(90 days)
The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles:
| Method | Parameter | Cycle | |
|---|---|---|---|
| Cycle 1 | Cycle 2 | ||
| Pre-vacuumSteam | Enclosure | Double Wrap orRigid Container | Double Wrap orRigid Container |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | 30 minutes | 30 minutes |
The maximum product load for the tray is as follows:
| Tray Description | Catalog Number | Maximum TrayProduct Load | Maximum TrayWeight |
|---|---|---|---|
| Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)Cleaning Wire (Qty 1)Torque Wrench (Qty 1) | 6.85 lb |
The Sonopet iQ Sterilization Tray is a reusable device manufactured of perforated stainless steel for the base and lid to allow for sterilization of the enclosed devices. The tray is used to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The tray is compatible with pre-vacuum steam sterilization. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The tray is provided in a non-sterile condition, and must be sterilized prior to use.
The provided text describes the 510(k) summary for the Sonopet iQ Sterilization Tray, focusing on its substantial equivalence to a predicate device. It includes details on the device's indications for use, technological characteristics, and a summary of nonclinical testing.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (typically from relevant standards or internal protocols) | Reported Device Performance |
|---|---|---|
| Sterilization Effectiveness | Biological Indicators (BIs) with Geobacillus stearothermophilus spores must be inactivated after pre-vacuum steam autoclave half-cycle exposures, demonstrating effective sterilization. | Sterilization validations were performed using an autoclave cycle with pre-vacuum air removal. The study evaluated the resistance of biological indicators (BIs) with Geobacillus stearothermophilus spores to pre-vacuum steam autoclave half cycle exposures. The Sonopet iQ Sterilization Tray was validated per ANSI/AAMI/ISO 17665-1, indicating successful sterilization. |
| Dry Time | The device must achieve proper dryness after sterilization cycles. | Dry time was evaluated after sterilization, implying successful achievement of dryness within specified parameters (specific results not detailed, but overall "All results of performance testing met acceptance criteria" suggests it passed). |
| Cleaning Effectiveness | Cleaning methods must be effective in removing soil from all designated surfaces of the tray, as validated per AAMI TIR 30:2011. | A manual and automated cleaning validation was performed per AAMI TIR 30:2011. The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the Sonopet iQ Sterilization Tray that might be accessible to the end user. |
| Biocompatibility (Cytotoxicity) | Materials of construction must be non-cytotoxic, generally showing grade 2 or less cell lysis and reactivity per ISO 10993-5. | Biocompatibility testing was conducted on all materials used in construction per ISO 10993-5 using the MEM Elution method. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels. |
| Handle Strength | Handle strength must meet the requirements of ANSI/AAMI ST77:2013. | Design verification testing included handle strength, which "met the requirements of ANSI/AAMI ST77" (for the predicate, and subject stated as "Design verification testing included handle strength... All results of performance testing met acceptance criteria"). |
| Latch Force | Latch force must meet the requirements of ANSI/AAMI HE75:2009. | Design verification testing included latch force, which "met requirements of ANSI/AAMI HE75:2009" (for the predicate, and subject stated as "Design verification testing included... latch force. All results of performance testing met acceptance criteria"). |
| Stacking | Stacking features must meet requirements per DIN EN 868-8. | Design verification testing included stacking features which were tested per DIN EN 868-8 (for the predicate, and implicitly passed for the subject as "All results of performance testing met acceptance criteria"). |
| Weight | The tray's weight must be verified and supported by its design. | Design verification testing included weight verification (implicitly passed as "All results of performance testing met acceptance criteria"). The maximum tray weight is specified as 6.85 lb. |
| Life Cycle Testing (Durability and Integrity) | The device must maintain functional quality, material integrity, and traceability (artwork and UDI legibility) after repeated worst-case processing cycles (e.g., 100 cycles). | Life cycle testing was performed to verify that the Sonopet iQ Sterilization Tray maintained functional quality requirements, material integrity, and traceability (artwork and UDI legibility) after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles, and simulated functional use of the components (kitting, latch and handle actuation). "All results of performance testing met acceptance criteria." |
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 specific sample sizes for the test sets in the non-clinical performance testing (sterilization, cleaning, biocompatibility, design verification, life cycle testing). It mentions that "All results of performance testing met acceptance criteria."
- Sterilization Validation: Tests were performed using "an autoclave cycle" and evaluated "Biological Indicators (BIs)." The number of cycles performed and the number of BIs used per cycle are not specified.
- Cleaning Validation: "A manual and automated cleaning validation" was performed. The number of cycles, number of trays, or specific soil coupon types are not mentioned.
- Biocompatibility: "Biocompatibility testing was conducted on all materials used in construction." It doesn't specify the number of test articles or replicates.
- Life Cycle Testing: "Life cycle testing was performed to verify that the Sonopet iQ Sterilization Tray maintained functional quality requirements... after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use." While it mentions "repeated...cycles," the exact number of test units or total cycles for each unit is not given. However, the predicate device mentions "Life cycle testing to 100 worst-case processing cycles," and the subject device states "Same" for this characteristic, implying a similar number of cycles were performed.
The data provenance would be considered prospective as these are specific tests conducted by the manufacturer (Paragon Medical, Pierceton, IN, USA) to demonstrate the safety and effectiveness of their new device for regulatory submission. The country of origin of the data would be the USA (Indiana).
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 device is a sterilization tray, which is a medical device accessory, not an AI or diagnostic tool. The ground truth for its performance is established through objective, standardized laboratory testing (e.g., biological indicator kill rates, gravimetric soil removal, cytotoxicity assays, mechanical strength tests) against established industry standards (ANSI/AAMI/ISO 17665-1, AAMI TIR 30:2011, ISO 10993-5, ANSI/AAMI ST77, DIN EN 868-8, ANSI/AAMI HE75). Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (like radiologists for image interpretation) is not directly applicable here. The "experts" involved would be qualified laboratory technicians, microbiologists, and engineers conducting and interpreting these standardized tests, ensuring compliance with the cited standards. Their qualifications are inherent in their ability to conduct such validated testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for subjective outcomes (e.g., radiology reads). For the objective, laboratory-based performance testing of a sterilization tray, such external adjudication methods are not typically used. The "adjudication" is inherent in the pass/fail criteria defined by the relevant industry standards and internal protocols, and the tests are performed to verify compliance with these objective criteria. Any discrepancies or failures would lead to investigation and retesting by the laboratory performing the validation.
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
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images (e.g., AI in radiology). The Sonopet iQ Sterilization Tray is a mechanical device accessory for sterilization, and its evaluation does not involve "human readers" or "AI assistance" in the diagnostic pipeline.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an AI algorithm without human involvement. Since the Sonopet iQ Sterilization Tray is not an AI-powered device, this question is not applicable. The equivalent "standalone performance" for this device would be its ability to pass the specified sterilization, cleaning, biocompatibility, and mechanical tests on its own, which was done (its performance was evaluated independently).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the Sonopet iQ Sterilization Tray is based on objective, verifiable scientific and engineering principles and established industry standards:
- Sterilization: The "ground truth" for sterilization is the inactivation of a specified challenge organism (biological indicator spores) to a statistically defined sterility assurance level (SAL), as demonstrated through validated cycles and confirmed by microbial testing.
- Cleaning: The "ground truth" for cleaning is the removal of a specified soil load to analytically undetectable or clinically acceptable levels, as demonstrated by validated cleaning protocols and analytical testing (e.g., protein, hemoglobin assays).
- Biocompatibility: The "ground truth" for biocompatibility (cytotoxicity) is the absence of unacceptable cellular toxicity as quantified by standardized cell culture assays against clear international standards (ISO 10993-5).
- Mechanical Integrity/Life Cycle: The "ground truth" for handle strength, latch force, stacking, and life cycle performance is the demonstration that the device meets predefined physical and functional specifications after repeated use and processing, validated against established engineering standards (e.g., ANSI/AAMI ST77, DIN EN 868-8, ANSI/AAMI HE75).
8. The sample size for the training set
This question is applicable to AI/ML devices where a model is trained on a dataset. The Sonopet iQ Sterilization Tray is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in this context.
9. How the ground truth for the training set was established
As there is no training set for an AI/ML algorithm, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows 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.
June 13, 2019
Paragon Medical C/o Rebecca Walker Regulatory Affairs Manager 8 Matchett Dr Pierceton, Indiana 46562
Re: K190667
Trade/Device Name: Sonopet iQ Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 7, 2019 Received: May 8, 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth F. Claverie-Williams, MS Assistant Director. THT4B2: Disinfection Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices 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)
K190667
Device Name
Sonopet iQ Sterilization Tray
Indications for Use (Describe)
The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles:
| Method | Parameter | Cycle | |
|---|---|---|---|
| Cycle 1 | Cycle 2 | ||
| Pre-vacuumSteam | Enclosure | Double Wrap orRigid Container | Double Wrap orRigid Container |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | 30 minutes | 30 minutes |
The maximum product load for the tray is as follows:
| Tray Description | Catalog Number | Maximum TrayProduct Load | Maximum TrayWeight |
|---|---|---|---|
| Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)Cleaning Wire (Qty 1)Torque Wrench (Qty 1) | 6.85 lb |
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 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.
510(k) Summary for Sonopet iQ Sterilization Tray, K190667
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: | Jill BouillonQuality ManagerJill.bouillon@nninc.comPhone: 574-594-2140 ext. 10403 |
| 3. Date Prepared: | June 12, 2019 |
| 4. Trade Name: | Sonopet iQ Sterilization Tray |
| 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: | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscopeand Camera Sterilization Tray and Camera Sterilization Tray. |
-
- Device Description: The Sonopet iQ Sterilization Tray is a reusable device manufactured of perforated stainless steel for the base and lid to allow for sterilization of the enclosed devices. The tray is used to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The tray is compatible with pre-vacuum steam sterilization. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The tray is provided in a non-sterile condition, and must be sterilized prior to use.
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Image /page/4/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. To the right of the pentagon is the text "PARAGON" in black, with the text "MEDICAL" below it, also in black. There are two black lines above and below the text.
-
- Indications for Use: The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles:
| Method | Parameter | Cycle | |
|---|---|---|---|
| Cycle 1 | Cycle 2 | ||
| Pre-vacuumSteam | Enclosure | Double Wrap orRigid Container | Double Wrap orRigid Container |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | 30 minutes | 30 minutes |
The maximum product load for the tray is as follows:
| Tray Description | Catalog Number | Maximum Tray Product Load | Maximum Tray Weight |
|---|---|---|---|
| Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)Cleaning Wire (Qty 1)Torque Wrench (Qty 1) | 6.85 lb |
-
- Technological Characteristics: The following pages contain a detailed comparison of the subject device to the predicate comparison of the technological (Table 1) and performance (Table 2) characteristics of the subject and predicate device.
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Image /page/5/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 on the left. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other, with a black line above and below the words.
| Table 1: Comparison of Technological Characteristics | |||||
|---|---|---|---|---|---|
| Predicate Device (K152951) | Subject Device (K190667) | ||||
| Device Name | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope andCamera Sterilization Tray and Camera Sterilization Tray | Sonopet iQ Sterilization Tray | |||
| Manufacturer | Paragon Medical8 Matchett DrPierceton, IN 46562 | Paragon Medical8 Matchett DrPierceton, IN 46562 | |||
| 510(k)Number | K152951 | K190667 | |||
| Product Code | KCT | KCT | |||
| Design | The trays (stainless steel base with a removable stainless steel lid)have an evenly distributed perforated steam hole pattern to facilitatesterilant/steam penetration.The base includes silicone brackets for Stryker endoscopy devicefixation within the tray and two (2) latches to affix the lid to the base.Handles on the sides of the base facilitate carrying of the tray. Thetrays are reusable and provided in a non-sterile condition. | The trays (stainless steel base with a removable stainless steel lid)has an evenly distributed perforated steam hole pattern to facilitatesterilant/steam penetration.The base includes stainless steel and silicone brackets for devicefixation within the tray and two (2) stainless steel latches to affixthe lid to the base. Two retractable handles on the sides of the basefacilitate carrying of the tray. The trays are reusable and provided ina non-sterile condition. | |||
| Materials | Stainless Steel, Silicone | Stainless Steel, Silicone, Thermoplastic Polymers | |||
| Indications forUse | The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscopeand Camera Sterilization Tray, and Camera Sterilization Tray areintended to enclose and organize Stryker Endoscopy reusable medicalinstruments during sterilization at a healthcare facility. The trays areoptional accessories to the Stryker Endoscopy instruments for whichthey are designed. The trays are not intended to maintain sterility;they are intended to be used in conjunction with legally marketed,FDA-cleared sterilization wrap in order to maintain sterility of theenclosed devices. The Advanced Imaging Modality (AIM) SterilizationTray, Endoscope and Camera Sterilization Tray, and CameraSterilization Tray are intended for use in any of the following standardsterilization machines / cycles: | The Sonopet iQ Sterilization Tray is intended to enclose andorganize Stryker Sonopet iQ reusable medical instruments duringprocessing at a healthcare facility. The tray is not intended tomaintain sterility; it is intended to be used in conjunction with alegally marketed, FDA-cleared sterilization wrap or rigid container inorder to maintain sterility of the enclosed devices. The Sonopet iQSterilization Tray is intended for use in any of the following standardsterilization cycles: | |||
| Method | Cycle | ||||
| EthyleneOxide (EtO) | Preconditioning Parameters | ||||
| Temperature (°C) 55°C (131°F) | |||||
| Chamber Humidity 70% RH | |||||
| Vacuum Set Points 1.3 psia | |||||
| Time 30 minutes | |||||
| Exposure | |||||
| Concentration 725 mg/L, 100% EO | |||||
| Temperature (°C) 55°C +2°C (131°F +5°F) | |||||
| Time 1 hour | |||||
| Chamber Humidity (%) 70% RH (50-80%) +5% | |||||
| Aeration | |||||
| Aeration Time 12 hours | |||||
| Temperature 35°C - 54°C (95°F - 129°F) | |||||
| Pre-vacuumSteam | Cycle 1 | Cycle 2 | |||
| Wrapping Double | Double | ||||
| Temperature 132°C(270°F) | 134°C(273°F) | ||||
| Sterilization Time 4 minutes | 3 minutes | ||||
| Pre-vacuumSteam | Parameter | Cycle | |||
| Enclosure | Cycle 1 Double Wrapor Rigid Container | Cycle 2 Double Wrapor Rigid Container | |||
| Temperature | 132°C(270°F) | 134°C(273°F) | |||
| Sterilization Time | 4 minutes | 3 minutes | |||
| Dry Time | 30 minutes | 30 minutes | |||
| The maximum product load for the tray is as follows: | |||||
| CatalogNumber | Maximum Tray ProductLoad | Maximum TrayWeight | |||
| 5500-800-278 | Handpiece (Qty 1)Torque Wrench (Qty 1)Cleaning Wire (Qty 1) | 6.85 lb. | |||
| Dry Time | 30 minutes | 30 minutes | |||
| Gravity | Cycle 1 | Cycle 2 | |||
| Steam | Wrapping | Double | Double | ||
| 132°C | 134°C | ||||
| Temperature | (270°F) | (273°F) | |||
| Sterilization Time | 15 minutes | 10 minutes | |||
| Dry Time | 30 minutes | 30 minutes | |||
| MethodSTERIS® V-PRO® 1STERIS® V-PRO® 1 Plus | Cycle | ||||
| Standard | |||||
| Non-Lumen or Lumen | |||||
| STERIS® V-PRO® maX | Non-Lumen or Lumen | ||||
| STERRAD® 100S | Standard | ||||
| STERRAD® NX® | Standard | ||||
| STERRAD® 100NX® | Standard | ||||
| In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, | |||||
| Endoscope and Camera Sterilization Tray, and Camera Sterilization | |||||
| Tray are validated for the following Immediate Use Steam | |||||
| Sterilization cycles for emergency situations ONLY: | |||||
| Immediate | Cycle 1 | Cycle 2 | |||
| Use Steam | Wrapping | None | None | ||
| Sterilization | 132°C | 134°C | |||
| ("Flash") | Temperature | (270°F) | (273°F) | ||
| Pre-vacuum | Sterilization Time | 4 minutes | 3 minutes | ||
| Steam | Dry Time | None | None | ||
| The maximum product loads for the trays are as follows: | |||||
| Total | |||||
| Tray | Catalog | Max Tray Product | Loaded | ||
| Description | Number | Load | Tray | ||
| Weight | |||||
| Advanced | 0233-032- | Camera (Qty 1) | 10.58 lbs | ||
| Imaging | 301 | Light Cable (Qty 1) | |||
| Modality | Coupler (Qty 1) | ||||
| Sterilization | Scope (Qty 2) | ||||
| Adapter (Qty 2) | |||||
| (AIM) Tray | |||||
| Endoscope | 0233-032- | Camera (Qty 1) | 10.58 lbs | ||
| and Camera | 302 | Light Cable (Qty 1) | |||
| Sterilization | Coupler (Qty 1) | ||||
| Tray | Scope (Qty 2) | ||||
| Adapter (Qty 2) | |||||
| Camera | 0233-410- | Camera (Qty 1) | 8.83 Ibs | ||
| Sterilization | 002 | Light Cable (Qty 1) | |||
| Tray | Coupler (Qty 1) | ||||
| Configuration | |||||
| and | AIM/Endoscope and Camera Trays: 21.2 x 10.5 x 2.9 inches | 9.80 x 9.80 x 2.87 inches | |||
| Dimensions | Camera Tray: 15.6 x 10.5 x 2.9 inches | ||||
| Percent of | AIM/Endoscope and Camera Trays: 10.3% | ||||
| SurfacePerforations | Camera Tray: 9.9 % | 12.41% |
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Image /page/6/Picture/0 description: The image contains a logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center on the left side of the image. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other with a black line above and below the words.
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Image /page/7/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.
| SterilizationMethod | Pre-vacuum Steam, Pre-Vacuum Steam Immediate Use (Flash),Gravity Steam, STERRAD 100S, STERRAD NX, STERRAD 100NX, SterisV-PRO, Steris V-PRO 1 Plus, Steris V-PRO 1 maX, Ethylene Oxide | Pre-vacuum Steam |
|---|---|---|
| Single Use/Reusable | Reusable | Reusable |
| SterilizationBarrier | Sterilization Wrap | Sterilization WrapRigid Container |
| PatientContact | No direct patient contact | No direct patient contact |
| Table 2: Comparison of Performance Characteristics | ||
|---|---|---|
| Predicate Device (Advanced Imaging Modality (AIM) SterilizationTray, Endoscope and Camera Sterilization Tray and CameraSterilization Tray) | Subject Device (Sonopet iQ Sterilization Tray) | |
| MaterialCompatibilitywithSterilizationProcess | Materials are compatible with indicated sterilization methods.Performance testing demonstrated that the materials of constructionare compatible with repeated sterilization cycles. | Same |
| ToxicologicalProperties | Cytotoxicity testing demonstrated that the materials are non-cytotoxic. | Same |
| Life cycleTesting | Life cycle testing to 100 worst-case processing cycles showed novisual degradation or alteration to form, function or operation of thetray | Same |
| DesignVerification | Handle Strength testing met the requirements of ANSI/AAMIST77:2013 and DIN EN 868-8:2009-09, Latch Force testing metrequirements of ANSI/AAMI HE75:2009 | Design verification testing included handle strength, latch force,stacking, and weight. |
11. Summary of Nonclinical Testing: The following non-clinical performance testing were conducted on the Sonopet iQ Sterilization Tray:
● Sterilization and Dry Time Validation
Sterilization validations were performed to verify the effectiveness of steam sterilization of a fully loaded Sonopet iQ Sterilization Tray sterilized in a rigid sterilization container and double-wrapped with sterilization wrap. Tests were performed using an autoclave cycle with pre-vacuum air removal. The study evaluated the resistance of biological indicators (Bls) with 10° Geobacillus stearothermophilus spores to pre-vacuum steam autoclave half cycle exposures. Dry time was evaluated after sterilization. The Sonopet iQ Sterilization Tray was validated per ANSI/AAMI/ISO 17665-1.
. Cleaning Validation
A manual and automated cleaning validation was performed per AAMI TIR 30:2011 to validate the cleaning instructions. The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the Sonopet iQ Sterilization Tray that might be accessible to the end user.
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. Biocompatibility
Biocompatibility testing was conducted on all materials used in construction of the Sonopet iQ Sterilization Tray per ISO 10993-5 using the MEM Elution method. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels. -
. Design Verification
Design verification testing included verification of the handle strength and weight per ANSI/AAMI ST77, stacking features per DIN EN 868-8, and latch force. -
. Life Cycle Testing
Life cycle testing was performed to verify that the Sonopet iQ Sterilization Tray maintained functional quality requirements, material integrity, and traceability (artwork and UDI legibility) after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use of the components, which included kitting the tray, latch and handle actuation).
All results of performance testing met acceptance criteria.
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- Conclusion: Based on the intended use, technological characteristics, performance data, and nonclinical testing performed, the subject device is substantially equivalent to the legally marketed predicate device.
§ 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).