Who is the manufacturer of Pivot System Sterilization case?

Rp Medical, Inc. filed the 510(k) submission for Pivot System Sterilization case (K181845).

What is the FDA product code for Pivot System Sterilization case?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Pivot System Sterilization case?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Pivot System Sterilization case?

Stryker Universal Select Sterilization Tray System (K173615).

Who can help prepare an FDA 510(k) submission like Pivot System Sterilization case?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Pivot System Sterilization case

K181845 · Rp Medical, Inc. · KCT · Nov 25, 2019 · General Hospital

Device Facts

Record ID	K181845
Device Name	Pivot System Sterilization case
Applicant	Rp Medical, Inc.
Product Code	KCT · General Hospital
Decision Date	Nov 25, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended 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: 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

Device Story

Sterilization tray system for Pivot System surgical instruments; organizes, encloses, and protects instruments during steam sterilization, transport, and storage. Constructed of thermoplastic, aluminum, and stainless steel; features perforated design for steam penetration, 2-level storage racks, and sliding latch mechanism. Used in healthcare facilities; operated by clinical staff. Instruments placed in racks; tray wrapped in FDA-cleared sterilization wrap; processed in standard autoclave (pre-vacuum 132°C). Output is sterile, organized instrument set; facilitates efficient surgical preparation and instrument maintenance; ensures sterility maintenance until point of use.

Clinical Evidence

Bench testing only. No clinical data. Testing included cytotoxicity (ISO 10993-5), handle weight capacity (AAMI ST77:2013), and reliability testing (100 sterilization cycles) demonstrating no significant wear, peeling, or cracking. Validated for pre-vacuum steam sterilization at 132°C for 4 minutes with 30-minute dry time.

Technological Characteristics

Materials: Stainless steel, anodized aluminum, silicone, thermoplastic polymers. Design: Perforated 2-level rack system with sliding latch. Dimensions: Case 19.51" x 9.13" x 3.125". Sterilization: Pre-vacuum steam (132°C). Standards: AAMI ST77:2013, AAMI TIR 30, ISO 17665-1, ISO 10993-1, ISO 14971. Non-sterile, reusable.

Indications for Use

Indicated for organizing, enclosing, sterilizing, transporting, and storing Pivot System surgical instruments within healthcare facilities. Used with FDA-cleared sterilization wrap to maintain sterility. No specific patient population or contraindications described.

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

Stryker Universal Select Sterilization Tray System (K173615)

Reference Devices

Aesculap SterilContainer (K792558)

Related Devices

K123175 — DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 · Conmed Corporation · Feb 21, 2013
K131455 — RESTORE MODULAR STERILIZATION TRAY SYSTEM · Restore Medical Solutions, Inc. · Aug 30, 2013
K203177 — Sterisystem Dry-Base Instrument Tray · O&M Halyard, Inc. · Jan 2, 2022
K201878 — ST-Z5 · Z-Systems AG · Mar 25, 2021
K183701 — Stryker ChestShield Sterilization Tray System · Paragon Medical · May 7, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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, 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K181845 #### Device Name Pivot System Sterilization Case #### Indications for Use (Describe) 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 Case 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 {3}------------------------------------------------ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 Avenue Maple Ridge, BC V2X 6E7 Canada | |-----------------------------|-----------------------------------------------------------------------------| | Contact Person: | Ross Paul President | | Phone: | 604-418-4554 | | Manufacturer | RP Medical, Inc. 22715 Holyrood Avenue Maple 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 | II 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 | {5}------------------------------------------------ # 510(k) SUMMARY (Continued) ### D. 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. ### E. 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: | 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 | {6}------------------------------------------------ | Configuration | Maximum Validated Load Set Contents | |--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | The maximum validated product loads for the trays in containers are as follows: {7}------------------------------------------------ ## 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 | {8}------------------------------------------------ | | Subject Device | | | | Predicate Device | Comparison | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Cycle | Temp. | Exposure Time (min) | Dry Time (min) | | | | | Pre-vacuum | 132 °C | 4 | 30 | | | | | The maximum validated product loads for the sterilization case are as follows: | | | | The maximum validated product loads for the tray system in containers are as follows: | Different | | | Configuration1 | | | Maximum | Configuration1 Maximum Validated Load Set Contents2,5 | | | Indications for Use (continued) | 2-Level Rack, Level 2 Rigid Sterilization Container3 39.1960.01, RP OST Tool Handle 39.1960.02, RP OST Tool Rod 39.1960.51.01, RP OST Tool 1D RH 16mm 39.1960.51.02 RP OST Tool 1D RH 22mm 39.1960.20.01 RP OST Angle 162mm 39.1960.20.02 RP OST Angle 19mm 39.1960.20.03 RP OST Angle 21.5mm 39.1960.40.01 RP TM Spike Blade 39.1960.60.01 OST Reverse Blade 11mm 39.1960.60.02 OST Reverse Blade 16mm 39.1960.30.01 RP OST Tool Curve 16mm 39.1960.30.02 RP OST Tool Curve 19mm 39.1960.30.03 RP OST Tool Curve 21.5mm 39.1960.10.01 RP OST Straight 20mm 39.1960.10.02 RP OST Straight 40mm 39.1960.10.03 RP OST Straight 43mm 39.1960.10.04 RP OST Straight 47.5mm 39.1960.52.01, RP OST Tool 1D LH 16mm 39.1960.52.02 RP OST Tool 1D LH 22mm 2-Level Rack - Level 1 Rigid Sterilization Container4 39.1960.01, RP OST Tool Handle 39.1960.02, RP OST Tool Rod 39.1960.05, Retractor 39.1960.07, RP OST System 39.1960.70.01 RP Curved Hip Long 39.1960.70.02 RP Curved Hip Short 39.1960.70.03 RP Curved Hip | | | | 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941) 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941) 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941) 29-17901 1.7 Mid-Face Plates Module with Lid (29- 13941) 3-Level Rack -Qty.23 29-17903 1.7 Orthognathic Plates Inlay 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921) 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) 29-23900 2.0/2.3 Mandible Screws Module with Lid (29- 13941) 29-23901 2.0/2.3 Mandible Plates Module with Lid (29- 13941) 29-23905 2.0/2.3 Mini Plates Inlay, Large 29-13904 Mandible Fracture Instrument Tray with Lid (29- 13921) 29-13905 Trocar Instrument | | {9}------------------------------------------------ | | Tray with Lid (29-13921) | | |--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | | | | 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941) | | | | 3-Level Rack – Qty. 14 | | | | 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay | | | | 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | | | | 29-13905 Trocar Instrument Tray with Lid (29- 3921) | | | | 29-13920 $\frac{1}{4}$ DIN Instrument/Accessory Tray with Lid (29- 13921) | | | | 1 Model numbers shown in table are Stryker® model numbers | | | | 2 Contents in the validated Tray System included: Single-use implants (plates, meshes, bone screws, etc.), single-use instruments (drills), and reusable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.) | | | | 3 Tray system components part of the worst- case configuration in a full DIN Rigid Sterilization Container validation in an Aesculap SterilContainer Base (JK446) and Lid (JK489) cleared under K792558 | | | | 4 Tray system components part of the worst- case configuration in a 1/2 DIN Rigid Sterilization Container validation in an Aesculap SterilContainer Base (JK346) and Lid (JK389) cleared under K792558 | | | | 5 No lumened devices were validated within the tray system as part of the product load. The Stryker Universal Select Sterilization Tray System does have any lumen claims. | | {10}------------------------------------------------ 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 Outer 19.51" x 9.13" x 3.125" Lid - Generic Outer Lid 20.00"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 inches 3-level Rack 9.80 x 9.70 x 7.57 inches 1/4 DIN Instrument/Accessory 9.31 x 4.09 x 1.54 inches Tray ¼ DIN Instrument/Accessory 9.29 x 4.30 x 0.51 inches Tray Lid 1/2 DIN Instrument/Accessory 9.31 x 8.55 x 1.54 inches Tray 1/2 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. {11}------------------------------------------------ | | Subject Device | | | Predicate Device | | | Comparison | |---------------------------------------------|---------------------------------------------------|-------------------|----------|---------------------------------------------------|-------------------|----------|------------| | | | | | | | | Different | | | Cycle | Temp | Exposure | Cycle | Temp | Exposure | | | Sterilization Parameters (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 | | Sterilization Method | Pre-vacuum | | | Pre-vacuum | | | Same | | Reusable | Yes | | | Yes | | | Same | | Patient Contact | No direct patient contact | | | No direct patient contact | | | Same | | Air Permeance | 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 | {12}------------------------------------------------ | | | 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. There was 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. In addition, there was no peeling and/or cracking of any of the components of the sterilization 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 - 2. AAMI TIR 30, A compendium of processes, materials, test methods, and acceptable criteria for cleaning reusable medical devices - 3. 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 - 4. ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process. - 5. 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).