Sterisystem Dry-Base Instrument Tray

K203177 · O&M Halyard, Inc. · KCT · Jan 2, 2022 · General Hospital

Device Facts

• Record ID: K203177
• Device Name: Sterisystem Dry-Base Instrument Tray
• Applicant: O&M Halyard, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jan 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Reusable sterilization tray system; stainless steel metal mesh base and silicone components; designed to hold surgical instruments during steam sterilization. Input: surgical instruments placed in tray; tray wrapped in FDA-cleared sterilization wrap. Operation: perforated design allows steam penetration and air removal during pre-vacuum steam cycle. Output: sterilized, wrapped instrument set. Used in clinical/hospital settings by sterile processing staff. Benefits: protects instruments, facilitates sterilization, maintains sterility post-processing when wrapped. Healthcare providers use output for surgical procedures.

Clinical Evidence

Bench testing only. Sterilization effectiveness validated using Geobacillus stearothermophilus biological indicators in pre-vacuum steam cycles (132°C); all samples negative for growth. Cleaning validation (manual/automated) confirmed effective soil removal. Biocompatibility testing per ISO 10993 showed acceptable cytotoxicity (grade 2 or less). Life cycle testing confirmed functional integrity and material durability after repeated sterilization and washing cycles. 30-day shelf-life storage validated.

Technological Characteristics

Materials: Stainless steel and silicone. Design: Perforated metal mesh base for sterilant penetration. Energy: Steam (thermal). Form factor: Various tray/lid sizes. Connectivity: None. Sterilization: Pre-vacuum steam (132°C).

Indications for Use

Indicated for protection of surgical instruments and facilitation of sterilization via sterilant penetration and air removal. Used with FDA-cleared sterilization wrap for maintaining sterility of enclosed devices. Validated for pre-vacuum steam sterilization (132°C, 4 min exposure, 30 min dry time). Max weight 25 lbs. Suitable for storage up to 30 days.

Regulatory Classification

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

• Smith & Nephew Multi Purpose Instrument Tray (K102122)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

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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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# 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.<br>1 Edison Drive<br>Alpharetta, GA 30005 |
| Primary Contact for<br>this 510(k) Submission: | Steven Dowdley, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Device Trade Name: | Sterisystem Dry-Base Instrument Tray |
| Device Common Name: | Sterilization Tray |
| Device Product Code<br>and Classification Name: | KCT<br>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.<br>The trays are not intended to maintain sterility by themselves. Prior<br>to sterilization, the trays must be wrapped with an appropriate FDA-cleared<br>sterilization wrap to provide a microbial barrier which allows sterilant to<br>permeate throughout the interior of the loaded tray.<br>The tray configurations are all trays and lids, available in various sizes. All<br>trays are constructed of stainless steel metal meshbase and the lid are<br>constructed of stainless steel and silicone. The tray and lid designs have a<br>higher percentage of open cells than metal mesh allowing for complete<br>permeation of sterilant. The trays have latches designed to fasten the lid onto<br>the base. |
| Indications for Use: | The Sterisystem Dry-Base Instrument Tray are intended to protect medical<br>device instrumentation and facilitate the sterilization process by sterilant<br>penetration and air removal. When used in conjunction with an FDA cleared<br>sterilization wrap, sterility of the enclosed medical device is maintained until<br>used.<br>The system has been validated for the use in the following sterilization cycle:<br>Pre-Vacuum Steam<br>Temperature<br>132°C (270°F)<br>Sterilization Time<br>4 minutes<br>Drying time<br>30<br>Maximum Tray Weight<br>Up to 25lbs depending on the<br>weight limit of the cleared<br>sterilization wrap used. |
| | Pre-Vacuum sterilized devices may be stored in a protective storage for up to<br>30 days provided integrity of the container is not comprised. |

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# 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<br>on |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| FDA Product Code: | KCT | KCT | Same |
| FDA Classification: | Class II | Class II | Same |
| Regulation<br>Number: | 880.6250 | 880.6250 | Same |
| Common Name: | Sterilization Tray | Sterilization Tray | Same |
| Intended Use | The Sterisystem Dry-Base Instrument<br>Tray are intended to protect medical<br>device instrumentation and facilitate the<br>sterilization process by sterilant<br>penetration and air removal. When used<br>in conjunction with an FDA cleared<br>sterilization wrap, sterility of the enclosed<br>medical device is maintained until used.<br>The system has been validated for the<br>use in the following pre-vacuum steam<br>sterilization cycle:<br><br>Pre-Vacuum Steam<br>Temperature 132°C (270°F)<br>Sterilization Time 4 minutes<br>Drying time 30 minutes<br>Maximum Weight 25lbs<br><br>Pre-Vacuum sterilized devices may be<br>stored in a protective storage for up to 30<br>days provided integrity of the container is<br>not comprised. The maximum weight<br>load is 25lbs.<br>(See IFU for table of part numbers &<br>contents) | Smith & Nephew Multi-<br>Purpose Sterilization trays are<br>intended to contain Smith &<br>Nephew reusable surgical<br>instruments for convenient<br>organized storage, sterilization<br>and transport between usages.<br>The subject instrument trays<br>are suitable for use in a<br>prevacuum steam<br>sterilization method.<br><br>The subject instrument trays<br>are not intended to maintain<br>sterility; they are intended to<br>be used in conjunction with an<br>FDA cleared sterilization wrap<br>in order to<br>maintain sterility of the<br>enclosed devices<br><br>Method: Pre-vacuum steam<br>Temp: 132 - 135C<br>Exposure 4 minutes<br>Drying Time: 30 minutes | Same |
| Models | 47413 Low/Small Size Tray only<br>(4 3/4 x 9 13/16 x 2 1/2)<br><br>47414 Low/Mid Size Tray only<br>(9 7/16 x 9 13/16 x 2 1/2)<br><br>47914 Low/Small Size Lid & Tray<br>(5 3/4 x 10 1/8 x 2 7/8)<br><br>47915 Low/Full Size Lid & Tray | Not listed | Different |
| | | | |
| Composition: | Stainless steel, Silicone | Stainless steel/ Silicone | Similar |
| | 47916 High/Full Size Lid & Tray<br>(19 11/64 x 10 1/8 x 4 3/8) | | |
| | 47416 Low/Full Size Tray only<br>(18 7/8 x 9 13/16 x 2 1/2) | | |
| | 47917 Low/Small Size Lid & Tray<br>(5 3/64 x 12 3/12 x 2 7/8) | | |
| | 47417 High/Mid Size Tray only<br>(9 7/16 x 9 13/16 x 3 15/16) | | |
| | 47918 Low/Mid Size Lid & Tray<br>(9 49/64 x 12 3/12 x 2 7/8) | | |
| | 47418 High/Full Size Tray only<br>(18 7/8 x 9 13/16 x 3 15/16) | | |
| | 47919 Low/Full Size Lid & Tray<br>(19 11/64 x 12 3/12 x 2 7/8) | | |
| | 47419 Low/Small Size Tray only<br>(4 3/4 x 11 13/16 x 2 1/2) | | |
| | 47920 Low/Mid Size Lid & Tray<br>(9 49/64 x 10 1/8 x 2 7/8) | | |
| | 47921 High/Mid Size Lid & Tray<br>(9 49/64 x 10 1/8 x 4 3/8) | | |
| | 47922 Low/Large Size Lid & Tray<br>(14 31/64 x 10 1/8 x 2 7/8) | | |
| | 47426 Low/Full Size Tray only<br>(18 7/8 x 11 13/16 x 2 1/2) | | |
| | 47425 Low/Mid Size Tray only<br>(9 7/16 x 11 13/16 x 2 1/2) | | |
| | 47428 Small Size Lid<br>(4 3/4 x 9 13/16 x 13/16) | | |
| | 47429 Full Size Lid<br>(18 7/8 x 9 13/16 x 13/16) | | |
| | 47430 Small Size Lid<br>(4 3/4 x 11 13/16 x 13/16) | | |
| | 47431 Mid Size Lid<br>(9 7/16 x 11 13/16 x 13/16) | | |
| | 47432 Full Size Lid<br>(18 7/8 x 11 13/16 x 13/16) | | |
| | 47442 Mid Size Lid<br>(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<br>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 |

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#### 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