The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals.

The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time.

The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.

Device Description

Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission.

AI/ML Overview

The provided document describes the acceptance criteria and the performance testing for the Straumann® Surgical Cassettes, which are used to organize, sterilize, and transport surgical instruments.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Type of Testing	Purpose (Acceptance Criteria)	Reported Device Performance
Manual Cleaning Validation (AAMI TIR 30:2011)	Evaluate and validate the manual cleaning of the subject devices: • No visible soil • Amount of protein per sample <100 µg • Amount of protein/cm² <3.0 µg/cm² • Amount of hemoglobin/cm² <2.2 µg/cm²	Pass
Automated Cleaning Validation (AAMI TIR 30:2011)	Evaluate and validate the automated cleaning of the subject devices: • No visible soil • Amount of protein per sample <100 µg • Amount of protein/cm² <3.0 µg/cm² • Amount of hemoglobin/cm² <2.2 µg/cm²	Pass
Sterilization Validation (ISO 17665-1:2006/(R)2013)	Validate a sterilization cycle and drying time of the subject devices: • SAL ≤10⁻⁶ using the biological indicator (BI) overkill method	Pass
Reprocessing of Medical Devices in a Health Care Setting (Life Cycle)	Life Cycle (simulated use) testing after 100 cleaning and sterilization cycles: • Test samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without compromising function	Pass
Biocompatibility (ISO 10993-5)	Cytotoxicity Testing: • Viability of cultures treated with test extracts >70%	Pass

2. Sample size used for the test set and the data provenance:

The document states: "The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio and worst-case instruments to be contained."
It also mentions "Test samples must withstand 100 cycles of use". This indicates that at least one "worst-case" sample was subjected to repeated testing for the life cycle validation.
Specific numerical sample sizes for each test (e.g., number of cassettes for cleaning validation, or number of sterilization runs) are not provided in the excerpt.
Data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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 device and study. The "ground truth" for these performance tests is based on established scientific and regulatory standards (e.g., ISO, AAMI standards) and objective measurements of sterilization, cleaning efficacy, and material biocompatibility, rather than expert consensus on interpretive tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the evaluation of device performance in these tests is based on objective measurements against defined criteria, not on subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is not an AI-powered diagnostic or assistive tool for human readers. It is a physical medical device (sterilization cassette).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing is based on objective measurements against established scientific and regulatory standards. For example:
- Cleaning efficacy: Measured levels of protein and hemoglobin, and visual inspection for soil, compared against quantitative thresholds.
- Sterilization: Sterility Assurance Level (SAL) of ≤10⁻⁶ using biological indicators, which is a quantitative measure of microbial inactivation.
- Biocompatibility: Cell viability percentage (>70%) compared against a quantitative threshold in cytotoxicity testing.
- Life cycle: Functional integrity after a specified number of cycles, assessed objectively.

8. The sample size for the training set:

This information is not applicable as the device is not an AI algorithm that requires a training set. The performance testing validates the physical characteristics and reprocessing effectiveness of the cassettes.

9. How the ground truth for the training set was established:

This information is not applicable as the device is not an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2021

Straumann USA, LLC Jennifer Jackson Director, Regulatory Affairs 60 Minuteman Rd Andover, Massachusetts 01810

Re: K203753

Trade/Device Name: Straumann Surgical Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 25, 2021 Received: June 28, 2021

Dear Jennifer Jackson:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K203753

Device Name

Straumann® Surgical Cassettes

Indications for Use (Describe)

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

Residential Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Straumann® Surgical Cassettes

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023
Prepared By &Alternate Contact:	Chanrasmey White, MSRegulatory Affairs SpecialistStraumann, USA, LLC
Date of Submission:	July 29, 2021

Name of the Device

Trade Names:	Straumann® Surgical Cassettes
Common Name:	Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories
Classification Name:	Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories
Regulation Number:	§880.6850
Device Classification:	II
Product Code(s):	KCT
Classification Panel:	General Hospital

Predicate Device(s)

Primary Predicate:

. K180791 – Straumann BLX Surgical Cassette (Institut Straumann AG)

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Straumann® Surgical Cassettes

510(k) Summary

Reference Devices:

K191522 Straumann Modular Surgical Cassette (Institut Straumann AG) .

Device Description

Intended Use

The Straumann Cassettes are intended to store, organize and reprocess surgical instruments and auxiliaries of the Straumann® Dental Implant System during implant/prosthetic treatment and sterilization.

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Straumann® Surgical Cassettes

510(k) Summary

Indications for Use

The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: prevacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time.

Technological Characteristic Comparison

The subject and predicate device share the following characteristics:

Equivalent indications for use .
. Equivalent design
ldentical sterilization method .
. Equivalent sterilization parameters
. Reusable

The subject device is technologically different from the predicate device as follows:

. Materials (the only part of the cassette made out of stainless steel is the lid hinge)
Vent-to-Volume ratio .
. Drying time

The technological characteristics of the subject devices are compared to the predicate devices in Table 1.

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Straumann® Surgical Cassettes

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE	COMPARISON
K Number	K203753	K180791	K191522
Indications forUse	The Straumann Cassettes are usedto organize, store, sterilize andtransport surgical instruments andauxiliaries between and duringsurgical uses. They are indicated tobe used in healthcare facilities byhealthcare professionals.The Straumann Cassettes are to beenclosed in FDA cleared sterilizationpouches in two layers to maintainthe sterility of the enclosed devicesusing the following sterilizationparameters: pre-vacuum steamexposure at 132°C (270° F) for 4minutes, 30 minutes drying time.The Straumann Cassettes havebeen validated for a maximum loadof 1005 grams for the SurgicalCassettes, 2007 grams for theOsteotome Cassettes, 283 gramsfor the Bone Block Fixation Cassetteand 65 grams for the ScrewContainer, including cassette andinstruments.	The Straumann BLX Cassette isused in healthcare facilities toorganize, enclose, cleaning,sterilize, transport, and storemedical devices between surgicaluses. The BLX Cassette is notintended to maintain sterility; it isintended to be used in conjunctionwith a legally marketed, validatedsterilization wrap.The BLX Cassette has beenvalidated for a maximum load of 300grams, including cassette andinstruments.Sterilization parameters:Pre-vacuum steam: 132°C (270° F)for 4 minutes with 20 minutes dryingtime.	Straumann® Modular Cassette is used inhealthcare facilities to organize, enclose,sterilize, transport and store Straumanninstruments between surgical uses.Straumann® Modular Cassette is notintended to maintain sterility on its own,but is intended to be used in conjunctionwith a legally marketed, validatedsterilization double pouch to maintain thesterility of the enclosed devices.The Straumann® Modular Cassette hasbeen validated for the followingmaximum loads:Module A 400gBCC Maximum permissible stackBCC 611gThe A module is intended to be sterilizedindividually, without stacking with othermodules.The B and C module are intended to besterilized individually, or by stacking theB module on top of C module bases. Themaximum permissible stack forsterilization is one B module on top oftwo C module bases.The B module lid and C module lid couldbe used to enclose an ultrasonic mat(Art. No. 041.774) for ultrasonic bathcleaning used instruments.Only use the following sterilizationparameters:Fractionated vacuum: 132°C (270 °F) for4 minutes with 30 minutes drying time	Similar
Product Code	KCT	KCT	KCT	Same
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE PREDICATE DEVICE	COMPARISON
K Number	K203753	K180791	K191522
Design	Reusable rigid container, casebottom (base), a removable innertray base (tray), and tray lid (lid).	Plastic tray and lid	Plastic modules, trays and lids	Similar
Materials	Polyphenylsulfone (Radel 5000)Tecapro MT, Propylux SiliconeStainless SteelEUROPLEX® PPSU99050 GT, greyPP HS2 WHV200 WM, white	Polyphenylsulfone (Radel R5000)Silicone	PolyphenylsulfoneSiliconeStainless Steel	Similar
Materialscompatible withsterilizationMethod	Yes	Yes	Yes	Same
Perforated	Yes; allows moist heat (steam)penetration to achieve sterilization	Yes; allows moist heat (steam)penetration to achieve sterilization	Yes; allows moist heat (steam)penetration to achieve sterilization	Same
Reusable	Yes, up to 100x	Yes, up to 100x	Yes, up to 100x	Same
Sterilizationmethod	Moist heat (steam)	Moist heat (steam)	Moist heat (steam)	Same
Cycles	Pre-vacuum	Pre-vacuum	Fractionated vacuum	Same asK180791
Parameters	Pre-Vacuum:132º C (270º F) for 4 minutes;30 minutes drying time	Pre-Vacuum:132º C (270º F) for 4 minutes;20 minutes drying time	Fractionated vacuum:132°C (270 °F) for 4 minutes;30 minutes drying time	Same asK180791
Sterile barrier	FDA cleared sterilization pouch	FDA cleared sterilization pouch	FDA cleared sterilization pouch	Same
Biocompatibility	The Biocompatibility assessmentwas performed per ISO 10993-1 andtesting was performed usingmethods described in ISO 10993-5.The results indicate that the subjectdevices are non-cytotoxic.	The Biocompatibility assessmentwas performed per ISO 10993-1 andtesting was performed usingmethods described in ISO 10993-5.The results indicate that the subjectdevices are non-cytotoxic.	The Biocompatibility assessment wasperformed per ISO 10993-1 and testingwas performed using methods describedin ISO 10993-5. The results indicate thatthe subject devices are non-cytotoxic.	Same

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Straumann® Surgical Cassettes

510(k) Summary

Table 1 – Comparison Matrix

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Traditional 510(k) Submission

Straumann® Surgical Cassettes

510(k) Summary

Performance Testing

The performance during multiple reprocessing steps for the Straumann® Surgical Cassettes, as recommended in the labeling, was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio and worstcase instruments to be contained. The summary of testing performed is provided in Table 2.

Type of Testing	Purpose	Acceptance Criteria	Result
Manual CleaningValidation(AAMI TIR 30:2011)	Evaluate and validatethe manual cleaning ofthe subject devices	• No visible soil• Amount of protein persample <100 µg• Amount of protein/cm²<3.0 µg/cm²• Amount ofhemoglobin/cm² <2.2µg/cm²	Pass
Automated CleaningValidation(AAMI TIR 30:2011)	Evaluate and validatethe automated cleaningof the subject devices	• No visible soil• Amount of protein persample <100 µg• Amount of protein/cm²<3.0 µg/cm²• Amount ofhemoglobin/cm² <2.2µg/cm²	Pass
Sterilization Validation(ISO 17665-1:2006/(R)2013)	Validate a sterilizationcycle and drying time ofthe subject devices	• SAL ≤10⁻⁶ using thebiological indicator(BI) overkill method	Pass
Reprocessing ofMedical Devices in aHealth Care Setting	Life Cycle (simulateduse) testing after 100cleaning andsterilization cycles	• Test samples mustwithstand 100 cyclesof use (cleaning,sterilization, andfunctional tests)without compromisingfunction	Pass

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Traditional 510(k) Submission

Straumann® Surgical Cassettes

510(k) Summary

Biocompatibility(ISO 10993-5)	Cytotoxicity Testing	• Viability of culturestreated with testextracts >70%	Pass
-----------------------------------	----------------------	---------------------------------------------------------------	------

Table 2 – Performance testing summary

Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203753, Straumann Surgical Cassettes, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180791 and K191522.

Regulation Number and Section

§ 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).