(261 days)
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a reusable container, with no mention of AI or ML capabilities.
No.
The device is a sterilization container used to enclose other medical devices for sterilization and maintain their sterility; it does not directly treat or diagnose a disease or condition.
No.
The device is a sterilization container intended to enclose other medical devices for sterilization and maintain their sterility, rather than diagnose a medical condition.
No
The device is a physical sterilization container system made of aluminum alloy, stainless steel, and silicone, with accessories like trays, baskets, and filters. It is clearly a hardware device.
Based on the provided text, the InstruSafe® Sterilization Container is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to enclose another medical device for sterilization and maintain sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the physical characteristics of the container and its use in sterilizing surgical instruments. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing human specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
The device is clearly intended for the sterilization and storage of other medical devices used in healthcare settings.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The InstruSafe® Sterilization Container proved to be successful in all the non-clinical tests conducted. The non-clinical tests conducted included the tests listed below:
- Pre-Vacuum Steam Efficacy and Thermal Profile
- Dry Time
- Maintenance of sterility (180 days)
- Microbial Aerosol Challenge
- Biocompatibility
- Cleaning/reusability (AAMI TIR12)
- Handle Testing
- Gasket Testing
- Lid/Base Compatibility Testing
- Locking Tag/Label Compatibility Testing
Non-Clinical Testing Summary: The following Non-Clinical Testing was conducted using current standards and FDA guidance.
- Pre-Vacuum Steam Efficacy and Thermal Profile, and Dry Time per AAMI TIR12:2010, ANSI/AAMI ST77:2013 and ANSI/AAMI ST79:2013/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 testing within a risk management process", ANSI/AAMI/ISO 10993-5:2009 and ANSI/AAMI/ISO 10993-12:2012
- Mechanical Cleaning per AAMI TIR12:2010, AAMI TIR30:2011 and ANSI/AAMI ST81:2004(R)2010
- Handle Testing, Gasket Testing, Lid/Base Compatibility Testing and Locking 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 or better than the legally marketed predicate device (Ermis Medizintechnik Sterilization Container System K123234).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ermis Medizintechnik Sterilization Container System - K123234
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Aesculap SterilContainer System – K112671 (reference)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
2
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 Loaded
Maximum 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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3
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 100 | |
St. Paul, MN 55121 USA | |
Official Correspondent: | Nicole Dove |
Director of Quality Assurance & Regulatory Affairs | |
Tel: (651) 789-3921 / Fax: (651) 789-3961 | |
ndove@innoviamedical.com | |
Subject Device | |
Trade/Device Name: | InstruSafe® Sterilization Container |
Common or Usual Name: | Instrument Tray, Sterilization Tray, Sterilization Cassettes, Instrument |
Delivery 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 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 |
4
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 Bottom | |||||
Full 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-5000 | ||||||
CS-5001 | Extra Large Perforated Container Lid | |||||
Extra Large Perforated Container Bottom | 30 7/8 x 12 3/4 x 7 1/2 | |||||
30 7/8 x 12 3/4 x 7 1/2 | Not applicable | |||||
25 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 Subject
Device to Predicate Devices | Indications for Use | ||||
---|---|---|---|---|---|
InstruSafe® | |||||
Sterilization | |||||
Container | 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 | | | |
| | | Model
Number | Description | Total Container
Loaded
Maximum
Weight (lbs) | Load
Description |
| | | 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 Container
Lid | Not applicable | Steel) surgical
instruments |
| | | 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-5XXX
CS-5XXX | XL Perforated Container Lid
XL Container Bottom | Not applicable
25 lbs | including
lumened
/cannulated
instruments. |
| | Reference
Device
Aesculap
SterilContainer
System
K112671 | The Aesculap SterilContainer System 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 360 days. The
SterilContainer System includes accessories such as mats, baskets, trays,
holders, organizers, filters, indicator cards and tamper proof locks. | | | |
6
| Predicate
Device:
Ermis
Medizintechnik Sterilization
Container
System
K123234 | 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) | |
Dental | |||
Container | 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) |
| Technological
Characteristics/Performance
Comparison of Subject
Device to Predicate Device | InstruSafe® Sterilization
Container
(K180528) | Reference Device:
Aesculap
SterilContainer
System K112671 | Predicate Device:
Ermis
Medizintechnik
Sterilization
Container K123234 | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Materials | Anodized Aluminum Alloy,
Stainless Steel, Silicone | Anodized Aluminum
Alloy/Radel R | Anodized Aluminum
Alloy, Stainless Steel,
Silicone | |
| Properties | | | | |
| - Instruments to be sterilized in
vacuum steam sterilizers | Yes | Yes | Yes | |
| - Reusable | Yes | Yes | Yes | |
| - Closed System | Yes | Yes | Yes | |
| - Sealed | Yes | Yes | Yes | |
| - Filtered to Permit Entry of
Sterilant | Yes | Yes | Yes | |
| - Filtered to Prevent Microbial
Migration during Transport | Yes | Yes | Yes | |
| - Incorporates security lid to
prevent damage/contamination
of filter unit during transport | No | No | Yes | |
| Performance | | | | |
| - Load Weight | Up to 25 lbs | Up to 25 lbs | Up to 22 lbs | |
| - Lumened/ cannulated
instruments | Yes | Yes | No | |
| - Stainless steel medical
devices | Yes | Yes | Yes | |
| Shelf life | 180 Days | 360 Days | 90 Days | |
| Biocompatibility | meets requirements of
ISO 10993-1 | meets requirements of
ISO 10993-1 | meets requirements of
ISO 10993-1 | |
| Discussion on Technological /
Performance Characteristic
Differences | 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 weight
3) Lumened/cannulated instruments
4) Shelf life
Scientific methods (bench testing) and sterilization standards, exist for evaluating different technical characteristics.
Specifically:
- 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.
- 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 intended
- Lumened/Cannulated instruments a. The sterilization containers were tested with lumened/cannulated instruments during sterilization efficacy testing.
- 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 Container
proved to be successful in
all the non-clinical tests
conducted. The non-clinical
tests conducted included the
tests listed below: | The Aesculap
SterilContainer System
conducted the
following non-clinical
tests:
- Reprocessing
Validation &
Verification | The Ermis
Sterilization
Container System
conducted the
following non-
clinical tests: - Pre-Vacuum
Steam Efficacy | |
| | - Pre-Vacuum Steam
Efficacy and Thermal
Profile - Dry Time
- Maintenance of
sterility (180 days) - Microbial Aerosol
Challenge - Biocompatibility
- Cleaning/reusability
(AAMI TIR12) - Handle Testing
- Gasket Testing
- Lid/Base Compatibility
Testing - Locking Tag/Label
Compatibility Testing | - Sterilization Efficacy - Sterility
- Maintenance | and Thermal
Profile - Dry Time
- Shelf Life
- Microbial Aerosol
Challenge - Biocompatibility
- Mechanical
Cleaning - Reusability
(repetitive
exposure) - Handle Testing
- Lock Testing | |
| Non-Clinical Testing
Summary | The following Non-Clinical Testing was conducted using current standards
and FDA guidance. - Pre-Vacuum Steam Efficacy and Thermal Profile, and Dry Time per
AAMI TIR12:2010, ANSI/AAMI ST77:2013 and ANSI/AAMI
ST79:2013/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 testing
within a risk management process", ANSI/AAMI/ISO 10993-5:2009 and
ANSI/AAMI/ISO 10993-12:2012 - Mechanical Cleaning per AAMI TIR12:2010, AAMI TIR30:2011 and
ANSI/AAMI ST81:2004(R)2010 - Handle Testing, Gasket Testing, Lid/Base Compatibility Testing and
Locking 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 or
better than the legally marketed predicate device (Ermis Medizintechnik
Sterilization 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.