(276 days)
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.
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.
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 TestANSI/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 TestASTM 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 ReprocessingANSI/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 penetrationAANSI/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 ≤ 2Source: 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 ≤ 2Source: 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 ElastomerANSI/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 ≤ 2Source: 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 AluminumANSI/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 ≤ 2Source: 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 AluminumAANSI/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 <0.972 - <1.28 EU / device. The devices met the acceptance criteria. |
| Biocompatibility – Stainless SteelANSI/AAMI/ISO 10993-5:2009 | Testing performed on the Stainless Steel material to ensure it meets the Cytotoxicity requirements of ISO 10993 for a device with potential indirect patient contact. | Grade ≤ 2Source: ANSI/AAMI/ISO 10993-5:2009 | The 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 – Stainless SteelANSI/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: 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 <2.93 - <3.02 EU / device. The devices met the acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for each test set in numerical terms (e.g., "N units tested"). However, it indicates specific test methodologies and the types of materials or components tested. For example:
- Handle Durability Test: "conducted on the three handle styles"
- Transport / Shipping Test: Implied that the Steripack Case and Tray Systems were subjected to various shipping condition tests.
- Life Cycle Testing / Repeated Reprocessing: Tested "After the 100 sterilization cycles" suggesting a single unit or a small number of units underwent 100 cycles.
- Sterilant Penetration: Validated for "the Steripack case and tray worst case volume to vent ratio device," implying one or a small number of representative "worst case" devices were used.
- Biocompatibility Tests: Performed on "Thermoplastic Coating (Nylon 11)," "Silicone (Elastomer)," "eight color variations of the Silicone elastomer," "Anodized Aluminum," and "Stainless Steel." For some, such as Acute Systemic Toxicity and Implantation Test, it mentions "mice" and "rabbits" respectively, and for BET tests, "three specimens."
The data provenance (country of origin, retrospective/prospective) is not specified. These are nonclinical, laboratory-based tests based on recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. These are engineering and laboratory tests based on established industry standards and scientific methodologies, not requiring expert human interpretation of medical images or conditions for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This refers to the process of resolving discrepancies among multiple human readers for ground truth establishment, which is not relevant for the described nonclinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a nonclinical study for a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a nonclinical study for a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests is defined by the acceptance criteria specified in recognized industry standards (e.g., ANSI/AAMI ST77:2006(R)2010, ASTM D4169-09, ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO 10993 series, AANSI/AAMI ST 72:2011). These standards outline specific measurable thresholds or observable conditions that the device must meet to be considered safe and effective for its intended purpose. For example, for sterilant penetration, the ground truth is achieving a 10^-6 SAL based on established microbiological principles. For biocompatibility, it's meeting defined cytotoxicity grades or showing no signs of toxicity/irritation.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an algorithm or AI model undergoing development.
9. How the ground truth for the training set was established
Not applicable. There is no "training set."
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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
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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
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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.
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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 DriveFort Wayne, IN 46825 |
| Contact Person: | Heidi FunstonDesign Quality Engineering ManagerAvalign Technologies, Inc.Phone: (574) 933-3344Email: 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
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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,withoutInsert, 11" x 23" x 8" |
| 2000-100-116 | Lap Chole Case 11" x 27" x 8"without insert |
| 3088-100-001 | Terumo Cardiovascular Systems ComponentSterilization Tray |
| 3089-100-001 | Terumo Cardiovascular Systems EndoscopeSterilization 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 (2screws & nuts), with pin mat,1.5" x 3.5" x 1" |
| 2000-100-134 | Accessory Box single level, Scanlon only withhardware (2 screws & nuts), with embossed pinmat, 1.5"x3.5"x1" |
| 2000-100-117 | Accessory Box single level, with hardware (2screws & nuts) 1.5" x 3.5" x 1" |
| 2000-100-135 | Accessory Box single level, Scanlon only withhardware (2 screws & nuts), with embossed pinmat, 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 mmdiameters in one vertical slot 5" long, 6 position |
| 2000-162-054 | Universal keyhole bracket, 10 - 5 - 3 mmdiameters in one vertical slot 7.5" long, 6 position |
| 2000-162-056 | Universal keyhole bracket, 10 - 5 - 3 mmdiameters in one vertical slot 7.5" long, 10position |
| 2000-162-052 | Universal keyhole bracket, 10 - 5 - 3 mmdiameters in one vertical slot 9.25" long, 14position |
| 2000-162-055 | Universal keyhole bracket, 10 - 5 - 3 mmdiameters in one vertical slot 10" long , 15position |
| 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 elevatesingle wide brackets from the case floor |
| 2000-300-058 | Pin Mate Grid Style4.50" Length, 1.00" Width |
| 2000-300-059 | Pin Mate Grid Style9.63" Length, 1.00" Width |
| 2000-300-060 | Pin Mate Grid Style14.25" Length, 1.00" Width |
| 2000-300-061 | Pin Mate Grid Style18.25" Length, 1.00" Width |
| 2000-300-062 | Pin Mate Grid Style4.50" Length, 1.50" Width |
| 2000-300-063 | Pin Mate Grid Style7.13" Length, 1.50" Width |
| 2000-300-064 | Pin Mate Grid Style9.12" Length, 1.50" Width |
| 2000-300-065 | Pin Mate Grid Style16.88" Length, 3.45" Width |
| 2000-300-066 | Pin Mate Grid Style10.12" Length, 4.25" Width |
| 2000-300-067 | Pin Mate Grid Style9.75" Length, 4.25" Width |
| 2000-300-068 | Pin Mate Grid Style8.56" Length, 8.12" Width |
| 2000-300-069 | Pin Mate Grid Style18.25" Length, 8.25" Width |
| 2000-300-070 | Pin Mate Grid Style14.13" Length, 9.63" Width |
| 2000-300-071 | Pin Mate Grid Style18.25" Length, 9.63" Width |
| 2000-300-072 | Pin Mate Grid Style9.50" Length, 9.50" Width |
| 2000-300-073 | Pin Mate Grid Style18.25" Length, 10.12" Width |
| 2000-300-074 | Pin Mate Grid Style18.25" Length, 1.50" Width |
| 2000-300-075 | Pin Mate Grid Style6.75" Length, 10.12" Width |
| 2000-300-076 | Pin Mate Grid Style3.40" Length, 10.12" Width |
| Item number | Specification/ dimensions |
| 2000-300-077 | Pin Mate Grid Style6.50" Length, 10.12" Width |
| 2000-300-078 | Pin Mate Grid Style5.00" Length, 10.12" Width |
| 2000-300-079 | Pin Mate Grid Style5.75" Length, 10.12" Width |
| 2000-300-080 | Pin Mate Grid Style17.50" Length, 6.75" Width |
| 2000-300-081 | Pin Mate Grid Style10.12" Length, 6.00" Width |
| 2000-300-082 | Pin Mate Grid Style10.12" Length, 6.00" Width |
| 2000-300-083 | Pin Mate Grid Style7.63" Length, 4.00" Width |
| 2000-300-084 | Pin Mate Grid Style15.25" Length, 6.00" Width |
| 2000-300-085 | Pin Mate Grid Style14.13" Length, 9.63" Width |
| 2000-300-086 | Pin Mate Grid Style9.50" Length, 9.50" Width |
| 2000-300-087 | Pin Mate Grid Style4.50" Length, 1.50" Width |
| 2000-300-088 | Pin Mate Grid Style10.12" Length, 6.00" Width |
| 2000-300-089 | Pin Mate Grid Style18.25" Length, 9.63" Width |
| 2000-300-090 | Pin Mate Grid Style3.15" Length, 1.42" Width |
| 2000-300-091 | Pin Mate Grid Style9.00" Length, 7.00" Width |
| 2000-300-092 | Pin Mate Grid Style10.00" Length, 9.00" Width |
| 2000-300-093 | Pin Mate Grid Style7.00" Length, 10.50" Width |
| 2000-300-094 | Pin Mate Grid Style7.50" Length 13.50" Width |
List of Steripack Item numbers
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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.
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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.
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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/SterilizationCassettes (K163279) | Comparison |
|---|---|---|---|
| Trade Name | Steripack Case and Tray Systems | Medtronic Transportation/Sterilization Cassettes | N/A |
| FundamentalScientific Technology | Sterilization Cassette | Sterilization Cassette | Same |
| Intended Use | The Steripack case and tray systemare intended for use in healthcarefacilities to organize, enclose,sterilize, transport, and store medicaldevices and other instrumentationbetween surgical and other medicaluses.The Steripack case and tray systemare not intended on their own tomaintain sterility; they are intendedto be used in conjunction with alegally marketed, validated, FDA-cleared sterilization wrap. | The Medtronic Transportation/SterilizationCassettes are intended for use in healthcarefacilities to organize, enclose, sterilize, transport,and store medical devices and otherinstrumentation between surgical and othermedical uses.The Medtronic Transportation/SterilizationCassettes are not intended on their own tomaintain sterility; it is intended to be used inconjunction with a legally marketed, validated,FDA-cleared sterilization wrap. | Same |
| Product Code | KCT | KCT | Same |
| MaterialComposition | Thermoplastic polymers,aluminum, Silicone and stainlesssteel | Thermoplastic polymers, aluminum, and stainlesssteel | Similar |
| Feature | Steripack Case and Tray Systems(K193066) | Medtronic Transportation/SterilizationCassettes (K163279) | Comparison |
| Design | A base, a lid with a locking latch,and individual inserts | A base, a lid with a locking latch, and individualinserts | Same |
| Dimensions | The greatest challenge dimensionwas assessed to be: 21.06 x 10.00 x4.28 inches The inserts are offeredin different sizes | The greatest challenge dimension was assessed tobe:22.75 x 11.26 x 5.51 inches The inserts are offeredin 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 ratiodata. The challenge device was the subject of thesterilization validation. | Similar |
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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.
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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 |
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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/SterilizationCassettes (K163279) | Comparison | |||
|---|---|---|---|---|---|---|
| Cycle Type: Prevacuum | Cycle | Temperature | ExposureTime | MinimumDry Time | Similar | |
| SterilizationParameters | Temperature: 132 °C (270°F) | GravityDisplacement | 270°F(132°C) | 30 Minutes | 30 Minutes | |
| Exposure Time: 4 Minutes | GravityDisplacement | 275°F(135°C) | 15 Minutes | 30 Minutes | ||
| Pulses:3 | GravityDisplacement | 250°F(121°C) | 10 Minutes | 30 Minutes | ||
| Drying Time: 40 Minutes | Dynamic AirRemoval (4Pulses) | 270°F(132°C) | 4 Minutes | 30 Minutes | ||
| Dynamic AirRemoval (4Pulses) | 275°F(135°C) | 3 Minutes | 30 Minutes | |||
| Reusable | Yes | Yes | Same |
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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 theMethodology andCitation Name | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| Handle DurabilityTestANSI/AAMIST77:2006(R)2010 | This test wasperformed todetermine theability of the casehandle to maintainthe lid to baseconnection whensubjected totypical forcesexperiencedduring routine use.The test wasconducted on thethree handle stylesavailable in theSteripack case andtray system: Utype, rail style, andring style | 50 lb load to be held for30 minutes (safety factorof 2X max load of 25 lbs)Source: ANSI/AAMIST77:2006(R)2010indicates maximum loadfor reusable case andtrays are 25 lbs. | The three handle styles were able tosupport the 50 lb load for therequired 30 minutes without failure.Therefore, the handle designs meetthe requirements of ANSI/AAMIST77:2006(R)2010 and the handlesare safe and effective for use with theSteripack case and tray systems. | |
| Transport / ShippingTestASTM D4169-09 | This test wasperformed todetermine theability of theSteripack Caseand Tray Systemsto withstand theshipping andstoragerequirementsduring productshipping andtransportation.The testsconducted perASTM D4169-09were ManualHandling, VehicleStacking, Loose-load Vibration,Low PressureHazard, VehicleVibration, andConcentratedImpact. | The case system will beconsidered to beacceptable if it meets thefollowing acceptancecriteria:• Instruments mustremain in theirdesignated locationinside the outer caseand lid system.• There must be nodamage to thecase/tray that wouldprevent it fromholding andprotecting theinstruments fortransport orsterilizationprocessing.• There must be nodamage to theinternal instruments.Source: ASTM D4169-09 | Test: ManualHandlingResults: Acceptancecriteria weremet,instrumentswere held, nodamage wasinflicted on thecase and traysystem or theenclosedinstruments.Test: VehicleStackingResults: Acceptancecriteria weremet,instrumentswere held, nodamage wasinflicted on thecase and traysystem or theenclosedinstruments.Test: Loose-loadVibrationResults: Acceptancecriteria weremet,instrumentswere held, no | |
| Name of theMethodology andCitation Name | Purpose | Acceptance Criteria | Results | |
| Low PressureHazardVehicleVibrationConcentratedImpact | inflicted on thecase and traysystem or theenclosedinstruments.Acceptancecriteria weremet,instrumentswere held, nodamage wasinflicted on thecase and traysystem or theenclosedinstruments.Acceptancecriteria weremet,instrumentswere held, nodamage wasinflicted on thecase and traysystem or theenclosedinstruments.Acceptancecriteria weremet,instrumentswere held, nodamage wasinflicted on thecase and traysystem or theenclosedinstruments. | |||
| Life Cycle Testing /RepeatedReprocessingANSI/AAMIST77:2006(R)2010. | This test wasperformed todemonstrate thatthe Steripack Caseand Tray systemcould withstandrepeatedreprocessingthrough a steamsterilization cycle. | After the 100 sterilizationcycles the case and traymaterials of constructionmust be durable andcompatible with thesterilization process.• No materials maybreak down.• All handles, latches,and hinges mustmove freely and asintended.• No visible rust ordiscoloration isacceptable on laseretching.• Screen print cannotbleed, peel, or shift.• No visiblediscoloration isacceptable on | After 100 cycles were complete, allfunctional testing and materialrequirements described abovepassed. The only observation madewas four of the nylon coated bracketshad the nylon coating begin tobubble. This was not deemed afunctional failure because the nyloncoating did not crack and no metalwas exposed. | |
| Name of theMethodology andCitation Name | Purpose | Acceptance Criteria | Results | |
| stainless steel oranodizedcomponents.Cracking nyloncoating or exposedmetal through nylonis not acceptable.Radel andpolypropylenecannot be deformed.Source: Test wasconducted to showmaterials meet thedurability andsterilization compatibilityrequirements ofANSI/AAMIST77:2006(R)2010. | ||||
| Sterilant penetrationAANSI/AAMI/ISO17665-1:2006/(R)2013 | To validate thesterilizationefficacy of theSteripack case andtray worst casevolume to ventratio device, whenprocessed fullyloaded in a steampre-vacuumsterilization cycleat 132° C (270°F)with four (4)minutes ofexposure time. | The overkill method wasselected to verify thesterilization efficacy ofthe samples, perAAMI/ISO guidelines.In this method, validationwas accomplished bydemonstrating that aminimum of 1.0 x 106highly resistantGeobacillusstearothermophilusspores were killed in ahalf-cycle (6-logreduction). A full cyclewould therefore result ina 12-log reduction ofspores and produce a 10-6SAL, which reflects aone-in-a-million chanceof a non-sterile item.Source:AANSI/AAMI/ISO17665-1:2006/(R)2013 | Results from testing validate that theSteripack Instrument Tray and CaseSystems allow sterilant penetrationsufficient to achieve a 10-6 SALafter processing in the pre-vacuumsterilization cycle at 132°C (270°F)and four (4) minutes of exposuretime. | |
| Biocompatibility –ThermoplasticCoating (Nylon 11)ANSI/AAMI/ISO10993-5:2009 | Testing performedon theThermoplasticCoating asmanufactured toensure it meets theCytotoxicity(MEM elutiontest) requirementsof ISO 10993 for adevice withpotential indirectpatient contact. | Grade ≤ 2Source:ANSI/AAMI/ISO 10993-5:2009 | Test specimen was subjected to acytotoxicity test ISO MEM elutionL-929 cells (ATCC CCL-1).Method: Incubated at 37±1° C with5±1% CO2 for 72 ± 3 hours.The test article scored a Grade 0,eliciting no cytotoxic effect. | |
| Name of theMethodology andCitation Name | Purpose | Acceptance Criteria | Results | |
| ThermoplasticCoating (Nylon 11)ANSI/AAMI/ISO10993-1:2009 | on theThermoplasticCoating to ensureit meets the AcuteSystemic Toxicityrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | clinical signs of toxicityduring the 72 hour studyperiod.Source:ANSI/AAMI/ISO 10993-1:2009 | Acute Systemic Toxicity test onmice.Method: The extraction mixtures andcorresponding control blanks wereincubated for 72 ± 2 hours at 50 ± 2 °CNone of the animals on study wereobserved with abnormal clinicalsigns indicative of toxicity during the72 hour test period. All were alive atthe end of the 72 hour test durationand body weight loss was withinacceptable parameters over thecourse of the study | |
| Biocompatibility –ThermoplasticCoating (Nylon 11)ANSI/AAMI/ISO10993-1:2009 | Testing performedon theThermoplasticCoating to ensureit meets theIntracutaneousIrritationrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | Extract from the testspecimen must not causelocal irritation to thedermal tissue of a rabbit.Source:ANSI/AAMI/ISO 10993-1:2009 | Test specimen was subjected to anAcute Systemic Toxicity test onmice.Method: The extraction mixtures andcorresponding control blanks wereincubated for 72 ± 2 hours at 50 ± 2 °CNo significant dermal reactions wereobserved in the test subjects. | |
| Biocompatibility –ThermoplasticCoating (Nylon 11)ANSI/AAMI/ISO10993-1:2009 | Testing performedon theThermoplasticCoating to ensureit meets theImplantation Testrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | The differences betweenaverage scores of theencapsulation of the testarticle implantation siteand the negative controlsite cannot score greaterthan 1.0.Source:ANSI/AAMI/ISO 10993-1:2009 | Test specimen was subjected to anintramuscular implantation test onrabbits. The test article wasimplanted in the animal subject for 1week.Method: test article was cut intopieces approximately 3 mm x 1 0mm. and instead to the paravertebralmuscle.There was no difference (Score of 0)between the average encapsulationscores between the implantation sitesand the negative control sites. | |
| Biocompatibility –ThermoplasticCoating (Nylon 11)ANSI/AAMI/ISO10993-5:2009 | Testing performedon theThermoplasticCoating aftersterilization toensure it meets theCytotoxicity(MEM elutiontest) requirementsof ISO 10993 for adevice withpotential indirectpatient contactthroughleachables. | Grade ≤ 2Source:ANSI/AAMI/ISO 10993-5:2009 | The test article induced nocytotoxicity (Grade 0). Thereforethe test article is not considered toelicit a cytotoxic effect under theconditions employed. | |
| Biocompatibility –Silicone (Elastomer) | Testing performedon the SiliconeElastomer material | No cytopathic effect. | Cytotoxicity testing reports wereprovided by the supplier (DOWCORNING). Per biocompatibility |
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| Name of theMethodology andCitation Name | Purpose | Acceptance Criteria | Results | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ANSI/AAMI/ISO10993-5:2009 | to ensure it meetsthe Cytotoxicityrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | ANSI/AAMI/ISO 10993-5:2009 | reports, "Cell Culture" test wasperformed on "Elastomers" and"Cell culture medium extract ofelastomer" for the cytotoxicityevaluation.No Cytopathic effect (morphologychanges). No Cytopathic effect(morphology changes): ≥ 75%visibility (by neutral red) | ||||||||||||||
| Biocompatibility –Silicone (Elastomer)ANSI/AAMI/ISO10993-10:2009 | Testing performedon the SiliconeElastomer materialto ensure it meetsthe Sensitizationrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | No sensitization whenexposed to an extract ofthe test article.Source:ANSI/AAMI/ISO 10993-10:2009 | Skin Sensitization test wasperformed on Elastomer, SalineExtract of elastomer and Ethanol oracetone extract of elastomer for thesensitization evaluation.Test meets ISO 10993-1requirements with no sensitization. | ||||||||||||||
| Biocompatibility –Silicone (Elastomer)ANSI/AAMI/ISO10993-10:2009 | Testing performedon the SiliconeElastomer materialto ensure it meetsthe IntracutaneousReactivityrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | Test article to be non-irritating and non-toxic.Source:ANSI/AAMI/ISO 10993-10:2009 | Intracutaneous reactivity test wasperformed on Saline Extract ofelastomer, Extract if elastomer in 5%ethanol 95% saline, PEG 400 extractof elastomers and Cottonseed oilextract of elastomer for theintracutaneous reactivity evaluation.The test article was non-irritating andnon-toxic relative to controls | ||||||||||||||
| Biocompatibility –Silicone (Elastomer)ANSI/AAMI/ISO10993-10:2009 | Testing performedon the SiliconeElastomer materialto ensure it meetsthe SystemicToxicityrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | Test article to be non-irritating and non-toxic.Source:ANSI/AAMI/ISO 10993-10:2009 | Systemic toxicity test was performedon Saline Extract of elastomer,Extract if elastomer in 5% ethanol95% saline, PEG 400 extract ofelastomers and Cottonseed oil extractof elastomer for the intracutaneousreactivity evaluation.The test article was non-irritating andnon-toxic relative to controls | ||||||||||||||
| Biocompatibility –Silicone ElastomerANSI/AAMI/ISO10993-5:2009 | Testing performedon the eight colorvariations of theSilicone elastomerafter sterilizationto ensure it meetsthe Cytotoxicity(MEM elutiontest) requirementsof ISO 10993 for adevice withpotential indirectpatient contactthroughleachables. | Grade ≤ 2Source:ANSI/AAMI/ISO 10993-5:2009 | Description TestSampleGrade Test Coupon: BlackSilicone Extrusion 0 Test Coupon: BlueSilicone Extrusion 1 Test Coupon: Blue V-Rubber Extrusion 1 Test Coupon: BlackPin Mat 0 Test Coupon: Blue PinMat 2 Test Coupon: Flat 0 |
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| Name of theMethodology andCitation 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 AluminumANSI/AAMI/ISO10993-5:2009 | Testing performedon the AnodizedAluminummaterial to ensureit meets theCytotoxicityrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | Grade ≤ 2Source:ANSI/AAMI/ISO 10993-5:2009 | Test article was subjected to acytotoxicity test ISO MEM elutionL-929 cells (ATCC CCL-1).Method: Incubated at 37±1° C with5±1% CO2 for 48 ± 3 hoursThe test article scored "0" at 48 ± 3hours for all 3 cell monolayers. |
| Biocompatibility –Anodized AluminumAANSI/AAMI ST72:2011 | Testing performedon the AnodizedAluminummaterial to ensureit meets therequirements ofANSI/AAMI ST72 forpyrogenicity. | For a medical device,endotoxin limit is >20EU/device.Source: AANSI/AAMIST 72:2011 | Test specimen was subjected to aBET test.Method: The extraction wasperformed by immersing the testarticle in endotoxin free water andplacing it on an orbital shaker in anincubator for 40-60 minutes at 37 -40°C.The range for the three specimenswas <0.972 - <1.28 EU / device.The devices met the acceptancecriteria. |
| Biocompatibility –Stainless SteelANSI/AAMI/ISO10993-5:2009 | Testing performedon the StainlessSteel material toensure it meets theCytotoxicityrequirements ofISO 10993 for adevice withpotential indirectpatient contact. | Grade ≤ 2Source:ANSI/AAMI/ISO 10993-5:2009 | The test article was subjected to acytotoxicity test ISO MEM elutionL-929 cells (ATCC CCL-1).Method: Incubated at 37±1° C with5±1% CO2 for 48 ± 3 hoursThe test article scored "0" at 48 ± 3hours for all 3 cell monolayers. |
| Biocompatibility –Stainless SteelANSI/AAMI ST72:2011 | Testing performedon the AnodizedAluminummaterial to ensureit meets therequirements ofANSI/AAMI ST72 forpyrogenicity. | For a medical device,endotoxin limit is >20EU/device.Source: ANSI/AAMI ST72:2011 | Test specimen was subjected to aBET test.Method: The extraction wasperformed by immersing the testarticle in endotoxin free water andplacing it on an orbital shaker in anincubator for 40-60 minutes at 37 -40°C.The range for the three specimenswas <2.93 - <3.02 EU / device. Thedevices met the acceptance criteria. |
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Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject Steripack Case and Tray Systems devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device Medtronic Transportation/Sterilization Cassettes cleared under K163279.
§ 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).