K Number

Device Name

Air Gap Fiber

Manufacturer

WON TECH Co., Ltd.

Date Cleared

2024-01-08

(178 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.

Device Description

The WONTECH Air Gap Fibers are available in 3 sizes. These are 272, 365 and 550 microns and designated as hard clad silica material. These sizes refer to the core diameters of the silica. All fibers are Low OH (hydroxide), especially adapted to delivering wavelengths of laser that are highly absorbed by water. However, for those wavelengths in which water absorption is not a limiting factor, Low OH fiber optic cables may be used as well. The fiber assemblies are configured with standardized SMA-905 connectors, which are the most commonly found connectors in use today. These Air Gap fibers are packaged in sterile, single use, peel away pouches for direct use in operating theaters. The Air Gap fibers are indicated for soft and hard tissue contact and prepared with a polished, flat distal end. The Air Gap fibers is standardized at 3 meters. These Air Gap Fibers may be used with laser outputs from 1-120 watts. The Air Gap Fibers are intended for use in laser surgical procedures including open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K170366

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical properties and intended use of laser fibers, with no mention of AI or ML capabilities. The performance studies are bench tests verifying physical specifications and compliance with standards, not evaluating algorithmic performance.

Therapeutic

Yes
The device is described as an accessory to laser systems used in surgical procedures for therapeutic actions like "ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application." These actions are medical treatments.

Diagnostic

No
The device description and intended use clearly state that the WONTECH Air Gap Fibers are delivery devices for surgical lasers, used for procedures like ablation, coagulation, incision, excision, or vaporizing of tissue. This indicates a therapeutic or surgical function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly details physical components (fibers, connectors, packaging) and bench testing related to physical properties (bend radius, tensile strength), indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the WONTECH Air Gap Fibers are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the fibers are for use in surgical procedures involving laser systems for soft and hard tissue applications (ablation, coagulation, incision, excision, vaporizing). This is a direct interaction with the patient's body during surgery.
Device Description: The description details a physical fiber optic cable designed to deliver laser energy for surgical purposes.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment.

IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. The WONTECH Air Gap Fibers are a surgical tool used on the body during a procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

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)

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
Sterilization: ISO 11737-2 2019, ISO 11737-1:2018, ASTM F1980-21, ISO 11135:2014/Amd 1:2018
Packaging: ASTM F1929-15 (No Leak result), ASTM F88/F88M-15 (Pass result)
Performance Testing: Accuracy and Stability, Bend Radius and tensile. No clinical studies were considered necessary and performed.

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.

K170366

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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

January 8, 2024

WON TECH Co., Ltd. Hyun Yoon General Manager 64 Techno8-ro, Yuseong-gu Daejeon, 34028 Korea, South

Re: K232106

Trade/Device Name: Air Gap Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 14, 2023 Received: August 2, 2023

Dear Hyun Yoon:

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.

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 (OS) 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 mediation-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-devices/deviceadvice-comprehensive-regulatory-assistance/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).

Sincerely.

Tanisha L. Hithe Tanisha L. s 2024.01.08 Hithe -S 20:38:15 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K232106

Device Name WONTECH Air Gap Fibers

Indications for Use (Describe)

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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Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside it, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is orange, while the "TECH" part is gray.

510(k) Summary

[As required by 21 CFR 807.92]

K232106

1. Date Prepared [21 CFR 807.92(a)(a)]

December 21th, 2023

2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]

Name of Manufacturer: WON TECH Co., Ltd.
Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028,
Republic of Korea
Contact Name: Hyun Sik Yoon
Telephone No.: +82-10-6750-5346
Fax No.: +82-70-7836-0110
Email Address: yoonhs21@wtlaser.com

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Common name: Laser, Fiber Optic Cable Trade name: Air Gap Fiber

Classification Description	21 CFR Section	Product Code
Powered Laser Surgical Instrument	878.4810	GEX

As stated in 21 CFR, parts 878.4810, the generic type of devices has been classified as Class II.

Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic to the left of the text "WONTECH". The graphic appears to be a stylized letter "W" or a checkmark symbol. The word "WON" is in orange, while "TECH" is in gray.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow:

Predicate device #1

. K170366 510(k) Number:
Applicant: Laser Peripherals LLC
Classification Name: Powered Laser Surgical Instrument ●
Trade Name: Family of Bare Laser Fibers

Description of the Device [21 CFR 807.92(a)(4)] ട്.

Indications for Use [21 CFR 807.92(a)(5)] 6.

Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea

TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491

7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between Air Gap Fiber and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.

	Proposed Device	Predicate Device #1	SE Decision
K Number	-	K170366	-
Manufacturer	WON TECH Co., Ltd.	Laser Peripherals LLC	-
Model	Air Gap Fiber	Family of Bare Laser Fibers	-
Intended Use	The WONTECH Air Gap Fibers are
indicated for use in all surgical
specialties in which compatible laser
systems with operational wavelengths
between 500 - 2200 nanometers have
received regulatory clearance. The Air
Gap Fiber delivery devices are
intended for use with any surgical
laser configured with an SMA-905
connector.	The Laser Peripherals Laser Fiber is
indicated for use in all surgical
specialties in which compatible laser
systems with operational wavelengths
between 500 - 2200 nanometers have
received regulatory clearance. The
Laser Peripherals Laser Fiber
delivery devices are intended for use
with any surgical laser configured
with an SMA-905 connector.	Same
Material	Silica Core & Cladding,
Fluoropolymer buffer.	Silica Core & Cladding,
Fluoropolymer buffer.	Same
Numerical
Aperture	0.22 - 0.048	0.22 - 0.048	Same
Fiber Material	Low Hydroxide	Low Hydroxide	Same
Configuration Tip	Flat	Flat	Same
Use	Universal handpieces, endoscopes,
cannulas	Universal handpieces, endoscopes,
cannulas	Same
Core Sizes	272, 365 and 550 microns	272, 365 and 550 microns	Same
Laser
Power
Range	1 to 120 watts	1 to300 watts	Similar but the
range of
the
proposed
device
is
included in the
range of the
predicate
device.
Suitable
Laser
Wavelengths	980 to 2200 nanometers	500 to 2200 nanometers	Similar but the
range of
the
proposed
device
is
included in the
range of the
predicate
device.
Laser
Compatibility	Any cleared or approved lasers	Any cleared or approved lasers	Same

Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH" in two different colors. The "WON" part of the text is in orange, while the "TECH" part is in gray.

The WONTECH Air Gap Fibers are substantially equivalent to the predicate device.

The accompanying table of comparison details the specification of the predicate (K170366) Laser Peripherals, LLC Family of Laser Fibers and the proposed device.

This table compares the intended use, features, and technological characteristics of the proposed subject device and the predicate.

The Intended Uses for the WONTECH Air Gap Fibers and the predicate devices are not different in any evaluative manner.

The WONTECH Air Gap Fibers are similar to the predicate devices in that all make almost identical claims. These differences are not critical to the intended therapeutic, surgical use of the device and do not raise any new issues of safety or efficacy. Wavelength range does not vary between the predicate devices.

Image /page/8/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside it, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray.

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1) Sterilization

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

| Standard

(Edition)	Standard Title
ISO 11737-2 2019	Sterilization of medical devices - Microbiological methods - Part 2: Tests
of sterility performed in the definition, validation and maintenance of a
sterilization process
ISO 11737-1:2018	Sterilization of health care products - Microbiological methods – Part 1.
Determination of a population of microorganisms on products.
ASTM F1980-21	Standard Guide for Accelerated Aging of Sterile Barrier Systems for
Medical Devices
ISO 11135:2014/Amd 1:2018	Sterilization of health care products -- Ethylene oxide -Requirements for
development, validation and routine control of a sterilization process for
medical devices

2) Software Validation

There is no software available for this device.

3) Biocompatibility

| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|-------|-------------|----------------------------------------------------|---------------------------------------|-----------------------|
| Fiber | Silica Core | Blood path,
indirect
tissue/
bone/dentin. | Limited
(