(252 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of surgical optic fibers for laser systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a surgical optic fiber used for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, which are direct therapeutic actions.
No
The device is a surgical optic fiber used for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, primarily for delivering laser energy, not for diagnosis.
No
The device description clearly identifies the device as "surgical laser fiber" and describes physical components (bare-typed fiber, radial-typed fiber, distal end shape). The performance studies section also details bench tests conducted on the physical device, referencing standards related to sterilization, packaging, and biocompatibility, which are not applicable to software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the WONTECH Surgical Optic Fibers are indicated for use in surgical specialties for procedures like incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue. This describes a device used on the body during a surgical procedure.
- Device Description: The description further reinforces this by detailing its use with surgical laser systems and its function in delivering laser energy for tissue modification.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
The device is a surgical instrument used to deliver laser energy for therapeutic purposes during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.
Product codes
GEX
Device Description
WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R as surgical laser fiber is indicated for use in general surgical applications of incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode with a compatible laser system marketed for use in the desired application. Especially, they are indented for endovascular of blood vessels. WT-SMA-400(or BA400)/WT-SMA-600(or BA600) is bare-typed fiber and BA400R/BA600R is radial-typed fiber. The shape of distal end of fiber is different between bare and radial fiber. Bare fiber distal end is flat to radiate laser straightly, but radial fiber distal end is conical to radially.
Additionally, BA400 and BA600 have same design with the each original model(WT-SMA-400 and WT-SMA-600). The additional model name(BA400 and BA600) and each original model name(WT-SMA-400 and WT-SMA-600) need to be alternatively exchanged and labeled depending on customer requirement.
WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode and output power less than 30 W.
They are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Tm:YAG pulsed and continuous wave CW laser devices. They were designed to be connected with laser medical device consisted with SMA905 connector according to IEC 61754-22 and output power less than 30 W.
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:
1 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 EN 556-1:2001/AC:2006, Sterilization of medical devices- requirements for medical devices to be designated "STERILE"-Part1: Requirements for terminally sterilized medical devices
3 ISO 11138-1:2017, Sterilization of health care products - Biological indicators - Part 1: General requirements
4 ISO 11138-2:2017, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
5 ISO 11737-1:2018, Sterilization of health care products -- Microbiological methods Part 1: Determination of a population of microorganisms on products
6 ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of sterilization process.
7 ISO 11607-1:2019, Packaging for terminally sterilized medical device Part1: Requirements for materials, sterile barrier systems and packaging systems
8 ISO 11607-2:2019, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
9 ISO 11140-1:2014, Sterilization of health care products -- Chemical indicators - Part 1: General requirements
10 EN 1422:2014, Sterilizers for purposes - ethylene oxide sterilizers - specification
11 ISO 10993-7:2008/Amd 1:2019, Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals
The packaging of the WONTECH Surgical Optic Fibers is validated.
No. 1. Packaging dye penetration test, Standard: ASTM F1929-15 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Report No.: 2022-GPR-172 2022-GPR-208 2022-GPR-226. Result: No Leak.
No. 2. Packing sealing strength test, Standard: ASTM F88/F88M-15 – Standard Test Method for Seal Strength of Flexible Barrier Materials. Report No.: 2022-GPR-171 2022-GPR-207 2022-GPR-225. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below.
February 14, 2025
WONTECH Co., Ltd Hyun Sik Yoon General Manager 64 Techno-8ro. Yuseong-gu Daejeon, 34028 Korea. South
Re: K241643
Trade/Device Name: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600R) 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: January 14, 2025 Received: January 14, 2025
Dear Hyun Sik 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/cdrb/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.
1
Page 2
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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.
2
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-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).
Sincerely,
TANISHA - Digitally signed by L. HITHE -S 21:53:02 -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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Indications for Use (Describe)
WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.
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
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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 of it. To the right of the circle is the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
June 5th, 2024
Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.
-
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: WONTECH Surgical Optic Fiber Trade name: BA400/BA400R/BA600/BA600R
| 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.
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Image /page/5/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 a bold, sans-serif font. The "WON" part of the text is orange, while the "TECH" part is 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
- . 510(k) Number: K220189
- Applicant: Omni-Guide Holdings, Inc
- Classification Name: Powered Laser Surgical Instrument ●
- Trade Name: LISA Laser Surgical Fibers
5. Description of the Device [21 CFR 807.92(a)(4)]
WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R as surgical laser fiber is indicated for use in general surgical applications of incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode with a compatible laser system marketed for use in the desired application. Especially, they are indented for endovascular of blood vessels. WT-SMA-400(or BA400)/WT-SMA-600(or BA600) is bare-typed fiber and BA400R/BA600R is radial-typed fiber. The shape of distal end of fiber is different between bare and radial fiber. Bare fiber distal end is flat to radiate laser straightly, but radial fiber distal end is conical to radially.
Additionally, BA400 and BA600 have same design with the each original model(WT-SMA-400 and WT-SMA-600). The additional model name(BA400 and BA600) and each original model name(WT-SMA-400 and WT-SMA-600) need to be alternatively exchanged and labeled depending on customer requirement.
WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode and output power less than 30 W.
They are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Tm:YAG pulsed and continuous wave CW laser devices. They were designed to be connected with laser medical device consisted with SMA905 connector according to IEC 61754-22 and output power less than 30 W.
Indications for Use [21 CFR 807.92(a)(5)] 6.
WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 532nm - 2200mm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.
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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside of it. To the right of the circle is the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
| Proposed Device | Predicate Device #1 | SE Decision | |
|---|---|---|---|
| K Number | - | K220189 | - |
| Manufacturer | WON TECH Co., Ltd. | Omni-Guide Holdings, Inc. | - |
| Model | WONTECH Surgical Optic Fibers | Omni-Guide LISA Laser Surgical | |
| Fibers | - | ||
| Indications for | |||
| Use | WONTECH Surgical Optic Fibers are | ||
| indicated for use in all surgical | |||
| specialties in which compatible laser | |||
| systems with operational wavelengths | |||
| between 532nm - 2200nm have | |||
| received regulatory clearance. | |||
| WONTECH Surgical Optic Fibers are | |||
| intended for use with any cleared | |||
| surgical laser with an SMA 905 | |||
| connector. | WONTECH Surgical Optic Fibers are | ||
| indicated for use in all surgical | |||
| specialties in which compatible laser | |||
| systems with operational wavelengths | |||
| between 500nm - 2200nm have | |||
| received regulatory clearance. | |||
| WONTECH Surgical Optic Fibers are | |||
| intended for use with any cleared | |||
| surgical laser with an SMA 905 | |||
| connector, SMA 906 connector, or | |||
| manufacturer specific connectors and | |||
| adapters. | Similar, the only | ||
| difference is types of | |||
| supported connector. | |||
| Laser Source | Use with any cleared surgical | ||
| laser with an SMA 905 | |||
| connector. | Use with any cleared surgical laser | ||
| with an SMA 905 connector, SMA 906 | |||
| connector, or manufacturer specific | |||
| connectors and adapters. | Similar, the only | ||
| difference is types of | |||
| supported connector. | |||
| Connectors | SMA 905 | SMA 905 connector, SMA 906 | |
| connector, or manufacturer specific | |||
| connectors and adapters. | Similar, but the | ||
| specification of | |||
| proposed device is | |||
| included in the range | |||
| of predicate device. | |||
| Wavelength | 532nm - 2100nm | 500nm - 2100nm | Similar, |
| but | |||
| the | |||
| specification | |||
| of | |||
| proposed device is | |||
| included in the range | |||
| of predicate device. | |||
| Maximum | |||
| Power | 1-30 Watts | 1-300 Watts | Same |
| Fiber Sizes | 400 and 600 microns | Fibers are offered in a range of sizes | |
| suitable to user needs. | Similar/Equivalent | ||
| Outer Diameter | Diameter 400 microns : 730 microns | ||
| Diameter 600 microns : 750 microns | Core diameters are offered in a range | ||
| of sizes suitable to user needs | Similar/Equivalent | ||
| Fiber Core | |||
| Material | Silica Glass | Fused Silica | Similar/Equivalent |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilizaton | EO gas | EO gas | Same |
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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange checkmark-like symbol on the left, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray. The logo has a clean and modern design.
| Method | |||
|---|---|---|---|
| -------- | -- | -- | -- |
The WONTECH Surgical Optic Fibers that are the subject of this premarket notification use identical or similar technology as that of the single-use fibers of the K220189 510(k). Differences between the proposed and predicate fibers do not raise new types of concerns for safety and effectiveness, and performance testing demonstrates that the Inno Voyce single-use optical fibers can be used safely and effectively for the proposed indications for use. The WONTECH Surgical Optic Fibers are considered to be substantially equivalent to the predicate K220189.
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 written in the sterilization test report are;
1 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 EN 556-1:2001/AC:2006, Sterilization of medical devices- requirements for medical devices to be designated "STERILE"-Part1: Requirements for terminally sterilized medical devices
3 ISO 11138-1:2017, Sterilization of health care products - Biological indicators - Part 1: General requirements
4 ISO 11138-2:2017, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
5 ISO 11737-1:2018, Sterilization of health care products -- Microbiological methods Part 1: Determination of a population of microorganisms on products
6 ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of sterilization process.
7 ISO 11607-1:2019, Packaging for terminally sterilized medical device Part1: Requirements for materials, sterile barrier systems and packaging systems
8
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, followed by the text "WONTECH" in orange. The "TECH" portion of the text is in a darker shade of gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
8 ISO 11607-2:2019, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
9 ISO 11140-1:2014, Sterilization of health care products -- Chemical indicators - Part 1: General requirements
10 EN 1422:2014, Sterilizers for purposes - ethylene oxide sterilizers - specification
11 ISO 10993-7:2008/Amd 1:2019, Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals
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
(