(134 days)
Not Found
No
The description focuses on mechanical filtration and vacuum technology, with no mention of AI or ML.
No
The device is described as a "Smoke Plume Evacuation System" intended to remove smoke created during surgical procedures. Its function is to clear the environment, not to directly treat a medical condition or ailment, which is characteristic of therapeutic devices.
No
The device is described as a "Smoke Plume Evacuation System" intended to remove smoke created during surgical procedures. Its function is to draw and filter surgical smoke, not to diagnose a medical condition.
No
The device description clearly outlines hardware components such as a vacuum motor, tubing, and a filter system, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove smoke created in surgical procedures at the surgical site." This describes a device used during a surgical procedure to manage the environment, not a device used to test a sample from the body to diagnose a condition, monitor a treatment, or screen for a disease.
- Device Description: The description focuses on the mechanical process of drawing and filtering smoke. It doesn't mention any analysis of biological samples or the use of reagents.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device's function is purely related to managing the surgical environment.
N/A
Intended Use / Indications for Use
The Surnic Surclear Smoke Plume Evacuation System with accessories is intended to remove smoke created in surgical procedures at the surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FYD
Device Description
The Surclear 8010 have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Surclear 8010 filter 8QF1 where the surgical smoke is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One 8QF1 filter contains four different stages within to capture the smoke plume.
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
Not Found
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)
Non-clinical testing was conducted to demonstrate that the Surclear Smoke Plume Evacuation System with its accessories functions as intended.
- Electrical Safety Testing: Evaluate Electrical Safety, Fulfil the requirement of IEC 60601-1:2012+2020 as applicable. Results: Passed.
- Electromagnetic Compatibility: Evaluate Electromagnetic Compatibility, Fulfil the requirements of IEC 60601-1-2:2014+2020 as applicable. Results: Passed.
- Software Validation: Evaluate Device Software, All test cases shall pass or deviations explained as to why it is acceptable. Results: Passed.
- Flow Rate Testing: Evaluate flow rate against design requirement, The flow rates at each flow mode are within the defined tolerances. Results: Passed.
- Plume Evacuation Evaluate: Evaluate System for evacuation of plume generated by medical devices, Fulfil the requirements of ISO 16571:2014 as applicable. Results: Passed.
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
§ 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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April 10, 2024
Surnic Corporation Helen Xie Project Director 480 Apollo Street, Ste. D Brea, California 92821
Re: K233789
Trade/Device Name: 8Q10 Surclear Smoke Plume Evacuation System Regulation Number: 21 CFR 878.5070 Regulation Name: Air-handling apparatus for a surgical operating room Regulatory Class: Class II Product Code: FYD Dated: March 11, 2024 Received: March 11, 2024
Dear Helen Xie:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Stephen A. Digitally signed by
Stephen A. stephen A. Anisko -S Anisko -S - S - 10:49:42 -04'00' For:
Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233789
Device Name
8010 Surclear Smoke Plume Evacuation System
Indications for Use (Describe)
The Surnic Surclear Smoke Plume Evacuation System with accessories is intended to remove smoke created in surgical procedures at the surgical site.
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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510(k) Summary - K233789
- Company Surnic Corporation 480 Apollo Street Ste. D Brea, CA 92821 USA
- Helen Xie Contact Telephone: (909) 979-9801 Email: helen@surnic.com
1.0 Date Prepared
April 1, 2024
2.0 Device Name
Trade Name: 8Q10 Surclear Smoke Plume Evacuation System Model: 8010 Common Name: Smoke Evacuator
3.0 Classification Name
Air-handling apparatus for surgical operating room (21 CFR 878.5070, Product Code FYD)
Regulatory Class
Class II
4.0 Predicate Device
The predicate device (K131402) is Visiclear Smoke Evacuation System by Buffalo Filter Co, Inc.
5.0 Device Description
The Surclear 8010 have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Surclear 8010 filter 8QF1 where the surgical smoke is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One 8QF1 filter contains four different stages within to capture the smoke plume.
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6.0 Indications for Use
The Surnic Surclear smoke plume evacuation system with accessories is intended to remove smoke created in surgical procedures at the surgical site.
7.0 Technological Characteristics
| Device | K233789 | K131402 | Discussion |
|---|---|---|---|
| Subject | Predicate | ||
| Indications for | |||
| Use | The Surnic Surclear | ||
| Smoke Plume Evacuation | |||
| System with accessories is | |||
| intended to remove smoke | |||
| created in surgical | |||
| procedures at the surgical | |||
| site. | The visiclear smoke | ||
| evacuation system is | |||
| designed to remove and | |||
| filter smoke and aerosols | |||
| from a surgical site | |||
| produced during | |||
| electrosurgical and laser | |||
| procedures | Similar | ||
| Static Motor | |||
| Suction | 25.69 kPa | 25.69 kPa | Same |
| Flow rates | |||
| (Max) | 25 cfm (707lpm) | ||
| @7/8(22mm) tubing | 30 cfm (839lpm) | ||
| @7/8(22mm) tubing | Similar, (cfm) 25vs30 is due to | ||
| different manufacturers' | |||
| understanding of the maximum | |||
| flow limit required in actual | |||
| applications. | |||
| Suction | |||
| control level | 10 Level | 10 Level | There are 10 control levels of |
| suction rate from 10% to | |||
| 100%. | |||
| Suction | |||
| blockage | |||
| warning | Yes | Yes | An occlusion warning safety |
| feature alerts the operator | |||
| when an occlusion has | |||
| occurred. | |||
| Foot control | Yes | Yes | The operator can foot-control |
| the suction of the device to | |||
| turn on or off. | |||
| Filter life | |||
| indication | Yes | Yes | Counter indicates filter status |
| and lifetime. | |||
| Filter | |||
| performance | The filter is 99.99% | ||
| efficiency at | |||
| 0.1-to-0.2-micron | |||
| particle size with a | |||
| filter life of up to 40 | |||
| hours. | The filter is 99.99% | ||
| efficiency at | |||
| 0.1-to-0.2-micron | |||
| particle size with a | |||
| filter life of up to 35 | |||
| hours. | Same filter efficiency, larger | ||
| filters can increase application | |||
| time from 35 to 40 hrs. | |||
| Power | |||
| Supply | 100-120VAC, 50/60Hz | ||
| 9A max | |||
| 220-240VAC, 50/60Hz | |||
| 4.5A max | 100/240VAC, 50/60Hz | ||
| 220/240 VAC | Same |
6
Non-clinical Tests 8.0
Non-clinical testing was conducted to demonstrate that the Surclear Smoke Plume Evacuation System with its accessories functions as intended. Below is a summary of testing conducted on the subject device:
| Title of Test | Purpose of Test | Acceptance Criteria | Results |
|---|---|---|---|
| Electrical Safety | |||
| Testing | Evaluate Electrical | ||
| Safety | Fulfil the requirement of IEC | ||
| 60601-1:2012+2020 as | |||
| applicable | Passed | ||
| Electromagnetic | |||
| Compatibility | Evaluate | ||
| Electromagnetic | |||
| Compatibility | Fulfil the requirements of | ||
| IEC 60601-1-2:2014+2020 | |||
| as applicable | Passed | ||
| Software Validation | Evaluate Device | ||
| Software | All test cases shall pass or | ||
| deviations explained as to | |||
| why it is acceptable | Passed | ||
| Flow Rate Testing | Evaluate flow rate | ||
| against design | |||
| requirement | The flow rates at each flow | ||
| mode are within the defined | |||
| tolerances. | Passed | ||
| Plume Evacuation | |||
| Evaluate | Evaluate System for | ||
| evacuation of plume | |||
| generated by medical | |||
| devices | Fulfil the requirements of | ||
| ISO 16571:2014 as | |||
| applicable | Passed |
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9.0 Conclusions
The conclusions drawn from the non-clinical testing of Surclear Smoke Plume Evacuation System demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K131402).