Sonopet iQ Sterilization Tray

K190667 · Paragon Medical · KCT · Jun 13, 2019 · General Hospital

Device Facts

• Record ID: K190667
• Device Name: Sonopet iQ Sterilization Tray
• Applicant: Paragon Medical
• Product Code: KCT · General Hospital
• Decision Date: Jun 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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: [Table of cycles omitted for brevity, see source].

Device Story

Reusable sterilization tray; stainless steel base and lid with perforated pattern for steam penetration; includes stainless steel and silicone brackets for device fixation; features two retractable handles and two stainless steel latches. Used in healthcare facilities to organize and protect Stryker Sonopet iQ instruments (handpiece, cleaning wire, torque wrench) during pre-vacuum steam sterilization. Tray is non-sterile upon receipt; requires sterilization before use. Does not maintain sterility independently; requires external sterilization wrap or rigid container. Benefits include organized, secure processing of instruments, ensuring compatibility with standard autoclave cycles and maintaining structural integrity over repeated use cycles.

Clinical Evidence

No clinical data. Bench testing only. Validations included sterilization efficacy (Geobacillus stearothermophilus BI), dry time, manual/automated cleaning (AAMI TIR 30:2011), biocompatibility (ISO 10993-5 MEM Elution), and design verification (handle strength, latch force, stacking, weight) per ANSI/AAMI ST77 and DIN EN 868-8. Life cycle testing confirmed integrity after repeated processing cycles.

Technological Characteristics

Materials: Stainless steel, silicone, thermoplastic polymers. Design: Perforated base/lid, retractable handles, latching mechanism. Sterilization: Pre-vacuum steam (132°C/4 min or 134°C/3 min). Standards: ANSI/AAMI ST77, DIN EN 868-8, AAMI TIR 30:2011, ISO 10993-5, ANSI/AAMI/ISO 17665-1. Connectivity: None.

Indications for Use

Indicated for enclosing and organizing Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. Not intended to maintain sterility; must be used with FDA-cleared sterilization wrap or rigid container. Intended for use in pre-vacuum steam sterilization cycles.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray and Camera Sterilization Tray (K152951)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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-vacuum<br>Steam | Enclosure | Double Wrap or<br>Rigid Container | Double Wrap or<br>Rigid Container |
| | Temperature | 132°C<br>(270°F) | 134°C<br>(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<br>Product Load | Maximum Tray<br>Weight |
|-------------------------------|----------------|---------------------------------------------------------------------|------------------------|
| Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)<br>Cleaning Wire (Qty 1)<br>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:

K152951

| 1. Applicant Information: | Paragon Medical<br>8 Matchett Drive<br>Pierceton, IN 46562 USA<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 2. Correspondent Contact Information: | Jill Bouillon<br>Quality Manager<br>[e-mail]<br>Phone: [phone] 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<br>(21 CFR 880.6850, Product Code KCT) |
| 7. Predicate Device: | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope<br>and Camera Sterilization Tray and Camera Sterilization Tray. |

- 8. 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.

- 9. 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-vacuum<br>Steam | Enclosure | Double Wrap or<br>Rigid Container | Double Wrap or<br>Rigid Container |
| | | | |
| | Temperature | 132°C<br>(270°F) | 134°C<br>(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)<br>Cleaning Wire (Qty 1)<br>Torque Wrench (Qty 1) | 6.85 lb |

- 10. 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 and<br>Camera Sterilization Tray and Camera Sterilization Tray | Sonopet iQ Sterilization Tray | | | |
| Manufacturer | Paragon Medical<br>8 Matchett Dr<br>Pierceton, IN 46562 | Paragon Medical<br>8 Matchett Dr<br>Pierceton, IN 46562 | | | |
| 510(k)<br>Number | K152951 | K190667 | | | |
| Product Code | KCT | KCT | | | |
| Design | The trays (stainless steel base with a removable stainless steel lid)<br>have an evenly distributed perforated steam hole pattern to facilitate<br>sterilant/steam penetration.<br>The base includes silicone brackets for Stryker endoscopy device<br>fixation within the tray and two (2) latches to affix the lid to the base.<br>Handles on the sides of the base facilitate carrying of the tray. The<br>trays are reusable and provided in a non-sterile condition. | The trays (stainless steel base with a removable stainless steel lid)<br>has an evenly distributed perforated steam hole pattern to facilitate<br>sterilant/steam penetration.<br>The base includes stainless steel and silicone brackets for device<br>fixation within the tray and two (2) stainless steel latches to affix<br>the lid to the base. Two retractable handles on the sides of the base<br>facilitate carrying of the tray. The trays are reusable and provided in<br>a non-sterile condition. | | | |
| Materials | Stainless Steel, Silicone | Stainless Steel, Silicone, Thermoplastic Polymers | | | |
| Indications for<br>Use | The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope<br>and Camera Sterilization Tray, and Camera Sterilization Tray are<br>intended to enclose and organize Stryker Endoscopy reusable medical<br>instruments during sterilization at a healthcare facility. The trays are<br>optional accessories to the Stryker Endoscopy instruments for which<br>they are designed. The trays are not intended to maintain sterility;<br>they are intended to be used in conjunction with legally marketed,<br>FDA-cleared sterilization wrap in order to maintain sterility of the<br>enclosed devices. The Advanced Imaging Modality (AIM) Sterilization<br>Tray, Endoscope and Camera Sterilization Tray, and Camera<br>Sterilization Tray are intended for use in any of the following standard<br>sterilization machines / cycles: | The Sonopet iQ Sterilization Tray is intended to enclose and<br>organize Stryker Sonopet iQ reusable medical instruments during<br>processing at a healthcare facility. The tray is not intended to<br>maintain sterility; it is intended to be used in conjunction with a<br>legally marketed, FDA-cleared sterilization wrap or rigid container in<br>order to maintain sterility of the enclosed devices. The Sonopet iQ<br>Sterilization Tray is intended for use in any of the following standard<br>sterilization cycles: | | | |
| | Method | Cycle | | | |
| | | | | | |
| | Ethylene<br>Oxide (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-vacuum<br>Steam | Cycle 1 | Cycle 2 | | |
| | | Wrapping Double | Double | | |
| | | Temperature 132°C<br>(270°F) | 134°C<br>(273°F) | | |
| | | Sterilization Time 4 minutes | 3 minutes | | |
| | Pre-vacuum<br>Steam | Parameter | Cycle | | |
| | | Enclosure | Cycle 1 Double Wrap<br>or Rigid Container | Cycle 2 Double Wrap<br>or Rigid Container | |
| | | Temperature | 132°C<br>(270°F) | 134°C<br>(273°F) | |
| | | Sterilization Time | 4 minutes | 3 minutes | |
| | | Dry Time | 30 minutes | 30 minutes | |
| The maximum product load for the tray is as follows: | | | | | |
| Catalog<br>Number | Maximum Tray Product<br>Load | Maximum Tray<br>Weight | | | |
| 5500-800-278 | Handpiece (Qty 1)<br>Torque Wrench (Qty 1)<br>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 | |
| |…