(219 days)
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 traywith instruments (gms.) |
|---|---|---|
| CST | 45 | 608.05 |
| ICST | 34 | 467.26 |
| IBST | 18 | 453.59 |
| IST | 0 | 404.37 |
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 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 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.
The provided text describes the performance testing for the InterActive Complete Surgical Tray, a device designed to hold dental surgical drills and tools for steam sterilization and transport. The relevant sections for acceptance criteria and the study proving it meets these criteria are primarily found under "7. Non-Clinical Performance Testing" and "TABLE 2: Substantial Equivalence: Comparison with Predicates on Performance Testing".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets in a dedicated table format. Instead, it refers to compliance with specific standards and successful conduct of tests. The reported device performance is indicated by "Yes" for meeting the test requirements.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance (as stated in document) |
|---|---|
| Sterilant Penetration: Validated as per AAMI/ANSI/ISO 17665; AAMI TIR 12 | Yes (Steam Sterilization Validations conducted as per AAMI/ANSI/ISO 17665; AAMI TIR 12) |
| Toxicological Properties (Biocompatibility): Tests as per ISO 10993-5; ISO 10993-12 | Yes (Cytotoxicity Tests conducted as per ISO 10993-5; ISO 10993-12) |
| Transportation Studies (Packaging Integrity): Tests as per ASTM D4169 | Yes (Distribution Studies conducted as per ASTM D4169) |
| Cleaning Instructions for Reusable Devices: Validations as per AAMI TIR 30; AAMI TIR 12 | Yes (Cleaning Validations conducted as per AAMI TIR 30; AAMI TIR 12) |
| Material Compatibility (Repeat Sterilization): Demonstrated for Radel | Yes (Radel Technical Data Sheet confirms material compatibility) |
| Drying Time: Validated in steam sterilization report AAMI/ANSI/ISO 17665; AAMI TIR 12 | Yes (Validated in Steam Sterilization report AAMI/ANSI/ISO 17665; AAMI TIR 12) |
| Vent/Volume Ratio: (Implicitly acceptable if sterilization is achieved) | All proposed trays are 0.184 in²/in³. The Complete Surgical Tray (CST) represents the worst-case vent to volume ratio and achieved sterilization successfully. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample size used for each specific non-clinical performance test. It only confirms that the tests were conducted.
The data provenance is retrospective, as these are non-clinical (laboratory/engineering) tests conducted on the device to demonstrate its performance against established standards. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. and international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of non-clinical device testing. "Ground truth" established by experts is typically relevant for studies involving human interpretation (e.g., diagnostic imaging studies). For this device, compliance is measured against engineering and sterilization standards.
4. Adjudication Method for the Test Set:
This information is not applicable to this type of non-clinical device testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving multiple human interpreters to resolve disagreements in expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a device or AI on human reader performance, usually in a diagnostic context. The document describes non-clinical performance testing for a sterilization tray and does not involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, standalone performance testing was done. The entire "Non-Clinical Performance Testing" section describes the performance of the device itself (the sterilization tray) under various conditions (steam sterilization, cleaning, transport, biocompatibility) without human intervention in its primary function.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance tests is defined by the acceptance criteria within the cited national and international engineering and sterilization standards. For example:
- Sterilant Penetration: Successfully killing biological indicators or defined sterility assurance levels (SALs) as per AAMI/ANSI/ISO 17665.
- Toxicological Properties: No cytotoxic effects observed as per ISO 10993-5.
- Cleaning: Reduction of bioburden/soil to acceptable levels as per AAMI TIR 30.
- Packaging Integrity: Maintenance of package integrity after transport simulations as per ASTM D4169.
8. The Sample Size for the Training Set:
This information is not applicable. The device described is a physical medical device (sterilization tray), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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 traywith 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 DriveThousand Oaks, CA 91362 |
| Registration Number | 3001617766 |
| Correspondence Contact | Debleena Sinha, M.SSpecialist, Regulatory AffairsPh: 818-444-3306Fax: 818-444-3406Email: debleena.sinha@implantdirect.com |
| 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
{6}------------------------------------------------
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 ModelName | Max no. of Instruments | Weight of each traywith 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 | ConMedLinvatech | PolyVac Inc. | TuttnauerUSA Co Ltd | C/TMedicalSystems |
|---|---|---|---|---|---|
| Proposed Device | Predicate | Predicate | Predicate | Predicate | |
| 510 (K) | K142519 | K052992 | K012105 | K990761 | K980065 |
| Trade Name | InterActiveComplete SurgicalTray | InstrumentSterilizationTray | SurgicalInstrumentDeliverySystem | MiniContainerCassette;StandardCassetteContainer | Sterilizationcassettes |
| Product Code | KCT | FRG | KCT | FRG | KCT |
| Intended Use | Perforatedinstrumentcassette systemto hold dentalinstruments inplace duringtransport, steamsterilization, andstorage | Perforated trayswith lids to holdsurgicalinstruments inplace duringtransport,steamsterilization,and storage | Perforatedtrays with lidsto hold surgicalinstruments inplace duringtransport,steamsterilization,and storage | Dentalinstrumentcassettesystem toholdinstrumentsin placeduringtransport,steamsterilization,and storage | Dentalinstrumentcassettesystem toholdinstrumentsin placeduringtransport,steamsterilization,and storage |
| MaterialComposition | Polymer ResinRadel-5000,biomedical gradesilicone | Polymer ResinRadel-5000,biomedicalgrade silicone | Radel-5000plastic,Biomedicalgrade silicone,and Aluminum,300 seriesstainless steel | PlasticPolymer,biomedicalgrade silicone | Plastic,Metal, andStainlessSteelcontainer |
| Manufacturer | Implant Direct | ConMedLinvatech | PolyVac Inc. | TuttnauerUSA Co Ltd | C/TMedicalSystems |
| Design | Plastic tray withlocking lid andsiliconecontainmentbrackets | Plastic tray withstainless steellatch andsiliconecontainmentbrackets | Tray made ofplastic or metalbase with lid | Small tomedium traywith siliconemat inserts | Trays andcassettesmade ofmetal andplastic. Latchmade ofstainlesssteel. |
| Sterilization by | |||||
| (1) GravitySteam | Yes | Yes | Yes | Yes | Yes |
| (2) Pre VaccumSteam | Yes | Yes | Yes | Yes | Yes |
| Air Permeance | Yes | Yes | Yes | Yes | Assume |
| Locking system tohold lid in place | Yes | Yes | Yes | Yes | Yes |
| Reusable | Yes | Yes | Yes | Yes | Yes |
| Materialcompatibilitywith sterilizationprocess | 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 | ConMedLinvatech | PolyVac Inc. | TuttnauerUSA Co Ltd | C/T MedicalSystems |
|---|---|---|---|---|---|
| Proposed Device | Predicate | Predicate | Predicate | Predicate | Predicate |
| Manufacturer | Implant Direct | ConMedLinvatech | PolyVac Inc. | TuttnauerUSA Co Ltd | C/T MedicalSystems |
| 510 (K) | K142519 | K052992 | K012105 | K990761 | K980065 |
| SterilantPenetrationStudies | YesSteamSterilizationValidationsconducted as perAAMI/ANSI/ISO17665;AAMI TIR 12 | Yes | Yes | Yes | Yes |
| ToxicologicalProperties(biocompatibilty) | YesCytotoxicityTests conductedas perISO 10993 - 5;ISO 10993 -12 | YesBrackets andcontainmentmats madefromBiomedicalgrade silicone | YesBiocomapatibiltytested to USPrequirements | YesCassetteinsertsmade frombiomedicalgradesilicone | Not statedin summary |
| Transportationstudies(PackagingIntegrity) | YesDistributionStudiesconducted as perASTM D4169 | Not stated insummary | Not stated insummary | Not stated insummary | Not statedin summary |
| CleaningInstructions forReusable devices | YesCleaningValidationsconducted as perAAMI TIR 30;AAMI TIR 12 | Not stated insummary | Not stated insummary | Not stated insummary | Yes |
| MaterialCompatibility(repeatsterilization) | YesRadel TechnicalData Sheet | YesRadel | YesRadel | Not statedin summary | Not statedin summary |
| Manufacturer | Implant Direct | ConMedLinvatech | PolyVac Inc. | TuttnauerUSA Co Ltd | C/T MedicalSystems |
| Drying Time | YesValidated inSteamSterilizationreportAAMI/ANSI/ISO17665;AAMI TIR 12 | Not stated insummary | Not stated insummary | Not statedin summary | YesDrying timein labeling |
| Vent/VolumeRatio | All proposedtrays are$0.184 in^2/in^3$ | Not stated insummary | $0.02276 in^2/in^3$ | Not statedin summary | Not statedin 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).
§ 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).