InterActive Complete Surgical Tray

K142519 · Implant Direct Sybron Manufacturing, LLC · KCT · Apr 15, 2015 · General Hospital

Device Facts

• Record ID: K142519
• Device Name: InterActive Complete Surgical Tray
• Applicant: Implant Direct Sybron Manufacturing, LLC
• Product Code: KCT · General Hospital
• Decision Date: Apr 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time. (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time. The trays are intended for sterilization of non-porous loads. The trays are recommended not to be stacked during sterilization. The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams. Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.

Device Story

Reusable rigid sterilization container system; holds dental surgical drills/tools during transport, steam sterilization, and storage. Composed of perforated base tray, lid, and internal insert tray; made of Radel R-5000 polymer resin with medical-grade silicone grommets/brackets for instrument retention. Used in healthcare facilities; operated by clinical staff. Requires enclosure in FDA-cleared sterilization wrap before processing in standard autoclaves (prevacuum or gravity steam cycles). Protects instruments during handling; ensures effective sterilant penetration via perforated design. Benefits include organized instrument management and maintenance of sterility post-processing.

Clinical Evidence

No clinical data. Bench testing only: steam sterilization validation (AAMI/ANSI/ISO 17665, AAMI TIR 12), cytotoxicity (ISO 10993-5/12), cleaning validation (AAMI TIR 30/12), and distribution studies (ASTM D4169).

Technological Characteristics

Materials: Radel R-5000 polymer resin (lid, base, insert), medical-grade silicone (grommets/brackets per FDA CFR 177.2600). Design: Perforated multi-piece rigid container with locking lid. Dimensions: 7.2" x 5.6" x 2.4". Sterilization: Steam (Gravity/Pre-vacuum). Connectivity: None. Software: None.

Indications for Use

Indicated for holding, organizing, steam sterilizing, and transporting dental surgical drills and tools in healthcare facilities. Intended for non-porous loads only.

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

• Conmed Linvatech Instrument Sterilization Tray (K052992)
• Polyvac Inc. Surgical Instrument Delivery Tray (K012105)
• Tuttnauer USA Co Ltd. Cassette Container (K990761)
• C/T Medical Systems Sterilization Cassettes (K980065)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15, 2015

Implant Direct Sybron Manufacturing LLC Debleena Sinha, M.S. Regulatory Affairs Specialist 3050 East Hillcrest Drive Thousand Oaks, CA 91362

Re: K142519

Trade/Device Name: InterActive Complete Surgical Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: March 20, 2015 Received: March 23, 2015

Dear Ms. Sinha:

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. 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.

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Page 2 - Debleena Sinha,M.S.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K142519

Device Name

InterActive Complete Surgical Tray

#### Indications for Use (Describe)

The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize. steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:

- (1) Prevaccum Steam At 132℃ for 4 minutes with a 20 minutes dry time.
- (2) Gravity Steam At 132% for 15 minutes with a 30 minutes dry time.
- The trays are intended for sterilization of non-porous loads.
- The trays are recommended not to be stacked during sterilization.
- The Complete Surgical Tray represents the worst case validated load due to the number of components) and the weight of 608.05 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Interactive Complete Surgical Tray.
- The tray will be marketed in following variations.

| Device Model Name | Max no. of Instruments | Weight of each tray<br>with instruments (gms.) |
|-------------------|------------------------|------------------------------------------------|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(K) Submission

# 510 (K) Summary (21CFR 807.92(a)(1))

### 1. Submitter Information

| 510 K Sponsor | Implant Direct Sybron Manufacturing LLC |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 3050 East Hillcrest Drive<br>Thousand Oaks, CA 91362 |
| Registration Number | 3001617766 |
| Correspondence Contact | Debleena Sinha, M.S<br>Specialist, Regulatory Affairs<br>Ph: 818-444-3306<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared | April 6, 2015 |

## 2. Device Name and Classification

| Trade Name | InterActive Complete Surgical Tray |
|---------------------|------------------------------------------------------------------------|
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes, and other Accessories |
| Common Name | Instrument Sterilization Tray |
| Regulation Number | 21 CFR 880.6850 |
| Product Code | KCT |
| Regulatory Class | II |

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Image /page/4/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features the company name in blue, with a blue curved line above the name. Below the company name, the words "simply smarter." are written in a smaller, white font. At the bottom of the logo, the words "Sybron Dental Specialties" are written in a smaller, blue font.

Traditional 510(K) Submission

#### 3. Predicate Devices

Conmed Linvatech Instrument Sterilization Tray (K052992) Polyvac Inc. Surgical Instrument Delivery Tray (K012105) Tuttnauer USA Co Ltd. Cassette Container (K990761) C/T Medical Systems Sterilization Cassettes (K980065)

#### 4. Description of Device

The InterActive Complete Surgical Tray is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components - a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal insert tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and ratchet. The tray is available in only one size of approximately 7.2 inches X 5.6 inches X 2.4 inches and will be marketed in four different variations – (1) InterActive Complete Surgical Tray (ICST) containing 34 instruments, (2) InterActive Basic Surgical Tray (IBST) containing almost half the number of instruments as ICST, (3) InterActive

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Image /page/5/Picture/0 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo is set against an orange background. The words "Implant Direct" are in blue, with a blue arc above them. Below that, the words "simply smarter" are in white, and below that, the words "Sybron Dental Specialties" are in gray.

Surgical Tray (IST), empty tray containing no instruments, and (4) Complete Surgical Tray (CST), containing 45 instruments.

The rigid multi-piece tray holds dental device apparatus and accessories before, during, and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.

The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC, and is identical to the Radel used in predicate device cleared under K052992 and K012105. Radel R 5000 CL 301 is used for the lid, and Radel R 5100 NT15 is used for base and insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain the drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA CFR 177.2600. These brackets and holders are used to secure the

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instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired.

The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools. The tools are class I exempt and the drills have Class II pre-market notification clearance.

### 5. Intended Use

The InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools 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 and sterilized in an FDA cleared sterilizer for one of the following cycles:

(1) Prevaccum Steam – At 132ºC for 4 minutes with a 20 minutes dry time.

(2) Gravity Steam - At 132ºC for 15 minutes with a 30 minutes dry time.

- -The trays are intended for sterilization of non-porous loads.
- -The trays are recommended not to be stacked during sterilization.
- -The Complete Surgical Tray represents the worst case validated load due to the number of components (45 instruments) and the weight of 608.05 grams.

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Image /page/7/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features the company name in blue, with a blue arc above the name. Below the company name is the tagline "simply smarter." in a smaller font. At the bottom of the logo is the text "Sybron Dental Specialties".

- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the -
InterActive Complete Surgical Tray.

- -The tray will be marketed in following variations.

| Device Model<br>Name | Max no. of Instruments | Weight of each tray<br>with instruments (gms.) |
|----------------------|------------------------|------------------------------------------------|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |

### 6. Substantial Equivalence

The tables below shows that the InterActive Complete Surgical Tray compared against 510(K) cleared products. The comparison analysis consists of the products' intended use, technological characteristics and performance testing to support the substantial equivalency to their corresponding predicate devices.

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Image /page/8/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features a blue swoosh above the company name. Below the company name is the tagline "simply smarter" in a smaller, white font. The logo also includes the text "Sybron Dental Specialties" in a smaller font.

## TABLE1: Substantial Equivalence: Comparison of Proposed Device with Predicates on Technological Considerations

| Manufacturer | Implant Direct | ConMed<br>Linvatech | PolyVac Inc. | Tuttnauer<br>USA Co Ltd | C/TMedical<br>Systems |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate | Predicate | Predicate | Predicate |
| 510 (K) | K142519 | K052992 | K012105 | K990761 | K980065 |
| Trade Name | InterActive<br>Complete Surgical<br>Tray | Instrument<br>Sterilization<br>Tray | Surgical<br>Instrument<br>Delivery<br>System | Mini<br>Container<br>Cassette;<br>Standard<br>Cassette<br>Container | Sterilization<br>cassettes |
| Product Code | KCT | FRG | KCT | FRG | KCT |
| Intended Use | Perforated<br>instrument<br>cassette system<br>to hold dental<br>instruments in<br>place during<br>transport, steam<br>sterilization, and<br>storage | Perforated trays<br>with lids to hold<br>surgical<br>instruments in<br>place during<br>transport,<br>steam<br>sterilization,<br>and storage | Perforated<br>trays with lids<br>to hold surgical<br>instruments in<br>place during<br>transport,<br>steam<br>sterilization,<br>and storage | Dental<br>instrument<br>cassette<br>system to<br>hold<br>instruments<br>in place<br>during<br>transport,<br>steam<br>sterilization,<br>and storage | Dental<br>instrument<br>cassette<br>system to<br>hold<br>instruments<br>in place<br>during<br>transport,<br>steam<br>sterilization,<br>and storage |
| Material<br>Composition | Polymer Resin<br>Radel-5000,<br>biomedical grade<br>silicone | Polymer Resin<br>Radel-5000,<br>biomedical<br>grade silicone | Radel-5000<br>plastic,<br>Biomedical<br>grade silicone,<br>and Aluminum,<br>300 series<br>stainless steel | Plastic<br>Polymer,<br>biomedical<br>grade silicone | Plastic,<br>Metal, and<br>Stainless<br>Steel<br>container |
| Manufacturer | Implant Direct | ConMed<br>Linvatech | PolyVac Inc. | Tuttnauer<br>USA Co Ltd | C/TMedical<br>Systems |
| Design | Plastic tray with<br>locking lid and<br>silicone<br>containment<br>brackets | Plastic tray with<br>stainless steel<br>latch and<br>silicone<br>containment<br>brackets | Tray made of<br>plastic or metal<br>base with lid | Small to<br>medium tray<br>with silicone<br>mat inserts | Trays and<br>cassettes<br>made of<br>metal and<br>plastic. Latch<br>made of<br>stainless<br>steel. |
| Sterilization by | | | | | |
| (1) Gravity<br>Steam | Yes | Yes | Yes | Yes | Yes |
| (2) Pre Vaccum<br>Steam | Yes | Yes | Yes | Yes | Yes |
| Air Permeance | Yes | Yes | Yes | Yes | Assume |
| Locking system to<br>hold lid in place | Yes | Yes | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes | Yes | Yes |
| Material<br>compatibility<br>with sterilization<br>process | Yes | Yes | Yes | Yes | Yes |

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Image /page/9/Picture/0 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo is set against an orange background. Above the company name is a blue curved line. Below the company name is the tagline "simply smarter."

Traditional 510(K) Submission

#### 7. Non-Clinical Performance Testing

The performance testing of the proposed device complies with a special control: 21 CFR 880.6850 - Class II Special Controls Guidance Document for sterilization wrap (pack, sterilization wrapper, bag, and accessories. The performance characteristics of the device are supported by Steam Sterilization validations, Cytotoxicity tests,

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Image /page/10/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background. The words "Implant Direct" are written in blue, with a blue arc above the words. Below the company name, the words "simply smarter" are written in white, and below that, the words "Sybron Dental Specialties" are written in gray.

Cleaning validations, and Distribution studies conducted on the Complete Surgical

Tray taking worst case scenarios into account.

## TABLE 2: Substantial Equivalence: Comparison with Predicates on Performance Testing

| Manufacturer | Implant Direct | ConMed<br>Linvatech | PolyVac Inc. | Tuttnauer<br>USA Co Ltd | C/T Medical<br>Systems |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------|
| Proposed Device | Predicate | Predicate | Predicate | Predicate | Predicate |
| Manufacturer | Implant Direct | ConMed<br>Linvatech | PolyVac Inc. | Tuttnauer<br>USA Co Ltd | C/T Medical<br>Systems |
| 510 (K) | K142519 | K052992 | K012105 | K990761 | K980065 |
| Sterilant<br>Penetration<br>Studies | Yes<br>Steam<br>Sterilization<br>Validations<br>conducted as per<br>AAMI/ANSI/ISO<br>17665;<br>AAMI TIR 12 | Yes | Yes | Yes | Yes |
| Toxicological<br>Properties<br>(biocompatibilty) | Yes<br>Cytotoxicity<br>Tests conducted<br>as per<br>ISO 10993 - 5;<br>ISO 10993 -12 | Yes<br>Brackets and<br>containment<br>mats made<br>from<br>Biomedical<br>grade silicone | Yes<br>Biocomapatibilty<br>tested to USP<br>requirements | Yes<br>Cassette<br>inserts<br>made from<br>biomedical<br>grade<br>silicone | Not stated<br>in summary |
| Transportation<br>studies<br>(Packaging<br>Integrity) | Yes<br>Distribution<br>Studies<br>conducted as per<br>ASTM D4169 | Not stated in<br>summary | Not stated in<br>summary | Not stated in<br>summary | Not stated<br>in summary |
| Cleaning<br>Instructions for<br>Reusable devices | Yes<br>Cleaning<br>Validations<br>conducted as per<br>AAMI TIR 30;<br>AAMI TIR 12 | Not stated in<br>summary | Not stated in<br>summary | Not stated in<br>summary | Yes |
| Material<br>Compatibility<br>(repeat<br>sterilization) | Yes<br>Radel Technical<br>Data Sheet | Yes<br>Radel | Yes<br>Radel | Not stated<br>in summary | Not stated<br>in summary |
| Manufacturer | Implant Direct | ConMed<br>Linvatech | PolyVac Inc. | Tuttnauer<br>USA Co Ltd | C/T Medical<br>Systems |
| Drying Time | Yes<br>Validated in<br>Steam<br>Sterilization<br>report<br>AAMI/ANSI/ISO<br>17665;<br>AAMI TIR 12 | Not stated in<br>summary | Not stated in<br>summary | Not stated<br>in summary | Yes<br>Drying time<br>in labeling |
| Vent/Volume<br>Ratio | All proposed<br>trays are<br>$0.184 in^2/in^3$ | Not stated in<br>summary | $0.02276 in^2/in^3$ | Not stated<br>in summary | Not stated<br>in summary |

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Image /page/11/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in blue, with the words "simply smarter" in a smaller font below. The text "Sybron Dental Specialties" is at the bottom of the logo. The background is orange.

Traditional 510(K) Submission

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Image /page/12/Picture/0 description: The image is a logo for Implant Direct. The logo is set on an orange background. The words "Implant Direct" are in blue, with a blue arc above them. Below that, in a smaller font, it says "simply smarter" and "Sybron Dental Specialties".

Traditional 510(K) Submission

The proposed devices have high vent to volume ratio, allowing easier sterilant penetration than the predicate device.

The Complete Surgical Tray (CST) container represents the worst case vent to volume

ratio for the Surgical Tray System making this container the most challenging

container to achieve sterilization.

### 8. Clinical Testing

No clinical tests were conducted.

#### 9. Summary and Conclusion

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Image /page/13/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo is set on an orange background and features a blue arc above the company name. Below the company name, in smaller letters, is the tagline "simply smarter." The text "Sybron Dental Specialties" is at the bottom of the logo.

Traditional 510(K) Submission

A comparison of the intended use, technological characteristics, and performance studies conducted on the InterActive Complete Surgical Tray demonstrate that the device is substantially equivalent to its predicate devices K052992 (ConMed Linvatech Instrument Sterilization Tray), K012105 (Polyvac Surgical Instrument Delivery System), K990761 (Tuttnauer USA Co Ltd. Cassette Container), and K980065 (C/T Medical Systems Sterilization Cassettes).