Straumann Modular Cassette by Institut Straumann AG

Straumann® Modular Cassette is used in healthcare facilities to organize, enclose, sterilize, transport and store Straumann instruments between surgical uses. Straumann® Modular Cassette is not intended to maintain sterility on its own, but is intended to be used in conjunction with a legally marketed, validated sterilization double pouch to maintain the sterility of the enclosed devices.

The Straumann® Modular Cassette has been validated for the following maximum loads:

Module A 400g .
. BCC Maximum permissible stack BCC 611g

The A module is intended to be sterilized individually, without stacking with other modules.

The B and C module are intended to be sterilized individually, or by stacking the B module on top of C module bases. The maximum permissible stack for sterilization is one B module on top of two C module bases.

The B module lid and C module lid could be used to enclose an ultrasonic mat (Art. No. 041.774) for ultrasonic bath cleaning used instruments.

Only use the following sterilization parameters:

Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time .

Device Description

Straumann Modular Cassette consists of three modules: A, B and C module.

The A module could be inserted with multiple removable instrument trays and grommet trays. The B module could be inserted with one removable workflow tray for the specific implant line. The trays consist of further subcomponents, strips and holders that are made out of silicone rubber and are intended to hold the instruments in place during the surgical procedure as well as during the sterilization process. The C module has fixed silicone supports for instrument storage.

To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System meant to be stored in the Straumann Modular Cassette are used for bed preparation, placement, maintenance and explantation of the implants from the 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.

AI/ML Overview

This document describes the Straumann Modular Cassette, a device used to organize, sterilize, transport, and store dental instruments. The device is intended for use in conjunction with a legally marketed, validated sterilization double pouch.

However, the provided text does not contain acceptance criteria or a detailed study description with performance metrics. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Straumann BLX Surgical Cassette) through a comparison of technological characteristics and a general statement about non-clinical testing.

Here's a breakdown of what is available and what is missing from the provided text against your requested information:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document. While there are "validated loads" and "sterilization parameters," these are operational specifications rather than acceptance criteria with corresponding performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not explicitly provided. The document mentions "limits of reuse testing (100 reprocessing cycles)" but does not specify the number of cassettes tested or other details about the test set. There's no information about data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing described is non-clinical performance testing (cleaning, sterilization, biocompatibility), which typically does not involve human expert adjudication for ground truth.

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

This information is not applicable as the testing described does not involve human adjudication for ground truth.

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 is not applicable as the device is a physical medical device (sterilization cassette), not an AI algorithm.

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

This is not applicable as the device is a physical medical device, not an AI algorithm.

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

For the non-clinical testing mentioned:

Sterilization validation: The ground truth for sterility is typically established through recognized microbiological methods, such as the absence of viable microorganisms after exposure to sterilization, aiming for a Sterility Assurance Level (SAL) of 10^-6 using the biological indicator (BI) overkill method.
Cleaning validation: The ground truth for cleaning effectiveness is established by measuring residual soil (e.g., protein, hemoglobin, carbohydrates) on the device after cleaning, demonstrating levels below specified thresholds.
Biocompatibility: The ground truth is established by standardized in-vitro tests (e.g., cytotoxicity) and often in-vivo tests, assessed against established biological response criteria defined in standards like ISO 10993.

8. The sample size for the training set:

This is not applicable as the device is a physical medical device and does not involve a training set for an algorithm.

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

This is not applicable as the device is a physical medical device and does not involve a training set for an algorithm.

Summary of available information regarding performance:

The document states that "The test results demonstrate that the Modular Cassette is similar to the predicate device" and concludes that it is "as safe, as effective, and performs as well as the legally marketed predicate devices."

Validated Operational Specifications/Performance Claims (from the "Indications for Use" and "Technological Characteristics" sections):

Parameter	Acceptance Criteria / Reported Performance	Study Proving Acceptance
Maximum Loads	Module A: 400g	"The Straumann® Modular Cassette has been validated for the following maximum loads" (implies in-house validation testing was conducted)
	B and C Modules: Maximum permissible stack 611g (one B module on top of two C module bases). A module sterilized individually.	"The Straumann® Modular Cassette has been validated for the following maximum loads" (implies in-house validation testing was conducted)
Sterilization Parameters	Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time	"The sterilization parameters have been validated to a sterility assurance level (SAL) of 10^-6 using the biological indicator (BI) overkill method. In addition to the SAL validation, dry times were validated using full cycle parameters and limits of reuse testing (100 reprocessing cycles) was validated by visual inspection." (Cleaning and Sterilization Validation section). The testing followed FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015."
Material Biocompatibility	No cytotoxic effect in in-vitro cytotoxicity test (similar to predicate)	"The biological assessment of the Modular Cassette was performed according to ISO 10993-1:2009 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and the biocompatibility evaluation flow chart according to the FDA Guidance document 'Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'... Results of conducted studies... show that it is biocompatible for its intended use."
Reusable Cycles	Validated for 100 reprocessing cycles (visual inspection)	"limits of reuse testing (100 reprocessing cycles) was validated by visual inspection." (Cleaning and Sterilization Validation section)

Missing Specifics: The document lacks detailed study reports including raw data, exact sample sizes for each test mentioned (e.g., how many cassettes were subjected to 100 cycles, how many sterilization cycles were performed for validation, lot numbers, etc.), statistical analysis, and specific quantitative results beyond the pass/fail statements. It refers to these as non-clinical tests that "demonstrate" equivalence but does not provide the specifics of the actual acceptance criteria or the numerical results achieved against those criteria.

Summary

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Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K191522

Trade/Device Name: Straumann Modular Cassette Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 31, 2019 Received: November 1, 2019

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

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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 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 (QS) 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 medical devices and radiation-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 Elizabeth F. Claverie-Williams, MS 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) K191522

Device Name :

Straumann Modular Cassette

Indications for Use (Describe)

Straumann® Modular Cassette is used in healthcare facilities to organize, sterilize, transport and store Straumann instruments between surgical uses.

Straumann® Modular Cassette is not intended to maintain sterility on its intended to be used in conjunction with a legally marketed, validated sterilization double pouch to maintain the sterility of the enclosed devices.

The Straumann® Modular Cassette has been validated for the following maximum loads:

. Module A 400g
BCC Maximum permissible stack BCC 611g

The A module is intended to be sterilized individually, without stacking with other modules.

The B and C module are intended to be sterilized individually, or by stacking the B module bases. The maximum permissible stack for sterilization is one B module on top of two C module bases.

The B module lid and C module lid could be used to enclose an ultrasonic mat (Art. No. 041.774) for ultrasonic bath cleaning used instruments.

Only use the following sterilization parameters:

Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time ●
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 SubpartC)

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Straumann Modular Cassette

K191522

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124002 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023
Prepared By:	Jenni VescovoRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number : +41 61 965 1604
Date of Submission:	November 29, 2019

Name of the Device

Trade Names:	Straumann Modular Cassette
Common Name:	Sterilization trays and cassettes
Classification Name:	Sterilization wrap containers, trays, cassettes & otheraccessories
Regulation Number:	§880.6850
Device Classification:	II
Product Code(s):	KCT
Classification Panel:	General Hospital

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Straumann Modular Cassette

K191522

Predicate Device(s)

Primary Predicate:

. K180791 - Straumann BLX Surgical Cassette

Device Description

Straumann Modular Cassette consists of three modules: A, B and C module.

Indications for Use

The Straumann® Modular Cassette has been validated for the following maximum loads:

Module A 400g .
. BCC Maximum permissible stack BCC 611g

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Straumann Modular Cassette

K191522

The A module is intended to be sterilized individually, without stacking with other modules.

The B module lid and C module lid could be used to enclose an ultrasonic mat (Art. No. 041.774) for ultrasonic bath cleaning used instruments.

Only use the following sterilization parameters:

Pre-vacuum: 132°C (270 °F) for 4 minutes with 30 minutes drying time .

Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate in the following table:

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Straumann Modular Cassette

K191522

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE
K Number	K191522	K180791
Indications forUse	Straumann® Modular Cassette isused in healthcare facilities toorganize, enclose, sterilize,transport and store Straumanninstruments between surgical uses.Straumann® Modular Cassette isnot intended to maintain sterility onits own, but is intended to be usedin conjunction with a legallymarketed, validated sterilizationdouble pouch to maintain thesterility of the enclosed devices.The Straumann® Modular Cassettehas been validated for the followingmaximum loads:• Module A 400g• BCC Maximum permissiblestack BCC 611gThe A module is intended to besterilized individually, withoutstacking with other modules.The B and C module are intendedto be sterilized individually, or bystacking the B module on top of Cmodule bases. The maximumpermissible stack for sterilization isone B module on top of two Cmodule bases.The B module lid and C module lidcould be used to enclose anultrasonic mat (Art. No. 041.774) forultrasonic bath cleaning usedinstruments.Only use the following sterilizationparameters:• Pre-vacuum: 132°C (270 °F)for 4 minutes with 30 minutesdrying time	The Straumann BLXCassette is used inhealthcare facilities toorganize, enclose,cleaning, sterilize,transport, and storemedical devices betweensurgical uses. The BLXCassette is not intended tomaintain sterility; it isintended to be used inconjunction with a legallymarketed, validatedsterilization wrap.The BLX Cassette hasbeen validated for amaximum load of 300grams, including cassetteand instruments.Sterilization parameters:Pre-vacuum steam: 132°C(270° F) for 4 minutes with20 minutes drying time.	Similar
Product Code	KCT	KCT	Same
Design	Plastic modules, trays and lids	Plastic tray and lid	Similar
Materials	PolyphenylsulfoneSiliconeStainless steel (lid hinge)	Polyphenylsulfone (RadelR5000)Silicone	Similar
Biocompatibility	No cytotoxic effect in in-vitrocytotoxicity test	No cytotoxic effect in in-vitro cytotoxicity test	Same
Materialscompatible withsterilizationMethod	Yes	Yes	Similar
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE
K Number	K191522	K180791
Perforated	Yes; allows moist heat (steam)penetration to achieve sterilization	Yes: allows moist heat(steam) penetration toachieve sterilization	Similar
Reusable	Yes	Yes	Same
Sterilizationmethod	Moist heat (steam)	Moist heat (steam)	Same
Cycles	Pre-vacuum	Pre-vacuum	Similar
Parameters	Pre-Vacuum:132º C (270º F) for 4 minutes;30 minutes drying time	Pre-Vacuum:132º C (270º F) for 4minutes:20 minutes drying time	Similar
Sterile barrier	FDA cleared sterilization pouch	FDA cleared sterilizationpouch	Same

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Straumann Modular Cassette

K191522

Table 1 - Comparison of subject device versus primary predicate device

The subject and predicate device share the following characteristics:

indications for use .
design ●
identical sterilization method and similar 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 .

Nevertheless, the related performance is proven through testing.

Summary of Non-Clinical Testing

The performance during multiple reprocessing steps for the Modular Cassette, 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 test results demonstrate that the Modular Cassette is similar to the predicate device.

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Straumann Modular Cassette

K191522

Cleaning and Sterilization Validation

The subject device is a multiple-use device provided non-sterile which needs to be end user cleaned and sterilized. The cleaning and sterilization procedures reflect the FDA quidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

The sterilization parameters have been validated to a sterility assurance level (SAL) of 10° using the biological indicator (BI) overkill method. In addition to the SAL validation, dry times were validated using full cycle parameters and limits of reuse testing (100 reprocessing cycles) was validated by visual inspection.

Biocompatibility

The biological assessment of the Modular Cassette was performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016".

Results of conducted studies based upon the biological safety profile of the Modular Cassette show that it is biocompatible for its intended use.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

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).