Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a light-guided needle and light source for visual guidance during a medical procedure. There is no mention of AI, ML, image processing, or data analysis for decision-making or interpretation.

Therapeutic

No
The device is a light-guided needle system used to indicate an injection site during laryngoplasty. It does not deliver drugs, treat, mitigate, or cure any disease or condition. Its primary function is to aid in the procedure by providing visual guidance.

Diagnostic

No

The device is described as a light-guided needle system used for injection laryngoplasty to indicate the injection site with visible light, not to diagnose a medical condition. Its function is to facilitate a procedure by illuminating the target area.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components: a needle, a light generator (AC-powered), fiber optic cables, and connectors. Performance studies also include biocompatibility, electrical safety, and EMC testing, which are typical for hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that the Lightin System is a needle with an optical fiber and a light source used for injection laryngoplasty. Its purpose is to indicate the injection site with visible light during a surgical procedure. It does not analyze any biological samples or provide diagnostic information based on such analysis.
Intended Use: The intended use is for a surgical procedure to address glottic incompetence, not for diagnostic testing.
Device Description: The description focuses on the physical components and how they function to deliver light and facilitate injection, not on any analytical capabilities.

Therefore, the Lightin System is a surgical tool used during a procedure, not a device that performs in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Lightin is a needle for injection laryngoplasty with an optical fiber.

Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin.

Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.

Product codes

SBS, EQH

Device Description

Lightin System consists of Lightin and Lightin Generator.

Lightin is a light-guided needle used injection laryngoplasty and Light generator delivers the light energy to Lightin by generating LED light from an AC-powered light source.

Lighin consists of injection needle, Y-connector and SMA connector/cable.

The light transmitted from the Lightin Generator is emitted from the tip of fiber optics embedded within Lightin.

Lightin system used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

glottic, vocal fold

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 performance testing has been performed for the proposed device;

Biocompatibility Testing
Lightin was accessed for conformity with the requirements of ISO 10993 series.

ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Recognition No: 2-245)
ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization (Recognition No: 2-296)
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation (Recognition No: 2-291)
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (Recognition No: 2-255)
USP Pyrogen Test (Recognition No:2-292)

Electrical Safety & EMC Testing
Lightin Generator was accessed for conformity with the requirements of IEC series.

IEC 60601-1:2005/AMD2:2012 Edition 3.0 2012 MEDICAL ELECTRICAL EQUIPMENT - Part 1: General requirements for safety and essential performance. (Recognition No: 19-4)
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General requirements of basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition No: 19-8)
IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (Recognition No: 19-19)

Non-Clinical Performance Testing
Lightin was accessed for conformity with the below requirements.

ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (Recognition No: 5-133)
ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (Recognition No: 5-97)
ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methods (Recognition No : 6-379)
ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods (Recognition No: 6-380)
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] (Recognition No: 14-529)
ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Recognition No: 14-497)
ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (Recognition NO: 14-484)
ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials (Recognition No: 14-482)
USP Sterility Test (Recognition No: 14-569)
Internal test standard: light output test , Thermal measurement test
ASTM D4169-22: Standard Practice Performance Testing of Shipping Containers and Systems (Recognition No: 14-576)

Performance Testing
Lightin System was accessed for conformity with the below requirements.

The Lightin System successfully directs the laryngoplastic injection material to the target area within the vocal fold.
The tissue heating concerns by the tip illumination.

Lightin and Lightin Generator was accessed for conformity with the below requirements.

IEC 62471: 2006 Photobiological safety of lamps and lamp systems (Recognition No; 12-249)
Internal Test Standard: Light Output Test

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

510K Exempt (CL 1) (Aspen Surgical Products, Inc. Symmetry Surgical), 510K Exempt (CL 1) (AESCULAP AG AESCULAP® LED LIGHT SOURCE)

Reference Device(s)

K151604, K233037

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 10, 2024

Solmedix Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Ste 610 Houston, Texas 77054

Re: K232177

Trade/Device Name: Lightin System (Lightin, Lightin Generator) Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: SBS, EQH Dated: June 12, 2024 Received: June 12, 2024

Dear Dave Kim:

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.

1

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 (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.

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-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,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices

2

OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K232177

Device Name Lightin System (Lightin, Lightin Generator)

Indications for Use (Describe)

Lightin is a needle for injection laryngoplasty with an optical fiber.

Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin.

Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.

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 contains the logo for Solmedix. The logo features the word "solmedix" in gray, with a yellow accent mark on the left side of the word and a yellow trademark symbol on the right side. The font is sans-serif and the overall design is simple and modern.

#706, 330, Seongarm-ro, Map 03920 Rep. of Korea Tel +82-2-717-7852

510(k) Summary

K232177

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

Date: June 4. 2024

2. Manufacturer and 510(k) Sponsor

. Name: Solmedix Co., Ltd.
. Address: #706, 330, Seongarm-ro, Mapo-gu, Seoul, 03920 Republic of Korea
. Contact Name: Hyeroung Lee (Ms) / RA Part Leader
Telephone number: +81-2-3153-7717 ●
. E-mail address: hrlee@solmedix.com

3. Submission Correspondent

Name: Dave Kim, MBA ●
. Company Name: Mtech Group LLC
Address: 7505 Fannin St. Suite 610, Houston, TX 77054, USA
Telephone number: 713-467-2607
. E-mail address: davekim@mtechgroupllc.com

4. Device Identification

The subject device is comprised of the following components:

Trade Name	Lightin
Device Classification Name	Set, Laryngeal Injection
Regulation Number	21CFR§874.4420
Regulation Class	Class I
Classification Product Code	SBS
Classification Pannel	Ear Nose & Throat

Trade Name	Lightin Generator
Device Classification Name	Source, Carrier, Fiberoptic Light
Regulation Number	21CFR§874.4350
Regulation Class	Class I
Classification Product Code	EQH
Classification Pannel	Ear Nose & Throat

5

Image /page/5/Picture/0 description: The image shows the word "solmedix" in gray letters. The "s" and the "x" are connected to yellow accents. The yellow accent on the left is a vertical line, and the yellow accent on the right is a curved vertical line.

5. Legally Marketed Predicate Device

Predicate Device #1

Manufacturer	Aspen Surgical Products, Inc.
Trade Name	Symmetry Surgical
510(k)	510K Exempt (CL 1)
Regulation Number	21CFR§874.4420
Regulation Class	Class I
Product Code	KAA
Classification Panel	Ear Nose & Throat

Predicate Device #2

Manufacturer	AESCULAP AG
Trade Name	AESCULAP® LED LIGHT SOURCE
510(k)	510K Exempt (CL 1)
Regulation Number	21CFR&874.4350
Regulation Class	Class I
Classification Product Code	EQH
Classification Pannel	Ear Nose & Throat

Reference Device #1

Manufacturer	Peregrine Surgical Ltd
Trade Name	23ga and 25 ga Adjustable Chandelier Illuminator
510(k)	K151604
Regulation Number	21CFR&876.1500
Regulation Class	Class II
Product Code	MPA
Classification Pannel	Ear Nose & Throat

Reference Device #2

Manufacturer	Zhejiang Kindly Medical Device Co., Ltd.
Trade Name	Sterile Hypodermic Needles for Single Use
510(k)	K233037
Regulation Number	21 CFR&880.5570
Regulation Class	Class II
Product Code	FMI
Classification Pannel	General hospital

6. Device Description

Lightin System consists of Lightin and Lightin Generator.

Lightin is a light-guided needle used injection laryngoplasty and Light generator delivers the light energy to Lightin by generating LED light from an AC-powered light source.

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Image /page/6/Picture/0 description: The image shows the logo for "solmedix". The word "solmedix" is written in gray letters. There is a yellow bracket on the left side of the word and a yellow design on the right side of the word.

#706, 330, Seongarm-ro, Mapo-qu, Seoul 03920 Rep. of Korea Tel +82-2-717-7852

Lighin consists of injection needle, Y-connector and SMA connector/cable.

The light transmitted from the Lightin Generator is emitted from the tip of fiber optics embedded within Lightin.

Lightin system used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.

7. Indications for Use

Lightin is a needle for injection laryngoplasty with an optical fiber.

Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin.

Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.

7

Image /page/7/Picture/0 description: The image shows the logo for Solmedix, followed by their address: #706, 330, Seongarm-ro, Mapo-gu, Seoul. The image also includes the postal code, 03920, and the country, Rep. of Korea. Finally, the image shows the telephone number: +82-2-717-7852.

8. Comparison Table of Technological Characteristics with the predicated device

A. Lightin

Attribute	Predicate Device #1	Proposed device	Remark
Product name	Symmetry Surgical	Lightin,
Lightin System
510(k) no	510K Exempt (CL 1)	K232177
Product Code	KAA	SBS
Manufacturer	Aspen Surgical Products, Inc.	Solmedix Co., Ltd
Indications for use	An ear, nose, and throat manual
surgical instrument is one of a variety
of devices intended for use in surgical
procedures to examine or treat larynx.
This generic type of device includes
laryngeal injection set.	Lightin is a needle for injection
laryngoplasty with an optical fiber.
Lightin generator is an AC-powered
light source including Light Guide
which is fiber optic cable that
transmits light at the tip of fiber
optics embedded within Lightin.
Lightin System is used for injection
laryngoplasty to address glottic
incompetence to indicate the
injection site with visible light.	Similar
Predicate Device #1 and Lightin is the same
as that used for laryngeal injection.
Lightin uses LED light to indicate the injection
site and the LED source emits light through
the PMMA fiber in the needle. Considering
the application area and the indications for
use, Lightin has less risk than the predicate
device.
Appearance	No information	Image: A blue fiber optic cable	Similar
The needle tip resembles an injection needle,

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Image /page/8/Picture/0 description: The image shows the logo for "solmedix". The word "solmedix" is written in gray letters. There is a yellow bracket on the left side of the word and a yellow bracket on the right side of the word.

Tel +82-2-717-7852

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Image /page/9/Picture/0 description: The image shows the logo for "solmedix". The word "solmedix" is written in gray letters. There is a yellow bracket on the left side of the word and a yellow "J" on the right side of the word.

Tel +82-2-717-7852

Reference Device #1: K151604

Attribute	Reference device #1	Proposed device	Remark
Product name	23ga and 25ga Adjustable Chandelier
Illuminator	Lightin,
Lightin System
510(k) no	K151604	K232177
Product Code	MPA	SBS
Manufacturer	Peregrine Surgical, Ltd	Solmedix Co., Ltd
Indications for use	Adjustable Chandelier Illuminator family
of ophthalmic illuminators is for wide
angle illumination during ophthalmic
surgery.	Lightin is a needle for injection
laryngoplasty with an optical
fiber.
Lightin generator is an AC-
powered light source including
Light Guide which is fiber optic
cable that transmits light at the tip
of fiber optics embedded within
Lightin.
Lightin System is used for
injection laryngoplasty to address
glottic incompetence to indicate	Similar
For the reference #1, the main Indication for use is
for wide-angle illumination during ophthalmic
surgery. However, Lightin uses LED light to
indicate the injection laryngoplasty site. Although
there is a difference such as in the indication for
use, Reference #1 and Lightin have similar
technical characteristics in that the LED source
emits light through the PMMA fiber in the needle.
		the injection site with visible light.

Appearance	Image: Synergetics needle in packaging	Image: Blue needle	Similar
For Reference #1, its needle tip resembles an
injection needle, and its inclusion of a light-
transmitting fiber is similar.
Jacket Material	PTFE (Polytetrafluoroethylene)	PVC	Similar
The Reference #1 device has fiber optics inserted
in the needle, same as Lightin. The jacket
materials protecting the fiber optic of the two
devices are different, but both are commonly used.
Jacket Color	Black/Green
Black/Blue	Blue
Orange	Similar
Jacket is color coded for needle identification.
Color coding was applied to Lightin according to
the needle gauge standard.
Illumination Fiber -
OD	0.015"	0.125mm (0.004521")	Different
The difference of the illumination fiber outer
diameter (O.D.) is due to the functional
			characteristics of the two devices. Reference #1 is
used for wide-angle illumination and Lightin is used
for marking the injection laryngoplasty site. Due to
this functional difference, the illumination fiber OD
of the reference #1 is bigger than that of Lightin.
Illumination Fiber
Material	PMMA
(Polymethyl methacrylate with
Fluorinated Polymer Cladding)	PMMA
(Polymethyl methacrylate with
Fluorinated Polymer Cladding)	Same
Needle size	1. 23G

25G | 1. 23G
25G | Same |
| Needle Material | 304 stainless Steel | 304 stainless Steel | Same |
| Reusable/
Disposable | Disposable | Disposable | Same |
| Sterilization | EO | EO | Same |

Page 6 / 13

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Image /page/10/Picture/0 description: The image shows the word "solmedix" in gray font. There is a yellow bracket on the left side of the word and a yellow bracket on the right side of the word. The brackets are not complete, and they are only partially visible.

Tel +82-2-717-7852

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Image /page/11/Picture/0 description: The image shows the word "solmedix" in gray font. There is a yellow bracket on the left side of the word and a yellow "j" on the right side of the word. The font is sans-serif and the background is white.

03920 Rep. of Korea

Tel +82-2-717-7852

Reference Device #2: K233037

Attribute	Reference Device #2	Proposed device
Product name	Sterile Hypodermic Needles for
Single Use	Lightin,
Lightin System
510(k) no	K233037	K232177
Product Code	FMI	SBS
Manufacturer	Zhejiang Kindly Medical Device Co.,
Ltd.	Solmedix Co., Ltd
Indications for use	Sterile Hypodermic Needle for Single
Use are intended for use with
syringes and injection devices for	Lightin is a needle for injection
laryngoplasty with an optical fiber.
Lightin generator is an AC-powered light	Similar
Reference Device #2 and Lightin are
same as injection needles for a single

Page 8 / 13

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Image /page/12/Picture/0 description: The image contains the word "solmedix" in gray font. There is a yellow bracket on the left side of the word and a yellow bracket on the right side of the word. The right bracket has a trademark symbol next to it.

Tel +82-2-717-7852

| | general purpose fluid
injection/aspiration. | source including Light Guide which is fiber
optic cable that transmits light at the tip of
fiber optics embedded within Lightin.
Lightin System is used for injection
laryngoplasty to address glottic
incompetence to indicate the injection site
with visible light. | use.
Lightin is used for laryngeal injection and
RD #2 is used as an injection device for
general purpose.
Lightin has narrower indication of use
than RD#2. |
|------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Needle size | 14G~34G | 1. 23G
2. 25G | Similar |
| Needle Material | 304 Stainless Steel | 304 Stainless Steel | Same |
| Reusable/
Disposable | Disposable | Disposable | Same |
| Sterilization | EO | EO | Same |
| Performance
Specification | ISO7864
ISO9626
ISO80369-7
ISO8039-20 | ISO7864
ISO9626
ISO80369-7
ISO8039-20 | Same |

B. Lightin Generator

Attribute	Predicate device #2	Proposed device	Remark
Product name	AESCULAP® LED LIGHT SOURCE	Lightin Generator,
Lightin System
510(k) no	510K Exempt (CL 1)	K232177
Product code	EQH	EQH	Same
Manufacturer	AESCULAP, AG.	Solmedix co., Ltd

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Image /page/13/Picture/0 description: The image contains the word "solmedix" in gray font. The first and last letters of the word are enclosed in yellow brackets. The brackets are slightly raised above the word.

03920 Rep. of Korea

			Similar
Indications for use	The device is intended for use in
endoscopy systems for human
medicine. In combination with a light
lead, endoscope, camera and monitor,
its purpose is to illuminate the inside of
the human body.	Lightin generator is an AC-powered light
source including Light Guide which is fiber
optic cable that transmits light at the tip of
fiber optics embedded within Lightin.	Predicate Device #2 and Lightin
Generator are the same light sources that
generate LED light.

Lightin Generator, its intended use is
restricted solely to Lightin for injection
laryngoplasty.

Different
The adapter of PD #2 is compatible to
connect various optical fiber cables to the |
| | Optical Cable
Power cord | | LED light source, but the Lightin
Generator is exclusive to Lightin, so no
compatible parts are required. |
| Technical
Specification | Output (at the end light guide) : 240W | Output (at the end light guide): $\le$ 8mW | Different
The output of PD #2 is higher than that
of Lightin Generator because PD #2
uses the LED light to illuminate the board
surgical site during surgical procedures.
However, Lightin Generator needs much
lower output than PD #2 because Lightin
Generator uses the LED light to indicate
the small injection laryngoplasty site and
the low output of Lightin Generator is
technically sufficient for use. |
| Safety | IEC60601-1
IEC60601-1-2 | IEC60601-1
IEC60601-1-2 | Same |
| Reusable/Disposable | Reusable | Reusable | Same |
| Sterilization | N/A | N/A | Same |

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Image /page/14/Picture/0 description: The image contains the word "solmedix" in gray font. The first and last letters of the word are enclosed in yellow brackets. The brackets are slightly raised above the word.

03920 Rep. of Korea

Tel +82-2-717-7852

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Image /page/15/Picture/0 description: The image shows the logo for Solmedix. The word "solmedix" is written in gray letters. There is a yellow bracket on the left side of the word and a yellow "J" on the right side of the word.

#706, 330, Seongarm-ro, 03920 Rep. of Korea Tel +82-2-717-7852

9. Conclusion on SE based on Technical Comparison and Performance Data

The following performance testing has been performed for the proposed device;

Biocompatibility Testing

Lightin was accessed for conformity with the requirements of ISO 10993 series.

ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Recognition No: 2-245)
ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin ● sensitization (Recognition No: 2-296)
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation (Recognition No: 2-291)
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (Recognition No: 2-255)
. USP Pyrogen Test (Recognition No:2-292)

Electrical Safety & EMC Testing

Lightin Generator was accessed for conformity with the requirements of IEC series.

IEC 60601-1:2005/AMD2:2012 Edition 3.0 2012 MEDICAL ELECTRICAL EQUIPMENT ● - Part 1: General requirements for safety and essential performance. (Recognition No: 19-4)
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition No: 19-8)
IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment Part 4-2: Guidance ● and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems (Recognition No: 19-19)

Non-Clinical Performance Testing

Lightin was accessed for conformity with the below requirements.

ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (Recognition No: 5-133)
ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (Recognition No: 5-97)

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Image /page/16/Picture/0 description: The image contains the logo for "solmedix". The logo is in gray, except for the left bracket and the trademark symbol, which are in yellow. The text is in a sans-serif font and is slightly blurred.

#706, 330, Seongarm-ro, Mapo-qu, Seoul 03920 Rep. of Korea Tel +82-2-717-7852

. ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methods (Recognition No : 6-379)
ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods(Recognition No: 6-380)
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] (Recognition No: 14-529)
ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Recognition No: 14-497)
ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration (Recognition NO: 14-484)
ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier ● Materials (Recognition No: 14-482)
USP Sterility Test (Recognition No: 14-569)
Internal test standard: light output test , Thermal measurement test
ASTM D4169-22: Standard Practice Performance Testing of Shipping Containers and ● Systems (Recognition No: 14-576)

Performance Testing

Lightin System was accessed for conformity with the below requirements.

. The Lightin System successfully directs the laryngoplastic injection material to the target area within the vocal fold.
. The tissue heating concerns by the tip illumination.

Lightin and Lightin Generator was accessed for conformity with the below requirements.

IEC 62471: 2006 Photobiological safety of lamps and lamp systems (Recognition No; 12-● 249)
. Internal Test Standard: Light Output Test

10. Conclusions

Based on a comparison of the various predicate devices and the reference device with the proposed Lightin System in terms of indication for use, technological characteristics, material and performance specifications, Lightin System raises no new issues of safety and effectiveness and is substantially equivalent to the predicate devices.