← Product Code [KCT](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT) · K242834
# System 9 Sterile Battery Container (K242834)
_Stryker Instruments · KCT · Jan 16, 2025 · General Hospital · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242834
## Device Facts
- **Applicant:** Stryker Instruments
- **Product Code:** [KCT](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT.md)
- **Decision Date:** Jan 16, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6850
- **Device Class:** Class 2
- **Review Panel:** General Hospital
## 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.
## Device Story
System 9 Sterile Battery Container is a reusable rigid container for sterilizing Stryker battery packs via low-temperature hydrogen peroxide cycles. Device consists of a Radel (PPSU) base and stainless-steel lid with filter retention plate and single-use polypropylene filters. User loads battery pack into base, attaches lid, secures latching mechanism, and applies tamper-evident lock. Container maintains sterile barrier for up to 45 days post-sterilization. Used in healthcare facilities; operated by clinical staff. Output is a sterilized, protected battery pack ready for clinical use. Sterilization verification performed via indicator strips. Design allows battery charging while maintaining sterile barrier. Benefits include safe, efficient sterilization and storage of power components for surgical equipment.
## Clinical Evidence
No clinical data. Bench testing only. Performance validated via sterilization efficacy (ISO 14937, ISO 22441), toxicological risk assessment (ISO 10993-17), cleaning validation (AAMI ST98), maintenance of sterility (AAMI ST77), simulated use design validation, and human factors engineering (IEC 62366-1).
## Technological Characteristics
Rigid, reusable container. Base: Radel (PPSU). Lid: Stainless steel. Filter: Single-use polypropylene. Sterilization: Low-temperature hydrogen peroxide (STERRAD/Steris V-PRO cycles). Dimensions: Small (3.2"H x 4.2"W x 12.9"L), Large (3.9"H x 4.2"W x 12.9"L). Standards: ISO 14937, ISO 22441, ISO 10993-17, ISO 17664-1, AAMI TIR 12, AAMI ST98, AAMI ST77, IEC 62366-1.
## Regulatory 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.
## Predicate Devices
- Aesculap Aicon™ Container ([K214041](/device/K214041.md))
## Submission Summary (Full Text)
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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)
K242834
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 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 |
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 Device
System 9 Sterile Battery
Container | Predicate Device
Aesculap AICON TM
Container | Discussion |
| | 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. | 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. | |
| Classification | Class II | Class II | Identical |
| Product
Code | KCT | KCT | Identical |
| Condition of
Use | Professional Use Only,
Reusable, for use in a
healthcare facility | Professional Use Only,
Reusable, for use in a
healthcare facility | Identical |
| Patient
Population | Not intended for direct patient
contact | Not intended for direct
patient contact | Identical |
| Operating
Principle | The user loads Stryker Sterile
Battery Packs into the Sterile
Battery Container Base. The
Sterile Battery Container Lid
with installed filter and filter
retention plate is attached to the
Sterile Battery Container Base,
the external latching
mechanism is closed, and the
Tamper-Evident Lock is placed
on the outside latch. The lid,
filter, filter retention plate, and
base all generate a sterile
barrier. The loaded container
becomes sterile once it has been
run through a low-temperature
hydrogen peroxide sterilizer.
The indicator strips color-
change mechanism is used to
verify successful sterilization.
Once sterilized, the container
maintains sterility until opened,
up to 45 days. | The user places
instruments inside the
container in a manner to
allow proper sterilant
penetration. The
container lid is closed
securely with a locking
mechanism to ensure
airtight seal. The
container is placed in the
sterilization chamber
(under various
sterilization modalities).
After completion of
appropriate sterilization
cycle, verification of
sterilization is conducted
using indicator strips
color-change
mechanism. The
containers are then
stored in a clean, dry
environment to maintain
sterility and opened in a
sterile area when ready
to use. Once sterilized
the container maintains | Identical |
| | Subject Device | Predicate Device | Discussion |
| Description | System 9 Sterile Battery
Container | Aesculap AICON™
Container
sterility for 365 days or
until opened. | |
| Sterilization
Method | Low-temperature hydrogen
peroxide 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-temperature
hydrogen peroxide
sterilization 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 |
| Container
Base
Material | Radel® PPSU
Polyphenylsulfone | Anodized Aluminum | Different
The predicate
device is made
from material
that is
compatible with
a variety of
sterilization
methods. As the
subject device is
only being
cleared with
hydrogen
peroxide
sterilization,
Stryker has
chosen material
suitable for the
specific
sterilization
method and to
prevent
interference for
wireless charging |
| | Subject Device | Predicate Device | Discussion |
| Description | System 9 Sterile Battery
Container | Aesculap AICONTM
Container | |
| Container
Lid Material | Stainless Steel | Anodized Aluminum | Different
The predicate
device is made
from material
that is
compatible with
a variety of
sterilization
methods. As the
subject device is
only being
cleared with
hydrogen
peroxide
sterilization,
Stryker has
chosen material
suitable for the
specific
sterilization
method.
Verification and
Validation
Testing confirms
that the subject
device is safe and
effective for its
intended use and
the differences
do not raise
different types of
questions of |
| | | | battery and
charger.
Verification and
Validation
Testing confirms
that the subject
device is safe and
effective for its
intended use and
the differences
do not raise
different types of
questions of
Safety and
Effectiveness. |
| Description | Subject Device
System 9 Sterile Battery
Container | Predicate Device
Aesculap AICON™
Container | Discussion |
| Filter
Material | Polypropylene (Single Use) | Polypropylene (Single Use) | Identical |
| Maintenance
of Sterility | 45 Days | 365 Days | Different
The predicate
device maintains
a sterile barrier
on the shelf for
365 days,
whereas the
subject maintains
a sterile barrier
for 45 days.
Testing did not
raise any
different types of
questions of
Safety and
Effectiveness. |
| Device Size | Small: 3.2" H x 4.2" W x 12.9" L
Large: 3.9" H x 4.2" W x 12.9" L | Full size: 4" H x 11 ¾" W x 23 5/8" L
Full size: 6" H x 11 ¾" W x 23 5/8" L
Full size: 8" H x 11 ¾" W x 23 5/8" L
Full size:10" H x 11 ¾" W x 23 5/8" L
Three-Quarter: 4" H x
11 ¾" W x 18 3/8" L
Three-Quarter: 6" H x
11 ¾" W x 18 3/8" L
Three-Quarter: 8" H x
11 ¾" W x 18 3/8" L
Three-Quarter:10" H x
11 ¾" W x 18 3/8" L | Different
The predicate
offers a larger
range of sizes
while the subject
device is
designed to
specifically be
used with the
System 9 Sterile
Batteries, which
are available in
two sizes, small
and large.
Verification
testing confirms
that the subject
device is safe and
effective for its
intended use and
the differences
do not raise
different types of
questions of
Safety and
Effectiveness. |
| 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 in
compliance with | Acceptance Criteria | Results |
|-------------------------------------|----------------------------------|-------------------------------|---------|
| Sterilization
Efficacy | ISO 14937:2009
ISO 22441:2022 | Confirms sterile efficacy | Pass |
| Toxicological
Risk
Assessment | ISO 10993-17 | Confirms acceptable residuals | Pass |
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| Testing | Standard in
compliance with | Acceptance Criteria | Results |
|---------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 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
or
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 |
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, valid…
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242834](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242834)
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