(267 days)
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No
The device description and intended use clearly define the product as a physical tray for organizing, sterilizing, and transporting dental tools. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as a surgical tray designed to hold, sterilize, and transport dental tools, not to treat any medical condition.
No
The device is a surgical tray designed to organize, sterilize, and transport dental surgical drills and tools, not to diagnose a medical condition.
No
The device is a physical surgical tray designed to hold and sterilize dental instruments, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the trays are designed to hold, organize, sterilize, and transport dental surgical drills and tools. This is a function related to the handling and sterilization of surgical instruments, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description reinforces the intended use, focusing on the physical characteristics of the trays and their role in the sterilization process of surgical instruments.
- Lack of IVD characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information.
Therefore, the SWEDEN & MARTINA SURGICAL TRAYS are medical devices used in the context of surgical procedures and instrument sterilization, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
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
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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)
The worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
Sterilization validation was completed by: Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
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).
0
May 26, 2023
Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sweden & Martina S.p.A. Alessia Pezzato Quality Assurance Manager Via Veneto, 10 Due Carrare, Padova 35020 Italv
Re: K222640
Trade/Device Name: Sweden & Martina Surgical Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 27, 2022 Received: April 21, 2023
Dear Alessia Pezzato:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Image /page/1/Picture/5 description: The image shows a digital signature. The name "Eileen Cadel -S" is prominently displayed on the left side of the image. To the right, the text "Digitally signed by Eileen Cadel -S Date: 2023.05.26 14:38:09-04'00'" is present, indicating the date and time of the digital signature.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222640
Device Name SWEDEN & MARTINA SURGICAL TRAYS
Indications for Use (Describe)
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method
Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)
at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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