Who is the manufacturer of Steripack cases and Tray Systems?

Avalign Technologies, Inc. filed the 510(k) submission for Steripack cases and Tray Systems (K193066).

What is the FDA product code for Steripack cases and Tray Systems?

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 Steripack cases and Tray Systems?

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

Who can help prepare an FDA 510(k) submission like Steripack cases and Tray Systems?

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.

Steripack cases and Tray Systems

Q: What are the predicate devices for Steripack cases and Tray Systems?

Medtronic Transportation/Sterilization Cassettes (K163279).

K193066 · Avalign Technologies, Inc. · KCT · Aug 6, 2020 · General Hospital

Device Facts

Record ID	K193066
Device Name	Steripack cases and Tray Systems
Applicant	Avalign Technologies, Inc.
Product Code	KCT · General Hospital
Decision Date	Aug 6, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The Steripack case and tray system are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Steripack case and tray system are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.

Device Story

Steripack Case and Tray Systems are reusable containers used in healthcare facilities to organize, protect, and facilitate the sterilization and transport of surgical instruments. The system consists of perforated bases, lids, and internal inserts (e.g., brackets, pin mats, silicone retainers) made of thermoplastic polymers, aluminum, silicone, and stainless steel. The device is used by hospital staff to hold instruments during steam sterilization (prevacuum cycle) and subsequent transport/storage. Because the cases are perforated, they must be used with an FDA-cleared sterilization wrap to maintain sterility. The system protects instruments from physical damage during handling and ensures sterilant penetration to the contents. The device does not perform automated analysis; it is a mechanical containment system.

Clinical Evidence

No clinical data. Bench testing only: handle durability (ANSI/AAMI ST77), shipping/transport (ASTM D4169), repeated reprocessing (100 cycles), sterilant penetration (AAMI/ISO 17665-1, 10^-6 SAL achieved), and biocompatibility (ISO 10993-5, -10, -1, and AAMI ST72 for pyrogenicity).

Technological Characteristics

Materials: Thermoplastic polymers, aluminum, silicone, stainless steel. Design: Perforated base/lid with locking latch and inserts. Sterilization: Steam (prevacuum, 132°C, 4 min exposure, 40 min dry). Standards: ANSI/AAMI ST77, ASTM D4169, ISO 10993, AAMI ST72. Connectivity: None (mechanical).

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and instrumentation. Validated for up to 9.35 lb (4.24 kg) load of metal and polymer-handled instruments.

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

Medtronic Transportation/Sterilization Cassettes (K163279)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 6, 2020 Avalign Technologies, Inc. Heidi Funston Design Quality Engineering Manager 8727 Clinton Park Dive Fort Wayne, Indiana 46825 ## Re: K193066 Trade/Device Name: Steripack cases and Tray Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 30, 2020 Received: July 7, 2020 ## Dear Heidi Funston: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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 Ramesh K. Panguluri, Ph.D. Acting Assistant Director 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 510(k) Number (if known) K193066 #### Device Name Steripack Instrument Case and Tray System #### Indications for Use (Describe) The Steripack case and tray system are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Steripack case and tray system are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validation for the worst-case Steripack cases and tray system included surgical instrument such as rongeur forceps, endoscopes, wrenches, cutters, pliers, etc. The Steripack cases and tray system were validated for up to a 9.35 lb (4.24 kg) load of metal instruments and polymer handled instruments. ### Sterilization Parameters: Cycle Type: Prevacuum Temperature: 132°C (270°F) Exposure Time: 4 Minutes Pulses: 3 Drying Time: 40 Minutes Type of Use (Select one or both, as applicable) > 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a series of curved lines and dots on the left, followed by the word "AVALIGN" in a bold, red font. Below the word "AVALIGN" is the word "Technologies" in a smaller, gray font. The logo is simple and modern, and it is likely used to represent the company's brand. # 510(k) Summary | Date Prenared: | August 6, 2020 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Company Name: | Avalign Technologies, Inc. 8727 Clinton Park Drive Fort Wayne, IN 46825 | | Contact Person: | Heidi Funston Design Quality Engineering Manager Avalign Technologies, Inc. Phone: (574) 933-3344 Email: hfunston@avalign.com | | 510(k) Number: | K193066 | | Trade name: | Steripack Case and Tray Systems | | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | Regulation Number: | 21 CFR 880-6850 | | Regulatory Class: | Class II | | Device Panel: | General Hospital | | Product Code: | KCT | # Predicate Device: Medtronic Transportation/Sterilization Cassettes (Medtronic Sofamor Danek, USA, Inc. (K163279) cleared by FDA on February 23, 2017. ### Device Description: Steripack Case and Tray Systems are utilized to secure medical instruments during transport, storage and processing (cleaning and sterilization). Orthopedic instruments and {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a stylized symbol on the left, resembling a series of curved lines emanating from a central point. To the right of the symbol is the word "AVALIGN" in a bold, dark red font. Below "AVALIGN" and slightly offset to the right is the word "Technologies" in a smaller, lighter gray font. implants used in medical procedures are held in preconfigured cases and trays to facilitate transport to and from surgery and during cleaning and sterilization processes. Some of the Case/Tray Systems in the Steripack line are preconfigured for a specific type instrument or surgical procedure. Other Cases/Trays in the Steripack line have components that are sold separately so the system can be configured based on the use. Each Steripack Case and Tray Systems consist of multiple components designated to be integrated into a single unit. Which protects the interior components during the transportation, processing, and storage. All the component of the Steripack Case and Tray Systems are perforated with an evenly distributed hole pattern and are designed for stem sterilization. Since the Steripack Case and Tray Systems are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Steripack Case and Tray Systems are designed to be used with standard autoclaves used in the hospitals and healthcare facilities. | Item number | Specification/ dimensions | |--------------|---------------------------------------------------------------------------------------------------------------------| | 2000-100-022 | External size: 3.5" x 26" x 3.5" Internal size: 3.5" x 26" x 3.5" | | 2000-100-023 | External size: 6.5" x 31" x 3" Internal size: 6" x 30" x 2.5" | | 2000-100-017 | External size: 11" x 27" x 8" Internal size: 10.7" x 25.62" x 7.66" | | 2000-100-001 | External size: 9" x 10" x 3" Internal size: 8.47" x 8.68" x 2.55" | | 2000-100-011 | External size: 3" x 11" x 2.5" Internal size: 2.93" x 10.93" x 2.5" | | 2000-100-005 | External size: 9" x 20" x 4" Internal size: 8.47" x 18.68" x 3.55" | | 2000-100-006 | External size: 4" x 17.5" x 1.5" Internal size: 3.57" x 17.19" x 1.35" | | 2000-100-021 | External size: 9" x 9" x 1.5" Internal size: 8.57" x 8.72" x 1.18" | | 2000-100-019 | External size: 3" x 18" x 2.5" Internal size: 2.93" x 17.93" x 2.46" | | 2000-100-004 | External size: 9" x 20" x 4" Internal size: 8.47" x 18.68" x 3.55" | | 2000-100-015 | External size: 11" x 23" x 8" Internal size: 10.70" x 21.62" x 7.66" | | 2000-100-003 | External size: 5" x 10.5" x 2" Internal size: 4.50" x 10.29" x 1.63" | | 2000-100-020 | External size: 11" x 23" x 3.5" Internal size: 10.70" x 21.62" x 3.41" | | Item number | Specification/ dimensions | | 2000-100-030 | External size: 11" x 23" x 5" Internal size: 10.70" x 21.62" x 4.91" | | 2000-100-031 | External size: 11" x 23" x 5" Internal size: 10.7" x 21.62" x 4.91" | | 2000-100-032 | External size: 11" x 23" x 5" Internal size: 10.70" x 21.62" x 4.91" | | 2000-100-029 | Tray size: 10.5" x 21.5" x 2" | | 2000-100-034 | External size: 11" x 27" x 3.5" Internal size: 10.88" x 25.62" x 3.41" | | 2000-100-035 | External size: 10" x 21.5" x 2.5" Internal size: 9.72" x 20.65" x 2.42" | | 2000-100-026 | External size: 9.5" x 20" x 5.5" Fits in 10" x 20" x 6" container | | 2000-100-018 | External size: 9.5" x 20" x 5.5" Fits in 10" x 20" x 6" container | | 2000-100-079 | External size: 9.9" x 19.5" x 4.9" fits in a 10" x 20" x 6" container | | 2000-100-027 | External size: 9" x 11.5" x 3" Internal size: 8.57" x 11.12" x 2.38" | | 2000-100-010 | External size: 9" x 13" x 6" Internal size: 8.59" x 12.09" x 5.84" | | 2000-100-025 | External size: 9" x 15" x 5" Internal size: 8.59" x 13.84" x 4.84" | | 2000-204-022 | Tray size: 10.5" x 21.5" x 2.25" | | 2000-100-121 | External size: 5" x 10.5" x 2" Internal size: 4.50" x 10.29" x 1.53" | | 2000-100-122 | External size: 10.5" x 10.5" x 2.5" Internal size: 9.84" x 10.2" x 2.32" | | 2000-100-123 | External size: 10.5" x 10.5" x 1.5" Internal size: 9.84" x 10.2" x 1.23" | | 2000-100-124 | External size: 10.5" x 15" x 1.5" Internal size: 9.84" x 14.68" x 1.23" | | 2000-100-125 | External size: 10.5" x 15" x 2.5" Internal size: 9.84" x 14.60" x 2.32" | | 2000-100-126 | External size: 10" x 19.5" x 2.5" Internal size: 9.84" x 19" x 2.32" | | Item number | Specification/ dimensions | | 2000-100-127 | External size: 10.5" x 15" x 2.5" Internal size: 9.84" x 14.6" x 2.32" | | 2000-100-128 | External size: 10.5" x 19.5" x 2.5" Internal size: 9.84" x 19" x 2.32" | | 2000-100-037 | 19.50" x 9.90" x 4.90" | | 2000-100-129 | 10.73" x 15.48" x 2.64" | | 2000-100-131 | 10.60" x 10.55" x 1.55" | | 2000-100-104 | 9" x 13.34" x 7.13" | | 2000-100-132 | External size: 10.50" x 15" x 1.50" Internal size: 9.84" x 14.68" x 1.23" | | 2000-100-133 | External size: 19.88" x 10.74" x 2.63" | | 2000-100-115 | Lap Chole Case, w/latches, one level,without Insert, 11" x 23" x 8" | | 2000-100-116 | Lap Chole Case 11" x 27" x 8"without insert | | 3088-100-001 | Terumo Cardiovascular Systems Component Sterilization Tray | | 3089-100-001 | Terumo Cardiovascular Systems Endoscope Sterilization Tray | | 3317-100-002 | Surgical Case | | 2000-100-036 | Accessory Box single level, 1.5" x 3.5" x 1" | | 2000-100-130 | Accessory Box single level, with hardware (2 screws & nuts), with pin mat,1.5" x 3.5" x 1" | | 2000-100-134 | Accessory Box single level, Scanlon only with hardware (2 screws & nuts), with embossed pin mat, 1.5"x3.5"x1" | | 2000-100-117 | Accessory Box single level, with hardware (2 screws & nuts) 1.5" x 3.5" x 1" | | 2000-100-135 | Accessory Box single level, Scanlon only with hardware (2 screws & nuts), with embossed pin mat, 1.5"x3.5"x1" | | 2000-100-119 | Accessory Box single level, 1.5" x 3.5" x 1" | | Item number | Specification/ dimensions | | 2000-100-016 | External size: 1.5" x 3.5" x 1" Internal size: 1.44" x 3.16" x 1" | | 2000-100-036 | External size: 1.5" x 3.5" x 1" Internal size: 1.44" x 3.16" x 1" | | 2000-162-071 | Universal keyhole bracket, 10 - 5 - 3 mm diameters in one vertical slot 5" long, 6 position | | 2000-162-054 | Universal keyhole bracket, 10 - 5 - 3 mm diameters in one vertical slot 7.5" long, 6 position | | 2000-162-056 | Universal keyhole bracket, 10 - 5 - 3 mm diameters in one vertical slot 7.5" long, 10 position | | 2000-162-052 | Universal keyhole bracket, 10 - 5 - 3 mm diameters in one vertical slot 9.25" long, 14 position | | 2000-162-055 | Universal keyhole bracket, 10 - 5 - 3 mm diameters in one vertical slot 10" long , 15 position | | 2000-162-044 | Slotted U Brackets (2mm) 1.0" | | 2000-162-045 | Slotted U Brackets (3mm) 1.0" | | 2000-162-046 | Slotted U Brackets (4mm) 1.0" | | 2000-162-047 | Slotted U Brackets (5mm) 1.0" | | 2000-162-048 | Slotted U Brackets (6mm) 1.0" | | 2000-162-049 | Slotted U Brackets (7mm) 1.0" | | 2000-162-050 | Slotted U Brackets (10mm) 1.0" | | 2000-162-051 | Slotted U Brackets (12mm) 1.0" | | 2000-162-036 | Slotted U Brackets (2mm) 1.5" | | 2000-162-037 | Slotted U Brackets (3mm) 1.5" | | 2000-162-038 | Slotted U Brackets (4mm) 1.5" | | 2000-162-039 | Slotted U Brackets (5mm) 1.5" | | 2000-162-040 | Slotted U Brackets (6mm) 1.5" | | Item number | Specification/ dimensions | | 2000-162-041 | Slotted U Brackets (7mm) 1.5" | | 2000-162-042 | Slotted U Brackets (10mm) 1.5" | | 2000-162-043 | Slotted U Brackets (12mm) 1.5" | | 2000-162-030 | Pass Thru Brackets (6mm) 1.0" | | 2000-162-031 | Pass Thru Brackets (7mm) 1.0" | | 2000-162-032 | Pass Thru Brackets (9mm) 1.0" | | 2000-162-033 | Pass Thru Brackets (10mm) 1.0" | | 2000-162-034 | Pass Thru Brackets (12mm) 1.0" | | 2000-162-035 | Pass Thru Brackets (13mm) 1.0" | | 2000-162-024 | Pass Thru Brackets (6mm) 1.5" | | 2000-162-025 | Pass Thru Brackets (7mm) 1.5" | | 2000-162-026 | Pass Thru Brackets (9mm) 1.5" | | 2000-162-027 | Pass Thru Brackets (10mm) 1.5" | | 2000-162-028 | Pass Thru Brackets (12mm) 1.5" | | 2000-162-029 | Pass Thru Brackets (13mm) 1.5" | | 2000-162-014 | Keyhole Brackets (2mm) 1.0" | | 2000-162-015 | Keyhole Brackets (3 mm) 1.0" | | 2000-162-016 | Keyhole Brackets (4mm) 1.0" | | 2000-162-017 | Keyhole Brackets (5 mm) 1.0" | | 2000-162-019 | Keyhole Brackets (6 mm) 1.0" | | 2000-162-018 | Keyhole Brackets (7 mm) 1.0" | | 2000-162-020 | Keyhole Brackets (10 mm) 1.0" | | Item number | Specification/ dimensions | | 2000-162-021 | Keyhole Brackets (12 mm) 1.0" | | 2000-162-022 | Keyhole Brackets (13 mm) 1.0" | | 2000-162-001 | Keyhole Brackets (2 mm) 1.5" | | 2000-162-002 | Keyhole Brackets (3 mm) 1.5" | | 2000-162-003 | Keyhole Brackets (4 mm) 1.5" | | 2000-162-004 | Keyhole Brackets (5 mm) 1.5" | | 2000-162-005 | Keyhole Brackets (6 mm) 1.5" | | 2000-162-006 | Keyhole Brackets (7 mm) 1.5" | | 2000-162-007 | Keyhole Brackets (10 mm) 1.5" | | 2000-162-008 | Keyhole Brackets (12 mm) 1.5" | | 2000-162-009 | Keyhole Brackets (13 mm) 1.5" | | 2000-162-010 | Keyhole Brackets (15mm) 1.5" | | 2000-162-011 | Keyhole Brackets (19 mm) 1.5" | | 2000-162-012 | Keyhole Brackets (22 mm) 1.5" | | 2000-162-013 | Keyhole Brackets (25 mm) 1.5" | | 2000-162-023 | Keyhole Brackets (3-tier 10/5/3mm) 1.5" | | 2000-162-062 | V-Silicone Retainers 3.38" | | 2000-162-063 | V-Silicone Retainers 4.25" | | 2000-162-064 | V-Silicone Retainers 8.25" | | 2000-162-065 | V-Silicone Retainers 9.50" | | 2000-162-066 | V-Silicone Retainers 14.25" | | 2000-162-067 | V-Silicone Retainers 18.25" | | Item number | Specification/ dimensions | | 2000-162-058 | "L" brackets to support trays | | 2000-260-002 | SS Riser Bracket, .5" x 1.5", used to elevate single wide brackets from the case floor | | 2000-300-058 | Pin Mate Grid Style 4.50" Length, 1.00" Width | | 2000-300-059 | Pin Mate Grid Style 9.63" Length, 1.00" Width | | 2000-300-060 | Pin Mate Grid Style 14.25" Length, 1.00" Width | | 2000-300-061 | Pin Mate Grid Style 18.25" Length, 1.00" Width | | 2000-300-062 | Pin Mate Grid Style 4.50" Length, 1.50" Width | | 2000-300-063 | Pin Mate Grid Style 7.13" Length, 1.50" Width | | 2000-300-064 | Pin Mate Grid Style 9.12" Length, 1.50" Width | | 2000-300-065 | Pin Mate Grid Style 16.88" Length, 3.45" Width | | 2000-300-066 | Pin Mate Grid Style 10.12" Length, 4.25" Width | | 2000-300-067 | Pin Mate Grid Style 9.75" Length, 4.25" Width | | 2000-300-068 | Pin Mate Grid Style 8.56" Length, 8.12" Width | | 2000-300-069 | Pin Mate Grid Style 18.25" Length, 8.25" Width | | 2000-300-070 | Pin Mate Grid Style 14.13" Length, 9.63" Width | | 2000-300-071 | Pin Mate Grid Style 18.25" Length, 9.63" Width | | 2000-300-072 | Pin Mate Grid Style 9.50" Length, 9.50" Width | | 2000-300-073 | Pin Mate Grid Style 18.25" Length, 10.12" Width | | 2000-300-074 | Pin Mate Grid Style 18.25" Length, 1.50" Width | | 2000-300-075 | Pin Mate Grid Style 6.75" Length, 10.12" Width | | 2000-300-076 | Pin Mate Grid Style 3.40" Length, 10.12" Width | | Item number | Specification/ dimensions | | 2000-300-077 | Pin Mate Grid Style 6.50" Length, 10.12" Width | | 2000-300-078 | Pin Mate Grid Style 5.00" Length, 10.12" Width | | 2000-300-079 | Pin Mate Grid Style 5.75" Length, 10.12" Width | | 2000-300-080 | Pin Mate Grid Style 17.50" Length, 6.75" Width | | 2000-300-081 | Pin Mate Grid Style 10.12" Length, 6.00" Width | | 2000-300-082 | Pin Mate Grid Style 10.12" Length, 6.00" Width | | 2000-300-083 | Pin Mate Grid Style 7.63" Length, 4.00" Width | | 2000-300-084 | Pin Mate Grid Style 15.25" Length, 6.00" Width | | 2000-300-085 | Pin Mate Grid Style 14.13" Length, 9.63" Width | | 2000-300-086 | Pin Mate Grid Style 9.50" Length, 9.50" Width | | 2000-300-087 | Pin Mate Grid Style 4.50" Length, 1.50" Width | | 2000-300-088 | Pin Mate Grid Style 10.12" Length, 6.00" Width | | 2000-300-089 | Pin Mate Grid Style 18.25" Length, 9.63" Width | | 2000-300-090 | Pin Mate Grid Style 3.15" Length, 1.42" Width | | 2000-300-091 | Pin Mate Grid Style 9.00" Length, 7.00" Width | | 2000-300-092 | Pin Mate Grid Style 10.00" Length, 9.00" Width | | 2000-300-093 | Pin Mate Grid Style 7.00" Length, 10.50" Width | | 2000-300-094 | Pin Mate Grid Style 7.50" Length 13.50" Width | List of Steripack Item numbers {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a series of curved lines on the left, followed by the word "AVALIGN" in a bold, red font. Below the word "AVALIGN" is the word "Technologies" in a smaller, gray font. The logo is simple and modern, and it is likely used to represent the company's brand. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a series of curved lines on the left, followed by the word "AVALIGN" in a bold, red font. Below the word "AVALIGN" is the word "Technologies" in a smaller, gray font. The logo is simple and modern, and it is likely used to represent the company's brand. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a stylized symbol on the left, resembling a series of curved lines and dots, followed by the text "AVALIGN" in a bold, dark red font. Below "AVALIGN" and slightly to the right, the word "Technologies" is written in a smaller, lighter gray font. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Avalign Technologies. The logo features a stylized symbol on the left, resembling a series of curved lines emanating from a central point. To the right of the symbol is the word "AVALIGN" in a bold, sans-serif font, with the word "Technologies" in a smaller font beneath it. The color scheme is primarily red and gray. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for "AVALIGN Technologies". The logo consists of a stylized symbol on the left, resembling a series of curved lines emanating from a vertical dotted line. To the right of this symbol is the word "AVALIGN" in a bold, dark red font. Below "AVALIGN" and slightly offset to the right is the word "Technologies" in a smaller, gray font. The overall design is clean and modern. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a graphic to the left of the company name. The graphic is a series of curved lines emanating from a vertical line. The company name is in a bold, sans-serif font, with the word "Technologies" in a smaller font below the word "Avalign." {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Avalign Technologies. The logo features a stylized symbol to the left of the company name, "AVALIGN," which is written in a bold, red font. Below "AVALIGN" is the word "Technologies" in a smaller, gray font. The symbol to the left consists of a vertical line with three curved lines emanating from it. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a stylized graphic to the left of the company name. The graphic is a series of four short, curved lines emanating from a vertical dotted line. The company name, "AVALIGN," is in red, and the word "Technologies" is in gray and smaller font, located below and to the right of "AVALIGN." ### Indication for Use: The Steripack case and tray system are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Steripack case and tray system are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA- cleared sterilization wrap. Sterilization validation for the worst-case Steripack Case and Tray Systems included surgical instrument such as rongeur forceps, wrenches, cutters, pliers, etc. The Steripack Case and Tray Systems were validated, for up to a 9.35 lb (4.24 kg) load of metal instruments and polymer handled instruments. Sterilization Parameters: | Cycle Type: | Prevacuum | |----------------|----------------| | Temperature: | 132 °C (270°F) | | Exposure Time: | 4 Minutes | | Pulses: | 3 | | Drying Time: | 40 Minutes | ### Technological Characteristics Table 5.1 displays the comparison of the Steripack Case and Tray Systems compared against the predicate. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Avalign Technologies. The logo features a stylized graphic to the left of the company name. The graphic consists of a vertical dashed line with four dots and three curved lines emanating from the dashed line. The company name, "AVALIGN," is in a bold, red font, and the word "Technologies" is in a smaller, gray font below the company name. Table 5.1- Comparison of Steripack Case and Tray Systems (K193066) and Medronic Transportation/Sterilization Cassettes (K163279) | Feature | Steripack Case and Tray Systems (K193066) | Medtronic Transportation/Sterilization Cassettes (K163279) | Comparison | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Trade Name | Steripack Case and Tray Systems | Medtronic Transportation/Sterilization Cassettes | N/A | | Fundamental Scientific Technology | Sterilization Cassette | Sterilization Cassette | Same | | Intended Use | The Steripack case and tray system are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Steripack case and tray system are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA- cleared sterilization wrap. | The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. | Same | | Product Code | KCT | KCT | Same | | Material Composition | Thermoplastic polymers, aluminum, Silicone and stainless steel | Thermoplastic polymers, aluminum, and stainless steel | Similar | | Feature | Steripack Case and Tray Systems (K193066) | Medtronic Transportation/Sterilization Cassettes (K163279) | Comparison | | Design | A base, a lid with a locking latch, and individual inserts | A base, a lid with a locking latch, and individual inserts | Same | | Dimensions | The greatest challenge dimension was assessed to be: 21.06 x 10.00 x 4.28 inches The inserts are offered in different sizes | The greatest challenge dimension was assessed to be: 22.75 x 11.26 x 5.51 inches The inserts are offered in different sizes | Similar | | Configuration | Perforated bases, lids, and inserts | Perforated bases, lids, and inserts | Same | | Volume to Vent Ratio | All Vent to Volume Ratios: | Unable to access the challenge volume to vent ratio data. The challenge device was the subject of the sterilization validation. | Similar | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a stylized symbol on the left, resembling a series of curved lines and dots, followed by the text "AVALIGN" in a bold, dark red font. Below "AVALIGN" is the word "Technologies" in a smaller, lighter gray font. The overall design is clean and modern. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a stylized symbol on the left, resembling a series of curved lines and dots. To the right of the symbol is the word "AVALIGN" in a bold, dark red font. Below "AVALIGN" is the word "Technologies" in a smaller, light gray font. | Item Number | VtoV Ratio | | |----------------------|----------------------------------|-------------------------------------| | 2000-100-022 | 4.290 | | | 2000-100-023 | 4.902 | | | 2000-100-017 | 6.584 | | | 2000-100-001 | 7.240 | | | 2000-100-011 | 0.811 | | | 2000-100-005 | 7.383 | | | 2000-100-006 | 4.950 | | | 2000-100-021 | 3.871 | | | 2000-100-019 | 3.093 | | | 2000-100-004 | 7.383 | | | 2000-100-015 | 6.609 | | | 2000-100-003 | 6.039 | | | 2000-100-020 | 8.177 | | | 2000-100-030 | 10.476 | | | 2000-100-031 | 10.476 | | | 2000-100-032 | 10.476 | | | 2000-100-029 | 10.409 | | | 2000-100-034 | 7.956 | | | 2000-100-035 | 6.466 | | | 2000-100-026 | 6.068 | | | 2000-100-018 | 9.302 | | | 2000-100-079 | Open Case | | | 2000-100-027 | 6.360 | | | 2000-100-010 | 5.053 | | | 2000-100-025 | 4.419 | | | 2000-204-022 | Open Case | | | 2000-100-121 | 6.039 | | | 2000-100-122 | 5.061 | | | 2000-100-123 | 3.037 | | | 2000-100-124 | 2.945 | | | 2000-100-125 | 4.674 | | | | | | | 2000-100-126 | 4.651 | | | 2000-100-127 | 4.674 | | | 2000-100-128 | 4.758 | | | 2000-100-037 | N/A - Accessory | | | 2000-100-129 | 4.674 | | | 2000-100-131 | 2.945 | | | 2000-100-104 | 5.053 | | | 2000-100-132 | 2.945 | | | 2000-100-133 | 7.201 | | | 2000-100-115 | Open Case | | | 2000-100-116 | Open Case | | | 3088-100-001 | 2.420 | | | 3089-100-001 | 0.701 | | | 3317-100-002 | 2.441 | | | Percent Perforation | Evenly distributed hole pattern. | Evenly distributed hole pattern. | | Sterilization Method | Pre-Vacuum | Pre-Vacuum and Gravity Displacement | | | | | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a stylized symbol on the left, resembling a series of curved lines emanating from a central point. To the right of the symbol is the word "AVALIGN" in a bold, red font. Below "AVALIGN" is the word "Technologies" in a smaller, gray font. {17}------------------------------------------------ Image /page/17/Picture/0 description: The image shows the logo for Avalign Technologies. The logo features a stylized symbol to the left of the company name. The symbol consists of a vertical line with several dots and curved lines emanating from it. The company name is written in a bold, sans-serif font, with "AVALIGN" in a dark red color and "Technologies" in a smaller, light gray font below. | Feature | Steripack Case and Tray Systems (K193066) | Medtronic Transportation/Sterilization Cassettes (K163279) | | | Comparison | | |-----------------------------|----------------------------------------------|---------------------------------------------------------------|------------------|------------------|---------------------|---------| | | Cycle Type: Prevacuum | Cycle | Temperature | Exposure Time | Minimum Dry Time | Similar | | Sterilization Parameters | Temperature: 132 °C (270°F) | Gravity Displacement | 270°F (132°C) | 30 Minutes | 30 Minutes | | | | Exposure Time: 4 Minutes | Gravity Displacement | 275°F (135°C) | 15 Minutes | 30 Minutes | | | | Pulses: 3 | Gravity Displacement | 250°F (121°C) | 10 Minutes | 30 Minutes | | | | Drying Time: 40 Minutes | Dynamic Air Removal (4 Pulses) | 270°F (132°C) | 4 Minutes | 30 Minutes | | | | | Dynamic Air Removal (4 Pulses) | 275°F (135°C) | 3 Minutes | 30 Minutes | | | Reusable | Yes | Yes | | | | Same | {18}------------------------------------------------ Image /page/18/Picture/0 description: The image shows the logo for Avalign Technologies. The logo consists of a series of curved lines and dots on the left, followed by the word "AVALIGN" in a bold, red font. Below the word "AVALIGN" is the word "Technologies" in a smaller, gray font. The logo is simple and modern, and the use of red and gray gives it a professional look. # Summary of Nonclinical Testing: Shown below is the summary table of the nonclinical testing that was performed with the subject device to demonstrate that it met the acceptance criteria in the standard. | Name of the Methodology and Citation Name | Purpose | Acceptance Criteria | Results | | |--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Handle Durability Test ANSI/AAMI ST77:2006(R)2010 | This test was performed to determine the ability of the case handle to maintain the lid to base connection when subjected to typical forces experienced during routine use. The test was conducted on the three handle styles available in the Steripack case and tray system: U type, rail style, and ring style | 50 lb load to be held for 30 minutes (safety factor of 2X max load of 25 lbs) Source: ANSI/AAMI ST77:2006(R)2010 indicates maximum load for reusable case and trays are 25 lbs. | The three handle styles were able to support the 50 lb load for the required 30 minutes without failure. Therefore, the handle designs meet the requirements of ANSI/AAMI ST77:2006(R)2010 and the handles are safe and effective for use with the Steripack case and tray systems. | | | Transport / Shipping Test ASTM D4169-09 | This test was performed to determine the ability of the Steripack Case and Tray Systems to withstand the shipping and storage requirements during product shipping and transportation. The tests conducted per ASTM D4169-09 were Manual Handling, Vehicle Stacking, Loose- load Vibration, Low Pressure Hazard, Vehicle Vibration, and Concentrated Impact. | The case system will be considered to be acceptable if it meets the following acceptance criteria: • Instruments must remain in their designated location inside the outer case and lid system. • There must be no damage to the case/tray that would prevent it from holding and protecting the instruments for transport or sterilization processing. • There must be no damage to the internal instruments. Source: ASTM D4169- 09 | Test: Manual Handling Results: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments. Test: Vehicle Stacking Results: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments. Test: Loose-load Vibration Results: Acceptance criteria were met, instruments were held, no | | | Name of the Methodology and Citation Name | Purpose | Acceptance Criteria | Results | | | | | | Low Pressure Hazard Vehicle Vibration Concentrated Impact | inflicted on the case and tray system or the enclosed instruments. Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments. Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments. Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments. | | Life Cycle Testing / Repeated Reprocessing ANSI/AAMI ST77:2006(R)2010. | This test was performed to demonstrate that the Steripack Case and Tray system could withstand repeated reprocessing through a steam sterilization cycle. | After the 100 sterilization cycles the case and tray materials of construction must be durable and compatible with the sterilization process. • No materials may break down. • All handles, latches, and hinges must move freely and as intended. • No visible rust or discoloration is acceptable on laser etching. • Screen print cannot bleed, peel, or shift. • No visible discoloration is acceptable on | After 100 cycles were complete, all functional testing and material requirements described above passed. The only observation made was four of the nylon coated brackets had the nylon coating begin to bubble. This was not deemed a functional failure because the nylon coating did not crack and no metal was exposed. | | | Name of the Methodology and Citation Name | Purpose | Acceptance Criteria | Results | | | | | stainless steel or anodized components. Cracking nylon coating or exposed metal through nylon is not acceptable. Radel and polypropylene cannot be deformed. Source: Test was conducted to show materials meet the durability and sterilization compatibility requirements of ANSI/AAMI ST77:2006(R)2010. | | | | Sterilant penetration AANSI/AAMI/ISO 17665- 1:2006/(R)2013 | To validate the sterilization efficacy of the Steripack case and tray worst case volume to vent ratio device, when processed…

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