(116 days)
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Not Found
No
The summary describes a sterilization container and does not mention any AI/ML capabilities or related concepts like image processing, data analysis, or performance metrics associated with AI/ML.
No
The device is a container used for sterilizing other medical devices and maintaining their sterility, not for directly treating a disease or condition.
No
The device is described as an instrument reprocessing container used for sterilization and maintaining sterility of other medical devices, not for diagnosing conditions.
No
The device description and intended use clearly describe a physical container used for sterilization, not a software application.
Based on the provided information, the SALUS® - Hygiene device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose and sterilize other medical devices and maintain their sterility. This is a function related to the reprocessing and storage of medical instruments, not the testing of samples from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
The SALUS® - Hygiene is a device used in the process of preparing and storing medical instruments for use on patients, which falls under the category of medical device reprocessing, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SALUS® - Hygiene 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. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
Product codes
KCT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 24, 2017
SciCan Ltd. Teresa Boyce Director of Regulatory Affairs 1440 Don Mills Road Toronto, M3B 3P9 Ca
Re: K172292
Trade/Device Name: SALUS® - Hygiene Instrument Reprocessing Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 27, 2017 Received: October 31, 2017
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172292
Device Name
SALUS® - Hygiene Instrument Reprocessing Container
Indications for Use (Describe)
The SALUS® - Hygiene 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. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
Please refer the chart below for validated sterilization cycles.
| Steam Sterilizer Type | Cycle | Sterilization
Temperature
-0/+6°F (-0/+3°C) | Exposure
Time | Recommended
Drying Time | Load
Type | Maximum
Instrument
Load Per
Container |
|------------------------------------------------------------|---------|---------------------------------------------------|------------------|----------------------------|------------------------------------------------|------------------------------------------------|
| Dynamic-air-removal
(pre-vacuum) | Wrapped | 270°F (132°C) | 4 minutes | 16 minutes | Solid Hygiene
Instruments & | 0.487lb (221g) |
| Dynamic-air-removal
(steam-flush, pressure-pulse, SFPP) | Wrapped | 270°F (132°C) | 4 minutes | 30 minutes | Lumen Hygiene
Instruments | 0.478lb (217g) |
| Dynamic-air-removal
(pre-vacuum) | Wrapped | 273°F (134°C) | 4 minutes | 30 minutes | (Ø .028" [0.7mm] x L 3.35"
[85 mm], Qty. 1) | 0.473lb (215g) |
| 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 Subpart C)
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