(147 days)
Not Found
Not Found
No
The summary describes a steam sterilizer and does not mention any AI or ML capabilities.
No
The device is a sterilizer used to prepare medical instruments for use, not to directly treat a patient.
No
The device is a sterilizer for medical products. It is used to prepare instruments and materials for medical procedures, but it does not diagnose medical conditions.
No
The device is a steam sterilizer, which is a hardware device. The summary describes its function in sterilizing medical products using pressurized steam, indicating a physical apparatus.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BRAVO G4 is a steam sterilizer used to sterilize medical products (instruments). This is a process performed on medical devices, not a test performed on biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The BRAVO G4 is a medical device used for sterilization, which is a critical process in healthcare but falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterlizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The BRAVO G4 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
Not Found
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
health care provider
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)
Not Found
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.
Not Found
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
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
July 1, 2021
SciCan Ltd. Teresa Boyce Director of Regulatory Affairs 1440 Don Mills Road Toronto. ON M3B 3P9 Canada
Re: K210326
Trade/Device Name: Bravo G4 Chamber Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: May 28, 2021 Received: June 1, 2021
Dear Teresa Boyce:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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).
Sincerelv.
Clarence W. Murray III -S
Clarence W. Murray, III, PhD Assistant Director DHT41: Sterility Devices Team 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)
Device Name BRAVO G4 CHAMBER AUTOCLAVE
Indications for Use (Describe)
The BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterlizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The BRAVO G4 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
A table describing the BRAVO G4 programs, cycle times, temperatures and dry times is available on the next page.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
BRAVO G4 17 120V and 240V Sterilization Cycles
| PROGRAM
NAME | STERILIZATION
TEMPERATURE
AND TIME | DRYING
TIME (min)
() | MAXIMUM LOAD
17 () | LOAD DESCRIPTION () |
|--------------------------------------|------------------------------------------|-----------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (C1)
132°C
HOLLOW
WRAPPED | 132°C / 270°F
4 minutes | 13 | 1 kg / 2.21 lbs. | Unwrapped porous and fabric textiles |
| | | | 0.75 kg / 1.65 lbs. | Single wrapped porous and fabric textiles |
| | | | 0.60 kg / 1.32 lbs. | Double wrapped porous and fabric textiles |
| | | | 3 kg / 6.61 lbs. | Single wrapped or pouched metal or polymer
instruments and dental handpieces
Single wrapped tray or cassettes with metal
or polymer instruments and dental
handpieces |
| | | | 6 kg / 13.23 lbs. | Unwrapped metal or polymer instruments and
dental handpieces |
| | | | 1.5 kg / 3.31 lbs. | Double pouched metal or polymer
instruments and dental handpieces |
| (C2)
121°C
RUBBER &
PLASTIC | 121°C / 250°F
20 minutes | 13 | 1 kg / 2.21 lbs. | Unwrapped porous and fabric textiles |
| | | | 0.75 kg / 1.65 lbs. | Single wrapped porous and fabric textiles |
| | | | 0.60 kg / 1.32 lbs. | Double wrapped porous and fabric textiles |
| | | | 3 kg / 6.61 lbs. | Single wrapped or pouched metal or polymer
instruments and dental handpieces
Single wrapped tray or cassettes with metal
or polymer instruments and dental
handpieces |
| | | | 6 kg / 13.23 lbs. | Unwrapped metal or polymer instruments and
dental handpieces |
| | | | 1.5 kg / 3.31 lbs. | Double pouched metal or polymer
instruments and dental handpieces |
| (C3)
132°C SOLID
UNWRAPPED | 132°C / 270°F
4 minutes | 4 | 6 kg / 13.23 lbs. | Unwrapped metal or polymer instruments |
| (C4)
132° HOLLOW
UNWRAPPED | 132°C / 270°F
4 minutes | 4 | 6 kg / 13.23 lbs. | Unwrapped metal or polymer instruments and
dental handpieces |
| (C5)
132°C SOLID
WRAPPED | 132°C / 270°F
4 minutes | 13 | 3 kg / 6.61 lbs. | Single wrapped or pouched metal or polymer
instruments
Single wrapped cassettes with metal or
polymer instruments |
| | | | 6 kg / 13.23 lbs. | Unwrapped metal or polymer instruments |
(*) Default drying time, but the drying time can be manually increased.
(") Default drying time, but the can be manually increased.
() If the material is sterilized "unwrapped" the sterilized material shall be used immediately after sterlizatio considered as an Immediate Use Steam Sterilization (USS) cycle).
(*) Depending on the type of load, it may be necessary to optimize drying using the extra drying function.
(* * *) Depending on the type of load, it may be necessary to optimize drying using the extra drying function.
4
BRAVO G4 22 120V and 240V Sterilization Cycles
| PROGRAM
NAME | STERILIZATION
TEMPERATURE
AND TIME | DRYING
TIME (min)
() | MAXIMUM LOAD
17 () | LOAD DESCRIPTION () |
|--------------------------------------|------------------------------------------|-----------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (C1)
132°C
HOLLOW
WRAPPED | 132°C / 270°F
4 minutes | 15 | 1.2 kg / 2.65 lbs. | Unwrapped porous and fabric textiles |
| | | | 1 kg / 2.21 lbs. | Single wrapped porous and fabric textiles |
| | | | 0.75 kg / 1.65 lbs. | Double wrapped porous and fabric textiles |
| | | | 4 kg / 8.82 lbs. | Single wrapped or pouched metal or polymer
instruments and dental handpieces
Single wrapped tray or cassettes with metal
or polymer instruments and dental
handpieces |
| | | | 7.5 kg / 16.53 lbs. | Unwrapped metal or polymer instruments and
dental handpieces |
| | | | 2 kg / 4.41 lbs. | Double pouched metal or polymer
instruments and dental handpieces |
| (C2)
121°C
RUBBER &
PLASTIC | 121°C / 250°F
20 minutes | 15 | 1.2 kg / 2.65 lbs. | Unwrapped porous and fabric textiles |
| | | | 1 kg / 2.21 lbs. | Single wrapped porous and fabric textiles |
| | | | 0.75 kg / 1.65 lbs. | Double wrapped porous and fabric textiles |
| | | | 4 kg / 8.82 lbs. | Single wrapped or pouched metal or polymer
instruments and dental handpieces
Single wrapped tray or cassettes with metal
or polymer instruments and dental
handpieces |
| | | | 7.5 kg / 16.53 lbs. | Unwrapped metal or polymer instruments and
dental handpieces |
| | | | 2 kg / 4.41 lbs. | Double pouched metal or polymer
instruments and dental handpieces |
| (C3)
132°C SOLID
UNWRAPPED | 132°C / 270°F
4 minutes | 5 | 7.5 kg / 16.53 lbs. | Unwrapped metal or polymer instruments |
| (C4)
132° HOLLOW
UNWRAPPED | 132°C / 270°F
4 minutes | 5 | 7.5 kg / 16.53 lbs. | Unwrapped metal or polymer instruments and
dental handpieces |
| (C5)
132°C SOLID
WRAPPED | 132°C / 270°F
4 minutes | 15 | 4 kg / 8.82 lbs. | Single wrapped or pouched metal or polymer
instruments
Single wrapped cassettes with metal or
polymer instruments |
| | | | 7.5 kg / 16.53 lbs. | Unwrapped metal or polymer instruments |
(*) Default drying time, but the drying time can be manually increased.
(") Default drying time, but the can be manually increased.
() If the material is sterilized "unwrapped" the sterilized material shall be used immediately after sterlizatio considered as an Immediate Use Steam Sterilization (USS) cycle).
(*) Depending on the type of load, it may be necessary to optimize drying using the extra drying function.
(***) Depending on the type of load, it may be necessary to optimize drying using the extra drying function.