(231 days)
Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.
During the laparoscopic surgery, the smoke generated by the electrocautery dims the surgeon's vision, affecting the operation and causing the smoke to have a negative effect on the surgeon. It is used in connection with a laparoscopic trocar body or a single port used to expand the surgical site during laparoscopic surgery. This product filters smoke generated when the tissue is cauterized through the laparoscopic trocar body and a single port. The connecting part of the Trocar body or single port is 4.25 * 5.04mm in diameter. The device is consisted of 35cm tubing, a body with filters and an adaptor.
The provided text describes a 510(k) premarket notification for a medical device called "Smoklean," a passive smoke evacuation system for laparoscopic procedures. The document details the device's intended use, comparison to a predicate device, and performance data from various tests. However, it does not contain the specific acceptance criteria for these tests or a detailed study report that proves the device meets those criteria with specific performance metrics (e.g., specific filtration efficiency percentages, or quantitative measures of visual clarity).
Therefore, based on the provided text, I cannot complete all sections of your request. I will extract the information that is present and indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for specific performance metrics. The document identifies various tests performed. | The performed tests "support that the subject device is substantially equivalent to the predicate devices." (Quantitative results are not provided). |
| Example Criteria (hypothetical, as not provided in text): - Particle filtration efficiency > 99.9% for 0.3 micron particles - Ammonia removal efficiency > 90% - Formaldehyde removal efficiency > 90% - Maintain clear field of vision (qualitative assessment) | Example Performance (hypothetical, as not provided in text): - Achieved 99.99% filtration efficiency for 0.3 micron particles - Achieved 95% ammonia removal - Achieved 92% formaldehyde removal - Surgeons consistently reported a clear field of vision during simulated procedures. |
Missing Information: The document lists types of performance tests (e.g., "Smoke particulate filtration verification test," "Deodorization: Ammonia," "Deodorization: Formaldehyde") but does not provide the specific quantitative acceptance criteria or the numerical results achieved by the device against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information: The document lists "Performance Tests" but does not specify the sample size used for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not detailed for the performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable for this type of device and performance testing. The "ground truth" for a smoke evacuation system generally refers to measurable physical properties (like filtration efficiency, odor reduction) rather than expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not Applicable for this type of device and performance testing, as it doesn't involve subjective interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, as this is a smoke evacuation device, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop) performance was done. The "Performance Data" section lists various tests performed directly on the device, such as "Smoke particulate filtration verification test," "Deodorization: Ammonia," and "Deodorization: Formaldehyde." These are objective, standalone tests of the device's physical capabilities.
7. Type of Ground Truth Used
The ground truth for the performance tests would be based on objective, measurable physical and chemical standards, such as:
- Pre-defined concentrations of particles or gases (e.g., ammonia, formaldehyde) for filtration/deodorization tests.
- Standardized methods for measuring particle counts, gas concentrations, tensile strength, sterility, etc.
- Industry standards (e.g., ISO) for sterilization and biocompatibility.
8. Sample Size for the Training Set
Not Applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training set" concept is relevant for machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, this device does not use an AI/ML algorithm that requires a training set.
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May 18, 2018
Sejong Medical Co., Ltd. % Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K173108
Trade/Device Name: Smoklean Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus for a Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: April 5, 2018 Received: April 16, 2018
Dear Priscilla Chung:
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);
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Page 2 - Priscilla Chung
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,
Geeta K. Pamidimukkala -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
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Indications for Use
510(k) Number (if known)
Device Name
Smoklean
Indications for Use (Describe)
Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.
| 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) |
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510(k) Summary
K173108
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: _ 04/05/2018
1. Submitter/Applicant
Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880
Tel: +82-31-945-8191 Fax: +82-31-945-8190
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- . Trade Name: Smoklean
- Common Name: Air-handling apparatus for a surgical operating room
- Classification: Class II
- Classification regulation: 21 CFR 878.5070 ●
- . Product Code: FYD
Predicate Devices: 4.
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 (K992361) by PALL MEDICAL
5. Description:
During the laparoscopic surgery, the smoke generated by the electrocautery dims the surgeon's vision, affecting the operation and causing the smoke to have a negative effect on the surgeon.
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It is used in connection with a laparoscopic trocar body or a single port used to expand the surgical site during laparoscopic surgery. This product filters smoke generated when the tissue is cauterized through the laparoscopic trocar body and a single port.
The connecting part of the Trocar body or single port is 4.25 * 5.04mm in diameter.
Indication for use: 6.
Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.
7. Performance Data
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- · Sterilization Validation in accordance with ISO 11135-1:2007
- · Shelf Life Validation Test
- · Performance Tests: Appearance (visual inspection), Measurement, Deodorization : Ammonia, Ethylene Oxide Sterilization Residuals in accordance with ISO 10993-7:2008, Sterility Test in accordance with ISO 11737-2:2009, Tensile strength (adapter
tube), Tensile strength (tubebody), Deodorization: Formaldehyde, Smoke particulate filtration verification test.
Basis for Substantial Equivalence 8.
The subject device has the same intended use and the technical characteristics as the predicate device. They are also very similar in design and user interface. The major difference between the two devices would be filters used.
| Proprietary | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | Sejong Medical Co., Ltd. | PALL MEDICAL |
| Device Name | Smoklean | PALL SURGICLEAR LAPAROSCOPICSMOKE FILTRATION SYSTEM, MODELCLSF1 |
| 510(k) Number | K173108 | K992361 |
| DeviceClassificationName | apparatus, exhaust, surgical | apparatus, exhaust, surgical |
| ClassificationProduct Code | FYD | FYD |
| RegulationNumber | 878.5070 | 878.5070 |
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| Indications forUse | Smoklean is a passive smoke evacuationsystem which removes particles fromsurgical smoke generated in laparoscopicprocedures while maintaining a clearfield of vision. | The proposed device is intended for thefiltration of contaminants from smoke,generated during laparoscopic surgery,which can contain volatile organic productsof combustion (including those which areperceived as odor) and particles (includingcellular debris, bacteria, and viruses). |
|---|---|---|
| Design Features | The device is consisted of 35cm tubing, abody with filters and an adaptor.Image: Smoklean device with tubing | The device is consisted of 45cm tubing, abody with filters and an adaptor.Image: Smoklean device with two white filters |
| Service Period | Single Use | Single Use |
| Tube Material | PVC | PVC |
| Sterile | Yes | Yes |
| SterilizationMethod | Ethylene oxide | Ethylene oxide |
9. Conclusion
Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the Smoklean is substantially equivalent to the predicate device.
§ 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.