(81 days)
The Aesculap Sterilcontainer System is intended to be used to enclose another medical devices and The Aesculab Stericontainer System is intended to allow sterilization on the enclosed medical devices and be sterilized by a heatincale provinced to and used. The Aesolapp Sterilismanner System has been also maintain sterliny of the enclosed devices) undridded. The Alocallar Concerner. validated for use in an ozone sterlization system (TSO3 125L) to include hinged devices an as small as 3mm (diameter) and 550 mm (length).
The Aesculap Sterilcontainer is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with ozone sterilization. The container is made from anodized aluminum and utilizes a disposable (sinqle use) paper filter.
The documentation describes the Aesculap Sterilcontainer System, intended for sterilization and storage of medical devices, specifically validated for use with ozone sterilization systems (TSO3 125L).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Aesculap Sterilcontainer System, when used in an ozone sterilization cycle (TSO3 125L Sterilizer), are based on specific parameters for each phase of the sterilization cycle. The reported device performance is indicated by the "Actual values" achieved during the validation.
| Phase | Acceptance Criteria (Typical values) | Reported Device Performance (Actual values) |
|---|---|---|
| 1 - Vacuum | Pressure: approximately 1 torr | 1 torr |
| 2 - Humidification | Pressure range: 31-44 torr | 34-35 torr |
| 3 - Injection | Ozone concentration range: 160 - 200 mg/LPressure range: 400-500 torrOzone dose injected: 85 mg/L | 170-173 mg/L457-460 torr85 mg/L |
| 4 - Exposure | Pressure range: 400-500 torrDuration: approximately 15 minutes | 458-461 torr15 minutes |
| 5 - Vacuum | Pressure: approximately 1 torr | 1 torr |
| 6 - Humidification | Pressure range: 31-44 torr | 34-37 torr |
| 7 - Injection | Ozone concentration range: 160 - 200 mg/LPressure range: 400-500 torrOzone dose injected: 85 mg/L | 170-177 mg/L458-462 torr85 mg/L |
| 8 - Exposure | Pressure range: 400-500 torrDuration: approximately 15 minutes | 459-462 torr15 minutes |
| 9 - Ventilation | Not specified | 21 minutes |
The "Actual values" reported fall within or match the "Typical values" (acceptance criteria) for all specified phases, demonstrating that the device meets the established parameters for ozone sterilization.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The modified Aesculap Sterilcontainer system was fully validated for the additional indication of ozone sterilization by TSO3 in their model 125L sterilizer." It further mentions that this validation was "conducted in accordance with FDA guidance and available AAMI standards by qualified testing laboratories."
- Sample Size for Test Set: The document does not explicitly state the specific sample size used for the validation (e.g., number of containers, number of cycles, number of devices with lumened or hinged features tested). However, "fully validated" implies a sufficient number of tests to meet regulatory and standard requirements.
- Data Provenance: The data was generated by TSO3 in their 125L ozone sterilizer. The location of TSO3 is not specified but given the 510(k) submission to the FDA, it's implied that the testing was conducted to U.S. regulatory standards. The study is a prospective validation study as it specifically describes testing performed to ensure the device's compatibility with ozone sterilization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (medical device sterilization container) focuses on physical and biological efficacy rather than interpretative clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not directly applicable here.
- Number of Experts: Not applicable in the context of expert consensus for ground truth on a diagnostic task.
- Qualifications of Experts: The validation was performed by "qualified testing laboratories," implying personnel with expertise in microbiology, sterilization science, and engineering were involved in conducting the tests and analyzing the results, in accordance with FDA guidance and AAMI standards.
4. Adjudication Method (for the test set)
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data where disagreements need resolution. This is not directly relevant to the validation of a sterilization container's physical and biological performance. The "adjudication" in this context would be the adherence to predefined pass/fail criteria for sterility and container integrity, as outlined in the AAMI standards and FDA guidance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study assesses the impact of an AI tool on human clinician performance (e.g., diagnostic accuracy, reading time). The Aesculap Sterilcontainer System is a physical device used in a sterilization process, not a diagnostic AI tool. Therefore, an MRMC comparative effectiveness study is not applicable.
6. Standalone (Algorithm Only) Performance Study
- A standalone performance study was done in the sense that the performance of the Sterilcontainer System was evaluated independently within the specified ozone sterilization cycle. While not an "algorithm" in the software sense, the container's ability to maintain sterility and withstand the ozone process (i.e., its performance) was assessed in a standalone manner without human intervention influencing the sterilization outcome itself. The validation measured the physical parameters of the cycle and the sterility assurance level (which would typically involve biological indicators) within the container.
7. Type of Ground Truth Used
The ground truth for this sterilizer validation is based on:
- Physical Parameters: Confirmation that the sterilization cycle parameters (pressure, ozone concentration, temperature—though temperature is not explicitly listed, it's a standard parameter for such cycles) were met and maintained within acceptable ranges inside the container.
- Biological Efficacy: Although not explicitly detailed in this summary, "sterilization" validation inherently requires proving a certain level of microbial inactivation. This is typically demonstrated using biological indicators (BIs) placed within problematic areas of representative devices inside the container, confirming a Sterility Assurance Level (SAL) of 10^-6 or better. This would involve laboratory testing and microbiological assay.
- Integrity/Functionality: The container's ability to maintain sterility post-sterilization and its long-term compatibility with ozone processing would also be assessed.
8. Sample Size for the Training Set
- Not applicable. This is a hardware validation for a medical devicecontainer, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an algorithm, there is no ground truth established for it. The "ground truth" for the device's acceptable performance is derived from established regulatory standards (FDA guidance) and industry standards (AAMI) for sterilization efficacy and medical device compatibility.
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Sterilcontainer Ozone Indication
062510
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) в.
Aesculap Sterilcontainer System (Ozone Indication) 24 October 2006
NOV 17 2006
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 |
|---|---|
| CONTACT: | Matthew M. Hull610-984-9072 (phone)610-791-6882 (fax) |
| TRADE NAME: | Aesculap Sterilcontainer System |
| COMMON NAME: | Sterilization Container |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | FRG |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Sterilcontainer System for Ozone Sterilization is substantially equivalent to:
Aesculap Sterilcontainer System (K792558) & (K053389)
DEVICE DESCRIPTION
The Aesculap Sterilcontainer is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with ozone sterilization. The container is made from anodized aluminum and utilizes a disposable (sinqle use) paper filter.
INDICATIONS FOR USE
The Aesculap Sterilcontainer System is intended to enclose another medical device(s) that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed device(s) until used. The Aesculap Sterilcontainer System has been validated for use in ozone sterilization systems (TSO3 125L) to include hinged devices and lumened devices as small as 3mm (diameter) and 550 mm (length).
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TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s)}
This is exactly the same Aesculap sterilization container system that was cleared for use in prevacuum and gravity steam in 510(k) # K792558 and for use in flash sterilization in 510(k) #K053389. The anodized aluminum Aesculap Sterilcontainer was used by TSO3 in the validation of their 125L ozone sterilizer which was cleared in 510(k) #K020875. The version of the Aesculap container that is the subject of this submission is the same except for minor modifications to enhance the containers long-term compatibility with ozone sterilizer processing.
PERFORMANCE DATA
The modified Aesculap Sterilcontainer system was fully validated for the additional indication of ozone sterilization by TSO3 in their model 125L sterilizer. This validation was conducted in accordance with FDA guidance and available AAMI standards by qualified testing laboratories.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 2006
Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap®. Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K062510
Trade/Device Name: Aesculap Sterilcontainer System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: October 24, 2006 Received: October 25, 2006
Dear Mr. Hull:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Hull
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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sygti. Y. Michin Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT A.
510(k) Number: ______________K062510
Device Name: Aesculap Sterilcontainer System
Indications for Use:
The Aesculap Steriloontainer System is intended to be used to enclose another medical devices and The Aesculab Stericontainer System is intended to allow sterilization on the enclosed medical devices and be sterilized by a heatincale provinced to and used. The Aesolapp Sterilismanner System has been also maintain sterliny of the enclosed devices) undridded. The Alocallar Concerner.
validated for use in an ozone sterlization system (TSO3 125L) to include hinged devices an as small as 3mm (diameter) and 550 mm (length).
The following validated parameters are based on the validation of the Aesculap® Sterilcontainer in an ozone sterilization cycle using a TSO3 125L Sterilizer.
| Phase | Typical values | Actual values |
|---|---|---|
| 1 - Vacuum | Pressure: approx. 1 torr | 1 torr |
| 2 - Humidification | Pressure range: 31-44 torr | 34-35 torr |
| 3 - Injection | Ozone concentration range: 160 - 200 mg/LPressure range: 400-500 torrOzone dose injected: 85 mg/L | 170-173 mg/L457-460 torr85 mg/L |
| 4 - Exposure | Pressure range: 400-500 torrDuration: approx. 15 minutes | 458-461 torr15 minutes |
| 5 - Vacuum | Pressure: approx. 1 torr | 1 torr |
| 6 - Humidification | Pressure range: 31-44 torr | 34-37 torr |
| 7 - Injection | Ozone concentration range: 160 - 200 mg/LPressure range: 400-500 torrOzone dose injected: 85 mg/L | 170-177 mg/L458-462 torr85 mg/L |
| 8 - Exposure | Pressure range: 400-500 torrDuration: approx. 15 minutes | 459-462 torr15 minutes |
| 9 - Ventilation | 21 minutes |
The following containers and accessories are included in this system:
Item Description FULL-SIZE LID W/RETENTION PLATE RED FULL-SIZE LID W/RETENTION PLATE BLUE FULL-SIZE LID W/RETENTION PLATE GREEN FULL-SIZE LID W/RETENTION PLATE GOLD FULL-SIZE LID W/RETENTION PLATE SILVER FULL-SIZE SOLID BOTTOM 90MM FULL-SIZE SOLID BOTTOM120MM FULL-SIZE SOLID BOTTOM135MM FULL-SIZE SOLID BOTTOM 187MM FULL-SIZE SOLID BOTTOM 247MM FULL-SIZE PERF BOTTOM90MM FULL-SIZE PERF BOTTOM 120MM FULL-SIZE PERF BOTTOM 135MM FULL-SIZE PERF BOTTOM 187MM EXTRA LONG CONTAINER PERF BOTTOM 187MM
Shula P. Murphy, 16
nesthesiology. General Hospital
Number: K 0i2 510
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FULL-SIZE PERF BOTTOM 247MM 1/1 SIZE PERF BASKET 485X253X76MM 1/1 SIZE PERF BASKET LID 489X257MM 1/1 SIZE PERF BASKET 540X253X36MM 1/1 SIZE PERF BASKET 540X253X56MM 1/1 SIZE PERF BASKET 540X253X76MM 1/1 SIZE PERF BASKET 540X253X106MM 1/1 SIZE PERF BASKET LID 544X257MM FULL-SIZE WIRE BASKET 30MM FULL-SIZE WIRE BASKET 50MM FULL-SIZE WIRE BASKET 70MM FULL-SIZE WIRE BASKET 100MM FULL-SIZE INSTRUMENT PAD SILICONE BASKET LINER FULL-SIZE 3/4-SIZE LID W/RETENTION PLATE RED 3/4-SIZE LID W/RETENTION PLATE BLUE 3/4-SIZE LID W/RETENTION PLATE GREEN 3/4-SIZE LID W/RETENTION PLATE GOLD 3/4-SIZE LID W/RETENTION PLATE SILVER 3/4-SIZE SOLID BOTTOM 90MM 3/4-SIZE SOLID BOTTOM 120MM 3/4-SIZE SOLID BOTTOM 135MM 3/4-SIZE PERF BOTTOM90MM 3/4-SIZE PERF BOTTOM 120MM 3/4-SIZE PERF BOTTOM 135MM 3/4 SIZE PERF BASKET 406X253X36MM 3/4 SIZE PERF BASKET 406X253X56MM 3/4 SIZE PERF BASKET 406X253X76MM 3/4 SIZE PERF BASKET 406X253X106MM 3/4 SIZE PERF BASKET LID 410X257MM 3/4-SIZE WIRE BASKET 25MM 3/4-SIZE WIRE BASKET 50MM 3/4-SIZE WIRE BASKET 70MM 3/4-SIZE WIRE BASKET 100MM 3/4-SIZE INSTRUMENT PAD 1/2-SIZE LID W/RETENTION PLATE RED 1/2-SIZE LID W/RETENTION PLATE BLUE 1/2-SIZE LID W/RETENTION PLATE GREEN 1/2-SIZE LID W/RETENTION PLATE GOLD 1/2-SIZE LID W/RETENTION PLATE SILVER 1/2-SIZE SOLID BOTTOM 90MM 1/2-SIZE SOLID BOTTOM120MM 1/2-SIZE SOLID BOTTOM 135MM 1/2-SIZE SQLID BOTTOM187MM 1/2-SIZE SOLID BOTTOM 247MM 1/2-SIZE PERF BOTTOM 90MM 1/2-SIZE PERF BOTTOM 120MM 1/2-SIZE PERF BOTTOM 135MM 1/2-SIZE PERF BOTTOM 187MM 1/2-SIZE PERF BOTTOM247MM 1/2-SIZE WIRE BASKET50MM 1/2-SIZE WIRE BASKET 30MM 1/2-SIZE WIRE BASKET 70MM
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1/2-SIZE WIRE BASKET100MM 1/2 SIZE PERF BASKET 243X253X36MM 1/2 SIZE PERF BASKET 243X253X56MM 1/2 SIZE PERF BASKET 243X253X76MM 1/2 SIZE PERF BASKET 243X253X106MM 1/2 SIZE PERF BASKET LID 247X257MM HALF-SIZE INSTRUMENT PAD SILICONE BASKET LINER 1/2-SIZE MINI-SIZE LID W/RETENTION PLATE RED MINI-SIZE LID W/RETENTION PLATE BLUE MINI-SIZE LID W/RETENTION PLATE GREEN MINI-SIZE LID W/RETENTION PLATE GOLD MINI-SIZE LID W/RETENTION PLATESILVER MINI-SIZE SOLID BOTTOM 30MM MINI-SIZE SOLID BOTTOM 57MM MINI-SIZE PERF BOTTOM 40MM MINI-SIZE PERF BOTTOM 38MM MINI-SIZE PERF BOTTOM 67MM MINI CONTAINER 310X140X67MM SILVER MINI-HALF WIRE BASKET WITH LID MICRO-INST BASKET W/LID 235X137X42MM MINI-SIZE PERF BASKETW/LID49MM MINI-SIZE INSTRUMENT PAD SILICONE PAD BLUE 470X230X30MM SILICONE MAT LONG F/MD375 JF232R SILICONE PAD 277X126X17 SILICONE PAD 250X239X17 ROUND PAPER FILTERS STRINGER OPEN 350X65MM STRINGER OPEN 150X65MM STRINGER OPEN 150X125MM STRINGER OPEN 200X125MM STRINGER CLOSED W/LOCK 100X65MM STRINGER CLOSED W/LOCK 150X125MM STRINGER CLOSED W/LOCK 200 X 125MM STRINGER CLOSED W/LOCK 300 X 125MM STRINGER CLOSED W/LOCK 250 X 125MM STRINGER CLOSED W/LOCK150 X 65MM
| Prescription Use | |
|---|---|
| and/or Over-the-Counter Use | X |
| (per 21 CFR 801.109) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).