Smoklean

K173108 · Sejong Medical Co., Ltd. · FYD · May 18, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173108
• Device Name: Smoklean
• Applicant: Sejong Medical Co., Ltd.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended 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.

Device Story

Passive smoke evacuation system for laparoscopic surgery; connects to trocar body or single port; filters smoke generated during tissue cauterization; removes particles to maintain clear field of vision; single-use device; operated by surgical staff in operating room; benefits include improved visualization and reduced exposure to surgical smoke.

Clinical Evidence

Bench testing only. Performance data includes sterilization validation (ISO 11135-1:2007), shelf life, appearance, dimensional measurement, deodorization (ammonia, formaldehyde), EO residuals (ISO 10993-7:2008), sterility (ISO 11737-2:2009), tensile strength, and smoke particulate filtration verification.

Technological Characteristics

Passive smoke evacuation system; consists of 35cm PVC tubing, body with filters, and adapter (4.25 x 5.04mm connection). Sterilized via ethylene oxide. Single-use. No electronic components or software.

Indications for Use

Indicated for patients undergoing laparoscopic procedures to remove surgical smoke particles and maintain clear vision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 (K992361)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K173108

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) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> 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: [phone] Fax: [phone]

### 2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: [phone] Fax: [phone] Email: [e-mail]

### 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 (tube~body), 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<br>SMOKE FILTRATION SYSTEM, MODEL<br>CLSF1 |
| 510(k) Number | K173108 | K992361 |
| Device<br>Classification<br>Name | apparatus, exhaust, surgical | apparatus, exhaust, surgical |
| Classification<br>Product Code | FYD | FYD |
| Regulation<br>Number | 878.5070 | 878.5070 |

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| Indications for<br>Use | Smoklean is a passive smoke evacuation<br>system which removes particles from<br>surgical smoke generated in laparoscopic<br>procedures while maintaining a clear<br>field of vision. | The proposed device is intended for the<br>filtration of contaminants from smoke,<br>generated during laparoscopic surgery,<br>which can contain volatile organic products<br>of combustion (including those which are<br>perceived as odor) and particles (including<br>cellular debris, bacteria, and viruses). |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design Features | The device is consisted of 35cm tubing, a<br>body with filters and an adaptor.<br>Image: Smoklean device with tubing | The device is consisted of 45cm tubing, a<br>body with filters and an adaptor.<br>Image: Smoklean device with two white filters |
| Service Period | Single Use | Single Use |
| Tube Material | PVC | PVC |
| Sterile | Yes | Yes |
| Sterilization<br>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.