Steripack cases and Tray Systems

• K Number: K193066
• Device Name: Steripack cases and Tray Systems
• Manufacturer: Avalign Technologies, Inc.
• Date Cleared: 2020-08-06 ( 276 days)
• Product Code: KCT
• Regulation Number: 880.6850

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. 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.

Device Description

Steripack Case and Tray Systems are utilized to secure medical instruments during transport, storage and processing (cleaning and sterilization). Orthopedic instruments and 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.

Predicate Devices

K163279

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical case and tray system for organizing and sterilizing medical instruments. The description focuses on its physical properties, materials, and validation for sterilization processes. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device is described as a case and tray system for organizing, enclosing, sterilizing, transporting, and storing medical devices and other instrumentation, not for treating a disease or condition itself.

Diagnostic

No
The device is described as a case and tray system for organizing, enclosing, sterilizing, transporting, and storing medical devices. It is explicitly stated that it is "not intended on their own to maintain sterility" and is "intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap." Its purpose is to facilitate the handling and sterilization of other medical instruments, not to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (cases and trays) made of materials like aluminum and stainless steel, and the performance studies focus on the durability and biocompatibility of these physical components. There is no mention of software as a component of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the Steripack case and tray system is for organizing, enclosing, sterilizing, transporting, and storing medical devices and instrumentation. This is related to the handling and processing of medical devices, not for performing tests on biological samples to diagnose conditions.
• Device Description: The description focuses on the physical characteristics and function of the cases and trays for securing and protecting instruments during transport, cleaning, and sterilization. It does not mention any components or processes related to analyzing biological samples.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Reagents or assays
  • Analysis of biological samples (blood, urine, tissue, etc.)
  • Diagnostic purposes
  • Measurement of analytes

The Steripack case and tray system is a medical device used in the process of preparing other medical devices for use, specifically through sterilization and transport. It does not perform any diagnostic function itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 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

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

KCT

Device Description

Steripack Case and Tray Systems are utilized to secure medical instruments during transport, storage and processing (cleaning and sterilization). Orthopedic instruments and 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Nonclinical Testing:

1. Handle Durability Test (ANSI/AAMI ST77:2006(R)2010)

   • Purpose: To determine the ability of the case handle to maintain the lid to base connection when subjected to typical forces experienced during routine use. Tested on U type, rail style, and ring style handles.
   • Acceptance Criteria: 50 lb load to be held for 30 minutes (safety factor of 2X max load of 25 lbs).
   • Results: All three handle styles supported the 50 lb load for 30 minutes without failure, meeting the requirements of ANSI/AAMI ST77:2006(R)2010.

2. Transport / Shipping Test (ASTM D4169-09)

   • Purpose: To determine the ability of the Steripack Case and Tray Systems to withstand shipping and storage requirements. Tests conducted: Manual Handling, Vehicle Stacking, Loose-load Vibration, Low Pressure Hazard, Vehicle Vibration, Concentrated Impact.
   • Acceptance Criteria: Instruments must remain in their designated location; no damage to case/tray that would prevent holding/protecting instruments; no damage to internal instruments.
   • Results: All tests (Manual Handling, Vehicle Stacking, Loose-load Vibration, Low Pressure Hazard, Vehicle Vibration, Concentrated Impact) met acceptance criteria; instruments were held, and no damage was inflicted on the case/tray system or enclosed instruments.

3. Life Cycle Testing / Repeated Reprocessing (ANSI/AAMI ST77:2006(R)2010)

   • Purpose: To demonstrate that the Steripack Case and Tray system could withstand repeated reprocessing through a steam sterilization cycle.
   • Acceptance Criteria: After 100 sterilization cycles, materials must be durable and compatible with sterilization process; no material breakdown; all handles, latches, hinges must move freely; no visible rust or discoloration on laser etching or stainless steel/anodized components; screen print cannot bleed, peel, or shift; no cracking nylon coating or exposed metal.
   • Results: All functional testing and material requirements passed after 100 cycles. Four nylon coated brackets showed bubbling, but this was not deemed a functional failure as the coating did not crack and no metal was exposed.

4. Sterilant penetration (AANSI/AAMI/ISO 17665-1:2006/(R)2013)

   • Purpose: To validate the sterilization efficacy of the worst-case volume to vent ratio device, when processed fully loaded in a steam pre-vacuum sterilization cycle at 132°C (270°F) with four (4) minutes of exposure time.
   • Acceptance Criteria: Overkill method to achieve a minimum of 1.0 x 10^6^ highly resistant Geobacillus stearothermophilus spores killed in a half-cycle (6-log reduction) to produce a 10^-6^ SAL.
   • Results: Testing validated that the Steripack Instrument Tray and Case Systems allow sterilant penetration sufficient to achieve a 10^-6^ SAL after processing.

5. Biocompatibility – Thermoplastic Coating (Nylon 11) (ANSI/AAMI/ISO 10993-5:2009 for Cytotoxicity, ISO 10993-1:2009 for Acute Systemic Toxicity and Intracutaneous Irritation, Implantation Test requirements)

   • Purpose: To ensure the Thermoplastic Coating meets biocompatibility requirements for devices with potential indirect patient contact.
   • Acceptance Criteria: Cytotoxicity: Grade ≤ 2; Acute Systemic Toxicity: no clinical signs of toxicity; Intracutaneous Irritation: no local irritation; Implantation Test: difference in average scores of encapsulation not greater than 1.0.
   • Results: Cytotoxicity: Test article scored Grade 0 (no cytotoxic effect). Acute Systemic Toxicity: No abnormal clinical signs observed. Intracutaneous Irritation: No significant dermal reactions observed. Implantation Test: No difference (Score of 0) in average encapsulation scores. Cytotoxicity after sterilization: Induced no cytotoxicity (Grade 0).

6. Biocompatibility – Silicone (Elastomer) (ANSI/AAMI/ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2009 for Sensitization and Intracutaneous Reactivity, Systemic Toxicity after sterilization)

   • Purpose: To ensure the Silicone Elastomer material meets biocompatibility requirements.
   • Acceptance Criteria: Cytotoxicity: No cytopathic effect; Sensitization: No sensitization; Intracutaneous Reactivity: Non-irritating and non-toxic; Systemic Toxicity: Non-irritating and non-toxic.
   • Results: Cytotoxicity: No Cytopathic effect (morphology changes). Sensitization: No sensitization. Intracutaneous Reactivity: Test article was non-irritating and non-toxic relative to controls. Systemic Toxicity: Test article was non-irritating and non-toxic relative to controls. Cytotoxicity for eight color variations after sterilization: All samples met the requirement for a Grade ≤ 2.

7. Biocompatibility – Anodized Aluminum (ANSI/AAMI/ISO 10993-5:2009 for Cytotoxicity, AANSI/AAMI ST 72:2011 for Pyrogenicity)

   • Purpose: To ensure Anodized Aluminum meets biocompatibility requirements.
   • Acceptance Criteria: Cytotoxicity: Grade ≤ 2; Pyrogenicity: Endotoxin limit >20 EU/device.
   • Results: Cytotoxicity: Test article scored "0". Pyrogenocity: Range 20 EU/device.
   • Results: Cytotoxicity: Test article scored "0". Pyrogenocity: Range

Regulation Number and Section

§ 880.6850 Sterilization wrap.

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

Summary

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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 ([e-mail]) or phone [phone] 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 [e-mail]

"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."

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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: [phone]
Email: [e-mail]
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 fully
loaded in a steam
pre-vacuum
sterilization cycle
at 132° C (270°F)
with four (4)
minutes of
exposure time. | The overkill method was
selected to verify the
sterilization efficacy of
the samples, per
AAMI/ISO guidelines.
In this method, validation
was accomplished by
demonstrating that a
minimum of 1.0 x 106
highly resistant
Geobacillus
stearothermophilus
spores were killed in a
half-cycle (6-log
reduction). A full cycle
would therefore result in
a 12-log reduction of
spores and produce a 10-
6SAL, which reflects a
one-in-a-million chance
of a non-sterile item.
Source:
AANSI/AAMI/ISO
17665-1:2006/(R)2013 | Results from testing validate that the
Steripack Instrument Tray and Case
Systems allow sterilant penetration
sufficient to achieve a 10-6 SAL
after processing in the pre-vacuum
sterilization cycle at 132°C (270°F)
and four (4) minutes of exposure
time. | |
| Biocompatibility –
Thermoplastic
Coating (Nylon 11)
ANSI/AAMI/ISO
10993-5:2009 | Testing performed
on the
Thermoplastic
Coating as
manufactured to
ensure it meets the
Cytotoxicity
(MEM elution
test) requirements
of ISO 10993 for a
device with
potential indirect
patient contact. | Grade ≤ 2
Source:
ANSI/AAMI/ISO 10993-
5:2009 | Test specimen was subjected to a
cytotoxicity test ISO MEM elution
L-929 cells (ATCC CCL-1).
Method: Incubated at 37±1° C with
5±1% CO2 for 72 ± 3 hours.
The test article scored a Grade 0,
eliciting no cytotoxic effect. | |
| Name of the
Methodology and
Citation Name | Purpose | Acceptance Criteria | Results | |
| Thermoplastic
Coating (Nylon 11)
ANSI/AAMI/ISO
10993-1:2009 | on the
Thermoplastic
Coating to ensure
it meets the Acute
Systemic Toxicity
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | clinical signs of toxicity
during the 72 hour study
period.
Source:
ANSI/AAMI/ISO 10993-
1:2009 | Acute Systemic Toxicity test on
mice.
Method: The extraction mixtures and
corresponding control blanks were
incubated for 72 ± 2 hours at 50 ± 2 °
C

None of the animals on study were
observed with abnormal clinical
signs indicative of toxicity during the
72 hour test period. All were alive at
the end of the 72 hour test duration
and body weight loss was within
acceptable parameters over the
course of the study | |
| Biocompatibility –
Thermoplastic
Coating (Nylon 11)
ANSI/AAMI/ISO
10993-1:2009 | Testing performed
on the
Thermoplastic
Coating to ensure
it meets the
Intracutaneous
Irritation
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | Extract from the test
specimen must not cause
local irritation to the
dermal tissue of a rabbit.
Source:
ANSI/AAMI/ISO 10993-
1:2009 | Test specimen was subjected to an
Acute Systemic Toxicity test on
mice.
Method: The extraction mixtures and
corresponding control blanks were
incubated for 72 ± 2 hours at 50 ± 2 °
C

No significant dermal reactions were
observed in the test subjects. | |
| Biocompatibility –
Thermoplastic
Coating (Nylon 11)
ANSI/AAMI/ISO
10993-1:2009 | Testing performed
on the
Thermoplastic
Coating to ensure
it meets the
Implantation Test
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | The differences between
average scores of the
encapsulation of the test
article implantation site
and the negative control
site cannot score greater
than 1.0.
Source:
ANSI/AAMI/ISO 10993-
1:2009 | Test specimen was subjected to an
intramuscular implantation test on
rabbits. The test article was
implanted in the animal subject for 1
week.
Method: test article was cut into
pieces approximately 3 mm x 1 0
mm. and instead to the paravertebral
muscle.

There was no difference (Score of 0)
between the average encapsulation
scores between the implantation sites
and the negative control sites. | |
| Biocompatibility –
Thermoplastic
Coating (Nylon 11)
ANSI/AAMI/ISO
10993-5:2009 | Testing performed
on the
Thermoplastic
Coating after
sterilization to
ensure it meets the
Cytotoxicity
(MEM elution
test) requirements
of ISO 10993 for a
device with
potential indirect
patient contact
through
leachables. | Grade ≤ 2
Source:
ANSI/AAMI/ISO 10993-
5:2009 | The test article induced no
cytotoxicity (Grade 0). Therefore
the test article is not considered to
elicit a cytotoxic effect under the
conditions employed. | |
| Biocompatibility –
Silicone (Elastomer) | Testing performed
on the Silicone
Elastomer material | No cytopathic effect. | Cytotoxicity testing reports were
provided by the supplier (DOW
CORNING). Per biocompatibility | |

19

20

21

22

| Name of the
Methodology and

Citation Name	Purpose	Acceptance Criteria	Results
ANSI/AAMI/ISO
10993-5:2009	to ensure it meets
the Cytotoxicity
requirements of
ISO 10993 for a
device with
potential indirect
patient contact.	ANSI/AAMI/ISO 10993-
5:2009	reports, "Cell Culture" test was
performed on "Elastomers" and
"Cell culture medium extract of
elastomer" for the cytotoxicity
evaluation.

No Cytopathic effect (morphology
changes). No Cytopathic effect
(morphology changes): ≥ 75%
visibility (by neutral red) | | | | | | | | | | | | | | |
| Biocompatibility –
Silicone (Elastomer)
ANSI/AAMI/ISO
10993-10:2009 | Testing performed
on the Silicone
Elastomer material
to ensure it meets
the Sensitization
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | No sensitization when
exposed to an extract of
the test article.
Source:
ANSI/AAMI/ISO 10993-
10:2009 | Skin Sensitization test was
performed on Elastomer, Saline
Extract of elastomer and Ethanol or
acetone extract of elastomer for the
sensitization evaluation.

Test meets ISO 10993-1
requirements with no sensitization. | | | | | | | | | | | | | | |
| Biocompatibility –
Silicone (Elastomer)
ANSI/AAMI/ISO
10993-10:2009 | Testing performed
on the Silicone
Elastomer material
to ensure it meets
the Intracutaneous
Reactivity
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | Test article to be non-
irritating and non-toxic.
Source:
ANSI/AAMI/ISO 10993-
10:2009 | Intracutaneous reactivity test was
performed on Saline Extract of
elastomer, Extract if elastomer in 5%
ethanol 95% saline, PEG 400 extract
of elastomers and Cottonseed oil
extract of elastomer for the
intracutaneous reactivity evaluation.

The test article was non-irritating and
non-toxic relative to controls | | | | | | | | | | | | | | |
| Biocompatibility –
Silicone (Elastomer)
ANSI/AAMI/ISO
10993-10:2009 | Testing performed
on the Silicone
Elastomer material
to ensure it meets
the Systemic
Toxicity
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | Test article to be non-
irritating and non-toxic.
Source:
ANSI/AAMI/ISO 10993-
10:2009 | Systemic toxicity test was performed
on Saline Extract of elastomer,
Extract if elastomer in 5% ethanol
95% saline, PEG 400 extract of
elastomers and Cottonseed oil extract
of elastomer for the intracutaneous
reactivity evaluation.

The test article was non-irritating and
non-toxic relative to controls | | | | | | | | | | | | | | |
| Biocompatibility –
Silicone Elastomer
ANSI/AAMI/ISO
10993-5:2009 | Testing performed
on the eight color
variations of the
Silicone elastomer
after sterilization
to ensure it meets
the Cytotoxicity
(MEM elution
test) requirements
of ISO 10993 for a
device with
potential indirect
patient contact
through
leachables. | Grade ≤ 2
Source:
ANSI/AAMI/ISO 10993-
5:2009 | Description Test
Sample
Grade Test Coupon: Black
Silicone Extrusion 0 Test Coupon: Blue
Silicone Extrusion 1 Test Coupon: Blue V-
Rubber Extrusion 1 Test Coupon: Black
Pin Mat 0 Test Coupon: Blue Pin
Mat 2 Test Coupon: Flat 0 | | | | | | | | | | | | | | |

23

| Name of the
Methodology and

Citation Name	Purpose	Acceptance Criteria	Results
			Bottom Black Pin Mat
			Test Coupon: Flat Bottom Blue Pin Mat 0
			Test Coupon: Grid Pin Mat 0
			All samples met the requirement for a Grade ≤ 2.
Biocompatibility –
Anodized Aluminum

ANSI/AAMI/ISO
10993-5:2009 | Testing performed
on the Anodized
Aluminum
material to ensure
it meets the
Cytotoxicity
requirements of
ISO 10993 for a
device with
potential indirect
patient contact. | Grade ≤ 2

Source:
ANSI/AAMI/ISO 10993-
5:2009 | Test article was subjected to a
cytotoxicity test ISO MEM elution
L-929 cells (ATCC CCL-1).
Method: Incubated at 37±1° C with
5±1% CO2 for 48 ± 3 hours

The test article scored "0" at 48 ± 3
hours for all 3 cell monolayers. |
| Biocompatibility –
Anodized Aluminum

AANSI/AAMI ST
72:2011 | Testing performed
on the Anodized
Aluminum
material to ensure
it meets the
requirements of
ANSI/AAMI ST
72 for
pyrogenicity. | For a medical device,
endotoxin limit is >20
EU/device.

Source: AANSI/AAMI
ST 72:2011 | Test specimen was subjected to a
BET test.
Method: The extraction was
performed by immersing the test
article in endotoxin free water and
placing it on an orbital shaker in an
incubator for 40-60 minutes at 37 -
40°C.

The range for the three specimens
was 20
EU/device.

Source: ANSI/AAMI ST
72:2011 | Test specimen was subjected to a
BET test.
Method: The extraction was
performed by immersing the test
article in endotoxin free water and
placing it on an orbital shaker in an
incubator for 40-60 minutes at 37 -
40°C.

The range for the three specimens
was