(231 days)
Not Found
No
The description focuses on passive filtration and mechanical components, with no mention of AI/ML terms or functionalities.
No
The device is described as a smoke evacuation system that removes particles from surgical smoke. It does not treat a disease or condition in a patient. Instead, it seems to improve the surgical environment by maintaining a clear field of vision and minimizing the negative effects of smoke on the surgeon. The predicate device, also a smoke filtration system, further supports this view.
No
The device is a passive smoke evacuation system that removes surgical smoke particles during laparoscopic procedures and does not perform any diagnostic function.
No
The device description explicitly details physical components (tubing, body with filters, adaptor) and performance studies include physical tests (tensile strength, filtration verification), indicating it is a hardware device.
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 particles from surgical smoke generated during laparoscopic procedures. This is a physical process performed during surgery to improve visibility and remove harmful substances from the surgical environment.
- Device Description: The description details a system for filtering smoke, consisting of tubing, a body with filters, and an adaptor. This aligns with a physical filtration system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The device interacts with smoke generated in vivo (within the body during surgery).
Therefore, Smoklean is a surgical accessory used for smoke evacuation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.
Product codes (comma separated list FDA assigned to the subject device)
FYD
Device 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. 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.
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)
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.
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.
0
Image /page/0/Picture/0 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.
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);
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
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.
4
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 LAPAROSCOPIC |
| SMOKE FILTRATION SYSTEM, MODEL | ||
| CLSF1 | ||
| 510(k) Number | K173108 | K992361 |
| Device | ||
| Classification | ||
| Name | apparatus, exhaust, surgical | apparatus, exhaust, surgical |
| Classification | ||
| Product Code | FYD | FYD |
| Regulation | ||
| Number | 878.5070 | 878.5070 |
5
| Indications for
Use | Smoklean is a passive smoke evacuation
system which removes particles from
surgical smoke generated in laparoscopic
procedures while maintaining a clear
field of vision. | The proposed device is intended for the
filtration of contaminants from smoke,
generated during laparoscopic surgery,
which can contain volatile organic products
of combustion (including those which are
perceived as odor) and particles (including
cellular debris, bacteria, and viruses). |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design Features | The device is consisted of 35cm tubing, a
body with filters and an adaptor.
Image: Smoklean device with tubing | The device is consisted of 45cm tubing, a
body 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 |
| Sterilization
Method | 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.