(433 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization effectiveness, and cleaning of a reusable instrument tray. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an instrument tray intended to protect surgical instruments and facilitate their sterilization, not to treat a disease or condition.
No
Explanation: The device is a sterilization tray intended to protect surgical instruments and facilitate the sterilization process. It does not perform any diagnostic function.
No
The device description clearly states the device is constructed of stainless steel and silicone, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for protecting surgical instruments and facilitating the sterilization process. It is used in conjunction with sterilization wrap to maintain sterility of medical devices. This is a function related to the preparation and handling of medical devices for surgical procedures, not for diagnostic testing.
- Device Description: The description details a reusable sterilization tray made of stainless steel and silicone, designed to allow sterilant penetration. This aligns with a device used in the sterilization process of medical instruments.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on sterilization effectiveness, storage, cleaning, biocompatibility, and life cycle testing – all related to the device's function in the sterilization and handling of surgical instruments. There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide diagnostic information. This device's function is entirely separate from that.
N/A
Intended Use / Indications for Use
The Sterisystem Dry-Base Instrument Tray is intended to protect surgical instruments and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used.
The alone trays are not intended to maintain sterlity; they are intended to be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature: 132C (270F) Sterilization Time: 4 minutes Drying time: 30 minutes Maximum Weight: Up to 25lbs depending on the weight limit of the cleared sterilization wrap used.
Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Sterisystem Dry-Base Instrument Trays are reusable sterilization trays. The trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray. The tray configurations are all trays and lids, available in various sizes. All trays are constructed of stainless steel metal meshbase and the lid are constructed of stainless steel and silicone. The tray and lid designs have a higher percentage of open cells than metal mesh allowing for complete permeation of sterilant. The trays have latches designed to fasten the lid onto the base.
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
Not Found
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)
Sterilization Effectiveness:
Sterilization validations were performed to verify the effectiveness of steam sterilization of the Sterisystem Dry-Base Instrument Tray using a pre-vacuum cycle. The study evaluated the resistance of biological indicators (Bls) with 100 Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half cycle exposures.
For each sterilization wrap and tray tested:
- All biological indicator test samples were negative for growth following the incubation period.
- The positive controls were positive for growth.
- The negative and environmental controls were negative for growth.
- The integrators demonstrated steam penetration.
Dry time was also evaluated after sterilization and determined to be 30 minutes.
30 Day Storage:
The subject device is not intended to maintain sterilization tray is intended to be used in conjunction with an FDA cleared sterlization wrap in order to maintain sterility of the enclosed device. Maintenance of sterility was however evaluated on the subject device with a cleared sterilization for 30 days.
Cleaning Validation:
A manual and automated cleaning validation was performed to validate the cleaning instructions. The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the of the subject device.
Biocompatibility:
Biocompatibility testing was conducted on all materials used in construction of the subject device per ISO 10993. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels.
Life Cycle Testing:
Life cycle testing was performed to verify that the device maintained functional quality requirements, material integrity, and traceability after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use of the components. All results of performance testing met acceptance criteria.
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.
Smith & Nephew Multi Purpose Instrument Tray (K102122)
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.
Not Found
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 2, 2021
O&M Halyard, Inc Steven Dowdley Associate Director of Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005
Re: K203177
Trade/Device Name: Sterisystem Dry-Base Instrument Tray Regulation Number: 21 CFR 880.6250 Regulation Name: Sterilization Tray Regulatory Class: Class II Product Code: KCT Dated: November 12, 2021 Received: November 12, 2021
Dear Steven Dowdley:
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. 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203177
Device Name
Sterisystem Dry-Base Instrument Tray
Indications for Use (Describe)
The Sterisystem Dry-Base Instrument Tray is intended to protect surgical instruments and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used.
The alone trays are not intended to maintain sterlity; they are intended to be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
The system has been validated for the use in the following sterilization cycle: Pre-Vacuum Steam Temperature: 132C (270F) Sterilization Time: 4 minutes Drying time: 30 minutes Maximum Weight: Up to 25lbs depending on the weight limit of the cleared sterilization wrap used.
Pre-Vacuum sterilized devices may be stored in a protective storage for up to 30 days provided integrity of the container is not comprised.
| Code | Configuration Description | Dimension Description (inches) | Quantity |
|---|---|---|---|
| 47413 | Low/Small Size Tray only | (4 3/4 x 9 13/16 x 2 1/2) | 12 |
| 47414 | Low/Mid Size Tray only | (9 7/16 x 9 13/16 x 2 1/2) | 12 |
| 47914 | Low/Small Size Lid & Tray | (5 3/4 x 10 1/8 x 2 7/8) | 1 |
| 47915 | Low/Full Size Lid & Tray | (19 11/64 x 10 1/8 x 2 7/8) | 1 |
| 47916 | High/Full Size Lid & Tray | (19 11/64 x 10 1/8 x 4 3/8) | 1 |
| 47416 | Low/Full Size Tray only | (18 7/8 x 9 13/16 x 2 1/2) | 6 |
| 47917 | Low/Small Size Lid & Tray | (5 3/64 x 12 3/12 x 2 7/8) | 1 |
| 47417 | High/Mid Size Tray only | (9 7/16 x 9 13/16 x 3 15/16) | 6 |
| 47918 | Low/Mid Size Lid & Tray | (9 49/64 x 12 3/12 x 2 7/8) | 1 |
| 47418 | High/Full Size Tray only | (18 7/8 x 9 13/16 x 3 15/16) | 6 |
| 47919 | Low/Full Size Lid & Tray | (19 11/64 x 12 3/12 x 2 7/8) | 1 |
| 47419 | Low/Small Size Tray only | (4 3/4 x 11 13/16 x 2 1/2) | 12 |
| 47920 | Low/Mid Size Lid & Tray | (9 49/64 x 10 1/8 x 2 7/8) | 1 |
| 47921 | High/Mid Size Lid & Tray | (9 49/64 x 10 1/8 x 4 3/8) | 1 |
| 47922 | Low/Large Size Lid & Tray | (14 31/64 x 10 1/8 x 2 7/8) | 1 |
| 47426 | Low/Full Size Tray only | (18 7/8 x 11 13/16 x 2 1/2) | 6 |
| 47425 | Low/Mid Size Tray only | (9 7/16 x 11 13/16 x 2 1/2) | 12 |
| 47428 | Small Size Lid | (4 3/4 x 9 13/16 x 13/16) | 6 |
| 47429 | Full Size Lid | (18 7/8 x 9 13/16 x 13/16) | 6 |
| 47430 | Small Size Lid | (4 3/4 x 11 13/16 x 13/16) | 6 |
| 47431 | Mid Size Lid | (9 7/16 x 11 13/16 x 13/16) | 6 |
| 47432 | Full Size Lid | (18 7/8 x 11 13/16 x 13/16) | 6 |
| 47442 | Mid Size Lid | (9 7/16 x 9 13/16 x 13/16) | 6 |
FORM FDA 3881 (7/17)
3
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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4
K203177
510(k) Summary - Sterisystem Dry-Base Instrument Tray
In accordance with 21 CFR 807.92, the following 510(k) summary is provided:
| Date Summary was Prepared | November 5, 2021 |
|---|---|
| 510(k) Submitter: | O & M Halyard, Inc. |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| Primary Contact for | |
| this 510(k) Submission: | Steven Dowdley, RAC |
| Tel: 678-451-8062 | |
| Email: steven.dowdley@hyh.com | |
| Device Trade Name: | Sterisystem Dry-Base Instrument Tray |
| Device Common Name: | Sterilization Tray |
| Device Product Code | |
| and Classification Name: | KCT |
| Class II, 21 CFR §880.6850 | |
| Predicate Device: | Smith & Nephew Multi Purpose Instrument Tray (K102122) |
| Subject Device Description: | The Sterisystem Dry-Base Instrument Trays are reusable sterilization trays. |
| The trays are not intended to maintain sterility by themselves. Prior | |
| to sterilization, the trays must be wrapped with an appropriate FDA-cleared | |
| sterilization wrap to provide a microbial barrier which allows sterilant to | |
| permeate throughout the interior of the loaded tray. | |
| The tray configurations are all trays and lids, available in various sizes. All | |
| trays are constructed of stainless steel metal meshbase and the lid are | |
| constructed of stainless steel and silicone. The tray and lid designs have a | |
| higher percentage of open cells than metal mesh allowing for complete | |
| permeation of sterilant. The trays have latches designed to fasten the lid onto | |
| the base. | |
| Indications for Use: | The Sterisystem Dry-Base Instrument Tray are intended to protect medical |
| device instrumentation and facilitate the sterilization process by sterilant | |
| penetration and air removal. When used in conjunction with an FDA cleared | |
| sterilization wrap, sterility of the enclosed medical device is maintained until | |
| used. | |
| The system has been validated for the use in the following sterilization cycle: | |
| Pre-Vacuum Steam | |
| Temperature | |
| 132°C (270°F) | |
| Sterilization Time | |
| 4 minutes | |
| Drying time | |
| 30 | |
| Maximum Tray Weight | |
| Up to 25lbs depending on the | |
| weight limit of the cleared | |
| sterilization wrap used. | |
| Pre-Vacuum sterilized devices may be stored in a protective storage for up to | |
| 30 days provided integrity of the container is not comprised. |
5
Technological Characteristics
Shown below is a comparison of the technological and performance characteristics of the subject and predicate device.
| | Subject Device | Predicate Device K102122 | Comparis
on |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| FDA Product Code: | KCT | KCT | Same |
| FDA Classification: | Class II | Class II | Same |
| Regulation
Number: | 880.6250 | 880.6250 | Same |
| Common Name: | Sterilization Tray | Sterilization Tray | Same |
| Intended Use | The Sterisystem Dry-Base Instrument
Tray are intended to protect medical
device instrumentation and facilitate the
sterilization process by sterilant
penetration and air removal. When used
in conjunction with an FDA cleared
sterilization wrap, sterility of the enclosed
medical device is maintained until used.
The system has been validated for the
use in the following pre-vacuum steam
sterilization cycle:
Pre-Vacuum Steam
Temperature 132°C (270°F)
Sterilization Time 4 minutes
Drying time 30 minutes
Maximum Weight 25lbs
Pre-Vacuum sterilized devices may be
stored in a protective storage for up to 30
days provided integrity of the container is
not comprised. The maximum weight
load is 25lbs.
(See IFU for table of part numbers &
contents) | Smith & Nephew Multi-
Purpose Sterilization trays are
intended to contain Smith &
Nephew reusable surgical
instruments for convenient
organized storage, sterilization
and transport between usages.
The subject instrument trays
are suitable for use in a
prevacuum steam
sterilization method.
The subject instrument trays
are not intended to maintain
sterility; they are intended to
be used in conjunction with an
FDA cleared sterilization wrap
in order to
maintain sterility of the
enclosed devices
Method: Pre-vacuum steam
Temp: 132 - 135C
Exposure 4 minutes
Drying Time: 30 minutes | Same |
| Models | 47413 Low/Small Size Tray only
(4 3/4 x 9 13/16 x 2 1/2)
47414 Low/Mid Size Tray only
(9 7/16 x 9 13/16 x 2 1/2)
47914 Low/Small Size Lid & Tray
(5 3/4 x 10 1/8 x 2 7/8)
47915 Low/Full Size Lid & Tray | Not listed | Different |
| | | | |
| Composition: | Stainless steel, Silicone | Stainless steel/ Silicone | Similar |
| | 47916 High/Full Size Lid & Tray
(19 11/64 x 10 1/8 x 4 3/8) | | |
| | 47416 Low/Full Size Tray only
(18 7/8 x 9 13/16 x 2 1/2) | | |
| | 47917 Low/Small Size Lid & Tray
(5 3/64 x 12 3/12 x 2 7/8) | | |
| | 47417 High/Mid Size Tray only
(9 7/16 x 9 13/16 x 3 15/16) | | |
| | 47918 Low/Mid Size Lid & Tray
(9 49/64 x 12 3/12 x 2 7/8) | | |
| | 47418 High/Full Size Tray only
(18 7/8 x 9 13/16 x 3 15/16) | | |
| | 47919 Low/Full Size Lid & Tray
(19 11/64 x 12 3/12 x 2 7/8) | | |
| | 47419 Low/Small Size Tray only
(4 3/4 x 11 13/16 x 2 1/2) | | |
| | 47920 Low/Mid Size Lid & Tray
(9 49/64 x 10 1/8 x 2 7/8) | | |
| | 47921 High/Mid Size Lid & Tray
(9 49/64 x 10 1/8 x 4 3/8) | | |
| | 47922 Low/Large Size Lid & Tray
(14 31/64 x 10 1/8 x 2 7/8) | | |
| | 47426 Low/Full Size Tray only
(18 7/8 x 11 13/16 x 2 1/2) | | |
| | 47425 Low/Mid Size Tray only
(9 7/16 x 11 13/16 x 2 1/2) | | |
| | 47428 Small Size Lid
(4 3/4 x 9 13/16 x 13/16) | | |
| | 47429 Full Size Lid
(18 7/8 x 9 13/16 x 13/16) | | |
| | 47430 Small Size Lid
(4 3/4 x 11 13/16 x 13/16) | | |
| | 47431 Mid Size Lid
(9 7/16 x 11 13/16 x 13/16) | | |
| | 47432 Full Size Lid
(18 7/8 x 11 13/16 x 13/16) | | |
| | 47442 Mid Size Lid
(9 7/16 x 9 13/16 x 13/16) | | |
| | Image: Stainless steel tray with green silicone corners | | |
| | | Image: Stainless steel tray with holes and orange writing | |
| Reuse | Reusable device | Reusable device | Same |
| Sterilization: | Steam Sterilization | Steam Sterilization | Same |
| Material of
construction | Stainless Steel and silicone | Stainless Steel and silicone | Same |
| Design: | Perforated design | Perforated design | Same |
| Re-useable: | Reusable | Reusable | Same |
| Drying time: | 30 minutes | 30 minutes | Same |
6
7
Non-Clinical Performance Testing:
Sterilization Effectiveness
Sterilization validations were performed to verify the effectiveness of steam sterilization of the Sterisystem Dry-Base Instrument Tray using a pre-vacuum cycle. The study evaluated the resistance of biological indicators (Bls) with 100 Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half cycle exposures.
For each sterilization wrap and tray tested:
- All biological indicator test samples were negative for growth following the incubation period. .
- The positive controls were positive for growth. ●
- . The negative and environmental controls were neqative for growth.
- The integrators demonstrated steam penetration. .
Dry time was also evaluated after sterilization and determined to be 30 minutes.
30 Dav Storage
The subject device is not intended to maintain sterilization tray is intended to be used in conjunction with an FDA cleared sterlization wrap in order to maintain sterility of the enclosed device. Maintenance of sterility was however evaluated on the subject device with a cleared sterilization for 30 days.
Cleaning Validation
A manual and automated cleaning validation was performed to validate the cleaning instructions. The results indicate that the recommended cleaning methods were effective in removing soil from all designated surfaces of the of the subject device.
Biocompatibility
Biocompatibility testing was conducted on all materials used in construction of the subject device per ISO 10993. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels.
Life Cycle Testing
Life cycle testing was performed to verify that the device maintained functional quality requirements, material integrity, and traceability after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use of the components. All results of performance testing met acceptance criteria
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Sterisystem Dry-Base Instrument Tray is as safe, as effective and perform as well as or better than the legally marketed predicate device cleared under K102122