(218 days)
No
The device description and intended use clearly define the device as a physical container for organizing, sterilizing, and transporting surgical instruments. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on the physical reprocessing and sterilization of the cassettes.
No
Explanation: The device is a container for organizing, sterilizing, and transporting surgical instruments, not a device used directly for therapy.
No
The device is a medical instrument organization and sterilization cassette, not a diagnostic device. Its purpose is to organize, sterilize, and transport surgical instruments, not to diagnose medical conditions or diseases.
No
The device is a physical container (cassette) used for organizing, sterilizing, and transporting surgical instruments. The description details its physical components, materials, and validation for cleaning and sterilization processes, which are hardware-related aspects. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as organizing, sterilizing, and transporting surgical instruments and auxiliaries. This is a function related to the handling and preparation of medical devices for surgical procedures, not for performing tests on samples taken from the human body.
- Device Description: The description details a container for holding surgical tools and implants. It focuses on the physical structure and function of the cassette for sterilization and organization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. There are no reagents, assays, or analytical components described.
- Performance Studies: The performance studies focus on cleaning, sterilization, and life cycle testing of the cassette itself, not on the accuracy or reliability of diagnostic results.
- Predicate Device: The predicate device is also a surgical cassette, further indicating that this type of device is not classified as an IVD.
In summary, the Straumann Cassettes are medical devices used in the preparation and handling of surgical instruments, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities by healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Manual Cleaning Validation (AAMI TIR 30:2011): Evaluated and validated the manual cleaning of the subject devices. Acceptance criteria: No visible soil, amount of protein per sample 70%. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K203753
Device Name
Straumann® Surgical Cassettes
Indications for Use (Describe)
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.
| 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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3
Straumann® Surgical Cassettes
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023 |
| Prepared By &
Alternate Contact: | Chanrasmey White, MS
Regulatory Affairs Specialist
Straumann, USA, LLC |
| Date of Submission: | July 29, 2021 |
Name of the Device
| Trade Names: | Straumann® Surgical Cassettes |
|---|---|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Accessories | |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Accessories | |
| 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)
4
Straumann® Surgical Cassettes
510(k) Summary
Reference Devices:
- K191522 Straumann Modular Surgical Cassette (Institut Straumann AG) .
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.
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.
5
Straumann® Surgical Cassettes
510(k) Summary
Indications for Use
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: prevacuum 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.
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.
6
Straumann® Surgical Cassettes
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | COMPARISON |
|---|---|---|---|---|
| K Number | K203753 | K180791 | K191522 | |
| Indications for | ||||
| Use | The Straumann Cassettes are used | |||
| to organize, store, 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. | The Straumann BLX Cassette is | |||
| used in healthcare facilities to | ||||
| organize, enclose, cleaning, | ||||
| sterilize, transport, and store | ||||
| medical devices between surgical | ||||
| uses. The BLX Cassette is not | ||||
| intended to maintain sterility; it is | ||||
| intended to be used in conjunction | ||||
| with a legally marketed, validated | ||||
| sterilization wrap. | ||||
| The BLX Cassette has been | ||||
| validated for a maximum load of 300 | ||||
| grams, including cassette and | ||||
| instruments. | ||||
| Sterilization parameters: | ||||
| Pre-vacuum steam: 132°C (270° F) | ||||
| for 4 minutes with 20 minutes drying | ||||
| time. | 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 400gBCC Maximum permissible stack | ||||
| BCC 611gThe 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: | ||||
| Fractionated vacuum: 132°C (270 °F) for | ||||
| 4 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, case | |||
| bottom (base), a removable inner | ||||
| tray base (tray), and tray lid (lid). | Plastic tray and lid | Plastic modules, trays and lids | Similar | |
| Materials | Polyphenylsulfone (Radel 5000) | |||
| Tecapro MT, Propylux Silicone | ||||
| Stainless Steel | ||||
| EUROPLEX® PPSU | ||||
| 99050 GT, grey | ||||
| PP HS2 WHV200 WM, white | Polyphenylsulfone (Radel R5000) | |||
| Silicone | Polyphenylsulfone | |||
| Silicone | ||||
| Stainless Steel | Similar | |||
| Materials | ||||
| compatible with | ||||
| sterilization | ||||
| Method | 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 |
| Sterilization | ||||
| method | Moist heat (steam) | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Pre-vacuum | Pre-vacuum | Fractionated vacuum | Same as |
| K180791 | ||||
| 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 as | |||
| K180791 | ||||
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same |
| Biocompatibility | The Biocompatibility assessment | |||
| was performed per ISO 10993-1 and | ||||
| testing was performed using | ||||
| methods described in ISO 10993-5. | ||||
| The results indicate that the subject | ||||
| devices are non-cytotoxic. | The Biocompatibility assessment | |||
| was performed per ISO 10993-1 and | ||||
| testing was performed using | ||||
| methods described in ISO 10993-5. | ||||
| The results indicate that the subject | ||||
| devices are non-cytotoxic. | The Biocompatibility assessment was | |||
| performed per ISO 10993-1 and testing | ||||
| was performed using methods described | ||||
| in ISO 10993-5. The results indicate that | ||||
| the subject devices are non-cytotoxic. | Same |
7
Straumann® Surgical Cassettes
510(k) Summary
Table 1 – Comparison Matrix
8
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 Cleaning | |||
| Validation | |||
| (AAMI TIR 30:2011) | Evaluate and validate | ||
| the manual cleaning of | |||
| the subject devices | • No visible soil | ||
| • Amount of protein per | |||
| sample 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.