The RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices. The Pivot System Sterilization Tray System has been validated for use in the following sterilization cycles:

Enclosure Pivot System Sterilization Tray Cycle Pre-Vacuum 132°C (270°F) Temperature Sterilization Time 4 minutes Pressure 2-15 PSIA Minimum Dry Time 30 minutes in chamber

The maximum validated product loads for the trays in containers are as follows: 2-Level Rack, Level 2, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 3 each 39.1960.02, RP OST Tool Rod, 3 each 39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each 39.1960.51.02 RP OST Tool 1D RH 22mm, 1 each 39.1960.20.01 RP OST Angle 162mm, 1 each 39.1960.20.02 RP OST Angle 19mm, 1 each 39.1960.20.03 RP OST Angle 21.5mm , 1 each 39.1960.40.01 RP TM Spike Blade, 1 each 39.1960.60.01 OST Reverse Blade 11mm, 1 each 39.1960.60.02 OST Reverse Blade 16mm, 1 each 39.1960.30.01 RP OST Tool Curve 16mm, 1 each 39.1960.30.02 RP OST Tool Curve 19mm, 1 each 39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each 39.1960.10.01 RP OST Straight 20mm, 1 each 39.1960.10.02 RP OST Straight 40mm, 1 each 39.1960.10.03 RP OST Straight 43mm, 1 each 39.1960.10.04 RP OST Straight 47.5mm, 1 each 39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each 39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each

2-Level Rack - Level 1, Pivot System Sterilization Tray 39.1960.01, RP OST Tool Handle, 1 each 39.1960.02, RP OST Tool Rod, 1 each 39.1960.05, Retractor, 1 each 39.1960.07, RP OST System, 1 each 39.1960.70.01 RP Curved Hip Long, 1 each 39.1960.70.02 RP Curved Hip Short, 1 each 39.1960.70.03 RP Curved Hip, 1 each

Device Description

The RP Medical Pivot System Sterilization Tray System platform is designed to be compatible with the RP Medical Pivot Implant Extraction Osteotome surgical instruments. The Pivot System Sterilization Tray is constructed from thermoplastic plastics, aluminum and stainless steel. Each tray has evenly distributed steam holes.

Individuals instruments were designed to slide into 2 level storage racks. The racks have handles on the side to facilitate carrying. The Pivot System Sterilization Tray has a sliding latch mechanism to facilitate containment.

Each storage rack is set to a specific configuration and have stainless steel and silicone brackets and silkscreened artwork to assist the end user in correct placement of the instruments. The rack is designed to fit in a standard autoclave. The Pivot System Sterilization Tray System is reusable and provided in a non-sterile condition.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the RP Medical Pivot System Sterilization Tray System. The information provided primarily focuses on demonstrating substantial equivalence to a predicate device and includes non-clinical testing results.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Name of the Test Method	Purpose	Acceptance Criteria	Reported Device Performance
Agar Overlay Method per ISO 10993-5 (Cytotoxicity)	To evaluate an extract of the test article for cytotoxicity to mammalian cells in culture	Test articles scoring 0, 1 or 2 will be considered 'non-cytotoxic'.	The test article scored 0 at 24, 48 and 72 +/- 4 hours and is considered non-cytotoxic.
AAMI ST77:2013, Containment Devices for Reusable Medical Device Sterilization (Handle Weight Capacity Test)	Handle Weight Capacity Test for the Sterilization Case	No visible deformation, cracking or other evidence of damage on the Handles after testing.	There was no visible deformation, cracking or other evidence of damage on the Handles after testing.
Reliability testing for the Sterilization Case	No significant wear after 100 sterilization cycles.	Significant wear is defined as extreme discoloration, peeling and/or cracking of any component of the sterilization tray.	A side by side comparison of a new vs the Sterilization Case sterilized 102 times showed a "slight yellowing of the case color and the white print within the Sterilization Case." The "discoloration was minimum and none of the printing was erased or faded so that it could not be read." There was "no peeling and/or cracking of any of the components of the sterilization case."

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 sample sizes for the individual non-clinical tests (e.g., number of sterilization cases tested for cytotoxicity or reliability). The data provenance is not specified, but the applicant is RP Medical, Inc. from Maple Ridge, BC, Canada, suggesting the testing likely occurred in North America or at a lab collaborating with the applicant. The testing is for a new device seeking clearance, making it prospective in nature for regulatory purposes.

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 is a non-clinical device submission for a sterilization tray and does not involve human expert interpretation or ground truth establishment in the way that an AI/imaging device would. The "ground truth" for these tests are objective measurements and observations against pre-defined engineering and biological safety standards (e.g., cytotoxicity score, absence of visible damage, structural integrity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is a non-clinical device test where results are based on objective measurement against defined criteria, not human adjudication of subjective data.

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

Not applicable. This is a non-clinical device that is not an AI-powered diagnostic or interpretive tool, so no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (sterilization tray), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is based on objective laboratory measurements and observations against established industry standards and internal specifications regarding:

Biocompatibility: Absence of cytotoxicity as per ISO 10993-5.
Mechanical Integrity: Absence of visible deformation or damage under specified weight (AAMI ST77:2013).
Durability and Wear: Absence of "significant wear" (extreme discoloration, peeling, cracking) after a specified number of sterilization cycles.

8. The sample size for the training set

Not applicable. This is a non-clinical device; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 25, 2019

RP Medical, Inc. Jim Barley Director of RA/OA 22715 Holyrood Avenue Maple Ridge, V2X 6E7 Ca

Re: K181845

Trade/Device Name: Pivot System Sterilization case Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 19, 2019 Received: August 27, 2019

Dear Jim Barley:

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,

Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181845

Device Name Pivot System Sterilization Case

Indications for Use (Describe)

Enclosure Pivot System Sterilization Case Cycle Pre-Vacuum 132°C (270°F) Temperature Sterilization Time 4 minutes Pressure 2-15 PSIA Minimum Dry Time 30 minutes in chamber

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Prescription Use (Part 21 CFR 801 Subpart D)

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

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RP Medical

510(k) Summary (As required by 21 CFR 807.92(a)) K181845

Date Prepared: November 22, 2019

A. Applicant and Correspondent

Applicant Name and Address:	RP Medical, Inc.22715 Holyrood AvenueMaple Ridge, BC V2X 6E7 Canada
Contact Person:	Ross PaulPresident
Phone:	604-418-4554
Manufacturer	RP Medical, Inc.22715 Holyrood AvenueMaple Ridge, BC V2X 6E7 Canada

B. Name of Device

• Trade/Proprietary/Model Name:	Pivot System Sterilization Tray System
• Common Name of Devices:	Sterilization Tray
• Panel:	General Hospital and Personal Use

КСТ

21 CFR 880.6850

Classification Number: .
Classification Name: Sterilization wrap .
Regulatory Class: .
. Product Code:

C. Predicate Device

Device Name:	Stryker Universal Select Sterilization Tray System
Manufacturer:	Paragon Medical
Reference:	K173615

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510(k) SUMMARY (Continued)

D. Device Description

E. Indications for Use

Enclosure	Pivot System Sterilization Tray
	Pre-Vacuum
Temperature	132°C (270°F)
Sterilization Time	4 minutes
Pressure	2-15 PSIA
Minimum Dry Time	30 minutes in chamber

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Configuration	Maximum Validated Load Set Contents
2-Level Rack,Level 2Pivot SystemSterilization Tray	39.1960.01, RP OST Tool Handle, 3 each39.1960.02, RP OST Tool Rod, 3 each39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each39.1960.51.02, RP OST Tool 1D RH 22mm, 1 each39.1960.20.01 RP OST Angle 162mm, 1 each39.1960.20.02 RP OST Angle 19mm, 1 each39.1960.20.03 RP OST Angle 21.5mm, 1 each39.1960.40.01 RP TM Spike Blade, 1 each39.1960.60.01 OST Reverse Blade 11mm, 1 each39.1960.60.02 OST Reverse Blade 16mm, 1 each39.1960.30.01 RP OST Tool Curve 16mm, 1 each39.1960.30.02 RP OST Tool Curve 19mm, 1 each39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each39.1960.10.01 RP OST Straight 20mm, 1 each39.1960.10.02 RP OST Straight 40mm, 1 each39.1960.10.03 RP OST Straight 43mm, 1 each39.1960.10.04 RP OST Straight 47.5mm, 1 each39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each
2-Level Rack –Level 1Pivot SystemSterilizationTray	39.1960.01, RP OST Tool Handle, 1 each39.1960.02, RP OST Tool Rod, 1 each39.1960.05, Retractor, 1 each39.1960.07, RP OST System, 1 each39.1960.70.01 RP Curved Hip Long, 1 each39.1960.70.02, RP Curved Hip Short, 1each 39.1960.70.03 RP Curved Hip, 1 each

Configuration

Maximum Validated Load Set Contents

2-Level Rack,Level 2Pivot SystemSterilization Tray

39.1960.01, RP OST Tool Handle, 3 each39.1960.02, RP OST Tool Rod, 3 each39.1960.51.01, RP OST Tool 1D RH 16mm, 1 each39.1960.51.02, RP OST Tool 1D RH 22mm, 1 each39.1960.20.01 RP OST Angle 162mm, 1 each39.1960.20.02 RP OST Angle 19mm, 1 each39.1960.20.03 RP OST Angle 21.5mm, 1 each39.1960.40.01 RP TM Spike Blade, 1 each39.1960.60.01 OST Reverse Blade 11mm, 1 each39.1960.60.02 OST Reverse Blade 16mm, 1 each39.1960.30.01 RP OST Tool Curve 16mm, 1 each39.1960.30.02 RP OST Tool Curve 19mm, 1 each39.1960.30.03 RP OST Tool Curve 21.5mm, 1 each39.1960.10.01 RP OST Straight 20mm, 1 each39.1960.10.02 RP OST Straight 40mm, 1 each39.1960.10.03 RP OST Straight 43mm, 1 each39.1960.10.04 RP OST Straight 47.5mm, 1 each39.1960.52.01, RP OST Tool 1D LH 16mm, 1 each39.1960.52.02 RP OST Tool 1D LH 22mm, 1 each

2-Level Rack –Level 1Pivot SystemSterilizationTray

39.1960.01, RP OST Tool Handle, 1 each39.1960.02, RP OST Tool Rod, 1 each39.1960.05, Retractor, 1 each39.1960.07, RP OST System, 1 each39.1960.70.01 RP Curved Hip Long, 1 each39.1960.70.02, RP Curved Hip Short, 1each 39.1960.70.03 RP Curved Hip, 1 each

The maximum validated product loads for the trays in containers are as follows:

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F. Technological Characteristics:

The following chart compares the technological characteristics of the subject and predicate devices:

	Subject Device	Predicate Device	Comparison
Device Name	Pivot System Sterilization Tray System	Stryker Universal Select Sterilization Tray System	N/A
510(k) Number	K181845	K173615	N/A
Product Code	KCT	KCT	Same
Indications for Use	The RP Medical Pivot System Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Pivot System surgical instruments within a healthcare facility when used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap for use in healthcare facilities in order to maintain sterility of the enclosed devices.. The Pivot System Sterilization Tray System has been validated for use in the following sterilization cycles:	The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices.The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:Pre-Vacuum Steam Enclosure Rigid Container² Rigid Container² Temperature 132°C (270°F) 135°C (275°F) Sterilization Time 4 minutes 3 minutes Minimum Dry Time 30 minutes 30 minutes Maximum Weight 25 lbs / 11.36 kgs 25 lbs / 11.36 kgs Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid)		Different

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	Subject Device				Predicate Device	Comparison
	Cycle	Temp.	ExposureTime(min)	Dry Time(min)
	Pre-vacuum	132 °C	4	30
	The maximum validated product loads for thesterilization case are as follows:				The maximum validated product loads forthe tray system in containers are as follows:	Different
	Configuration1			Maximum	Configuration1 Maximum ValidatedLoad Set Contents2,5
Indications forUse(continued)	2-Level Rack,Level 2Rigid Sterilization Container339.1960.01, RP OST Tool Handle39.1960.02, RP OST Tool Rod39.1960.51.01, RP OST Tool 1D RH 16mm39.1960.51.02 RP OST Tool 1D RH 22mm39.1960.20.01 RP OST Angle 162mm39.1960.20.02 RP OST Angle 19mm39.1960.20.03 RP OST Angle 21.5mm39.1960.40.01 RP TM Spike Blade39.1960.60.01 OST Reverse Blade 11mm39.1960.60.02 OST Reverse Blade 16mm39.1960.30.01 RP OST Tool Curve 16mm39.1960.30.02 RP OST Tool Curve 19mm39.1960.30.03 RP OST Tool Curve 21.5mm39.1960.10.01 RP OST Straight 20mm39.1960.10.02 RP OST Straight 40mm39.1960.10.03 RP OST Straight 43mm39.1960.10.04 RP OST Straight 47.5mm39.1960.52.01, RP OST Tool 1D LH 16mm39.1960.52.02 RP OST Tool 1D LH 22mm2-Level Rack -Level 1Rigid Sterilization Container439.1960.01, RP OST Tool Handle39.1960.02, RP OST Tool Rod39.1960.05, Retractor39.1960.07, RP OST System39.1960.70.01 RP Curved Hip Long39.1960.70.02 RP Curved Hip Short39.1960.70.03 RP Curved Hip				29-12900 1.2 Upper-FacePlates/Screws Modulewith Lid (29-13941)29-12901 1.2 OrbitalPlates/Mesh Module withLid (29-13941)29-17900 1.7 Mid-FacePlates/Screws Module withLid (29-13941)29-17901 1.7 Mid-FacePlates Module with Lid (29-13941)3-Level Rack -Qty.2329-17903 1.7 OrthognathicPlates Inlay29-13901 Upper-/Mid-FaceInstrument Tray with Lid(29-13921)29-13920 ¼ DINInstrument/AccessoryTray with Lid (29-13921)29-23900 2.0/2.3Mandible Screws Modulewith Lid (29- 13941)29-23901 2.0/2.3 MandiblePlates Module with Lid(29- 13941)29-23905 2.0/2.3 Mini PlatesInlay, Large29-13904 Mandible FractureInstrument Tray with Lid(29- 13921)29-13905 Trocar Instrument

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	Tray with Lid (29-13921)
	29-23900 2.0/2.3 MandibleScrews Module with Lid(29-13941)
	29-23903 2.0/2.3 MandibleRecon Plates Module withLid (29-13941)
	3-Level Rack – Qty. 14
	29-23904 2.0/2.3 MandibleRecon Primary Plates Inlay
	29-13904 Mandible FractureInstrument Tray with Lid(29-13921)
	29-13905 Trocar InstrumentTray with Lid (29- 3921)
	29-13920 $\frac{1}{4}$ DINInstrument/Accessory Traywith Lid (29- 13921)
	1 Model numbers shown in table are Stryker®model numbers
	2 Contents in the validated Tray Systemincluded: Single-use implants (plates,meshes, bone screws, etc.), single-useinstruments (drills), and reusable surgicalinstruments (benders, forceps, handles, depthgauges, trocars, etc.)
	3 Tray system components part of the worst-case configuration in a full DIN RigidSterilization Container validation in anAesculap SterilContainer Base (JK446) andLid (JK489) cleared under K792558
	4 Tray system components part of the worst-case configuration in a 1/2 DIN RigidSterilization Container validation in anAesculap SterilContainer Base (JK346) andLid (JK389) cleared under K792558
	5 No lumened devices were validated withinthe tray system as part of the product load.The Stryker Universal Select SterilizationTray System does have any lumen claims.

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Process

	Subject Device	Predicate Device	Comparison
Design	The Pivot System Sterilization Tray platform is designed to be compatible with the Pivot system surgical instrumentation. Individual components were designed to slide in to 2-level storage racks. Racks have handles on the side to facilitate carrying. The tray lids have sliding latch mechanism to facilitate containment	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 2- and 3-level storage racks. Racks have handles on the side to facilitate carrying. Module and tray lids have sliding latch mechanism to facilitate containment.	Similar
Materials of Construction	Stainless Steel, Anodized Aluminum, Silicone and Thermoplastic Polymers	Stainless Steel, Anodized Aluminum, Silicone, PPSU, Polypropylux	Similar
Configuration and Dimensions	Perforated 2-level and 3-level Racks that house the following tray components:Case - double Outer19.51" x 9.13" x 3.125"Lid - Generic Outer Lid20.00"x 9.60" x 0.437"	Perforated 2-level and 3-level Racks that house the following tray components:2-level Rack 9.80 x 9.70 x 5.27 inches3-level Rack 9.80 x 9.70 x 7.57 inches1/4 DIN Instrument/Accessory 9.31 x 4.09 x 1.54 inches Tray¼ DIN Instrument/Accessory 9.29 x 4.30 x 0.51 inches Tray Lid1/2 DIN Instrument/Accessory 9.31 x 8.55 x 1.54 inches Tray1/2 DIN Instrument/Accessory 9.29 x 8.71 x 0.55 inches Tray Lid	Different

Material Compatibility with Sterilization	Performance testing demonstrated that the materials of construction are compatible with repeated steam	Performance testing demonstrated that the materials of construction are compatible with repeated steam	Same

sterilization cycles.

of construction are compatible with repeated steam

sterilization cycles.

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	Subject Device			Predicate Device			Comparison
							Different
	Cycle	Temp	Exposure	Cycle	Temp	Exposure
SterilizationParameters(Pre-Vacuum)	Pre-Vacuum	132° C(270°F)	4 Min	Pre-Vacuum	132° C(270°F)	4 Min	Different
					135°C(275°F)	4 Min
Perforation	Evenly distributed perforated steam hole pattern.			Evenly distributed perforated steam hole pattern.			Similar
SterilizationMethod	Pre-vacuum			Pre-vacuum			Same
Reusable	Yes			Yes			Same
PatientContact	No direct patient contact			No direct patient contact			Same
AirPermeance	Yes			Yes			Same

G. Summary of Non-clinical Testing

Shown below is a listing of the non-clinical test that was performed to verify that the subject device met the standards recommendation.

Name of the Test Method	Purpose	Acceptance Criteria	Results
Agar Overlay Method per ISO 10993-5	To evaluate an extract of the test article for cytotoxicity to mammalian cells in culture	Test articles scoring 0, 1 or 2 will be considered 'non-cytotoxic'	The test article scored 0 at 24, 48 and 72 +/- 4 hours and is considered non-cytotoxic.
AAMI ST77:2013, Containment Devices for Reusable Medical Device Sterilization.	Handle Weight Capacity Test for the Sterilization Case	No visible deformation, cracking or other evidence of damage on the Handles after testing.	There was no visible deformation, cracking or other evidence of damage on the

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		Handles after testing.
Reliability testing for theSterilization Case	No significant wear after100 sterilization cycles.Significant wear is definedas extreme discoloration,peeling and/or cracking ofany component of thesterilization tray.	A side by side comparison of anew vs the Sterilization Casesterilized 102 times.There was a slight yellowing ofthe case color and the white printwithin the Sterilization Case.The discoloration was minimumand none of the printing waserased or faded so that it couldnot be read. In addition, therewas no peeling and/or cracking ofany of the components of thesterilization case.

The Pivot System Sterilization Tray met the appropriate requirements contained in the following standards:

1. AAMI ST77:2013, Containment devices for reusable medical device sterilization
1. AAMI TIR 30, A compendium of processes, materials, test methods, and acceptable criteria for cleaning reusable medical devices
1. ANSI/AAMI/ISO 17665-1. Sterilization of health care products-Moist heat-Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
1. ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
1. ANSI AAMI ISO 14971:2007/(R)2010, Medical Devices Application of Risk Management to Medical Devices

H. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the RP Medical Pivot System Sterilization Tray System is as safe, as effective, and performs as well as or better than the legally marketed predicate, Stryker Universal Select Sterilization Tray System, cleared under K173615, Class II (21 CFR 880.6850, product code KCT).

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).