(352 days)
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.
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.
The provided document is a 510(k) summary for the Solmedix Lightin System, which is a medical device for injection laryngoplasty. This summary primarily focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in a format typical for an AI/ML device.
Here's an analysis based on the information provided, specifically addressing the points requested, while noting that many are not applicable or not explicitly detailed for this type of device submission:
1. Table of acceptance criteria and the reported device performance
For a Class I device seeking 510(k) clearance, the "acceptance criteria" are generally compliance with recognized standards and demonstration that the device performs as intended and is as safe and effective as a predicate device. This document lists the standards the device conforms to and describes various tests performed. It does not provide specific quantitative performance metrics with associated acceptance thresholds in the way an AI/ML device submission often would.
However, based on the non-clinical performance testing sections, we can infer some criteria and reported performance:
| Criterion Type | Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Lightin (Needle) | ||
| Biocompatibility | Conformity to ISO 10993 series for cytotoxicity, skin sensitization, irritation, systemic toxicity, and pyrogenicity. | Lightin was "accessed for conformity" and presumably passed all listed ISO 10993 tests (ISO 10993-5, -10, -23, -11) and USP <151> Pyrogen Test. |
| Small-bore Connectors | Conformity to ISO 80369-7 and ISO 80369-20 for intravascular/hypodermic connectors and common test methods. | Lightin was "accessed for conformity" and presumably passed ISO 80369-7 and ISO 80369-20. |
| Hypodermic Needles | Conformity to ISO 7864 for sterile hypodermic needles. | Lightin was "accessed for conformity" and presumably passed ISO 7864. |
| Stainless Steel Needle Tubing | Conformity to ISO 9626 for stainless steel needle tubing. | Lightin was "accessed for conformity" and presumably passed ISO 9626. |
| Sterilization (Ethylene Oxide) | Conformity to ISO 11135 for EO sterilization development, validation, and routine control. | Lightin was "accessed for conformity" and presumably passed ISO 11135. |
| Packaging Integrity | Conformity to ASTM F1980 (Accelerated Aging), ASTM F1929 (Dye Penetration), and ASTM F88/F88M (Seal Strength). | Lightin was "accessed for conformity" and presumably passed ASTM F1980, ASTM F1929, and ASTM F88/F88M. |
| Sterility | Conformity to USP <71> Sterility Test. | Lightin was "accessed for conformity" and presumably passed USP <71>. |
| Light Output | Internal test standard for light output. | Lightin was "accessed for conformity" and presumably passed the internal light output test. (No specific quantitative value provided). |
| Thermal Measurement | Internal test standard for thermal measurement. | Lightin was "accessed for conformity" and presumably passed the internal thermal measurement test. (No specific quantitative value provided). |
| Performance (Laryngoplasty) | Successfully directs injection material to target area within the vocal fold. | The Lightin System "successfully directs the laryngoplastic injection material to the target area within the vocal fold." (Qualitative statement). |
| Tissue Heating Concerns | Addresses tissue heating concerns by tip illumination. | Tissue heating concerns by tip illumination were addressed. (Qualitative statement, likely related to the "Thermal measurement test"). |
| Lightin Generator | ||
| Electrical Safety & EMC | Conformity to IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC). | Lightin Generator was "accessed for conformity" and presumably passed IEC 60601-1 and IEC 60601-1-2 (including IEC TR 60601-4-2 guidance). |
| Photobiological Safety | Conformity to IEC 62471 for photobiological safety of lamps and lamp systems. | Lightin Generator was "accessed for conformity" and presumably passed IEC 62471. |
| Light Output | Internal test standard for light output. | Lightin Generator was "accessed for conformity" and presumably passed the internal light output test. (No specific quantitative value provided beyond the max output ≤ 8mW in the comparison table). |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the tests conducted or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required or provided in a 510(k) summary for a Class I manual surgical instrument unless specific performance claims necessitate it. The tests listed are primarily engineering, electrical, and biocompatibility tests on device components or finished products, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is a surgical instrument, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation of data to establish ground truth for training or testing. The "ground truth" for this device relates to its physical performance, safety, and functionality (e.g., biocompatibility, sterility, light output), which are assessed through standardized laboratory and technical tests.
4. Adjudication method for the test set
This is not applicable for the reasons stated in point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable, as the device is not an AI/ML product designed to assist human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an AI/ML algorithm. It is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through adherence to recognized international and national standards (e.g., ISO, IEC, ASTM, USP) for materials, electrical safety, biocompatibility, sterilization, and basic functionality. For instance, successfully passing a cytotoxicity test per ISO 10993-5 serves as the "ground truth" for non-cytotoxicity. The statement that the system "successfully directs the laryngoplastic injection material to the target area" is a functional performance claim, likely verified through internal testing or benchtop models.
8. The sample size for the training set
This is not applicable, as there is no mention of a training set for an AI/ML model for this device.
9. How the ground truth for the training set was established
This is not applicable.
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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.
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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
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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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 |
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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.
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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 manualsurgical instrument is one of a varietyof devices intended for use in surgicalprocedures to examine or treat larynx.This generic type of device includeslaryngeal injection set. | Lightin is a needle for injectionlaryngoplasty with an optical fiber.Lightin generator is an AC-poweredlight source including Light Guidewhich is fiber optic cable thattransmits light at the tip of fiberoptics embedded within Lightin.Lightin System is used for injectionlaryngoplasty to address glotticincompetence to indicate theinjection site with visible light. | SimilarPredicate Device #1 and Lightin is the sameas that used for laryngeal injection.Lightin uses LED light to indicate the injectionsite and the LED source emits light throughthe PMMA fiber in the needle. Consideringthe application area and the indications foruse, Lightin has less risk than the predicatedevice. |
| Appearance | No information | Image: A blue fiber optic cable | SimilarThe needle tip resembles an injection needle,Differentinclusion of a light-transmitting fiber |
| Jacket Material | N/A | PVC | DifferentFiber optic cable is not included in the primarypredicate device (#1).The subject device has fiber optics inserted inthe needle. The jacket materials protectingthe fiber optic of both devices are commonlyused. |
| Jacket Color | N/A | BlueOrange | SimilarJacket is color coded for needle identification.Color coding was applied to Lightin accordingto the needle gauge standard. |
| Illumination Fiber -OD | N/A | 0.125mm (0.004521") | DifferentPD #1: No optic fiberLightin uses LED light to indicate the injectionsite and the LED source emits light throughthe PMMA fiber in the needle. Consideringthe application area and the indications foruse, Lightin has less risk than the predicatedevice. |
| Illumination FiberMaterial | N/A | PMMA(Polymethyl methacrylate withFluorinated Polymer Cladding) | Different |
| Needle size | No information | 1. 23G2. 25G | |
| Needle Material | No information | 304 stainless Steel | |
| Reusable/Disposable | No information | Disposable | |
| Sterilization | No information | EO |
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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
Page 5 / 13
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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 ChandelierIlluminator | 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 familyof ophthalmic illuminators is for wideangle illumination during ophthalmicsurgery. | Lightin is a needle for injectionlaryngoplasty with an opticalfiber.Lightin generator is an AC-powered light source includingLight Guide which is fiber opticcable that transmits light at the tipof fiber optics embedded withinLightin.Lightin System is used forinjection laryngoplasty to addressglottic incompetence to indicate | SimilarFor the reference #1, the main Indication for use isfor wide-angle illumination during ophthalmicsurgery. However, Lightin uses LED light toindicate the injection laryngoplasty site. Althoughthere is a difference such as in the indication foruse, Reference #1 and Lightin have similartechnical characteristics in that the LED sourceemits light through the PMMA fiber in the needle. |
| the injection site with visible light. | |||
| Appearance | Image: Synergetics needle in packaging | Image: Blue needle | SimilarFor Reference #1, its needle tip resembles aninjection needle, and its inclusion of a light-transmitting fiber is similar. |
| Jacket Material | PTFE (Polytetrafluoroethylene) | PVC | SimilarThe Reference #1 device has fiber optics insertedin the needle, same as Lightin. The jacketmaterials protecting the fiber optic of the twodevices are different, but both are commonly used. |
| Jacket Color | Black/GreenBlack/Blue | BlueOrange | SimilarJacket is color coded for needle identification.Color coding was applied to Lightin according tothe needle gauge standard. |
| Illumination Fiber -OD | 0.015" | 0.125mm (0.004521") | DifferentThe difference of the illumination fiber outerdiameter (O.D.) is due to the functional |
| characteristics of the two devices. Reference #1 isused for wide-angle illumination and Lightin is usedfor marking the injection laryngoplasty site. Due tothis functional difference, the illumination fiber ODof the reference #1 is bigger than that of Lightin. | |||
| Illumination FiberMaterial | PMMA(Polymethyl methacrylate withFluorinated Polymer Cladding) | PMMA(Polymethyl methacrylate withFluorinated Polymer Cladding) | Same |
| Needle size | 1. 23G2. 25G | 1. 23G2. 25G | Same |
| Needle Material | 304 stainless Steel | 304 stainless Steel | Same |
| Reusable/Disposable | Disposable | Disposable | Same |
| Sterilization | EO | EO | Same |
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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 | Remark |
|---|---|---|---|
| Product name | Sterile Hypodermic Needles forSingle 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 SingleUse are intended for use withsyringes and injection devices for | Lightin is a needle for injectionlaryngoplasty with an optical fiber.Lightin generator is an AC-powered light | SimilarReference Device #2 and Lightin aresame as injection needles for a single |
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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 fluidinjection/aspiration. | source including Light Guide which is fiberoptic cable that transmits light at the tip offiber optics embedded within Lightin.Lightin System is used for injectionlaryngoplasty to address glotticincompetence to indicate the injection sitewith visible light. | use.Lightin is used for laryngeal injection andRD #2 is used as an injection device forgeneral purpose.Lightin has narrower indication of usethan RD#2. | |
|---|---|---|---|
| Needle size | 14G~34G | 1. 23G2. 25G | Similar |
| Needle Material | 304 Stainless Steel | 304 Stainless Steel | Same |
| Reusable/Disposable | Disposable | Disposable | Same |
| Sterilization | EO | EO | Same |
| PerformanceSpecification | ISO7864ISO9626ISO80369-7ISO8039-20 | ISO7864ISO9626ISO80369-7ISO8039-20 | 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 inendoscopy systems for humanmedicine. In combination with a lightlead, endoscope, camera and monitor,its purpose is to illuminate the inside ofthe human body. | Lightin generator is an AC-powered lightsource including Light Guide which is fiberoptic cable that transmits light at the tip offiber optics embedded within Lightin. | Predicate Device #2 and LightinGenerator are the same light sources thatgenerate LED light.Lightin Generator, its intended use isrestricted solely to Lightin for injectionlaryngoplasty.Lightin Generator is used to transmitslight at the tip of fiber optics embeddedwithin Lightin for injection laryngoplasty.Both PD #2 are technically identical withLightin Generator. |
| Appearance | Image: Endoscopy system | Image: Lightin generator | Similar |
| Light Source | LED | LED | Same |
| Design | Dimension:$330 * 146 * 367$ mmWeight: 8.5kg | Dimension:$300 * 200 * 100$ mmWeight: 2.7kg(excluding adapter) | - |
| Accessories | Image: Sterile adapter | Adapter(Power Cord) | SamePD #2 has a cable to connect to the LEDlight source, and Lightin Generator has aLight Guide for the same purpose.DifferentThe adapter of PD #2 is compatible toconnect various optical fiber cables to the |
| Optical CablePower cord | LED light source, but the LightinGenerator is exclusive to Lightin, so nocompatible parts are required. | ||
| TechnicalSpecification | Output (at the end light guide) : 240W | Output (at the end light guide): $\le$ 8mW | DifferentThe output of PD #2 is higher than thatof Lightin Generator because PD #2uses the LED light to illuminate the boardsurgical site during surgical procedures.However, Lightin Generator needs muchlower output than PD #2 because LightinGenerator uses the LED light to indicatethe small injection laryngoplasty site andthe low output of Lightin Generator istechnically sufficient for use. |
| Safety | IEC60601-1IEC60601-1-2 | IEC60601-1IEC60601-1-2 | 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 <151> 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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#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 <71> 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.
§ 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.