K Number
K183701
Device Name
Stryker ChestShield Sterilization Tray System
Manufacturer
Date Cleared
2019-05-07

(127 days)

Product Code
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle: | | Pre-vacuum Steam | |--------------------|---------------------| | Enclosure | Rigid Container | | Temperature | 132°C (270°F) | | Sterilization Time | 4 minutes | | Minimum Dry Time | 30 minutes | | Maximum Weight1 | 19.23 lb. / 8.72 kg | 'The validated load configuration for the Stryker Chestin Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.
Device Description
The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a nonsterile condition and must be sterilized prior to and after each use.
More Information

Not Found

No
The device description and performance studies focus on the physical properties, sterilization efficacy, and mechanical integrity of a sterilization tray system, with no mention of AI or ML.

No
The device is a sterilization tray system designed to organize, enclose, sterilize, transport, and store other medical devices and instruments. It does not provide any therapeutic effect itself.

No.

The device is a sterilization tray system designed to organize, enclose, sterilize, transport, and store implantable devices and surgical instruments, not to diagnose medical conditions.

No

The device description clearly states it is a "tray system" consisting of physical components like anodized aluminum, stainless steel, and silicone brackets, designed to store implants and instruments. It is a hardware device used for sterilization and storage.

Based on the provided information, the Stryker ChestShield Sterilization Tray System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is clearly stated as organizing, enclosing, sterilizing, transporting, and storing implantable devices and surgical instruments. This is related to the preparation and handling of medical devices used in vivo (within the body), not for testing samples in vitro (in a lab).
  • Device Description: The description details a tray system for holding implants and instruments, made of materials like aluminum and stainless steel. This aligns with a device used in surgical settings for device management, not for performing diagnostic tests on biological samples.
  • Performance Studies: The performance studies focus on sterilization validation, lifecycle testing, biocompatibility, design verification, and cleaning validation. These are all relevant to the safety and efficacy of a device used to prepare surgical instruments, not to the analytical or clinical performance of a diagnostic test.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other activities typically associated with IVD devices.

Therefore, the Stryker ChestShield Sterilization Tray System is a medical device used in the preparation of other medical devices for surgical procedures, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle:
Pre-vacuum Steam
Enclosure: Rigid Container
Temperature: 132°C (270°F)
Sterilization Time: 4 minutes
Minimum Dry Time: 30 minutes
Maximum Weight: 19.23 lb. / 8.72 kg

Product codes

KCT

Device Description

The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a non-sterile condition and must be sterilized prior to and after each use.

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 facility

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  • Sterilization and Dry Time Validation: Sterilization validations were performed to verify the effectiveness of steam sterilization of a fully loaded Stryker ChestShield Sterilization Tray System sterilized in a rigid sterilization container using an autoclave cycle with pre-vacuum air removal. The study evaluated the resistance of biological indicators (Bls) with 10° Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half cycle exposures. Dry time was evaluated after sterilization. The Styker ChestShield Sterilization Tray System was validated per ANSI/AAMI/ISO 17665-1:2006.
  • Lifecycle Testing: Lifecycle testing was performed on the predicate device to verify that the tray system maintained functional quality requirements, material compatibility, and traceability after exposure to repeated pre-vacuum steam sterilization cycles and automated washing cycles and simulated functional use of the components.
  • Biocompatibility (ISO 10993-5): Cytotoxicity testing was performed on the predicate device per ISO 10993-5 using the MEM Elution method. Test article extracts met the criteria of grade 2 or less cell lysis and reactivity, demonstrating the device is non-cytotoxic.
  • Design Verification: Design verification was performed on the predicate device to demonstrate the device complies with AAMI/ANSI ST77:2013 for handle strength testing. Additional design verification included containment verification during transport and simulated use, stacking verification and edge sharpness testing.
  • Cleaning Validation: Manual and automated cleaning validations were performed on the predicate device to validate the cleaning instructions using the worst case configured tray system per AAMI TIR 30:2011. The results met the acceptance criteria of residual protein of less than 6.4 µg/cm² and residual hemoglobin of less than 2.2 µg/cm², indicating that the recommended cleaning methods were effective in removing soil from all designated surfaces of the tray system that might be accessible to the end user.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K173615

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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 7, 2019

Paragon Medical Rebecca Walker Regulatory Affairs Manager 8 Matchett Dr Pierceton, Indiana 46562

Re: K183701

Trade/Device Name: Stryker ChestShield Sterilization Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 3, 2019 Received: April 5, 2019

Dear Rebecca Walker:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 David Krause, PhD Acting 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) K183701

Device Name

Stryker ChestShield Sterilization Tray System

Indications for Use (Describe)

The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle:

Pre-vacuum Steam
EnclosureRigid Container
Temperature132°C (270°F)
Sterilization Time4 minutes
Minimum Dry Time30 minutes
Maximum Weight119.23 lb. / 8.72 kg

'The validated load configuration for the Stryker Chestin Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other in black font. There are black lines above and below the words.

510(k) Summary for Stryker ChestShield Sterilization Tray System, K183701

In accordance with 21 CFR 807.92, the following 510(k) summary is provided:

| 1. Applicant Information: | Paragon Medical
8 Matchett Drive
Pierceton, IN 46562 USA
Phone: 574-594-2140
Fax: 574-594-2154 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------|
| 2. Correspondent Contact Information: | Rebecca Walker
Regulatory Affairs Manager
Rebecca.walker@nninc.com
Phone: 574-594-2140 ext. 10384 |
| 3. Date Prepared: | May 2, 2019 |
| 4. Trade Name: | Stryker ChestShield Sterilization Tray System |
| 5. Common Name: | Sterilization Tray |
| 6. Classification Name: | Sterilization wrap containers, trays, cassettes and other accessories
(21 CFR 880.6850, Product Code KCT) |
| 7. Predicate Device: | Stryker Universal Select Sterilization Tray System, K173615 |

    1. Device Description: The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a nonsterile condition and must be sterilized prior to and after each use.
    1. Indications for Use: The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a

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Image /page/4/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center, and the words "PARAGON MEDICAL" in black text to the right of the pentagon. There are two black lines above and below the text.

healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle:

Pre-vacuum Steam
EnclosureRigid Container
Temperature132°C (270°F)
Sterilization Time4 minutes
Minimum Dry Time30 minutes
Maximum Weight119.23 lb. / 8.72 kg

¹The validated load configuration for the Stryker ChestShield Sterilization Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.

10. Technological Characteristics:

Shown below is a comparison of the technological (Table 1) and performance (Table 2) characteristics of the subject and predicate device.

Table 1: Technological Characteristics
Predicate DeviceSubject DeviceComparison
Device NameStryker Universal Select Sterilization Tray SystemStryker ChestShield Sterilization Tray System--
510(k) NumberK173615K183701--
Product CodeKCTKCTSame
The Stryker Universal Select Sterilization Tray System
is intended to organize, enclose, sterilize, transport
and store Stryker implantable devices and surgical
instruments within a healthcare facility when used in
conjunction with a validated, FDA cleared rigid
sterilization container in order to maintain sterility of
the enclosed devices.
The Stryker Universal Select Sterilization Tray System
has been validated for use in the following
sterilization cycles:The Stryker ChestShield Sterilization Tray System is
intended to organize, enclose, sterilize, transport, and
store Stryker implantable devices and surgical
instruments within a healthcare facility when used in
conjunction with a validated, FDA cleared rigid
sterilization container in order to maintain sterility of
the enclosed devices.
The Stryker ChestShield Sterilization Tray System has
been validated for use in the following sterilization
cycle:Similar
Differences include
maximum weight
and validated load
contents
Indications for
UsePre-vacuum Steam Cycles
EnclosureRigid ContainerRigid Container
Temperature132°C
(270°F)135°C
(275°F)
Sterilization Time4 min3 min
Minimum Dry Time30 min30 min
Maximum Weight125 lb./
11.36kg25 lb./
11.36kg
1Contents in the validated Tray System included: Single-use
implants (plates, meshes, bone screws, etc.), single-use
instruments (drills), and reusable surgical instruments
(benders, forceps, handles, depth gauges, trocars, etc.)
Pre-Vacuum Steam Cycle
EnclosureRigid Container
Temperature132°C (270°F)
Sterilization Time4 min
Minimum Dry Time30 min
Maximum Weight119.23 lb. / 8.72 kg
1The validated load configuration for the Stryker ChestShield
Sterilization Tray System included single-use implants (plates,
bone screws, etc.), single-use instruments (drills), reusable
surgical instruments (benders, forceps, drivers, etc.) and
lumened instruments.

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Image /page/5/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center. To the right of the pentagon are the words "PARAGON MEDICAL" stacked on top of each other, with a line above and below the words.

Table 1 (continued): Technological CharacteristicsPredicate DeviceSubject DeviceComparison
Intended UseThe Stryker Universal Select Sterilization Tray System
is intended to organize, enclose, sterilize, transport, and store medical devices between surgical uses in a healthcare facility.The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store medical devices between surgical uses in a healthcare facility.Same
DesignThe Stryker Universal Select Sterilization Tray System platform is designed to be compatible with Stryker implantable devices and surgical instrumentation. Individual components were designed to slide in to two and three level storage racks. Racks have handles on the side to facilitate carrying. Module and tray lids have sliding latch mechanism to facilitate containment.The design of the Stryker ChestShield Sterilization Tray System is the same as the predicate device, with specific instrument brackets and implant module layout for the intended Stryker surgical instrumentation and implantable devices. The individual tray components slide into the existing two-level storage rack part of the predicate device system.Similar
Differences include specific bracket, implant module and inlay layouts
Principles of OperationOperates on the principles of allowing steam penetration through perforations and open area designed into the components to achieve sterilization of the contained devices.Operates on the principles of allowing steam penetration through perforations and open area designed into the components to achieve sterilization of the contained devices.Same
Materials of ConstructionStainless Steel, Anodized Aluminum, USP Class VI Silicone, Thermoplastic PolymersSame as predicateSame
Sterilization ParametersCycle
Pre-Vacuum
                                                                                                                                                                                                                                                                                                                                                   | Temp

132° C (270°F)
135°C (275°F) | Exposure
4 Min
3 Min | Min Dry Time
30 Min
30 Min | Cycle
Pre-Vacuum | Temp
132°C (270°F) | Exposure
4 Min | Min Dry Time
30 Min | Similar |
| Perforations | Evenly distributed perforated steam hole pattern. | | | Evenly distributed perforated steam hole pattern. | | | Same | | |
| Vent to Volume ratio | The predicate Stryker Universal Select Sterilization Tray System components have the following worst-case vent to volume ratios: | | | The subject Stryker ChestShield Sterilization Tray System components have the following worst-case vent to volume ratios: | | | Similar | | |
| | Paragon Part Number | Stryker Part Number | Description | Vent to Volume Ratio | Paragon Part Number | Stryker Part Number | | Description | Vent to Volume Ratio |
| | 3009-1013 | 29-13904 | Mandible Fracture Instrument Tray with Lid (3349-0006/29-13921) | 0.321 | 3009-1040 | 4700002 | | SternalPlate Instrument Tray 2 with Lid (3349-0009/4700101) | 0.330 |
| | 2209-0109 | 29-23900 | 2.0/2.3 Mandible Screws Module with Lid (3349-0005/29-13941) | 0.054 | 2209-0115 | 4700201 | | SternalPlate Implant Module with Lid (3349-0008/4700102) | 0.082 |
| | 2219-0036 | 29-17903 | 1.7 Orthognathic Plates Inlay | 0.265 | 2219-0002 | 4700202 | | SternalPlate Plates Inlay | 0.288 |
| | 3009-1008 | 29-13900 | 2-Level Rack | 0.297 | | | | | |
| Sterilization Method | Pre-vacuum Steam | | | Pre-vacuum Steam | | | Same | | |
| Reusable | Yes | | | Yes | | | Same | | |
| Patient Contact | No direct patient contact | | | No direct patient contact | | | Same | | |
| Air Permeance | Yes | | | Yes | | | Same | | |

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Image /page/6/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center, and the words "PARAGON MEDICAL" in black text to the right of the pentagon. There are two black lines above and below the text.

| Configuration
and
Dimensions of

Device Models
Two-level Rack9.80 x 9.70 x 5.27"Two-level Rack¹9.80 x 9.70 x 5.27"Similar
Three level Rack9.80 x 9.70 x 7.57"
¼ DIN Inst/Accessory Tray9.31 x 4.09 x 1.54"¼ DIN Instrument Tray9.31 x 4.09 x 1.54"Differences include
slight dimensional
differences in the
¼ DIN Inst/Accessory Tray Lid9.29 x 4.30 x 0.49"¼ DIN Instrument Tray Lid9.21 x 4.30 x 0.49"
½ DIN Inst/Accessory Tray9.31 x 8.55 x 1.54"inlay of the subject
device to
½ DIN Inst/Accessory Tray Lid9.29 x 8.71 x 0.55"
¼ DIN Implant Module9.31 x 4.25 x 1.05"accommodate the
¼ DIN Screw Module9.31 x 4.25 x 1.75"¼ DIN Implant/Screw Module9.31 x 4.25 x 1.75"
¼ DIN Implant Module Lid9.33 x 4.22 x 0.44"¼ DIN Implant Module Lid
Inlay9.33 x 4.22 x 0.44"
4.09 x 3.31 x 0.63"intended implants.
Inlay4.34 x 3.85 x 0.53"
Inlay, large8.91 x 3.85 x 0.34"
Drill Caddy3.30 x 1.33 x 1.47"
¼ DIN Silicone Mat8.95 x 3.67 x 0.63"¹Two-level Rack is identical to
½ DIN Silicone Mat8.95 x 8.14 x 0.63"the predicate.
Table 2: Performance Characteristics
Predicate DeviceSubject DeviceComparison
Material
Compatibility
with Sterilization
ProcessPredicate device is compatible with steam
sterilization.Subject device is compatible with steam sterilization.Same
BiocompatibilityCytotoxicity (ISO 10993-5) testing results
demonstrated that the predicate device is non-
cytotoxicSubject device is identical in formulation and
processing to the predicate device; therefore,
cytotoxicity results of the predicate are applicable to
the subject device.Same
Performance
TestingThe following non-clinical testing was performed
on the Stryker Universal Select Sterilization Tray
System:
• Sterilization Validation
• Dry Time Validation
• Design Verification
• Life Cycle Testing
• Cleaning Validation
• BiocompatibilityThe following non-clinical testing was performed on
the Stryker ChestShield Sterilization Tray System:
• Sterilization Validation
• Dry Time Validation
The following non-clinical testing was leveraged from
the predicate to support the performance of the
subject device:
• Design Verification
• Life Cycle Testing
• Cleaning Validation
• BiocompatibilitySame

11. Non-Clinical Performance Testing: The following non-clinical testing was performed on the Stryker ChestShield Sterilization Tray System:

. Sterilization and Dry Time Validation

Sterilization validations were performed to verify the effectiveness of steam sterilization of a fully loaded Stryker ChestShield Sterilization Tray System sterilized in a rigid sterilization container using an autoclave cycle with pre-vacuum air removal. The study evaluated the resistance of biological indicators (Bls) with 10° Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half cycle exposures. Dry time was evaluated after sterilization. The Styker ChestShield Sterilization Tray System was validated per ANSI/AAMI/ISO 17665-1:2006.

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Image /page/7/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center. To the right of the pentagon are the words "PARAGON MEDICAL" stacked on top of each other, with a black line above and below the words.

The subject device is identical in formulation and processing to the predicate device; therefore, the following non-clinical performance testing performed on the predicate Stryker Universal Select Sterilization Tray System is applicable to the subject Stryker ChestShield Sterilization Tray System:

Lifecycle Testing .

Lifecycle testing was performed on the predicate device to verify that the tray system maintained functional quality requirements, material compatibility, and traceability after exposure to repeated pre-vacuum steam sterilization cycles and automated washing cycles and simulated functional use of the components.

. Biocompatibility (ISO 10993-5)

Cytotoxicity testing was performed on the predicate device per ISO 10993-5 using the MEM Elution method. Test article extracts met the criteria of grade 2 or less cell lysis and reactivity, demonstrating the device is non-cytotoxic.

The following non-clinical testing was leveraged from the predicate device to support the performance of the subject device:

. Design Verification

Design verification was performed on the predicate device to demonstrate the device complies with AAMI/ANSI ST77:2013 for handle strength testing. Additional design verification included containment verification during transport and simulated use, stacking verification and edge sharpness testing.

. Cleaning Validation

Manual and automated cleaning validations were performed on the predicate device to validate the cleaning instructions using the worst case configured tray system per AAMI TIR 30:2011. The results met the acceptance criteria of residual protein of less than 6.4 µg/cm² and residual hemoglobin of less than 2.2 µg/cm², indicating that the recommended cleaning methods were effective in removing soil from all designated surfaces of the tray system that might be accessible to the end user.

    1. Conclusion: Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject Stryker ChestShield Sterilization Tray System is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K173615.