(261 days)
The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.
The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated or non-perforated bottoms. All models are intended to be used with single use paper filter.
The container is a reusable device designed to be used with the following sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle:
4 minutes
132°C (270 °F)
Drying Time Minimum: 30 minutes
The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. They consist of various sizes of bottoms and lids that provide an effective packaging method for sterilization, storage and transportation of surgical instruments by healthcare providers. These containers are suitable for use in pre-vacuum Steam Sterilizers with a tray or basket accessory. Metal (Stainless Steel) surgical instruments like forceps, scissors, clamps, etc. including lumened/cannulated instruments are placed in the trays or baskets for sterilization.
Note: The maximum number of Lumens/Lumen Configuration is as follow:
2 lumens with ≥ 1mm I.D. x ≤ 200mm and a second lumen ≥ 5mm I.D. x ≤ 400mm
The containers are available in different models such as full size (1/1), three-quarter size (3/4), half size (1/2) and XL.
InstruSafe® Sterilization Container is manufactured using aluminum alloy, stainless steel, silicone and the surfaces are protected by a layer of anodized aluminum oxide to prevent corrosion.
The containers must only be used with single use paper filters.
This document describes the regulatory submission for the InstruSafe® Sterilization Container (K180528) and demonstrates its substantial equivalence to predicate devices. The information provided heavily relies on non-clinical performance data rather than a study with human readers or AI algorithms. As such, many of the requested data points related to MRMC studies, training sets, and expert consensus for ground truth are not applicable to this type of device and submission.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through various non-clinical performance tests, ensuring its ability to sterilize enclosed medical devices and maintain sterility.
| Acceptance Criteria Category | Specific Test/Attribute | Reported Device Performance |
|---|---|---|
| Device Functionality | Sterilization Efficacy and Thermal Profile (Pre-Vacuum Steam) | Successful; met AAMI TIR12:2010, ANSI/AAMI ST77:2013, and ANSI/AAMI ST79:2013/A4:2013 standards. Tested with lumened/cannulated instruments. |
| Dry Time | Successful; met AAMI TIR12:2010, ANSI/AAMI ST77:2013, and ANSI/AAMI ST79:2013/A4:2013 standards. | |
| Sterility Maintenance | Maintenance of Sterility (Shelf Life) | Maintained sterility for 180 days after sterilization efficacy testing. Met AAMI TIR12:2010, ANSI/AAMI ST77:2013, and ANSI/AAMI ST79:2010/A3:2012 standards. |
| Microbial Aerosol Challenge | Successful; met AAMI TIR12:2010, ANSI/AAMI ST77:2013, and ANSI/AAMI ST79:2010/A3:2012 standards. | |
| Biocompatibility | Biocompatibility | Meets requirements of ISO 10993-1, ANSI/AAMI/ISO 10993-5:2009, and ANSI/AAMI/ISO 10993-12:2012. |
| Device Performance Under Load | Load Weight Capability | Successfully tested with load weights up to 25 lbs (as claimed in indications for use) during sterilization efficacy and dry time testing. |
| Reusable Device Performance | Cleaning/Reusability (Mechanical Cleaning) | Successful; met AAMI TIR12:2010, AAMI TIR30:2011, and ANSI/AAMI ST81:2004(R)2010 standards. |
| Mechanical Integrity | Handle Testing | Successful; met ANSI/AAMI ST77:2013 standards. |
| Gasket Testing | Successful; met ANSI/AAMI ST77:2013 standards. | |
| Lid/Base Compatibility Testing | Successful; met ANSI/AAMI ST77:2013 standards. | |
| Locking Tag/Label Compatibility Testing | Successful; met ANSI/AAMI ST77:2013 standards. | |
| Design Feature Justification | Absence of security lid to prevent damage/contamination of filter unit during transport (as present in some predicates) | The sterilization containers were tested without a security lid during sterilization efficacy, dry time, microbial aerosol challenge, and shelf life testing and were found to have no failures that were caused by damage or contamination of the filter unit. The subject device functions as intended. The lack of this feature does not compromise safety or effectiveness. |
| Material Composition | Materials (Anodized Aluminum Alloy, Stainless Steel, Silicone) | Confirmed to be within acceptable and known safe specifications, comparable to predicate devices. |
| Compatibility with Instruments | Compatibility with Stainless Steel Medical Devices | Verified. |
| Compatibility with Lumened/Cannulated Instruments | Verified through sterilization efficacy testing. |
Study Proving Device Meets Acceptance Criteria
The studies detailed for the InstruSafe® Sterilization Container are non-clinical, bench-validation studies, rather than clinical trials or AI performance evaluations.
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not specify numerical sample sizes for the non-clinical tests (e.g., number of containers tested, number of sterilization cycles performed, or number of microbial challenges). It states "The sterilization containers were tested..." which implies a sufficient number for validation, but no precise count is given.
- Data Provenance: The studies were non-clinical bench testing. The country of origin for the data is not explicitly stated but can be inferred to be in the USA, given the FDA submission. The studies were designed to be prospective validation tests according to established medical device testing standards.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the studies are non-clinical, bench-level performance validations for a sterilization container. Ground truth is established by objective measurements against predefined industry standards (e.g., AAMI, ISO) rather than subjective expert interpretation of medical images or data.
-
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human readers and subjective assessments (e.g., radiology reads). For non-clinical, objective performance testing, results are determined by adherence to pre-defined scientific and engineering standards and pass/fail criteria.
-
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 device is a reusable sterilization container and does not involve AI or human "readers" in the context of medical image interpretation or diagnosis. Therefore, an MRMC comparative effectiveness study was not performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (sterilization container), not an AI algorithm.
-
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective, verifiable measurements against established medical device sterilization, biocompatibility, and mechanical performance standards, such as those published by AAMI (Association for the Advancement of Medical Instrumentation) and ISO (International Organization for Standardization). For example:
- Sterilization Efficacy: Measured by indicator organisms (bioburden reduction) after a sterilization cycle.
- Dry Time: Measured objectively following a sterilization cycle.
- Sterility Maintenance/Microbial Aerosol Challenge: Measured by preventing microbial ingress over time.
- Biocompatibility: In vitro and in vivo tests against ISO 10993 standards.
- Mechanical Integrity: Measured by stress tests, weight limits, and functional checks.
- The "ground truth" for this device is based on objective, verifiable measurements against established medical device sterilization, biocompatibility, and mechanical performance standards, such as those published by AAMI (Association for the Advancement of Medical Instrumentation) and ISO (International Organization for Standardization). For example:
-
The Sample Size for the Training Set:
- Not applicable. This device is hardware, not a machine learning model, so there is no "training set."
-
How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for a machine learning model, this question is irrelevant to the described device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2018
Summit Medical Inc. Nicole Dove Director of Quality Assurance and Regulatory Affairs 815 Northwest Parkway, Suite 100 St. Paul. Minnesota 55121
Re: K180528
Trade/Device Name: InstruSafe® Sterilization Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 16, 2018 Received: October 17, 2018
Dear Nicole Dove:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180528
Device Name InstruSafe® Sterilization Container
Indications for Use (Describe)
The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks.
The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated bottoms. All models are intended to be used with single use paper filters.
The container is a reusable device designed to be used with the following sterilization cycle parameters:
Pre-Vacuum Steam Sterilization Cycle: 4 minutes 132oC (270 oF) Drying Time Minimum: 30 minutes
| Model Number | Description | Total Container LoadedMaximum Weight (lbs) | Load Description |
|---|---|---|---|
| CS-3XXX | Full 1/1 Perforated Container Lid | Not applicable | Metal (Stainless Steel) |
| CS-3XXX | Full 1/1 Container Bottom | 25 lbs | surgical instruments |
| CS-2XXX | Three quarter 3/4 Perforated Container Lid | Not applicable | like forceps, scissors, |
| CS-2XXX | Three quarter 3/4 Container Bottom | 25 lbs | clamps, etc. including |
| CS-1XXX | One half 1/2 Perforated Container Lid | Not applicable | lumened /cannulated |
| CS-1XXX | One half 1/2 Container Bottom | 18 lbs | instruments. |
| CS-5XXX | XL Perforated Container Lid | Not applicable | |
| CS-5XXX | XL Container Bottom | 25 lbs |
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)
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Image /page/3/Picture/0 description: The image shows the logo for Summit Medical, which includes three blue diamonds above the word "SUMMIT" in a stylized font, with the word "medical" in smaller letters below. Below the logo, the text "510(k) Summary" is displayed, followed by "K180528".
Following is the 510(k) summary information in accordance with 21 CFR 807.92
| Date Prepared: | October 15, 2018 |
|---|---|
| Applicant: | Summit Medical, Inc.815 Vikings Parkway, Suite 100St. Paul, MN 55121 USA |
| Official Correspondent: | Nicole DoveDirector of Quality Assurance & Regulatory AffairsTel: (651) 789-3921 / Fax: (651) 789-3961ndove@innoviamedical.com |
| Subject Device | |
| Trade/Device Name: | InstruSafe® Sterilization Container |
| Common or Usual Name: | Instrument Tray, Sterilization Tray, Sterilization Cassettes, InstrumentDelivery System |
| Regulation Number: | 21 CFR 880.6850 |
| Regulation Name: | Sterilization wrap |
| Regulatory Class: | Class II |
| Product Code: | KCT |
| Indications for Use | The InstruSafe® Sterilization Container is a reusable sterilization containersystem intended to be used to enclose another medical device that is to besterilized by a healthcare provider. It is intended to allow sterilization of theenclosed device and also maintain sterility for 180 days. The InstruSafe®Sterilization Container includes accessories such as trays, baskets, filters, datacards and tamper proof locks.The InstruSafe® Sterilization Container consists of various models within thevalidated product line. All models are available with perforated lids and eitherperforated or non-perforated bottoms. All models are intended to be used withsingle use paper filter.The container is a reusable device designed to be used with the followingsterilization cycle parameters:Pre-Vacuum Steam Sterilization Cycle:4 minutes132°C (270 °F)Drying Time Minimum: 30 minutes |
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Image /page/4/Picture/0 description: The image shows the logo for Summit Medical. The logo has the word "SUMMIT" in a large sans-serif font. Below the word "SUMMIT" is the word "medical" in a smaller sans-serif font. Above the word "SUMMIT" are three blue diamonds.
| Model | Description | Total Container Loaded | Load Description | |||
|---|---|---|---|---|---|---|
| Number | Maximum Weight (lbs) | |||||
| CS-3XXX | Full 1/1 Perforated Container Lid | Not applicable | Metal (Stainless | |||
| CS-3XXX | Full 1/1 Container Bottom | 25 lbs | Steel) surgical | |||
| CS-2XXX | Three quarter 3/4 Perforated Container Lid | Not applicable | ir struments like | |||
| CS-2XXX | Three quarter 3/4 Container Bottom | 25 lbs | forceps, scissors, | |||
| CS-1XXX | One half ½ Perforated Container Lid | Not applicable | clamps, etc. | |||
| CS-1XXX | One half ½ Container Bottom | 18 lbs | ir cluding | |||
| CS-5XXX | XL Perforated Container Lid | Not applicable | lı mened/cannulated | |||
| CS-5XXX | XL Container Bottom | 25 lbs | ii struments. | |||
| The InstruSafe® Sterilization Container is a reusable sterilization container system intended | ||||||
| Device Description | ||||||
| to be used to enclose another medical device that is to be sterilized by a healthcare provider. | ||||||
| They consist of various sizes of bottoms and lids that provide an effective packaging method | ||||||
| for sterilization, storage and transportation of surgical instruments by healthcare providers. | ||||||
| These containers are suitable for use in pre-vacuum Steam Sterilizers with a tray or basket | ||||||
| accessory. Metal (Stainless Steel) surgical instruments like forceps, scissors, clamps, etc. | ||||||
| including lumened/cannulated instruments are placed in the trays or baskets for sterilization. | ||||||
| Note: The maximum number of Lumens/Lumen Configuration is as follow: | ||||||
| 2 lumens with ≥ 1mm I.D. x ≤ 200mm and a second lumen ≥ 5mm I.D. x ≤ 400mm | ||||||
| The containers are available in different models such as full size (1/1), three-quarter size | ||||||
| (3/4), half size (1/2) and XL. | ||||||
| InstruSafe® Sterilization Container is manufactured using aluminum alloy, stainless steel, | ||||||
| silicone and the surfaces are protected by a layer of anodized aluminum oxide to prevent | ||||||
| corrosion. | ||||||
| The containers must only be used with single use paper filters. | ||||||
| Maximum recommended loading: | ||||||
| Model | Description | Standard Dimension | Total Container | |||
| Number | Outside w/cover | Loaded Maximum | ||||
| LxWxH in inches | Weight (lbs) | |||||
| CS-3001 | Full 1/1 Perforated Container Lid | 23 1/8 x 11 x 1 1/4 | Not applicable | |||
| CS-3002 | Full 1/1 Solid Container Bottom | 23 1/8 x 11 x 4 1/4 | 25 lbs | |||
| CS-3003 | Full 1/1 Solid Container BottomFull 1/1 Solid Container Bottom | 23 1/8 x 11 x 6 1/4 | 25 lbs | |||
| CS-3004 | 23 1/8 x 11 x 8 1/4 | 25 lbs | ||||
| CS-3005 | Full 1/1 Solid Container Bottom | 23 1/8 x 11x 10 ½ | 25 lbs | |||
| CS-3012 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11 x 4 1/4 | 25 lbs | |||
| CS-3013 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11 x 6 1/4 | 25 lbs | |||
| CS-3014 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11 x 8 1/4 | 25 lbs | |||
| CS-3015 | Full 1/1 Perforated Container Bottom | 23 1/8 x 11x 10 1/2 | 25 lbs | |||
| CS-2001 | Three Quarter 3/4 Perforated Container Lid | 18 ¼ x 11 x 1 ¼ | Not applicable | |||
| CS-2002 | Three Quarter 3/4 Solid Container Bottom | 18 ¼ x 11 x 4 1/4 | 25 lbs | |||
| CS-2003 | Three Quarter ¾ Solid Container Bottom | 18 ¼ x 11 x 6 ¼ | 25 lbs | |||
| CS-2012 | Three Quarter ¾ Perforated Container Bottom | 18 ¼ x 11 x 4 1/4 | 25 lbs | |||
| CS-2013 | Three Quarter ¾ Perforated Container Bottom | 18 ¼ x 11 x 6 ¼ | 25 lbs | |||
| CS-1001 | One Half 1/2 Perforated Container Lid | 11 ½ x 11 x 1 1/4 | Not applicable | |||
| CS-1002 | One Half ½ Solid Container Bottom | 11 ½ x 11 x 4 ¼ | 18 lbs | |||
| CS-1003 | One Half ½ Solid Container Bottom | 11 ½×11×6¼ | 18 lbs | |||
| CS-1012 | One Half ½ Perforated Container Bottom | 11 ½ x 11 x 4 ¼ | 18 lbs | |||
| CS-1013 | One Half ½ Perforated Container Bottom | 11 ½ x 11 x 6 ¼ | 18 lbs | |||
| CS-5000CS-5001 | Extra Large Perforated Container LidExtra Large Perforated Container Bottom | 30 7/8 x 12 3/4 x 7 1/230 7/8 x 12 3/4 x 7 1/2 | Not applicable25 lbs |
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Image /page/5/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds. The logo is simple and modern, and the blue color gives it a professional look.
| Predicate Device | |
|---|---|
| Trade/Device Name/510(k) | Ermis Medizintechnik Sterilization Container System - K123234 |
| Reference Device | |
| Trade/Device Name/510(k) | Aesculap SterilContainer System – K112671 (reference) |
| Comparison of SubjectDevice to Predicate Devices | Indications for Use | ||||
|---|---|---|---|---|---|
| InstruSafe®SterilizationContainer | The InstruSafe® Sterilization Container is a reusable sterilization containersystem intended to be used to enclose another medical device that is to besterilized by a healthcare provider. It is intended to allow sterilization of theenclosed device and also maintain sterility for 180 days. The InstruSafe®Sterilization Container includes accessories such as trays, baskets, filters,data cards and tamper proof locks.The InstruSafe® Sterilization Container consists of various models within thevalidated product line. All models are available with perforated lids andeither perforated or non-perforated bottoms. All models are intended to beused with single use paper filter.The container is a reusable device designed to be used with the followingsterilization cycle parameters:Pre-Vacuum Steam Sterilization Cycle:4 minutes132°C (270°F)Drying Time Minimum: 30 minutes | ||||
| ModelNumber | Description | Total ContainerLoadedMaximumWeight (lbs) | LoadDescription | ||
| CS-3XXX | Full 1/1 Perforated Container Lid | Not applicable | Metal | ||
| CS-3XXX | Full 1/1 Container Bottom | 25 lbs | (Stainless | ||
| CS-2XXX | Three quarter ¾ Perforated ContainerLid | Not applicable | Steel) surgicalinstruments | ||
| CS-2XXX | Three quarter ¾ Container Bottom | 25 lbs | like forceps, | ||
| CS-1XXX | One half ½ Perforated Container Lid | Not applicable | scissors, | ||
| CS-1XXX | One half ½ Container Bottom | 18 lbs | clamps, etc. | ||
| CS-5XXXCS-5XXX | XL Perforated Container LidXL Container Bottom | Not applicable25 lbs | includinglumened/cannulatedinstruments. | ||
| ReferenceDeviceAesculapSterilContainerSystemK112671 | The Aesculap SterilContainer System is a reusable sterilization containersystem intended to be used to enclose another medical device that is to besterilized by a healthcare provider. It is intended to allow sterilization of theenclosed device and also maintain sterility for 360 days. TheSterilContainer System includes accessories such as mats, baskets, trays,holders, organizers, filters, indicator cards and tamper proof locks. |
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| PredicateDevice:ErmisMedizintechnik SterilizationContainerSystemK123234 | The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) aluminum bottom and a three-quarter size aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use paper filter (US751, US994), a single use polypropylene filter (MD344) and a reusable PTFE filter (JK090). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.The ERMIS Sterilization Container System is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size,³⁄₄ Size,½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters. | ||||
|---|---|---|---|---|---|
| The containers are reusable devices designed to be used with the following sterilization cycle parameters: | |||||
| Pre-Vacuum cycle: | |||||
| 4 minutes | |||||
| 132°C (270°F) | |||||
| Drying Time minimum 20 minutes | |||||
| 3 minutes | |||||
| 135°C (273°F) | |||||
| Drying Time minimum 16 minutes | |||||
| Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles | |||||
| Maximum recommended loading: | |||||
| Maximum Recommended Load in kg (lbs.) incl. Container weight | |||||
| Model | Dimension | Instruments | Textiles | ||
| 1/1 Size Container | 580x280x100 | 3.8 (8.3) | 3 (6.6) | ||
| 580x280x135 | 5.2 (11.4) | 4.1 (9.0) | |||
| 580x280x150 | 5.8 (12.7) | 4.6 (10.1) | |||
| 580x280x200 | 7.7 (16.9) | 6.1 (13.4) | |||
| 580x280x260 | 10 (22.0) | 8 (17.6) | |||
| 3/4 Size Container | 465x280x100 | 3.1 (6.8) | 2.5 (5.5) | ||
| 465x280x135 | 4.2 (9.2) | 3.3 (7.2) | |||
| 465x280x150 | 4.6 (10.1) | 3.7 (8.1) | |||
| 1/2 Size Container | 285x280x100 | 1.9 (4.1) | 1.5 (3.3) | ||
| 285x280x135 | 2.6 (5.7) | 2 (4.4) | |||
| 285x280x150 | 2.8 (6.1) | 2.2 (4.8) |
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Image /page/7/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the blue color gives it a professional look.
| 285x280x200 | 3.8 (8.3) | 3 (6.6) | |
|---|---|---|---|
| 285x280x260 | 4.9 (10.8) | 3.9 (8.5) | |
| Mini Container | 300x140x40 | 0.4 (0.8) | 0.3 (0.6) |
| 300x140x70 | 0.7 (1.5) | 0.5(1.1) | |
| 300x140x100 | 1 (2.2) | 0.8 (1.7) | |
| DentalContainer | 310x190x40 | 0.6(1.3) | 0.5(1.1) |
| 310x190x65 | 0.9 (1.9) | 0.7 (1.5) | |
| 310x190x80 | 1.2 (2.6) | 0.9 (1.9) | |
| 310x190x100 | 1.5 (3.3) | 1.2 (2.6) | |
| 310x190x130 | 1.8 (3.9) | 1.4 (3.0) |
| TechnologicalCharacteristics/PerformanceComparison of SubjectDevice to Predicate Device | InstruSafe® SterilizationContainer(K180528) | Reference Device:AesculapSterilContainerSystem K112671 | Predicate Device:ErmisMedizintechnikSterilizationContainer K123234 | |
|---|---|---|---|---|
| Materials | Anodized Aluminum Alloy,Stainless Steel, Silicone | Anodized AluminumAlloy/Radel R | Anodized AluminumAlloy, Stainless Steel,Silicone | |
| Properties | ||||
| - Instruments to be sterilized invacuum steam sterilizers | Yes | Yes | Yes | |
| - Reusable | Yes | Yes | Yes | |
| - Closed System | Yes | Yes | Yes | |
| - Sealed | Yes | Yes | Yes | |
| - Filtered to Permit Entry ofSterilant | Yes | Yes | Yes | |
| - Filtered to Prevent MicrobialMigration during Transport | Yes | Yes | Yes | |
| - Incorporates security lid toprevent damage/contaminationof filter unit during transport | No | No | Yes | |
| Performance | ||||
| - Load Weight | Up to 25 lbs | Up to 25 lbs | Up to 22 lbs | |
| - Lumened/ cannulatedinstruments | Yes | Yes | No | |
| - Stainless steel medicaldevices | Yes | Yes | Yes | |
| Shelf life | 180 Days | 360 Days | 90 Days | |
| Biocompatibility | meets requirements ofISO 10993-1 | meets requirements ofISO 10993-1 | meets requirements ofISO 10993-1 | |
| Discussion on Technological /Performance CharacteristicDifferences | There are four technological/performance characteristic differences between the predicate devices and the subject device (Reference Table above). These are: 1) Incorporates security lid to prevent damage/contamination of filter unit during transport,2) Load weight3) Lumened/cannulated instruments4) Shelf lifeScientific methods (bench testing) and sterilization standards, exist for evaluating different technical characteristics.Specifically:1) Incorporates security lid to prevent damage/contamination of filter unit during transport a. The sterilization containers were tested without a security lid during sterilization efficacy, dry time, microbial aerosol challenge and shelf life testing and were found to have no failures that were caused by damage or contamination of the filter unit. The subject device functions as intended.2) Load weight a. The sterilization containers were tested to the load weight claimed in the indications for use in the sterilization efficacy and dry time testing. The subject device functions as intended3) Lumened/Cannulated instruments a. The sterilization containers were tested with lumened/cannulated instruments during sterilization efficacy testing.4) Shelf life a. The sterilization containers were tested to the shelf life claimed in the indications for use during the sterilization efficacy testing. | |||
| Non-Clinical Testing | The InstruSafe®Sterilization Containerproved to be successful inall the non-clinical testsconducted. The non-clinicaltests conducted included thetests listed below: | The AesculapSterilContainer Systemconducted thefollowing non-clinicaltests:- ReprocessingValidation &Verification | The ErmisSterilizationContainer Systemconducted thefollowing non-clinical tests:- Pre-VacuumSteam Efficacy | |
| - Pre-Vacuum SteamEfficacy and ThermalProfile- Dry Time- Maintenance ofsterility (180 days)- Microbial AerosolChallenge- Biocompatibility- Cleaning/reusability(AAMI TIR12)- Handle Testing- Gasket Testing- Lid/Base CompatibilityTesting- Locking Tag/LabelCompatibility Testing | - Sterilization Efficacy- Sterility- Maintenance | and ThermalProfile- Dry Time- Shelf Life- Microbial AerosolChallenge- Biocompatibility- MechanicalCleaning- Reusability(repetitiveexposure)- Handle Testing- Lock Testing | ||
| Non-Clinical TestingSummary | The following Non-Clinical Testing was conducted using current standardsand FDA guidance.- Pre-Vacuum Steam Efficacy and Thermal Profile, and Dry Time perAAMI TIR12:2010, ANSI/AAMI ST77:2013 and ANSI/AAMIST79:2013/A4:2013- Shelf Life and Microbial Aerosol Challenge per AAMI TIR12:2010,ANSI/AAMI ST77:2013 and ANSI/AAMI ST79:2010/A3:2012- Biocompatibility per FDA Use of International Standard ISO 10993-1,"Biological evaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process", ANSI/AAMI/ISO 10993-5:2009 andANSI/AAMI/ISO 10993-12:2012- Mechanical Cleaning per AAMI TIR12:2010, AAMI TIR30:2011 andANSI/AAMI ST81:2004(R)2010- Handle Testing, Gasket Testing, Lid/Base Compatibility Testing andLocking Tag/Label Compatibility Testing per ANSI/AAMI ST77:2013 | |||
| Conclusion: | In summary, the non-clinical testing demonstrates that the InstruSafe®Sterilization Container is as safe, as effective and performs as well as orbetter than the legally marketed predicate device (Ermis MedizintechnikSterilization Container System K123234). |
510(k) Premarket Notification - InstruSafe® Sterilization Container Summit Medical, Inc.
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Image /page/9/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds, arranged in a horizontal row. The logo is simple and modern, and the blue color gives it a professional look.
§ 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).