Straumann Modular Cassette

K191522 · Institut Straumann AG · KCT · Dec 3, 2019 · General Hospital

Device Facts

• Record ID: K191522
• Device Name: Straumann Modular Cassette
• Applicant: Institut Straumann AG
• Product Code: KCT · General Hospital
• Decision Date: Dec 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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.

Device Story

The Straumann Modular Cassette is a reusable, non-sterile sterilization tray system designed for organizing and transporting dental surgical and prosthetic instruments. It consists of three modules (A, B, and C) made of polyphenylsulfone, silicone, and stainless steel (hinges). The device features instrument pictograms and color-coded workflows to assist in instrument positioning. It is used in healthcare facilities by dental staff. The cassette is loaded with instruments and placed in a validated sterilization double pouch before undergoing pre-vacuum steam sterilization (132°C for 4 minutes). The B and C module lids can also enclose an ultrasonic mat for cleaning. The device facilitates the sterilization process, ensuring instruments are organized and protected during transport and storage, thereby supporting efficient surgical workflows and maintaining instrument integrity.

Clinical Evidence

No clinical data. Bench testing only. Validation included sterilization efficacy (SAL 10^-6 using BI overkill method), drying time validation, 100-cycle reuse testing, and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Materials: Polyphenylsulfone, silicone, stainless steel (lid hinge). Design: Perforated plastic modules, trays, and lids. Sterilization: Moist heat (steam), pre-vacuum cycle (132°C, 4 min, 30 min dry). Reusable. Biocompatibility: Compliant with ISO 10993-1.

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, sterilize, transport, and store Straumann dental surgical and prosthetic instruments between uses. Not intended to maintain sterility independently; must be used with a validated sterilization double pouch.

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

• Straumann BLX Surgical Cassette (K180791)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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, LLC<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052<br>On the behalf of:<br>Institut Straumann AG<br>Peter Merian-Weg 12<br>4002 Basel, Switzerland |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Prepared By: | Jenni Vescovo<br>Regulatory Affairs and Compliance Manager<br>Institut Straumann AG<br>Phone number : [phone] |
| 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 & other<br>accessories |
| 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.

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.

### Indications for Use

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

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### Straumann Modular Cassette

K191522

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 .
### 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 PREDICATE<br>DEVICE | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K191522 | K180791 | |
| Indications for<br>Use | Straumann® Modular Cassette is<br>used in healthcare facilities to<br>organize, enclose, sterilize,<br>transport and store Straumann<br>instruments between surgical uses.<br>Straumann® Modular Cassette is<br>not intended to maintain sterility on<br>its own, but is intended to be used<br>in conjunction with a legally<br>marketed, validated sterilization<br>double pouch to maintain the<br>sterility of the enclosed devices.<br>The Straumann® Modular Cassette<br>has been validated for the following<br>maximum loads:<br>• Module A 400g<br>• BCC Maximum permissible<br>stack BCC 611g<br>The A module is intended to be<br>sterilized individually, without<br>stacking with other modules.<br>The B and C module are intended<br>to be sterilized individually, or by<br>stacking the B module on top of C<br>module bases. The maximum<br>permissible stack for sterilization is<br>one B module on top of two C<br>module bases.<br>The B module lid and C module lid<br>could be used to enclose an<br>ultrasonic mat (Art. No. 041.774) for<br>ultrasonic bath cleaning used<br>instruments.<br>Only use the following sterilization<br>parameters:<br>• Pre-vacuum: 132°C (270 °F)<br>for 4 minutes with 30 minutes<br>drying time | The Straumann BLX<br>Cassette is used in<br>healthcare facilities to<br>organize, enclose,<br>cleaning, sterilize,<br>transport, and store<br>medical devices between<br>surgical uses. The BLX<br>Cassette is not intended to<br>maintain sterility; it is<br>intended to be used in<br>conjunction with a legally<br>marketed, validated<br>sterilization wrap.<br>The BLX Cassette has<br>been validated for a<br>maximum load of 300<br>grams, including cassette<br>and instruments.<br>Sterilization parameters:<br>Pre-vacuum steam: 132°C<br>(270° F) for 4 minutes with<br>20 minutes drying time. | Similar |
| Product Code | KCT | KCT | Same |
| Design | Plastic modules, trays and lids | Plastic tray and lid | Similar |
| Materials | Polyphenylsulfone<br>Silicone<br>Stainless steel (lid hinge) | Polyphenylsulfone (Radel<br>R5000)<br>Silicone | Similar |
| Biocompatibility | No cytotoxic effect in in-vitro<br>cytotoxicity test | No cytotoxic effect in in-<br>vitro cytotoxicity test | Same |
| Materials<br>compatible with<br>sterilization<br>Method | Yes | Yes | Similar |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | |
| K Number | K191522 | K180791 | |
| Perforated | Yes; allows moist heat (steam)<br>penetration to achieve sterilization | Yes: allows moist heat<br>(steam) penetration to<br>achieve sterilization | Similar |
| Reusable | Yes | Yes | Same |
| Sterilization<br>method | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Pre-vacuum | Pre-vacuum | Similar |
| Parameters | Pre-Vacuum:<br>132º C (270º F) for 4 minutes;<br>30 minutes drying time | Pre-Vacuum:<br>132º C (270º F) for 4<br>minutes:<br>20 minutes drying time | Similar |
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization<br>pouch | 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.