FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

The information provided describes the acceptance criteria and results of nonclinical testing for the "Steripack Case and Tray Systems" device. This is a medical device, and the evaluation focuses on its physical characteristics, durability, sterilization efficacy, and biocompatibility, rather than diagnostic performance or human-in-the-loop aspects. Therefore, some of the requested categories, such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set details, are not applicable in this context.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Name of the Methodology and Citation Name	Purpose	Acceptance Criteria	Results
Handle Durability Test
ANSI/AAMI ST77:2006(R)2010	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.	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	To determine the ability of the Steripack Case and Tray Systems to withstand the shipping and storage requirements during product shipping and transportation. Tests conducted: 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	Manual Handling: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments.
Vehicle Stacking: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments.
Loose-load Vibration: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments.
Low Pressure Hazard: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments.
Vehicle Vibration: Acceptance criteria were met, instruments were held, no damage was inflicted on the case and tray system or the enclosed instruments.
Concentrated Impact: 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	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 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.	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.
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 10^6 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^-6 SAL, 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.
Biocompatibility – Thermoplastic Coating (Nylon 11)
ANSI/AAMI/ISO 10993-1:2009	Testing performed on the Thermoplastic Coating to ensure it meets the Acute Systemic Toxicity requirements of ISO 10993 for a device with potential indirect patient contact.	No 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 10 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)
ANSI/AAMI/ISO 10993-5:2009	Testing performed on the Silicone Elastomer material to ensure it meets the Cytotoxicity requirements of ISO 10993 for a device with potential indirect patient contact.	No cytopathic effect.
Source: ANSI/AAMI/ISO 10993-5:2009	Cytotoxicity testing reports were provided by the supplier (DOW CORNING). Per biocompatibility 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	All samples met the requirement for a Grade ≤ 2. Specific results for each coupon:
• Test Coupon: Black Silicone Extrusion: Grade 0
• Test Coupon: Blue Silicone Extrusion: Grade 1
• Test Coupon: Blue V- Rubber Extrusion: Grade 1
• Test Coupon: Black Pin Mat: Grade 0
• Test Coupon: Blue Pin Mat: Grade 2
• Test Coupon: Flat Bottom Black Pin Mat: Grade 0
• Test Coupon: Flat Bottom Blue Pin Mat: Grade 0
• Test Coupon: Grid Pin Mat: Grade 0
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

Summary

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).