(176 days)
Not Found
No
The device is a physical cassette for organizing and sterilizing instruments, with no mention of software, data processing, or AI/ML capabilities.
No.
The device is used to organize, enclose, sterilize, transport, and store instruments, not to treat a condition or disease.
No
Explanation: The device is described as a cassette used to organize, enclose, sterilize, transport, and store surgical instruments. Its function is to facilitate the handling and sterilization of instruments, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly indicates it is a physical product consisting of modules, trays, and silicone components used for organizing and sterilizing instruments. There is no mention of software as a component or the primary function of the device.
Based on the provided text, the Straumann® Modular Cassette is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "organize, enclose, sterilize, transport and store Straumann instruments between surgical uses." This describes a device used in the process of preparing and handling surgical instruments, not for performing tests on samples taken from the human body.
- Device Description: The description details the components of the cassette and how it holds surgical instruments. It mentions the instruments themselves are Class I exempt and used for dental implant procedures. There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies focus on the reprocessing (cleaning and sterilization) of the cassette and its biocompatibility for contact with instruments used in surgical procedures. This aligns with the intended use of a device used in a surgical setting, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
Therefore, the Straumann® Modular Cassette is a medical device used in the surgical workflow, specifically for handling and sterilizing surgical instruments, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 guidance 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^-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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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
2
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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3
Straumann Modular Cassette
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Institut Straumann AG
Peter Merian-Weg 12
4002 Basel, Switzerland |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Jenni Vescovo
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone 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 & other |
| accessories | |
| Regulation Number: | §880.6850 |
| Device Classification: | II |
| Product Code(s): | KCT |
| Classification Panel: | General Hospital |
4
Straumann Modular Cassette
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
5
Straumann Modular Cassette
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:
6
Straumann Modular Cassette
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K191522 | K180791 | |
| 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
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 | 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. | Similar |
| Product Code | KCT | KCT | Same |
| Design | Plastic modules, trays and lids | Plastic tray and lid | Similar |
| Materials | Polyphenylsulfone
Silicone
Stainless steel (lid hinge) | Polyphenylsulfone (Radel
R5000)
Silicone | Similar |
| Biocompatibility | No cytotoxic effect in in-vitro
cytotoxicity test | No cytotoxic effect in in-
vitro cytotoxicity test | Same |
| Materials
compatible with
sterilization
Method | Yes | Yes | Similar |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | |
| K Number | K191522 | K180791 | |
| Perforated | Yes; allows moist heat (steam)
penetration to achieve sterilization | Yes: allows moist heat
(steam) penetration to
achieve sterilization | Similar |
| Reusable | Yes | Yes | Same |
| Sterilization
method | 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 4
minutes:
20 minutes drying time | Similar |
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization
pouch | Same |
7
Straumann Modular Cassette
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.
8
Straumann Modular Cassette
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.