(119 days)
The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.
The Stryker System 9 Sterile Battery Container is a rigid, reusable device intended to enclose compatible Stryker sterile battery packs for hydrogen peroxide sterilization. The container consists of a stainless-steel perforated lid with a stainless-steel filter retention plate and a plastic (Radel®) base. The Sterile Battery container utilizes single use polypropylene filters and indicator cards. The container base is designed to exclusively fit onto the Stryker sterile battery charger to allow the sterile battery pack to charge while maintaining a sterile barrier. The Stryker System 9 Sterile Battery Container encompasses one distinct configuration in two sizes, small and large.
The provided text describes a 510(k) premarket notification for a medical device (Stryker System 9 Sterile Battery Container). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for novel devices.
Therefore, the study described is a non-clinical performance testing suite designed to show that the device performs as intended and is as safe and effective as its predicate, particularly in the context of sterilization efficacy and maintenance of sterility. It is not a clinical study involving human patients or complex AI algorithms requiring MRMC studies, expert consensus on images, or detailed ground truth establishment in a diagnostic context.
Here's an analysis based on the provided document, fulfilling the requested information where applicable. Many questions regarding AI/diagnostic device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device and submission, as it's a physical sterilization container, not a diagnostic imaging AI.
1. A table of acceptance criteria and the reported device performance
| Testing | Standard in compliance with | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | ISO 14937:2009, ISO 22441:2022 | Confirms sterile efficacy | Pass |
| Toxicological Risk Assessment | ISO 10993-17 | Confirms acceptable residuals | Pass |
| Cleaning Validation | AAMI ST98:2022 | Cleaning instructions were validated and demonstrated that the subject devices could be visually and quantifiably cleaned | Pass |
| Maintenance of Sterility | AAMI ST77:2013/(R)2018 | Demonstrates that the subject device is capable of maintaining product sterility for the duration of the shelf life | Pass |
| Simulated Use Design Validation | ISO 17664-1:2021, AAMI TIR 12:2020, ST77:2013/(R)2018 | Confirms that the device can undergo repeated processing to support that the device's performance is maintained following a minimum number of exposures to the proposed sterilization methods | Pass |
| Human Factors Engineering | IEC 62366-1 Ed 1.1 b 2020 | Confirms safety and effectiveness of the subject device for the intended users, uses, and use environments | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of containers tested, number of sterilization cycles performed) for each non-clinical test. It generally states that "A suite of non-clinical testing was performed."
- Data Provenance: The data comes from the manufacturer's (Stryker Instruments) internal testing as part of their premarket notification. The country of origin of the data is implied to be the USA, given the manufacturer's address in Michigan. These were prospective tests specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the non-clinical performance testing of a sterilization container. "Ground truth" in the context of diagnostic devices (e.g., AI for medical imaging) involves expert interpretation or pathological confirmation. For this device, the "truth" is established by adherence to validated sterilization standards and measurable outcomes (e.g., sterility, absence of toxic residuals, successful cleaning). The expertise would lie with the engineers and microbiologists performing and validating these standard-driven tests, not a panel of clinical experts interpreting data for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple human readers for diagnostic AI, to resolve disagreements. Here, validation is against objective, measurable criteria defined by established standards.
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. MRMC studies are specific to evaluating diagnostic AI systems, comparing human performance with and without AI assistance. This device is a physical sterile battery container, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This concept applies to AI algorithms. The "performance" of this device is its physical and chemical properties and its ability to maintain sterility, which are evaluated through direct testing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is adherence to established international and national standards for sterilization, cleaning, biocompatibility, and human factors. This includes:
- Microbiological testing for sterility (e.g., confirming no microbial growth after sterilization cycles).
- Chemical analysis for residuals.
- Physical measurements and observations for cleaning effectiveness and structural integrity after simulated use.
- Usability testing according to human factors standards.
This is not a diagnostic device where pathology or expert consensus on images would define the ground truth.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 16, 2025
Stryker Instruments Megan Guilbault Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K242834
Trade/Device Name: System 9 Sterile Battery Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 19, 2024 Received: September 19, 2024
Dear Megan Guilbault:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Stephen A. Anisko -S
Digitally signed by Stephen A. Anisko -S Date: 2025.01.16 20:37:15 -05'00'
for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control 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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Indications for Use
Submission Number (if known)
Device Name
System 9 Sterile Battery Container
Indications for Use (Describe)
The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.
Validated Low Temperature Hydrogen Peroxide Sterilization Cycles: Load Configuration Cycles
System 9 Sterile Battery Container Bundle, Small: STERRAD NX Standard cycle STERRAD 100NX Standard cycle STERRAD 100S short cycle Steris V-PRO maX Lumen cycle Steris V-PRO maX 2 Lumen cycle Steris V-PRO 60 Lumen cycle Steris V-PRO s2 Lumen cycle
System 9 Sterile Battery Container Bundle, Large: STERRAD NX Standard cycle STERRAD 100NX Standard cycle STERRAD 100S short cycle Steris V-PRO maX Lumen cycle
Steris V-PRO maX 2 Lumen cycle
Steris V-PRO 60 Lumen cycle
Steris V-PRO s2 Lumen cycle
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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1.0 Submitter Information
1.1 This Premarket Notification is submitted by:
Stryker Instruments 1941 Stryker Way Portage MI 49002 USA
1.2 Contact Information
| Contact name: | Megan Guilbault |
|---|---|
| Cellular Telephone: | (401) 241-6152 |
| Email: | megan.guilbault@stryker.com |
| Date Prepared: | January 15, 2025 |
1.3 Device Name
Table 1: Subject Device Information
| Subject Device Information | |
|---|---|
| Trade/Proprietary Name | System 9 Sterile Battery Container |
| Common Name | Sterilization Container Wrap |
| Classification | Class II |
| Classification Product Code | KCT |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification Regulation | 21 CFR 880.6850 |
| Review Panel | General Hospital |
1.4 Predicate Device
| Table 2: Predicate Device Information | |||
|---|---|---|---|
| Predicate Device Trade Name | 510(k) Number | Product Code | Manufacturer |
| Aesculap Aicon™ Container | K214041 | KCT | Aesculap, Inc. |
1.5 Device Description
The Stryker System 9 Sterile Battery Container is a rigid, reusable device intended to enclose compatible Stryker sterile battery packs for hydrogen peroxide sterilization. The container consists of a stainless-steel perforated lid with a stainless-steel filter retention plate and a plastic (Radel®) base. The Sterile Battery container utilizes single use polypropylene filters and indicator cards. The container base is designed to exclusively fit onto the Stryker sterile battery charger to allow the sterile battery pack to charge while maintaining a sterile barrier. The Stryker System 9 Sterile Battery Container encompasses one distinct configuration in two sizes, small and large.
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1.6 Indications for Use
The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.
| Load Configuration | Cycles |
|---|---|
| System 9 Sterile BatteryContainer Bundle,Small | STERRAD NX Standard cycle |
| STERRAD 100NX Standard cycle | |
| STERRAD 100S short cycle | |
| Steris V-PRO maX Lumen cycle | |
| Steris V-PRO maX 2 Lumen cycle | |
| Steris V-PRO 60 Lumen cycle | |
| Steris V-PRO s2 Lumen cycle | |
| System 9 Sterile BatteryContainer Bundle,Large | STERRAD NX Standard cycle |
| STERRAD 100NX Standard cycle | |
| STERRAD 100S short cycle | |
| Steris V-PRO maX Lumen cycle | |
| Steris V-PRO maX 2 Lumen cycle | |
| Steris V-PRO 60 Lumen cycle | |
| Steris V-PRO s2 Lumen cycle |
Validated Low Temperature Hydrogen Peroxide Sterilization Cycles:
1.7 Comparison of Technological Characteristics
A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included in Table 3 below.
| Description | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Intended Use | The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container | A device intended to be used to enclose another medical device that is to | Similar |
| Description | Subject DeviceSystem 9 Sterile BatteryContainer | Predicate DeviceAesculap AICON TMContainer | Discussion |
| intended to allow forsterilization, by hospitals,surgery centers, and healthcarefacilities, of the enclosed,compatible Stryker SterileBattery Packs and maintainsterility of the enclosed deviceuntil used. | be sterilized by a healthcare provider. It isintended to allowsterilization of theenclosed medical deviceand also to maintainsterility of the encloseddevice until used. | ||
| Classification | Class II | Class II | Identical |
| ProductCode | KCT | KCT | Identical |
| Condition ofUse | Professional Use Only,Reusable, for use in ahealthcare facility | Professional Use Only,Reusable, for use in ahealthcare facility | Identical |
| PatientPopulation | Not intended for direct patientcontact | Not intended for directpatient contact | Identical |
| OperatingPrinciple | The user loads Stryker SterileBattery Packs into the SterileBattery Container Base. TheSterile Battery Container Lidwith installed filter and filterretention plate is attached to theSterile Battery Container Base,the external latchingmechanism is closed, and theTamper-Evident Lock is placedon the outside latch. The lid,filter, filter retention plate, andbase all generate a sterilebarrier. The loaded containerbecomes sterile once it has beenrun through a low-temperaturehydrogen peroxide sterilizer.The indicator strips color-change mechanism is used toverify successful sterilization.Once sterilized, the containermaintains sterility until opened,up to 45 days. | The user placesinstruments inside thecontainer in a manner toallow proper sterilantpenetration. Thecontainer lid is closedsecurely with a lockingmechanism to ensureairtight seal. Thecontainer is placed in thesterilization chamber(under varioussterilization modalities).After completion ofappropriate sterilizationcycle, verification ofsterilization is conductedusing indicator stripscolor-changemechanism. Thecontainers are thenstored in a clean, dryenvironment to maintainsterility and opened in asterile area when readyto use. Once sterilizedthe container maintains | Identical |
| Subject Device | Predicate Device | Discussion | |
| Description | System 9 Sterile BatteryContainer | Aesculap AICON™Containersterility for 365 days oruntil opened. | |
| SterilizationMethod | Low-temperature hydrogenperoxide sterilization STERRAD NX Standard cycle STERRAD 100NX Standard cycle STERRAD 100S Short cycle Steris V-PRO maX Lumen cycle Steris V-PRO maX 2 Lumen cycle Steris V-PRO 60 Lumen cycle Steris V-PRO s2 Lumen cycle | Low-temperaturehydrogen peroxidesterilization Steam Sterilization STERIS V-PRO maX/maX 2: Lumen,Non-Lumen, Flex STERIS V-PRO 60:Lumen, Non- Lumen, Flex STERRAD 100NX:Standard, Express, Flex, Duo STERRAD NX:Standard, Advanced STERRAD 100S STERIZONE VP4 EtO | Similar |
| ContainerBaseMaterial | Radel® PPSUPolyphenylsulfone | Anodized Aluminum | DifferentThe predicatedevice is madefrom materialthat iscompatible witha variety ofsterilizationmethods. As thesubject device isonly beingcleared withhydrogenperoxidesterilization,Stryker haschosen materialsuitable for thespecificsterilizationmethod and topreventinterference forwireless charging |
| Subject Device | Predicate Device | Discussion | |
| Description | System 9 Sterile BatteryContainer | Aesculap AICONTMContainer | |
| ContainerLid Material | Stainless Steel | Anodized Aluminum | DifferentThe predicatedevice is madefrom materialthat iscompatible witha variety ofsterilizationmethods. As thesubject device isonly beingcleared withhydrogenperoxidesterilization,Stryker haschosen materialsuitable for thespecificsterilizationmethod.Verification andValidationTesting confirmsthat the subjectdevice is safe andeffective for itsintended use andthe differencesdo not raisedifferent types ofquestions of |
| battery andcharger.Verification andValidationTesting confirmsthat the subjectdevice is safe andeffective for itsintended use andthe differencesdo not raisedifferent types ofquestions ofSafety andEffectiveness. | |||
| Description | Subject DeviceSystem 9 Sterile BatteryContainer | Predicate DeviceAesculap AICON™Container | Discussion |
| FilterMaterial | Polypropylene (Single Use) | Polypropylene (Single Use) | Identical |
| Maintenanceof Sterility | 45 Days | 365 Days | DifferentThe predicatedevice maintainsa sterile barrieron the shelf for365 days,whereas thesubject maintainsa sterile barrierfor 45 days.Testing did notraise anydifferent types ofquestions ofSafety andEffectiveness. |
| Device Size | Small: 3.2" H x 4.2" W x 12.9" LLarge: 3.9" H x 4.2" W x 12.9" L | Full size: 4" H x 11 ¾" W x 23 5/8" LFull size: 6" H x 11 ¾" W x 23 5/8" LFull size: 8" H x 11 ¾" W x 23 5/8" LFull size:10" H x 11 ¾" W x 23 5/8" LThree-Quarter: 4" H x11 ¾" W x 18 3/8" LThree-Quarter: 6" H x11 ¾" W x 18 3/8" LThree-Quarter: 8" H x11 ¾" W x 18 3/8" LThree-Quarter:10" H x11 ¾" W x 18 3/8" L | DifferentThe predicateoffers a largerrange of sizeswhile the subjectdevice isdesigned tospecifically beused with theSystem 9 SterileBatteries, whichare available intwo sizes, smalland large.Verificationtesting confirmsthat the subjectdevice is safe andeffective for itsintended use andthe differencesdo not raisedifferent types ofquestions ofSafety andEffectiveness. |
| Description | Subject Device | Predicate Device | Discussion |
| System 9 Sterile Battery Container | Aesculap AICON™ Container | ||
| Half size: 4" H x 11 ¾" W x 11 7/8" L | |||
| Half size: 6" H x 11 ¾" W x 11 7/8" L | |||
| Half size: 8" H x 11 ¾" W x 11 7/8" L | |||
| Half size: 10" H x 11 ¾" W x 11 7/8" L | |||
| Container Design | Solid Bottom | Solid Bottom | Identical |
| Perforated Lid with filter retention plates and single use polypropylene filters | Perforated Lid with filter retention plates and single use polypropylene filters | ||
| Gasket | Gasket |
Table 3: Technological Comparison
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1.8 Summary of Non-Clinical Testing
The intended use of the subject device and the predicate device are identical, and the technological characteristics are similar. The differences between the two devices do not raise any new or different types of questions of safety and effectiveness.
Risk management was conducted in accordance with ISO 14971.
A suite of non-clinical testing was performed in accordance with applicable standards. See table below:
| Table 4: Performance Testing | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------ | -- |
| Testing | Standard incompliance with | Acceptance Criteria | Results |
|---|---|---|---|
| SterilizationEfficacy | ISO 14937:2009ISO 22441:2022 | Confirms sterile efficacy | Pass |
| ToxicologicalRiskAssessment | ISO 10993-17 | Confirms acceptable residuals | Pass |
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| Testing | Standard incompliance with | Acceptance Criteria | Results |
|---|---|---|---|
| CleaningValidation | AAMI ST98:2022 | Cleaning instructions were validated anddemonstrated that the subject devicescould be visually and quantifiably cleaned | Pass |
| Maintenance ofSterility | AAMIST77:2013/(R)2018 | Demonstrates that the subject device iscapable of maintaining product sterility forthe duration of the shelf life | Pass |
| Simulated UseDesignValidation | ISO 17664-1:2021AAMI TIR 12:2020ST77:2013/(R)2018 | Confirms that the device can undergorepeated processing to support that thedevice'sorperformance is maintained following aminimum number of exposures to theproposed sterilization methods | Pass |
| Human FactorsEngineering | IEC 62366-1 Ed 1.1 b2020 | Confirms safety and effectiveness of thesubject device for the intended users, uses,and use environments | Pass |
Performance testing was performed in compliance with the following standards:
- ISO 14937:2009 Sterilization of health care products Low temperature . vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical device
- . ISO 22441:2022 - Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical device
- . ISO 10993-17:2003 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
- ISO 17664-1:2021 Processing of health care products Information to be ● provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices.
- AAMI TIR 12:2020 Designing, testing, and labeling medical devices intended ● for processing by health care facilities: A guide for device manufacturers
- AAMI ST98:2022 -Cleaning validation of health care products Requirements ● for development and validation of a cleaning process for medical devices
- AAMI ST77:2013/(R)2018 Containment devices for reusable medical device ● sterilization.
- IEC 62366-1 Ed 1.1 b 2020 Medical Devices Part 1: Application of Usability ● Engineering to Medical Devices
1.9 Summary of Clinical Testing
Clinical testing was not required for this Traditional 510(k).
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1.10 Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the Stryker System 9 Sterile Battery Container is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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).