(99 days)
No
The device description and performance studies focus on the physical characteristics and manual operation of a needle, with no mention of AI or ML.
No
The device is described as a needle intended for injection or aspiration, which is a tool for delivering or removing substances, not a therapeutic device that performs a medical treatment itself.
No
The device is described as an injection and aspiration device (a needle and hub) used for therapeutic purposes (injecting medication or aspirating fluids), not for diagnosing a condition.
No
The device description clearly outlines a physical medical device consisting of a metal tube, hub, and connector, intended for manual operation with a syringe. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject into or aspirate from, the body." This describes a device used for direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a needle and hub designed for connecting to a syringe for injection or aspiration. This is a classic description of a medical device used for delivering substances or removing fluids from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are designed for testing these types of samples in vitro (outside the body).
- Performance Studies: The performance studies focus on physical characteristics (standards like ISO 9626, ISO 7864), biocompatibility, sterilization, packaging, and shelf life. These are typical tests for medical devices that interact with the body, not for devices that analyze biological samples.
In summary, the device described is a needle intended for injection and aspiration directly into the body, which falls under the category of a medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to inject into or aspirate from, the body. The device is intended for intravitreal use.
Product codes (comma separated list FDA assigned to the subject device)
QYM
Device Description
The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringe. The device can be used by health care professionals. The hub of the needle can be a standard size or a reduced size (low dead space) that is designed to reduce medication waste. The device is operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intradermal, and intravitreal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravitreal, subcutaneous, intramuscular, intradermal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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 subject device was tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods.
- ISO 7864: 2016 Sterile hypodermic needles for single-use Requirements and test methods
- ISO 80369-7: 2021 Small-bore connectors for liquid and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications.
The standard hub needle models meet the requirements for ISO 80369-7. The subject device meets the requirements for ISO 80369-7 with the exception of the needle hub length which creates the dead space for the low dead space needle models. There are currently no FDA recognized standards for low dead space needles, however, it is equivalent to K231734 which also has a low dead volume hub. The subject device's ability to meet the connection requirements of ISO 80369-7 confirms the device's ability to secure connection for the low dead space needles.
Biocompatibility testing was conducted in accordance with ISO 10993-1. The needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (, ISO 10993-11 Pyrogen Test
Sterilization validation was performed in accordance with:
- ISO 11137-1:2006/AMD 1:2013 Sterilization of health care products-Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2006 Sterilization of health care products-Radiation - Part 2: Establishing the sterilization dose
Packaging validation was performed in accordance with:
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
- ASTM D4169 – 22 Standard Practice for Performance Testing of Shipping Containers and Systems
Shelf life of 5 years validated using:
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
The result of non-clinical testing demonstrates the substantial equivalence of the subject device.
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.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 23, 2024
TSK Laboratory International Japan KK Seika Shiba Regulatory Affairs Specialist 2-1-5 Hirayanagi-Cho Tochigi-Shi, Tochigi 328-0012 Japan
Re: K242073
Trade/Device Name: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: QYM Dated: September 23, 2024 Received: September 24, 2024
Dear Seika Shiba:
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).
1
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
510(k) Number (if known) K242073
Device Name
STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
Indications for Use (Describe) The device is intended to inject into or aspirate from, the body. The device is intended for intravitreal use.
| 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."
4
Image /page/4/Picture/1 description: The image features the letters "TSK" in a bold, sans-serif font. The letters are white and are set against a blue background. The blue background has a slight gradient effect, with the top portion appearing lighter than the bottom.
510 (k) Summary
Preparation Date: October 22nd, 2024
1. Contact Details
Applicant Name: TSK Laboratory International Japan KK Applicant Address: 2-1-5 Hirayanagi-Cho Tochigi-Ken 328-0012 Japan Applicant Contact Telephone: 81 282 25 5200 Applicant Contact: Seika Shiba Applicant Contact Email: shiba@tsklab.com
2. Device Name
Device Trade Name: STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) Device: Ophthalmic Needle Classification Name: Ophthalmic Needle Regulation Name: Hypodermic single lumen needle Medical Specialty: General Hospital Regulation Number: 21 CFR 880.5570 Product Code(s): QYM (Ophthalmic Needle) Device Class: Class II
3. Legally Marketed Predicate Device
| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K230951 | Terumo Injection Filter Needle | QYM |
| Reference # | Reference Device Trade Name | Product Code |
|---|---|---|
| K231734 | STERiJECT Low Dead Space, STERiJECT The INVISIBLE Needle | QNS |
4. Device Description Summary
The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringe. The device can be used by health care professionals. The hub of the needle can be a standard size or a reduced size (low dead space) that is designed to reduce medication waste. The device is operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intradermal, and intravitreal.
5
Image /page/5/Picture/1 description: The image shows the letters "TSK" in white font on a blue background. The letters are bold and sans-serif. The background is a solid blue color, and the letters are centered on the background. The image is simple and clean, with a focus on the letters.
Models:
| Model | Connector Type | Thread Type | Dead Space |
|---|---|---|---|
| LDS | Luer lock, Luer slip | Thread | Low |
| HPC | Luer lock, Luer slip | Thread | Standard |
| PRC | Luer lock, Luer slip | Lug | Standard |
Product sizes and color codes of the label:
| Nominal OD | Nominal Gauge Size | Label Color | Length |
|---|---|---|---|
| (mm) | Ref Std | (mm) | |
| Φ 0.18 | ISO 34G | Orange | 4, 6, 9 |
| Φ 0.20 | ISO 33G | Black | 4, 6, 9, 13 |
| Φ 0.23 | ISO 32G | Deep Green | 4, 6, 9, 13 |
| Φ 0.24 | ENE 33G | Black | 4, 6, 9, 13 |
| Φ 0.25 | ISO 31G | White | 4, 6, 9, 13 |
| Φ 0.26 | ENE 32G | Deep Green | 4, 6, 9, 13 |
| Φ 0.28 | ENE 31G | White | 4, 6, 9, 13 |
| Φ 0.30 | ISO 30G | Yellow | 4, 6, 9, 13 |
| Φ 0.33 | ISO 29G | Red | 4, 6, 9, 13 |
| Φ 0.36 | ISO 28G | Blue Green | 4, 6, 9, 13 |
| Φ 0.40 | ISO 27G | Medium Grey | 4, 6, 9, 13 |
5. Intended Use/Indication for Use
The device is intended to inject into or aspirate from, the body. The device is indicated for intravitreal use.
6. Indications for Use Comparison
The subject device has completed testing to show that the device meets its intended use/indication for use and demonstrates substantial equivalence to the predicate device K230951.
7. Technological Comparison
The table below includes a comparison of the technological characteristics between the subject device and those of the predicate device and reference device:
6
Image /page/6/Picture/1 description: The image features the letters 'TSK' in a bold, sans-serif font. The letters are white and stand out against a blue background. The overall design is simple and clean, with a focus on readability and contrast.
| Technological
| Characteristic | Subject Device | Predicate Device | Reference Device | Discussions |
|---|---|---|---|---|
| Trade name | STERIJECT | |||
| ophthalmic | ||||
| Needle; STERIJECT | ||||
| Ophthalmic | ||||
| Needle Low Dead | ||||
| Space (LDS), | Terumo Injection Filter | |||
| Needle (NF- | ||||
| 3013RBKE05M) | ||||
| (K230951) | STERIJECT Low | |||
| Dead Space (LDS); | ||||
| STERIJECT The | ||||
| INVISIBLE Needle | ||||
| Indications | ||||
| for Use | The device is | |||
| intended to inject | ||||
| into or aspirate | ||||
| from, the body. | ||||
| The device is | ||||
| indicated for | ||||
| intravitreal use. | The Terumo Injection | |||
| Filter Needle is | ||||
| indicated for general | ||||
| application - for | ||||
| treatment - injection | ||||
| of fluids into parts of | ||||
| the body below the | ||||
| surface of the skin and | ||||
| into the vitreous. | (K231734) | |||
| To inject fluids | ||||
| into or aspirate | ||||
| from, the body. | Same | |||
| Regulation | 880.5570 | 880.5570 | 880.5570 | Same |
| Product Code | QYM | QYM | QNS | Same |
| Class | Class II | Class II | Class II | Same |
| Gauge | 27G - 34G | 30G | 21G - 34G | Different. |
| See Discussion #2 | ||||
| Length | 4mm - 13mm | 12mm ( ½" ) | 4mm - 120mm | Different. |
| See Discussion #2 | ||||
| Dead Volume | ||||
| OPHTHALMIC | ||||
| NEEDLE | ||||
| OPHTHALMIC | ||||
| NEEDLE LDS | Standard | Unspecified | 0.0028ml | Different. |
| See Discussion #4 | ||||
| 0.0028ml | ||||
| Safety | ||||
| Feature | No safety feature | unspecified | No safety feature | See Discussion #1 |
| Syringe | ||||
| compatibility | Luer Lock or | |||
| Luer Slip | Unspecified | Luer Lock or | ||
| Luer Slip | Same | |||
| Hub | Polycarbonate | PMMA/Masterbatch | Polycarbonate | Different. |
| See Discussion #5 | ||||
| Needle tube | Stainless Steel | Stainless Steel | Stainless Steel | Same |
| Adhesive | Epoxy | Acrylic Glue | Epoxy | Different. |
| See Discussion #5 | ||||
| Lubricant | Silicon oil | Silicone | ||
| (Polydimethylsiloxane) | Silicon oil | Same | ||
| Sterilization | Gamma | EO gas | Gamma | Different |
| method | irradiation | irradiation | See Discussion #3 |
7
Image /page/7/Picture/1 description: The image features a blue rectangular button with the letters 'TSK' in white. The letters are bold and slightly stylized, giving them a modern appearance. The blue background is a solid color, providing a strong contrast to the white letters, making them easily readable.
Discussions of differences in technological characteristics
Discussion #1
The subject device does not have a safety feature. In general, the safety feature is optional for hypodermic or ophthalmic needles and not having the safety feature does not raise new or different questions of safety and effectiveness when compared to the predicate device.
Discussion #2
The difference in specifications does not raise new questions of safety and effectiveness. The subject device was tested to the same standards as the predicate device K230951. The substantial equivalence of the device is confirmed through performance testing.
Discussion #3
The sterility of the subject device has been validated to achieve SAL of 10-6 in accordance with ISO 11137-1 and ISO 11137-2. Packaging integrity tests were conducted according to ISO 11607-1 and ASTM F3039 to ensure that the hard pack packaging serving as the sterile barrier system is maintained over the life of the device. K230951 is sterilized using EtO gas sterilization which uses standards ISO 11135 whereas the subject device uses gamma irradiation. K231734, which does use gamma irradiation, has been validated to achieve SAL of 10-6 in accordance with ISO 11137-1 and ISO 11137-2, therefore the difference between the subject and predicate device does not raise new or different questions of safety and effectiveness.
Discussion #4
The subject device has standard hubs or low dead space hubs. Standard hubs meet all the requirements for ISO 80369-7 which defines the connector requirements for standard needle hub connections. Low dead space hub meets the requirement for ISO 80369-7 with the exception of the needle hub depth. There are currently no recognized standards for low dead space needles, however the physical characteristic of the low dead space hub is identical to K231734. The difference between the subject and predicate device does not raise new or different questions of safety and effectiveness.
Discussion #5
Although the materials of the subject device are different the from predicate device K230951, the biocompatibility of the materials was tested and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. Shelf-life study was conducted, and the result demonstrates the subject device continues to meet its specifications for 5 years after gamma irradiation.
8
Image /page/8/Picture/1 description: The image shows the letters "TSK" in white font on a blue background. The letters are bold and sans-serif. The background is a solid, light blue color. The image is simple and clean, with a focus on the text.
The substantial equivalence of the subject device has been demonstrated by non-clinical testing data, hence the differences between the subject device and the predicate do not raise any new or different questions of safety or effectiveness. Therefore, it is concluded that the subject device is substantially equivalent to the legally marketed predicate device K230951.
8. Non-clinical and/or Clinical Tests Summary & Conclusions
The subject device was tested and demonstrated to be in conformance with the following FDA recognized standards.
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods.
- ISO 7864: 2016 Sterile hypodermic needles for single-use Requirements and test methods
- ISO 80369-7: 2021 Small-bore connectors for liquid and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications.
The standard hub needle models meet the requirements for ISO 80369-7. The subject device meets the requirements for ISO 80369-7 with the exception of the needle hub length which creates the dead space for the low dead space needle models. There are currently no FDA recognized standards for low dead space needles, however, it is equivalent to K231734 which also has a low dead volume hub. The subject device's ability to meet the connection requirements of ISO 80369-7 confirms the device's ability to secure connection for the low dead space needles.
Biocompatibility
In accordance with ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", the needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( , ISO 10993-11 Pyrogen Test
Sterility, Shipping and Shelf-Life
Sterilization validation was performed in accordance with standards listed below.
- . ISO 11137-1:2006/AMD 1:2013 Sterilization of health care products-Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2006 Sterilization of health care products-Radiation - Part 2: Establishing the sterilization dose
Packaging validation was performed in accordance with the standards listed below.
- . ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
- ASTM D4169 – 22 Standard Practice for Performance Testing of Shipping Containers and Systems
Shelf life of 5 years validated using the standard listed below.
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
The result of non-clinical testing demonstrates the substantial equivalence of the subject device.
9. Conclusion
The differences between the predicate devices and the subject device do not raise any new or different questions of safety or effectiveness. The subject device is substantially equivalent to K230951.