(293 days)
Not Found
No
The device description and performance studies focus on air filtration and flow technology, with no mention of AI or ML capabilities.
No.
The device creates a clean surgical environment for ophthalmic surgery by filtering air and reducing contaminants, but it does not directly treat or diagnose a disease or condition in a patient.
No
Explanation: The SurgiCube® is described as a standalone device that creates a sterile surgical environment by directing HEPA-filtered air to reduce particulate matter and microorganisms. Its function is to prevent contamination during surgery, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical apparatus with a mechanical filter system and air flow technology, not solely software.
Based on the provided information, the SurgiCube® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SurgiCube® Function: The SurgiCube® is a device that creates a controlled environment with filtered air during surgery. Its purpose is to reduce airborne contamination at the surgical site and on instruments. It does not analyze any biological specimens from the patient.
- Intended Use: The intended use clearly states it creates a surgical operating environment with directed airflow to the surgical site and instruments.
- Device Description: The description focuses on the air filtration system and the creation of a clean air area.
- Performance Studies: The performance studies measure air quality (CFU levels and particle counts) within the device's operating area, not the analysis of patient samples.
Therefore, the SurgiCube® falls under the category of a surgical or environmental control device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SurgiCube® is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Surgicube International B.v. Ger Vijfvinkel CEO Seggelant-noord 4 Vierpolders, 3237 MG NL
Re: K163455
Trade/Device Name: Surgicube Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: ORC Dated: August 24, 2017 Received: August 28, 2017
Dear Ger Vijfvinkel:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163455
Device Name SurgiCube®
Indications for Use (Describe)
SurgiCube® is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-fittered to reduce the presence of particulate matter to reduce the microorganisms to a level of 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."
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Image /page/3/Picture/0 description: The image is a logo for SurgiCube International. The logo features a blue square with a white curved line inside, next to the text "SurgiCube" in a blue sans-serif font. Below "SurgiCube" is the word "International" in a smaller, also blue, sans-serif font. The logo is clean and modern, with a focus on the company name.
510(k) Summary
Date the summary was prepared is September 25, 2017
The submitter of the 510(k) is:
- Ger Vijfvinkel CEO SurgiCube International B.V. Seggelant-Noord 4 3237 MG Vierpolders The Netherlands Phone +31 181 760 660 Email g.vijfvinkel@surgicube.com
Device subject to this 510(k)
| Trade name: | SurgiCube® |
|---|---|
| Common name: | Air handling apparatus for surgery |
| Classification name | Air-handling apparatus for a surgical operating room |
| Device class | II |
| Regulation number | 21 CFR 878.5070 |
| Product code | ORC |
Predicate device
The legally marketed device to which substantial equivalence
is claimed is: Operio K153498 Cleared 07/20/2016
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Image /page/4/Picture/0 description: The image contains the logo for "SurgiCube International". The logo consists of a blue square with a white square inside, and a white curved line inside the inner square. To the right of the square is the text "SurgiCube" in a blue sans-serif font, with the word "International" underneath in a smaller font.
Device description
The SurgiCube® is an apparatus that provides a localized, optimally HEPA filtered, surgical environment to carry out minimally invasive surgery for ophthalmic procedures. It supplies air around the operating surface using uni directional air flow technique. Possible sources of contamination are sidelined. The patient is physically positioned outside the surgical area; just the operating area is in the field. The surgical team can move around the operating surface without interfering with the air. The uni directional flow together with correct surgical draping create a compact and manageable surgical area that will eliminate airborne contamination risks for patients. The SurgiCube® is equipped with a multiple mechanical filter system, including a High Efficiency Particle Air (HEPA) filter with an efficiency of filtering 99,995% of all particles of 0.3um.
Indications for use
SurgiCube®is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of