Standard Sterilizable Tray

K202524 · Implant Direct Sybron Manufacturing, LLC · KCT · Jan 28, 2021 · General Hospital

Device Facts

• Record ID: K202524
• Device Name: Standard Sterilizable Tray
• Applicant: Implant Direct Sybron Manufacturing, LLC
• Product Code: KCT · General Hospital
• Decision Date: Jan 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time. The tray is intended for sterilization of non-porous loads. Do not stack trays during sterilization. The tested Tray represents the worst case validated load of 667.52 grams. Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

Device Story

Standard Sterilizable Tray is a reusable perforated instrument cassette system; holds dental surgical and prosthetic instruments. Components include lid, base, and variable inner tray made of Radel R5000 polyphenylsulfone; includes co-molded silicone rubber and silicone grommets; optional stainless-steel pan. Used in dental clinics to organize instruments for steam sterilization and transport. Healthcare providers place instruments in tray, enclose in FDA-cleared sterilizable wrap, and process in steam sterilizer (prevacuum or gravity cycles). Tray protects instruments during sterilization and transport; ensures organized storage. Benefits include efficient instrument management and validated sterilization performance for non-porous loads.

Clinical Evidence

Bench testing only. Validated per ISO 10993-5 (cytotoxicity), ISO 17664 (processing/performance), TIR30/TIR12 (cleaning effectiveness: <12 µg/cm2 TOC, <6.4 µg/cm2 protein), ISO 17665-1 (sterilization: 6-log reduction at half-cycle), and ASTM D4169-16 (shipping durability). All tests passed.

Technological Characteristics

Materials: Radel R5000 (base, lid, inner tray), silicone (grommets/supports), stainless steel (pan). Dimensions: 7.3" x 5.5" x 2.4". Sterilization: Moist heat (gravity or prevacuum). Vent-to-volume ratio: 0.021 in-1. Reusable. Non-sterile.

Indications for Use

Indicated for holding dental surgical and prosthetic instruments for organization, steam sterilization, and transport. Intended for non-porous loads. Contraindicated for stacked sterilization.

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

• Mini Sterilizable Tray (K200858)

Submission Summary (Full Text)

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January 28, 2021

Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362

Re: K202524

Trade/Device Name: Standard Sterilizable Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 21, 2020 Received: December 28, 2020

Dear Reina Choi:

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,

for Clarence W. Murray, III, PhD Acting 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) K202524

Device Name Standard Sterilizable Tray

Indications for Use (Describe)

The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.

- (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.
- The tray is intended for sterilization of non-porous loads.

- Do not stack trays during sterilization.

- The tested Tray represents the worst case validated load of 667.52 grams.

- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

| Model Name | Model<br>Number | Max # of<br>Instruments | Max Load (g) | Vent to volume<br>Ratio (in⁻¹) |
|---------------------------------|-----------------|-------------------------|--------------|--------------------------------|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| Standard Surgical Kit Empty | SSK | | 385.2 | 0.021 |
| InterActive™ Surgical Kit | CISK | 34 | 662.70 | 0.021 |
| InterActive™ Surgical Kit Empty | ISK | | 384.2 | 0.021 |

Type of Use (Select one or both, as applicable)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

_ Prescription Use (Part 21 CFR 801 Subpart D)

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K202524

#### 510(k) Summary

#### I. SUBMITTER

Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362

Contact Person: Reina Choi, Requlatory Affairs Manager E-mail: [e-mail] Phone: [phone]

Date Prepared: January 27, 2021

II. DEVICE

Name of Device: Standard Sterilizable Tray Common or Usual Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Classification Name: Sterilization Wrap (21 CFR 880.6850) Requlatory Class: II Product Code: KCT

III.PREDICATE DEVICE

Primary Predicate: Mini Sterilizable Tray (K200858)

#### IV. DEVICE DESCRIPTION

The Standard Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.

The Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel pan may be included in the tray.

The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.

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| Model name | Model<br>number | Max # of<br>Instruments | Max load<br>(g) | Vent to volume<br>ratio (in⁻¹) |
|------------------------------|-----------------|-------------------------|-----------------|--------------------------------|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| InterActive™ Surgical<br>Kit | CISK | 34 | 662.70 | 0.021 |

The Standard Sterilizable Tray is available either empty or loaded with surgical and prosthetic instruments to support endosseous dental implants and abutments that are not subject devices to this submission. The empty tray, along with a complete load of instruments, weighs a maximum of 667.52 grams. The variable Inner Tray offers two configuration options to allow for the assembly of supporting surgical and prosthetic instruments.

## V. INDICATIONS FOR USE

The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.

- (2) Gravity Steam At 132°C for 15 minutes with a 30 minutes dry time.
- The tray is intended for sterilization of non-porous loads.
- Do not stack trays during sterilization.
- The tested Tray represents the worst case validated load of 667.52 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

| Model Name | Model<br>Number | Max # of<br>Instruments | Mass(g) | Vent to volume<br>Ratio (in⁻¹) |
|---------------------------------|-----------------|-------------------------|---------|--------------------------------|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| Standard Surgical Kit Empty | SSK | | 385.2 | 0.021 |
| InterActive™ Surgical Kit | CISK | 34 | 662.70 | 0.021 |
| InterActive™ Surgical Kit Empty | ISK | | 384.2 | 0.021 |

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| Technological<br>characteristics | Subject Device<br>(K202524) | | Primary Predicate<br>(K200858) | | Comparison | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------------|-----------|
| | Standard Sterilizable Tray | | Mini Sterilizable Tray | | | |
| Manufacturer | Implant Direct Sybron Manufacturing, LLC | | Implant Direct Sybron Manufacturing, LLC | | Same | |
| General design | Plastic tray with locking lid co-molded silicone and<br>silicone grommet supports and stainless steel<br>component | | Plastic tray with locking lid co-molded<br>silicone and silicone grommet supports<br>and stainless steel components | | Same | |
| Dimensions | 7.3 in x 5.5 in x 2.4 in | | 5.5 in x 4.0 in 2.25 in | | Different | |
| Materials | Base - Radel 5000<br>Lid - Radel 5000<br>Inner tray - Radel 5000<br>Tooling support - Silicone<br>Pan - Stainless steel | | Base - Radel 5000<br>Lid - Radel 5000<br>Inner tray - Radel 5000<br>Tooling support - Silicone<br>Pan - Stainless steel<br>Bracket - Stainless steel | | Same | |
| Air permeance | Yes | | Yes | | Same | |
| Design Characteristic | Maximum<br>number of<br>instruments | CSSK | 46 | CSSKM | 21 | Different |
| | | CISK | 34 | CISKM | 20 | |
| | | | | CDSKL | 36 | |
| | | | | CDSKS | 32 | |
| | | | | CPKM | 14 | |
| | Mass of<br>maximum<br>sterilization load | CSSK | 667.52g | CSSKM | 278.50 g | Different |
| | | CISK | 662.70g | CISKM | 276.60 g | |
| | | | | CDSKL | 354.10 g | |
| | | | | CDSKS | 209.10 g | |
| | | | | CPKM | 262.55 g | |
| | Vent to volume<br>ratio | CSSK | 0.021 in-1 | CSSKM | 0.082 in-1 | Different |
| | | CISK | 0.021 in-1 | CISKM | 0.082 in-1 | |
| | | | | CDSKL | 0.087 in-1 | |
| | | | | CDSKS | 0.087 in-1 | |
| | | | | CPKM | 0.087 in-1 | |

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| Technological<br>characteristics | | Subject Device<br>(K202524)<br>Standard Sterilizable Tray | | | Primary Predicate<br>(K200858)<br>Mini Sterilizable Tray | | Comparison | |
|----------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|-----------------|
| Sterility | | Non-sterile | | | Non-sterile | | Same | |
| Sterilization<br>method | | Moist heat gravity or pre vacuum | | | Moist heat gravity or pre vacuum | | Same | |
| Reusable | | Yes | | | Yes | | Same | |
| Intended use | | Perforated instrument cassette system to hold<br>dental instruments in place during transport, steam<br>sterilization, and storage | | | Perforated instrument cassette system<br>to hold dental instruments in place<br>during transport, steam sterilization, and<br>storage | | Same | |
| Indication for Use | | The Standard Sterilizable Tray is designed to hold<br>various dental surgical and prosthetic instruments<br>in order to organize, steam sterilize, and transport<br>the instruments between uses. The tray is to be<br>enclosed in an FDA cleared steam sterilizable<br>wrap (Maximum thickness KC300) and sterilized<br>in an FDA cleared sterilizer for one of the<br>following cycles:<br><br>(1) Prevacuum Steam – At 132°C for 4 minutes<br>with a 20 minutes dry time.<br>(2) Gravity Steam – At 132°C for 15 minutes with<br>a 30 minutes dry time.<br><br>- The tray is intended for sterilization of non-<br>porous loads.<br>- Do not stack trays during sterilization.<br>- The tested Tray represents the worst case<br>validated load of 667.52 grams.<br>- Implant Direct Sybron Manufacturing LLC<br>does not make any lumen claims for the<br>Standard Sterilizable Tray. | | | The Mini Sterilizable Tray is designed to<br>hold various dental surgical and<br>prosthetic instruments in order to<br>organize, steam sterilize, and transport<br>the instruments between uses. The tray<br>is to be enclosed in an FDA cleared<br>steam sterilizable wrap and sterilized in<br>an FDA cleared sterilizer for one of the<br>following cycles:<br><br>(1) Prevacuum Steam – At 132°C for 4<br>minutes with a 20 minutes dry time.<br>(2) Gravity Steam - At 132°C for 15<br>minutes with a 30 minutes dry time.<br><br>- The trays are intended for sterilization<br>of non-porous loads.<br>- Do not stack trays during sterilization.<br>- The tested Tray represents the worst<br>case validated load of 354.10 grams.<br>- Implant Direct Sybron Manufacturing<br>LLC does not make any lumen claims<br>for the Mini Sterilizable Tray. | | Similar | |
| | | Model<br>Name | Model<br>Number | Max #<br>of | Mass<br>(g) | Vent to<br>volume | Model Name | Model<br>Number |
| Technological<br>characteristics | Subject Device<br>(K202524)<br>Standard Sterilizable Tray | | | Primary Predicate<br>(K200858)<br>Mini Sterilizable Tray | | Comparison | | |
| | | Instruments | Ratio<br>(in-1) | | | | | |
| | Standard<br>Surgical Kit | CSSK | 46 | 667.52 | 0.021 | Standard Surgical Kit Mini<br>CSSKM | | |
| | Standard<br>Surgical Kit<br>Empty | SSK | | 385.2 | 0.021 | Standard Surgical Kit Mini<br>Empty<br>SSKM | | |
| | InterActiveTM<br>Surgical Kit | CISK | 34 | 662.70 | 0.021 | InterActiveTM Surgical Kit<br>Mini<br>CISKM | | |
| | InterActiveTM<br>Surgical Kit<br>Empty | ISK | | 384.2 | 0.021 | InterActiveTM Surgical Kit<br>Mini Empty<br>ISKM | | |
| | | | | | | Drill Stop Kit – Long<br>CDSKL | | |
| | | | | | | Drill Stop Kit – Long<br>Empty<br>DSKL | | |
| | | | | | | Drill Stop Kit - Short<br>CDSKS | | |
| | | | | | | Drill Stop Kit - Short<br>Empty<br>DSKS | | |
| | | | | | | Prosthetic Kit<br>CPKM | | |
| | | | | | | Prosthetic Kit Empty<br>PKM | | |
| | | | | | | Drill Stop Kit Bracket Set -<br>Long<br>DSK-<br>BKTL | | |
| | | | | | | Drill Stop Kit Bracket Set -<br>Short<br>DSK-<br>BKTS | | |
| | | | | | | Replacement Kit Pan<br>PAN | | |

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## Comparison Between Subject Device and Predicate

The Standard Sterilizable Tray is larger in size than the predicate and made of same materials as the predicate. The use of Standard Sterilizable Tray has been validated through biocompatibility and sterilization testing. Therefore, this does not raise new questions of substantial equivalence.

The vent to volume ratio for the Standard Sterilizable Tray is 0.021 in 1 while the predicate vent to volume ratio is 0.087 in-1. While the Standard Sterilizable Tray has a lower vent to volume ratio, this has been demonstrated to not be an issue through sterilization validation testing.

The Standard Sterilizable Tray can hold more instruments and has a larger maximum sterilization load. The maximum sterilization load for the Standard Sterilizable Trav is 667,52g, while the predicate's maximum sterilization load is 354.10g. While the Standard Sterilizable Tray has a larger weight and more instruments, this has been demonstrated to not be an issue through sterilization testing and has been validated to assure a SAL of 10-6.

The Standard Sterilizable Trays and predicate device have the same intended use. The indication for use is the same except for and various versions of inner tray for the predicate and the weight of the validated trays.

| Testing<br>Methodology | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO 10993-5<br>Biological<br>evaluation of<br>medical devices —<br>Part 5: Tests for in<br>vitro cytotoxicity | The purpose of<br>the testing is to<br>observe the<br>cytoxicity<br>potential of the<br>device extract. | Morphological Grade 2<br>(mild) or better | Pass |
| | | | |
| ISO 17664<br>Processing of<br>health care<br>products —<br>Information to be<br>provided by the<br>medical device<br>manufacturer for<br>the processing of<br>medical devices | The purpose of<br>this testing is to<br>verify the<br>continued<br>performance of<br>the device<br>during its<br>useful life. | No visual degradation,<br>silicone retention<br>performance | Pass |
| TIR30- A<br>compendium of<br>processes,<br>materials, test<br>methods, and<br>acceptance criteria<br>for cleaning<br>reusable medical<br>devices<br>And TIR 12-<br>Designing, testing<br>and labeling<br>reusable medical<br>devices for<br>reprocessing in<br>health care<br>facilities: A guide<br>for medical device<br>manufacturers | The purpose of<br>this testing is to<br>verify the<br>effectiveness of<br>the<br>recommended<br>cleaning<br>process. | < 12 µg/cm2 of TOC will be<br>recovered from devices<br>cleaned using the<br>recommended minimum<br>cleaning<br>processes.<br>< 6.4 µg/cm2 of protein will<br>be recovered from devices<br>cleaned using the<br>recommended minimum<br>cleaning<br>processes. | Pass |
| ISO 17665-1<br>Sterilization of<br>health care<br>products — Moist<br>heat — Part 1:<br>Requirements for<br>the development,<br>validation and<br>routine control of a<br>sterilization<br>process for<br>medical devices | The purpose of<br>this testing is to<br>verify the ability<br>of the<br>sterilization<br>process to<br>adequately<br>sterilize the<br>load. | 6 log reduction at half-cycle | Pass |
| ASTM D4169-16<br>Standard Practice<br>for Performance<br>Testing of<br>Shipping<br>Containers and<br>Systems | The purpose of<br>this testing is to<br>verify the<br>durability of the<br>device during<br>transportation. | No damage | Pass |

# VII. SUMMARY OF NON-CLINICAL TESTING

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# VIII. CONCLUSIONS

The conclusions drawn from the non-clinical test data demonstrates that the Standard Sterilizable Tray is as safe, as effective, and performs as well as or better than the legally marketed predicate, Mini Sterilizable Tray (K200858).