Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization tray, a passive container for medical instruments, and the description focuses on its material, sterilization compatibility, and physical properties. There is no mention of any computational or analytical functions that would involve AI/ML.

Therapeutic

No
The device is a sterilization tray used to hold medical instruments during processing; it does not directly treat or diagnose any medical condition.

Diagnostic

No
The Sonopet iQ Sterilization Tray is used to enclose and organize reusable medical instruments for sterilization, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a reusable device manufactured of perforated stainless steel, indicating it is a physical hardware product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sonopet iQ Sterilization Tray is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the tray is for enclosing and organizing reusable medical instruments during processing and sterilization. It is not used to perform tests on biological samples or to diagnose conditions.
Device Description: The description reinforces its function as a container for sterilization, made of stainless steel.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls

The device is a medical device used in the processing and sterilization of other medical devices. Its function is related to infection control and preparing instruments for surgical or other medical procedures, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
Pre-vacuum
Steam	Enclosure	Double Wrap or
Rigid Container	Double Wrap or
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:

| 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 |

Product codes (comma separated list FDA assigned to the subject device)

KCT

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.

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)

Summary of Nonclinical Testing:

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.

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152951

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For 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

2

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
Steam	Enclosure	Double Wrap or
Rigid Container	Double Wrap or
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:

| 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 |

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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
8 Matchett Drive
Pierceton, IN 46562 USA
Phone: 574-594-2140
Fax: 574-594-2154 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 2. Correspondent Contact Information: | Jill Bouillon
Quality Manager
Jill.bouillon@nninc.com
Phone: 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, Endoscope
and Camera Sterilization Tray and Camera Sterilization Tray. |

1. 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.

4

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.

1. 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
Steam	Enclosure	Double Wrap or
Rigid Container	Double Wrap or
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:

Tray Description	Catalog Number	Maximum Tray Product Load
Sonopet iQ Sterilization Tray	5500-800-278	Handpiece (Qty 1)
Cleaning Wire (Qty 1)
Torque Wrench (Qty 1)	6.85 lb

1. 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
Camera Sterilization Tray and Camera Sterilization Tray	Sonopet iQ Sterilization Tray
Manufacturer	Paragon Medical
8 Matchett Dr
Pierceton, IN 46562	Paragon Medical
8 Matchett Dr
Pierceton, 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 facilitate
sterilant/steam penetration.
The base includes silicone brackets for Stryker endoscopy device
fixation 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. The
trays 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 facilitate
sterilant/steam penetration.
The base includes stainless steel and silicone brackets for device
fixation within the tray and two (2) stainless steel latches to affix
the lid to the base. Two retractable handles on the sides of the base
facilitate carrying of the tray. The trays are reusable and provided in
a non-sterile condition.
Materials	Stainless Steel, Silicone	Stainless Steel, Silicone, Thermoplastic Polymers
Indications for
Use	The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope
and Camera Sterilization Tray, and Camera Sterilization Tray are
intended to enclose and organize Stryker Endoscopy reusable medical
instruments during sterilization at a healthcare facility. The trays are
optional accessories to the Stryker Endoscopy instruments for which
they 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 the
enclosed devices. The Advanced Imaging Modality (AIM) Sterilization
Tray, Endoscope and Camera Sterilization Tray, and Camera
Sterilization Tray are intended for use in any of the following standard
sterilization machines / cycles:	The Sonopet iQ Sterilization Tray is intended to enclose and
organize Stryker Sonopet iQ reusable medical instruments during
processing at a healthcare facility. 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 Sonopet iQ
Sterilization Tray is intended for use in any of the following standard
sterilization cycles:
	Method	Cycle

	Ethylene
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
Steam	Cycle 1	Cycle 2
		Wrapping Double	Double
		Temperature 132°C
(270°F)	134°C
(273°F)
		Sterilization Time 4 minutes	3 minutes
	Pre-vacuum
Steam	Parameter	Cycle
		Enclosure	Cycle 1 Double Wrap
or Rigid Container	Cycle 2 Double Wrap
or 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:
Catalog
Number	Maximum Tray Product
Load	Maximum Tray
Weight
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
	Method
STERIS® V-PRO® 1
STERIS® 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%
Surface
Perforations	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.

| Sterilization
Method | Pre-vacuum Steam, Pre-Vacuum Steam Immediate Use (Flash),
Gravity Steam, STERRAD 100S, STERRAD NX, STERRAD 100NX, Steris
V-PRO, Steris V-PRO 1 Plus, Steris V-PRO 1 maX, Ethylene Oxide | Pre-vacuum Steam |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Single Use/
Reusable | Reusable | Reusable |
| Sterilization
Barrier | Sterilization Wrap | Sterilization Wrap
Rigid Container |
| Patient
Contact | No direct patient contact | No direct patient contact |

Table 2: Comparison of Performance Characteristics
	Predicate Device (Advanced Imaging Modality (AIM) Sterilization
Tray, Endoscope and Camera Sterilization Tray and Camera
Sterilization Tray)	Subject Device (Sonopet iQ Sterilization Tray)
Material
Compatibility
with
Sterilization
Process	Materials are compatible with indicated sterilization methods.
Performance testing demonstrated that the materials of construction
are compatible with repeated sterilization cycles.	Same
Toxicological
Properties	Cytotoxicity testing demonstrated that the materials are non-
cytotoxic.	Same
Life cycle
Testing	Life cycle testing to 100 worst-case processing cycles showed no
visual degradation or alteration to form, function or operation of the
tray	Same
Design
Verification	Handle Strength testing met the requirements of ANSI/AAMI
ST77:2013 and DIN EN 868-8:2009-09, Latch Force testing met
requirements 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.

8

Image /page/8/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, with a black line above and below the words.

. 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.

1. 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.