(127 days)
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.
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.
The provided document is a 510(k) summary for the Stryker ChestShield Sterilization Tray System. It describes the device, its intended use, and comparative information with a predicate device. The document also details the non-clinical performance testing conducted to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Stryker ChestShield Sterilization Tray System are primarily tied to its functionality as a sterilization tray within a specific sterilization cycle. The performance is demonstrated through validation against established standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Validation |
|---|---|---|
| Sterilization Efficacy | Effective steam sterilization of fully loaded tray. | Sterilization Validation: Demonstrated effective steam sterilization using a fully loaded Stryker ChestShield Sterilization Tray System sterilized in a rigid sterilization container with a pre-vacuum air removal autoclave cycle. Evaluated resistance of biological indicators (BIs) with 10^6 Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half-cycle exposures. Validated per ANSI/AAMI/ISO 17665-1:2006. |
| Dry Time Efficacy | Adequate dry time after sterilization. | Dry Time Validation: Evaluated dry time after sterilization cycles. (Specific performance value for dry time is 30 minutes, likely met based on successful validation). |
| Material Compatibility | Compatible with steam sterilization process. | Material Compatibility with Sterilization Process: Subject device is compatible with steam sterilization. Confirmed by direct testing. |
| Biocompatibility | Non-cytotoxic. | Biocompatibility (ISO 10993-5): "Subject device is identical in formulation and processing to the predicate device; therefore, cytotoxicity results of the predicate are applicable to the subject device." Predicate tested as non-cytotoxic (Grade 2 or less cell lysis and reactivity) using MEM Elution method. |
| Functional Quality/Durability | Maintained functional quality, material compatibility, and traceability after repeated cycles and simulated use. | Lifecycle Testing: Leveraged from predicate device. Performed on predicate device to verify maintenance of functional quality requirements, material compatibility, and traceability after repeated pre-vacuum steam sterilization cycles, automated washing cycles, and simulated functional use. |
| Design Compliance/Safety | Complies with AAMI/ANSI ST77:2013 for handle strength. | Design Verification: Leveraged from predicate device. Performed on predicate device to demonstrate compliance with AAMI/ANSI ST77:2013 for handle strength. Also included containment verification during transport and simulated use, stacking verification, and edge sharpness testing. |
| Cleaning Efficacy | Effective removal of soil from all designated surfaces. | Cleaning Validation: Leveraged from predicate device. Manual and automated cleaning validations performed on predicate device using worst-case configured tray system per AAMI TIR 30:2011. Results met acceptance criteria of residual protein < 6.4 µg/cm² and residual hemoglobin < 2.2 µg/cm². |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the numerical sample sizes for each test (e.g., how many trays were tested for sterilization validation, how many cycles for lifecycle testing, etc.). However, it refers to "biological indicators (BIs) with 10^6 Geobacillus stearothermophilus spores" for sterilization validation. This implies testing with a sufficient number of BIs to demonstrate a certain sterility assurance level.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of medical device testing for 510(k) clearance, these are typically prospective, controlled laboratory or simulated environment studies conducted by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This category does not apply as the device is a sterilization tray system, not an AI or diagnostic tool that requires expert interpretation for ground truth establishment. The "ground truth" here is objective physical and biological performance (e.g., sterility, cleanliness, material integrity) measured against established scientific standards and regulatory requirements for sterilization.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This category does not apply. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations of medical data (e.g., imaging reads by radiologists). For device validation tests like sterilization efficacy or material biocompatibility, results are objective measurements against predefined acceptance criteria, not subject to expert consensus or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This category does not apply. MRMC studies are used for evaluating diagnostic performance of AI-assisted systems where human readers interpret cases. The Stryker ChestShield Sterilization Tray System is a physical medical device (sterilization tray), not a diagnostic tool or AI assistance system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This category does not apply to a physical device like a sterilization tray.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation of the Stryker ChestShield Sterilization Tray System is based on:
- Biological Standards: For sterilization efficacy, the "ground truth" is the inactivation of a specified challenge organism (Geobacillus stearothermophilus spores) to a statistically determined sterility assurance level, as measured by biological indicators.
- Physical/Chemical Standards: For dry time, material compatibility, cleaning validation (residual protein/hemoglobin), and design verification (handle strength, containment), the "ground truth" is measured against established physical and chemical limits and engineering specifications defined by recognized consensus standards (e.g., ANSI/AAMI/ISO 17665-1, AAMI TIR 30, ISO 10993-5, AAMI/ANSI ST77) or internal design requirements.
8. The sample size for the training set
This category does not apply. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This category does not apply, as there is no training set for this type of device.
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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
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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
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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 | |
|---|---|
| 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.
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 Medical8 Matchett DrivePierceton, IN 46562 USAPhone: 574-594-2140Fax: 574-594-2154 |
|---|---|
| 2. Correspondent Contact Information: | Rebecca WalkerRegulatory Affairs ManagerRebecca.walker@nninc.comPhone: 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 |
-
- 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.
-
- 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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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 | |
|---|---|
| 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 |
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 Device | Subject Device | Comparison | |
| Device Name | Stryker Universal Select Sterilization Tray System | Stryker ChestShield Sterilization Tray System | -- |
| 510(k) Number | K173615 | K183701 | -- |
| Product Code | KCT | KCT | Same |
| The Stryker Universal Select Sterilization Tray Systemis intended to organize, enclose, sterilize, transportand store Stryker implantable devices and surgicalinstruments within a healthcare facility when used inconjunction with a validated, FDA cleared rigidsterilization container in order to maintain sterility ofthe enclosed devices.The Stryker Universal Select Sterilization Tray Systemhas been validated for use in the followingsterilization cycles: | The Stryker ChestShield Sterilization Tray System isintended to organize, enclose, sterilize, transport, andstore Stryker implantable devices and surgicalinstruments within a healthcare facility when used inconjunction with a validated, FDA cleared rigidsterilization container in order to maintain sterility ofthe enclosed devices.The Stryker ChestShield Sterilization Tray System hasbeen validated for use in the following sterilizationcycle: | SimilarDifferences includemaximum weightand validated loadcontents | |
| Indications forUse | Pre-vacuum Steam Cycles | ||
| Enclosure | Rigid Container | Rigid Container | |
| Temperature | 132°C(270°F) | 135°C(275°F) | |
| Sterilization Time | 4 min | 3 min | |
| Minimum Dry Time | 30 min | 30 min | |
| Maximum Weight1 | 25 lb./11.36kg | 25 lb./11.36kg | |
| 1Contents in the validated Tray System included: Single-useimplants (plates, meshes, bone screws, etc.), single-useinstruments (drills), and reusable surgical instruments(benders, forceps, handles, depth gauges, trocars, etc.) | |||
| Pre-Vacuum Steam Cycle | |||
| Enclosure | Rigid Container | ||
| Temperature | 132°C (270°F) | ||
| Sterilization Time | 4 min | ||
| Minimum Dry Time | 30 min | ||
| Maximum Weight1 | 19.23 lb. / 8.72 kg | ||
| 1The validated load configuration for the Stryker ChestShieldSterilization Tray System included single-use implants (plates,bone screws, etc.), single-use instruments (drills), reusablesurgical instruments (benders, forceps, drivers, etc.) andlumened 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 Characteristics | Predicate Device | Subject Device | Comparison | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Intended Use | The Stryker Universal Select Sterilization Tray Systemis 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 | ||||||
| Design | The 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. | SimilarDifferences include specific bracket, implant module and inlay layouts | ||||||
| Principles of Operation | Operates 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 Construction | Stainless Steel, Anodized Aluminum, USP Class VI Silicone, Thermoplastic Polymers | Same as predicate | Same | ||||||
| Sterilization Parameters | CyclePre-Vacuum | Temp132° C (270°F)135°C (275°F) | Exposure4 Min3 Min | Min Dry Time30 Min30 Min | CyclePre-Vacuum | Temp132°C (270°F) | Exposure4 Min | Min Dry Time30 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.
| ConfigurationandDimensions ofDevice Models | |||||
|---|---|---|---|---|---|
| Two-level Rack | 9.80 x 9.70 x 5.27" | Two-level Rack¹ | 9.80 x 9.70 x 5.27" | Similar | |
| Three level Rack | 9.80 x 9.70 x 7.57" | ||||
| ¼ DIN Inst/Accessory Tray | 9.31 x 4.09 x 1.54" | ¼ DIN Instrument Tray | 9.31 x 4.09 x 1.54" | Differences includeslight dimensionaldifferences in the | |
| ¼ DIN Inst/Accessory Tray Lid | 9.29 x 4.30 x 0.49" | ¼ DIN Instrument Tray Lid | 9.21 x 4.30 x 0.49" | ||
| ½ DIN Inst/Accessory Tray | 9.31 x 8.55 x 1.54" | inlay of the subjectdevice to | |||
| ½ DIN Inst/Accessory Tray Lid | 9.29 x 8.71 x 0.55" | ||||
| ¼ DIN Implant Module | 9.31 x 4.25 x 1.05" | accommodate the | |||
| ¼ DIN Screw Module | 9.31 x 4.25 x 1.75" | ¼ DIN Implant/Screw Module | 9.31 x 4.25 x 1.75" | ||
| ¼ DIN Implant Module Lid | 9.33 x 4.22 x 0.44" | ¼ DIN Implant Module LidInlay | 9.33 x 4.22 x 0.44"4.09 x 3.31 x 0.63" | intended implants. | |
| Inlay | 4.34 x 3.85 x 0.53" | ||||
| Inlay, large | 8.91 x 3.85 x 0.34" | ||||
| Drill Caddy | 3.30 x 1.33 x 1.47" | ||||
| ¼ DIN Silicone Mat | 8.95 x 3.67 x 0.63" | ¹Two-level Rack is identical to | |||
| ½ DIN Silicone Mat | 8.95 x 8.14 x 0.63" | the predicate. |
| Table 2: Performance Characteristics | |||
|---|---|---|---|
| Predicate Device | Subject Device | Comparison | |
| MaterialCompatibilitywith SterilizationProcess | Predicate device is compatible with steamsterilization. | Subject device is compatible with steam sterilization. | Same |
| Biocompatibility | Cytotoxicity (ISO 10993-5) testing resultsdemonstrated that the predicate device is non-cytotoxic | Subject device is identical in formulation andprocessing to the predicate device; therefore,cytotoxicity results of the predicate are applicable tothe subject device. | Same |
| PerformanceTesting | The following non-clinical testing was performedon the Stryker Universal Select Sterilization TraySystem:• Sterilization Validation• Dry Time Validation• Design Verification• Life Cycle Testing• Cleaning Validation• Biocompatibility | The following non-clinical testing was performed onthe Stryker ChestShield Sterilization Tray System:• Sterilization Validation• Dry Time ValidationThe following non-clinical testing was leveraged fromthe predicate to support the performance of thesubject device:• Design Verification• Life Cycle Testing• Cleaning Validation• Biocompatibility | Same |
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.
-
- 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.
§ 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).