Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Device Facts
| Record ID | K241856 |
|---|---|
| Device Name | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) |
| Applicant | Hlb Lifescience Co., Ltd. |
| Product Code | FMF · General Hospital |
| Decision Date | Dec 23, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.
Device Story
Manual piston syringe system; includes barrel, plunger, gasket, and optional needle/cap. Used for fluid injection or aspiration. Membrane filter variant removes foreign substances from drug solutions during injection. Operated by clinicians or healthcare providers in clinical settings. Output is controlled delivery or withdrawal of fluids. Benefits include precise fluid management and filtration of particulates.
Clinical Evidence
Bench testing only. Compliance with ISO 7886-1 (Piston syringes), ISO 7864 (Sterile hypodermic needles), and ISO 9626 (Stainless steel needle tubing) demonstrated substantial equivalence.
Technological Characteristics
Materials: Polypropylene (barrel, plunger, cap, hub), thermoplastic elastomer (gasket), polydimethylsiloxane (silicone lubricant), epoxy resin (adhesive), stainless steel SUS 304L (needle). Manual operation; Luer Slip or Luer Lock tip. EO sterilization (SAL 10^-6).
Indications for Use
Indicated for general purpose fluid injection or aspiration in patients requiring medical fluid administration or withdrawal.
Regulatory Classification
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Predicate Devices
- Sofjec Piston Syringe (K212635)
Submission Summary (Full Text)
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December 23, 2024
HLB LifeScience Co., Ltd. % Yongjun Lee Consultant MEDIGUIDE Inc. #410, 17, Deogan-ro 104beon-gil, Gwangmyeong-si Gyeonggi-do, 14353 Korea, South
Re: K241856
Trade/Device Name: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: June 27, 2024 Received: December 3, 2024
Dear Yongjun Lee:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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2
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 bear a unique 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-udi-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.
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).
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# Sincerely, Shruti N. Mistry -S
Shruti Mistry Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241856
Device Name
Sofjec (Single use Needle);
Sofjec (Single use Syringe with or without Needle);
Sofjec (Membrane Filter Syringe)
ndications for Use (Describe)
Single use Needle(108 model codes including Sofjec-16-13) Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13) Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Membrane Filter Syringe (16 model codes including HJM-18-1)
Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for HLB Life Science. The logo consists of the letters "HLB" in a stylized font, enclosed within an oval shape. Below the logo, the words "HLB Life Science" are written in a simple font. The color scheme is primarily brown and white.
# 510(k) Summary
Date of Preparation: December 23, 2024
Subject: "Special 510(k) Premarket Notification" for Sofjec - Device Modification.
Model: Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13)
#### Applicant Information:
- . Manufacturer: HLB Life Science Co., Ltd.
- Address: 122-39, Gieopdanji-ro, Gongdo-eup, Anseong-si, Gyeonggi-do, Republic of Korea
- . Tel: +82 (41) 554 6181
- . Fax: +82 (41) 554 7178
- . Manufacturer Contact: JiWon Han (hlblsra@hlb-ls.com)
#### 510(k) Correspondent:
Yongjun Lee, Consultant of MEDIGUIDE Inc. guide33@medi-guide.com / Tel: +82 (70) 5057 6201
#### Identification of Predicate Device
| Trade Name | Subject Device Special 510(k) No. | Predicate Device 510(k) No. |
|------------|-----------------------------------|-----------------------------|
| Sofjec | K241856 | K212635 |
#### Device name and Classification name
- Trade Name: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
- . Model:
- (1) Single use Needle(108 model codes including Sofjec-16-13)
- (2) Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13)
- (3) Membrane Filter Syringe (16 model codes including HJM-18-1)
| Classification Description | 21 CFR Section | Product Code | Class |
|----------------------------------|----------------|--------------|-------|
| Syringe, Piston | 880.5860 | FMF | II |
| Needle, Hypodermic, Single Lumen | 880.5570 | FMI | II |
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Image /page/5/Picture/0 description: The image shows the logo for HLB Life Science. The logo consists of the letters "HLB" in orange, enclosed in an orange oval. Below the logo is the text "HLB Life Science" in a smaller font. The text "Republic of Korea" is at the bottom of the image.
#### Reason for Submission
HLB Life Science Co., Ltd. hereby submits this Special 510(k) to provide notification of modification to:
- . Hwajin Medical Co., Ltd., Sofjec Piston Syringe K212635
This Special 510(k) has been submitted to change the "Single use Syringe with Needle (1734 model codes including HJ-1-16G-13) in primary predicate device (K212635) to "Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13).
Modification to this piston syringe includes:
- . Basic Change: Additional Syringe model with 60 (mL) to existing HJ/HJL series of 1, 2, 2.5, 3, 5, 10, 20, 30, 50 (mL)
- . Additional Change: Additional Syringe model without Needle for HJ/HJL-x WO series to existing HJK/HJKL-x series.
#### Indication for Use
- (1) Single use Needle (108 model codes including Sofjec-16-13) Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
- (2) Single use Syringe with or without Needle (2186 model codes including HJ-1-16G-13) Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
- (3) Membrane Filter Syringe (16 model codes including HJM-18-1) Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions.
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Image /page/6/Picture/0 description: The image contains the logo for HLB Life Science. The logo is an oval shape with the letters "HLB" in orange. Below the logo, the words "HLB Life Science" are written in a smaller font, also in orange. The background is white.
#### Device Description
#### Single use Syringe with or without Needle
Single use Syringe with or without Needle consist of Syringe, Cap, Needle and Hub and Blister paper. Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization, and the syringes of Luer Slip and Luer Lock.
These devices are injecting the medicine with syringes. Biocompatibility testing and performance testing has been completed to support the substantial equivalence of the device.
#### Additional Model List for the subject Special 510(k)
In this special 510(k) submission, a new volume (60mL) of syringe luer slip/luer lock with or without needle is covered. The intended use, raw material, manufacturing site, sterilization method, sterilization site, packaging material is the same as the devices cleared in K212635. The table below describes the additional model for this Special 510(k) submission.
| Syringe<br>Volume | Gauge | Length | Luer Type | Approval No. |
|-------------------|--------------------------------------------------------------------------|---------------------------------------------|-----------|-----------------------|
| 1 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | Without Needle | | Luer Lock | |
| 1 mL | | | Luer Slip | Current<br>Submission |
| | | | Luer Lock | |
| 2 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | | | Luer Lock | |
| 2 mL | Without Needle | | Luer Slip | Current<br>Submission |
| | | | Luer Lock | |
| 2.5 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | | | Luer Lock | |
| 2.5 mL | Without Needle | | Luer Slip | Current<br>Submission |
| | | | Luer Lock | |
| 3 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | | | Luer Lock | |
| 3 mL | Without Needle | | Luer Slip | Current<br>Submission |
| | | | Luer Lock | |
| 5 mL | | | Luer Slip | K212635 |
| Syringe<br>Volume | Gauge | Length | Luer Type | Approval No. |
| | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Lock | |
| | Without Needle | | Luer Slip | Current<br>Submission |
| 10 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | Without Needle | | Luer Lock | |
| 20 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | Without Needle | | Luer Lock | Current<br>Submission |
| 30 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | Without Needle | | Luer Lock | Current<br>Submission |
| 50 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | K212635 |
| | Without Needle | | Luer Lock | Current<br>Submission |
| 60 mL | 16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19,<br>25, 32, 38 (mm) | Luer Slip | Current<br>Submission |
| | Without Needle | | Luer Lock | Current<br>Submission |
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Image /page/7/Picture/0 description: The image shows the logo for HLB Life Science. The logo consists of the letters "HLB" in a bold, sans-serif font, colored in orange. The letters are enclosed within an orange oval shape. Below the oval, the words "HLB Life Science" are written in a smaller, sans-serif font, also in orange.
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Image /page/8/Picture/0 description: The image shows the logo for HLB Life Science. The logo consists of the letters "HLB" in a bold, orange font, enclosed within an orange oval shape. Below the oval, the words "HLB Life Science" are written in a smaller, sans-serif font, also in orange.
#### Comparison table of Modified Device and Predicate Device
| Item | Modified Device<br>Single use Syringe with or without Needle | Primary Predicate Device<br>Single use Syringe with Needle<br>(K212635) | SE<br>decision |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indications for<br>Use | Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. | Single use Syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. | Difference |
#### Difference
Additional syringe model with 60 (mL) to existing HJ/HJL series of 1, 2, 2.5, 3, 5, 10, 20, 30, 50 (mL) The dimension of the 60mL syringe is identical with 50mL syringe in K212635. The only difference between 60mL syringe (modified device) and 50mL syringe (predicate device) is scale depicted on the barrel of the syringe. The performance tests covered the 50ml syringe in the cleared K212635 can be leveraged for the proposed 60ml syringe.
Addition of single use syringe without needle
The model of single use syringe without needle [HJ/HJL-x WO of 1, 2, 2.5, 3, 5, 10, 20, 30, 50, 60 (mL)] are added in the existing HJK/HJKL-x series of the Single use Syringe with Needle (K212635). The dimension, raw material, technological characteristics of the additional models are same with the Single use Syringe with needle.
| Operation<br>Mode | | For manual use only | For manual use only<br>Luer slip | | Same |
|---------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Configuration | | Piston, Plunger, Barrel, (Needle) | Piston, Plunger, Barrel, (Needle) 10, 20,<br>30, 50 (ml) | | Same |
| Tip type | | Luer Slip, Luer Lock | Luer Slip, Luer Lock | | Same |
| Principle of<br>operation | | Normal | Normal<br>Needle gauge<br>16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | | Same |
| Volume/Sizes | Luer slip | | Luer Lock | | Difference |
| | | Syringe Volume<br>1, 2, 2.5, 3, 5, 10, 20,<br>30, 50, 60 (ml)<br>Needle gauge<br>16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31 (G) | | Syringe Volume<br>1, 2, 2.5, 3, 5, 10, 20,<br>1G, 1W, 1B (ml)<br>Needle gauge<br>16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31(G) | |
| | Luer Lock | | | | |
| | | Syringe Volume<br>1, 2, 2.5, 3, 5, 10, 20,<br>30, 50, 60, 1G, 1W,<br>1B (ml) | | | |
| | | Needle gauge<br>16, 17, 18, 19, 20, 21,<br>22, 23, 24, 25, 26, 27,<br>28, 29, 30, 31(G) | | | |
#### Different- Syringe Volume
The Syringe volume of modified device is different from the primary predicate devices(K212635). However, this difference is just in volume. The physical dimension of the 60mL syringe is the 50mL syringe. The scale depicted on the barrel of the syringe is difference does not affect the devices intended use. Successful performance testing has been completed using FDA recognized standards to support that this difference in syringe volume does not raise new or different questions of safety and effectiveness when compared to the predicate device.
| Needle<br>Lengths | 4, 5, 6, 10, 13, 16, 19, 25, 32, 38 (mm) | 4, 5, 6, 10, 13, 16, 19, 25, 32, 38 (mm) | Same |
|-------------------|------------------------------------------|------------------------------------------|------|
|-------------------|------------------------------------------|------------------------------------------|------|
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Image /page/9/Picture/0 description: The image contains the logo for HLB Life Science. The logo features the letters "HLB" in a bold, sans-serif font, enclosed within an oval shape. Below the oval, the words "HLB Life Science" are written in a smaller, sans-serif font. The color scheme is a warm, earthy tone, with the letters and oval in a shade of brown.
| Item | Modified Device | | Primary Predicate Device | SE decision | |
|------------------------------|-----------------------------------------------------|----------------------------|-----------------------------------------------------|----------------------------|------|
| | Single use Syringe with or without Needle | | Single use Syringe with Needle (K212635) | | |
| | Single use Syringe with or without Needle | | Single use Syringe with Needle | | |
| | Part | Raw material | Part | Raw material | |
| Materials | Barrel | Polypropylene (PP) | Barrel | Polypropylene (PP) | Same |
| | Gasket | Thermoplastic elastomer | Gasket | Thermoplastic elastomer | |
| | Plunger | Polypropylene (PP) | Plunger | Polypropylene (PP) | |
| | | Pigment | | Pigment | |
| | Silicone | Polydimethylsiloxane | Silicone | Polydimethylsiloxane | |
| | Adhesives | Epoxy Resin | Adhesives | Epoxy Resin | |
| | Protective cap | PP | Protective cap | PP | |
| | Hub | PP | Hub | PP | |
| | | Pigment | | Pigment | |
| | Needle | Stainless Steel (SUS 304L) | Needle | Stainless Steel (SUS 304L) | |
| | Silicone | Polydimethylsiloxane | Silicone | Polydimethylsiloxane | |
| Sterilization method and SAL | Sterilized by ethylene oxide gas SAL = 10-6 | | Sterilized by ethylene oxide gas SAL = 10-6 | | Same |
| Product performance | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | | Complied with<br>ISO 7886-1<br>ISO 7864<br>ISO 9626 | | Same |
122-39, Gieopdanji-ro, Gongdo-eup, Anseong-si, Gyeonggi-do, Republic of Korea
#### Conclusion
The difference between the cleared (predicate) and the modified device do not raise any new or different questions of safety and effectiveness since the modified devices are tested in accordance with the ISO 7886 -1 standard. The subject devices are substantially equivalent to the predicate devices with respect to the indications for use, target populations, treatment method, and technological characteristics.
