(179 days)
Not Found
No
The device description and intended use are for basic medical devices (syringes and needles) and do not mention any AI/ML capabilities or related technologies.
No.
The device is described as being used for general purpose fluid injection/aspiration, and for injecting or withdrawing fluid from the body, which are not therapeutic actions. It is a delivery/withdrawal tool, not a device that directly treats a condition.
No
The device is described as a "Single use Needle" and "Single use Syringe with or without Needle" intended for "general purpose fluid injection/aspiration" and "to inject fluid into or withdraw fluid from body." Its function is delivery or removal of substances, not diagnosing a medical condition.
No
The device description clearly outlines physical components like syringes, needles, caps, hubs, and blister paper, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "general purpose fluid injection/aspiration," "inject fluid into or withdraw fluid from body," and "injecting the medicine." These are all actions performed on the body, not on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical components and function of syringes and needles for injecting or withdrawing fluids. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
These devices are classified as medical devices used for administering or withdrawing substances from the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance tests covered the 50ml syringe in the cleared K212635 can be leveraged for the proposed 60ml syringe.
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.
The modified devices are tested in accordance with the ISO 7886 -1 standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).
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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).
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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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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
| Volume | Gauge | Length | Luer Type | Approval No. |
|---|---|---|---|---|
| 1 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Without Needle | Luer Lock | |||
| 1 mL | Luer Slip | Current | ||
| Submission | ||||
| Luer Lock | ||||
| 2 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Luer Lock | ||||
| 2 mL | Without Needle | Luer Slip | Current | |
| Submission | ||||
| Luer Lock | ||||
| 2.5 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Luer Lock | ||||
| 2.5 mL | Without Needle | Luer Slip | Current | |
| Submission | ||||
| Luer Lock | ||||
| 3 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Luer Lock | ||||
| 3 mL | Without Needle | Luer Slip | Current | |
| Submission | ||||
| Luer Lock | ||||
| 5 mL | Luer Slip | K212635 | ||
| Syringe | ||||
| Volume | Gauge | Length | Luer Type | Approval No. |
| 16, 17, 18, 19, 20, 21, | ||||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Lock | |||
| Without Needle | Luer Slip | Current | ||
| Submission | ||||
| 10 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Without Needle | Luer Lock | |||
| 20 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Without Needle | Luer Lock | Current | ||
| Submission | ||||
| 30 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Without Needle | Luer Lock | Current | ||
| Submission | ||||
| 50 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | K212635 | ||
| Without Needle | Luer Lock | Current | ||
| Submission | ||||
| 60 mL | 16, 17, 18, 19, 20, 21, | |||
| 22, 23, 24, 25, 26, 27, | ||||
| 28, 29, 30, 31 (G) | 4, 5, 6, 10, 13, 16, 19, | |||
| 25, 32, 38 (mm) | Luer Slip | Current | ||
| Submission | ||||
| Without Needle | Luer Lock | Current | ||
| Submission |
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Comparison table of Modified Device and Predicate Device
| Item | Modified Device
Single use Syringe with or without Needle | Primary Predicate Device
Single use Syringe with Needle
(K212635) | SE
decision |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indications for
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
Mode | | For manual use only | For manual use only
Luer slip | | Same |
|---------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Configuration | | Piston, Plunger, Barrel, (Needle) | Piston, Plunger, Barrel, (Needle) 10, 20,
30, 50 (ml) | | Same |
| Tip type | | Luer Slip, Luer Lock | Luer Slip, Luer Lock | | Same |
| Principle of
operation | | Normal | Normal
Needle gauge
16, 17, 18, 19, 20, 21,
22, 23, 24, 25, 26, 27,
28, 29, 30, 31 (G) | | Same |
| Volume/Sizes | Luer slip | | Luer Lock | | Difference |
| | | Syringe Volume
1, 2, 2.5, 3, 5, 10, 20,
30, 50, 60 (ml)
Needle gauge
16, 17, 18, 19, 20, 21,
22, 23, 24, 25, 26, 27,
28, 29, 30, 31 (G) | | Syringe Volume
1, 2, 2.5, 3, 5, 10, 20,
1G, 1W, 1B (ml)
Needle gauge
16, 17, 18, 19, 20, 21,
22, 23, 24, 25, 26, 27,
28, 29, 30, 31(G) | |
| | Luer Lock | | | | |
| | | Syringe Volume
1, 2, 2.5, 3, 5, 10, 20,
30, 50, 60, 1G, 1W,
1B (ml) | | | |
| | | Needle gauge
16, 17, 18, 19, 20, 21,
22, 23, 24, 25, 26, 27,
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
| 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 | ||||
| ISO 7886-1 | |||||
| ISO 7864 | |||||
| ISO 9626 | Complied with | ||||
| ISO 7886-1 | |||||
| ISO 7864 | |||||
| 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.