulatory Affairs | |
| Email: dkridner@comcast.net | |
| Subject Device | |
| Trade/Device Name: | InstruSafe® Instrument Protection Systems |
| Common or | |
| Usual Name: | Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument Delivery |
| System | |
| Device Classification | |
| Regulation Number | 21 CFR 880.6850 |
| Classification | |
| Name: | Sterilization wrap containers, trays, cassettes and other accessories |
| Regulatory | |
| Class: | 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:
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
5
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.
6
| Representative
of
STERIZONE®
VP4 Sterilizer
Validation
Load No.
(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 channeled instruments:
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-R
cassettes. Additional rigid channel instruments were
added to reach a total of 15 channels.
Each cassette included appropriate silicone
instrument holders and was wrapped. | Load 4a =
5 lbs/cassette,
15 lbs total |
| | Load 4b: Consisted of the load limit for rigid and
semi-rigid channeled instruments:
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-TF
cassettes. Additional rigid channeled instruments were
added to reach a total of 15 channels.
Each cassette included appropriate silicone
instrument holders and was placed in an Aesculap
JM440 rigid container. | Load 4b =
11 lbs/cassette,
33 lbs total |
Table – Description of InstruSafe Instrument Protect System Loads.
7
| Representative
of
STERIZONE®
VP4 Sterilizer
Validation
Load No.
(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 weight limit for general medical instruments
representing the following geometries:
• Box-lock hinge
• Pivot hinge
• Luer-lock
General medical instruments were spread across
three (3) IN-7323-R cassettes with appropriate
silicone holders, each weighing 25 lbs. The cassettes
were wrapped. | Load 7a =
25 lbs/cassette
75 lbs total |
| | Summit Medical Validation Load 7b: Consisted of
the load weight limit for general medical instruments
representing the following geometries:
• Box-lock hinge
• Pivot hinge
• Luer-lock
General medical instruments were spread across
three (3) IN-0006-TF cassettes with appropriate
silicone holders. Cassettes were placed in Aesculap
JM440 containers, each weighing 25 lbs. | Load 7b =
25 lbs/cassette
75 lbs total |
8
| Representative
of
STERIZONE®
VP4 Sterilizer
Validation
Load No.
(K190260) | Summit Medical Validation Load Description | Total Load
Weight
(excludes the 25-
lbs. loading
rack) |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 8 | Summit Medical Validation Load 8a: Consisted of
the load limit of five (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 – 1 mm x 850 mm) was
packaged in an IN-0004-R cassette. Cassettes included appropriate silicone holders and
were wrapped. | Load 8a =
4.3 lbs/cassette,
13 lbs total |
| | Summit Medical Validation Load 8b: Consisted of
the load limit of four (4) total flexible endoscope
channels in cassettes packaged in rigid 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
silicone holders. Each cassette was placed inside an Aesculap JM442
container | Load 8b =
8.3 lbs/cassette,
25 lbs total |
9
Technological Characteristic Comparison Table
| Comparison of Subject
Device to Predicate
Device | Subject Device
InstruSafe® Instrument
Protection Systems
(K210836) | Predicate Device
InstruSafe® Instrument
Protection Systems
(K150540) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Trade/Device Name | InstruSafe® Instrument Protection
Systems | InstruSafe® Instrument Protection
Systems | Same |
| Common or
Usual Name | Instrument Tray, Sterilization
Tray, Sterilization Cassettes,
Instrument Delivery System | Instrument Tray, Sterilization
Tray, Sterilization Cassettes,
Instrument Delivery System | Same |
| Device Classification
Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Classification
Name: | Sterilization wrap containers,
trays, cassettes and other
accessories | Sterilization wrap containers,
trays, cassettes and other
accessories | Same |
| Regulatory
Class: | II | II | Same |
| Product Code: | KCT | KCT | Same |
| 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.
InstruSafe 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 InstruSafe
Instrument Protection System cassettes are
not intended on their own to maintain
sterility.
Summit Medical has validated the use of
the InstruSafe 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 InstruSafe
Instrument Protection System cassettes to
ensure that all models fall within the
validated limits for cassette ventilation,
internal shelving, and weight: | Instru-Safe® Instrument
Protection System cassettes are
used to organize and protect other
medical devices that are sterilized
by a healthcare provider. Instru-Safe Instrument Protection
System cassettes are intended to
allow sterilization of the enclosed
medical devices during Amsco V-PRO Low Temperature
Sterilization Cycles. The Instru-Safe Instrument Protection
System cassettes are intended to
be used in conjunction with
legally marketed wrap or
Aesculap rigid container. The
Instru-Safe Instrument Protection
System cassettes are not intended
on their own to maintain sterility. | 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
Characteristics/
Performance
Comparison of
Subject Device to
Predicate Device | Subject Device
InstruSafe® Instrument Protection
Systems
(K210836) | Predicate Device
InstruSafe® Instrument Protection
Systems
(K150540) | Comparison |
| Material Composition | No changes from predicate device | The cassette contains components made of
anodized aluminum, stainless steel, blue silicone,
black silicone, polyester, ultem™ 1000 | Same |
| Physical
Properties | InstruSafe Instrument Protection System
cassettes 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 System
cassettes include - Perforated cassette base
- Perforated cassette cover
- Silicone inserts (hold-it / hold
down) - 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 surface
perforations | Not Applicable | Not Applicable | - |
| Sterilant Penetration | Sterizone VP4 sterilizer with vapor
hydrogen peroxide and ozone dual
sterilant | Amsco V-PRO Low Temperature Sterilization
Systems with vapor hydrogen peroxide
sterilant | Similar
Hydrogen
peroxide base
sterilants |
| Microbial Barrier
Properties
(Packaging
Integrity) | Not Applicable | Not Applicable | – |
| Material
Compatibility | No changes from predicate device | No changes from reference device (K133015) | Same |
| Toxicological
Properties
(Biocompatibility,
including Sterilant
Residue Limits) | MEM Elution Cytotoxicity (ISO 10993-5)
Levels of residual hydrogen peroxide on
materials met the limit for safety
established by the sterilizer manufacturer
(The limit for safety was provided in
K141163 -TS03 Sterizone Sterilizer) | MEM Elution Cytotoxicity (ISO 10993-5)
NA | Same |
| Shelf Life | Reusable (5 year accelerated shelf-life
study) | Reusable (5 year accelerated shelf-life study) | Same |
| Test Methodology | Purpose | Acceptance Criteria | Results |
| Cleaning Validations (Manual,
Mechanical, and Ultrasonic) FDA
Guidance Reprocessing Medical
Devices in Health CareSettings:
Validation Methods and Labeling
(Issued March 2015) AAMI
TIR30:2011 | The purpose of this study was 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 $≤$ 6.4 µg/cm²
Total Organic Carbon assay: TOC $≤$ 2.2
µg/cm² | Pass |
| Sterilization Efficacy Validation:
Half-Cycle Overkill Approach
ANSI/AAMI/ISO 14937:2009 | The purpose of the study was 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 106 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 | The purpose of the study was 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 | The purpose of the test was to
demonstrate the integrity of sterilization
wrap as a sterile barrier after exposure to
Cycle 1 using a microbial aerosol
challenge of $≥$ 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 | The purpose of the test was 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 | The purpose of this test is toevaluate the
cytotoxicity potential of the test article
using an in vitro cell culture
assay. | Acceptance criterion:
Non-cytotoxic a reactivity grade of $≤$ 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) | The purpose of this test is to validate the
service life of the trays as stated in the
Instructions for Use. | Acceptance criteria:
Visual inspection, component dimensional fit
verification, functional closure/latch
verification for 100 use cycles | Pass |
| Cassette handle safety test.
ANSI/AAMI ST77:2013 | The purpose of this test was 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 |
10
11
Technological Characteristics Comparison Table
12
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) ●
13
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.