(175 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, biocompatibility, and sterility of a hypodermic needle, with no mention of AI or ML.
No.
The device is described as being for "general purpose fluid injection/aspiration" and "to aspirate and inject of fluids for medical purpose," which are diagnostic or procedural uses, not therapeutic ones in themselves.
No
Explanation: The device is described as a sterile hypodermic needle for fluid injection/aspiration, which is a therapeutic or delivery device, not one used for diagnosis. Its intended use is to "inject/aspirate fluids," not to gather diagnostic information or interpret patient conditions.
No
The device description clearly states it consists of a needle and a needle hub, which are physical hardware components. The performance studies also focus on physical and material properties of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose fluid injection/ aspiration." This describes a procedure performed on a patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description focuses on the physical components and function of a needle used for injecting or aspirating fluids directly from or into a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing a sample.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnostic, monitoring, or screening purposes. This device is a tool for administering or withdrawing substances directly from a patient.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for general purpose fluid injection/ aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Sterile Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle and a needle hub. The proposed device is available in variety of needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe.
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)
Non-Clinical Testing:
- Conformance with ISO 80369-7: 2016, ISO 80369-20:2015, ISO 7864: 2016, ISO 9626:2016.
- Biocompatibility testing (Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Material Mediated Toxicity) in accordance with ISO10993-1.
- Particulate matter testing in accordance with USP .
- Sterilization process validated according to ISO 11135:2014, with EO and ECH residuals below ISO 10993-7:2008 limits. Bacterial Endotoxin Levels below 20 EU/device (USP ).
- Shelf-life of 5 years validated using ASTM F1980-16, supported by baseline and accelerated shelf life testing.
- Sterile Barrier Packaging testing: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88-15), Dye penetration (ASTM F1929-15).
- Simulated transportation testing in accordance with ASTM D4169-16.
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
§ 880.5570 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2022
Sichuan Prius Biotechnology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K221066
Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: August 26, 2022 Received: September 8, 2022
Dear Diana Hong:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
CAPT Alan Stevens 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221066
Device Name
Sterile Hypodermic Needles for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for general purpose fluid injection/ aspiration.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K221066 -510 K Summary
-
- Date of Preparation: 10/08/2022
-
- Sponsor Identification
Sichuan Prius Biotechnology Co., Ltd.
No.2 Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: Not registered yet
Contact Person: Yan Liu Position: Management Representative Tel: +86-831-3839889 Fax: +86-831-3839887 Email: 48363603@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Sterile Hypodermic Needles for Single Use Common Name: Syringe Needle
Regulatory Information Classification Name: Needle, Hypodermic, Single Lumen Classification: II; Product Code: FMI; Regulation Number: 21CFR 880.5570; Review Panel: General Hospital;
- న. Predicate
K180417, Sterile Hypodermis Needles for Single Use
6. Device Description
The Sterile Hypodermic Needles for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle and a needle hub. The proposed device is available in variety of needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe.
| Needle Sizes | ||
|---|---|---|
| Needle Length | Needle gauge | Wall |
| 32mm | 16G | TW |
| 38mm | 16G | TW |
| 32mm | 18G | TW |
| 38mm | 18G | TW |
| 32mm | 19G | TW |
| 38mm | 19G | TW |
| 32mm | 20G | TW |
| 38mm | 20G | TW |
| 32mm | 21G | TW |
| 38mm | 21G | TW |
| 32mm | 22G | TW |
| 38mm | 22G | TW |
| 19mm | 23G | TW |
| 25mm | 23G | TW |
| 32mm | 23G | TW |
Needle specification:
5
| 19mm | 24G | RW |
|---|---|---|
| 25mm | 24G | RW |
| 32mm | 24G | RW |
| 16mm | 25G | RW |
| 19mm | 25G | RW |
| 25mm | 25G | RW |
| 13mm | 26G | RW |
| 16mm | 26G | RW |
| 19mm | 26G | RW |
| 13mm | 27G | RW |
| 16mm | 27G | RW |
| 19mm | 27G | RW |
| 13mm | 28G | RW |
| 16mm | 28G | RW |
| 13mm | 29G | RW |
| 16mm | 29G | RW |
| 13mm | 30G | RW |
| 16mm | 30G | RW |
7. Indication for Use
| Characterization | Proposed device | Predicate Device | ||
|---|---|---|---|---|
| Sterile Hypodermic Needles for | ||||
| Single Use | ||||
| K221066 | Sterile Hypodermic Needles for | |||
| Single Use | ||||
| K180417 | ||||
| Indication for Use | The Sterile Hypodermic Needles | |||
| for Single Use are intended to be | ||||
| used with a luer slip or luer lock | ||||
| syringe for general purpose fluid | ||||
| injection/ aspiration. | The Sterile Hypodermic Needles for | |||
| Single Use are intended to be used | ||||
| with a luer slip or luer lock syringe | ||||
| for general purpose fluid injection/ | ||||
| aspiration. | ||||
| Prescription or OTC (over | ||||
| the counter) | Prescription use | Prescription use | ||
| Technological | ||||
| Characteristic | Proposed Device | Predicate Device | ||
| Sterile Hypodermic Needles for | ||||
| Single Use | Sterile Hypodermic Needles for | |||
| Single use | ||||
| K221066 | K180417 | |||
| Configuration | Needle hub | |||
| Protective cap | ||||
| Needle | Needle hub | |||
| Protective cap | ||||
| Needle | Same | |||
| Operation Mode | For manual use only | For manual use only | Same | |
| Single Use | Single Use | Single Use | Same | |
| Needle | ||||
| Performance | Complied with | |||
| ISO 7864, | ||||
| ISO 9626 | Complied with | |||
| ISO 7864, | ||||
| ISO 9626 | Same | |||
| Needle Gauge | 16G, 18G, 19G, 20G, 21G, | |||
| 22G, 23G, 24G, 25G, 26G, | ||||
| 27G, 28G, 29G, 30G | 14G, 15G, 16G, 17G, 18G, | |||
| 19G, 20G, 21G, 22G, 23G, | ||||
| 24G, 25G, 26G, 27G, 28G, | ||||
| 29G, 30G | Different | |||
| See comment # | ||||
| 1 | ||||
| Needle Length | 13mm, 16mm, 19mm, 25mm, | |||
| 32mm, 38mm | 6mm, 9mm, 12mm, 13mm, | |||
| 16mm, 20mm, 25mm, 38mm, | ||||
| 50mm, 60mm | Different | |||
| See comment # | ||||
| 2 | ||||
| Wall type | TW: 16G, 18G, 19G, 20G, 21G, | |||
| 22G, 23G | ||||
| RW: 24G, 25G, 26G, 27G, 28G, | ||||
| 29G, 30G | TW: 14G, 15G, 16G, 17G, 18G, | |||
| 19G, 20G, 21G, 22G, 23G, | ||||
| 29G, 30G | ||||
| RW: 14G, 15G, 16G, 18G, 19G, | ||||
| 20G, 21G, 22G, 24G, 25G, | ||||
| 26G, 27G, 29G, 30G | Different | |||
| See comment # | ||||
| 3 | ||||
| Needle | Stainless Steel SUS304 | Stainless Steel SUS304 | Same | |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same | |
| Needle cap | Polypropylene (PP) | Polypropylene (PP) | Same | |
| Lubricants | Polydimethylsiloxane | Polydimethylsiloxane | Same | |
| Adhesive | Epoxy adhesive | HTU-3312 Glue | Different | |
| See comment # | ||||
| 4 |
8. Technological Characteristic
The table below includes a comparison of the technological characteristics between the new device and those of the predicate.
Table 1 Comparison of Technology Characteristics
6
Discussions of differences in technological characteristics
Comment # 1 – Needle Gauge
The proposed device has the less gauges compared to the predicate device and the proposed gauge can be covered by the range of needle gauge available in the predicate device. In addition, the needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.
7
Comment # 2 – Needle Length
The proposed device has less needle lengths compared to the proposed needle length specifications can be covered by the range of available needle lengths for the predicate device. In addition, the needle performance has been tested and the results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.
Comment # 3 – Wall Type
The proposed device is available in thin wall and normal wall. The predicate device also has thin wall and normal wall. The performance data results demonstrate that the needs the requirements of ISO 7864 and ISO 9626.
Comment # 4 – Material of Adhesive
The proposed device has different adhesive compared to the predicate device. This difference does not impact intended use and does not raise new questions of safety and effectiveness. However, biocompatibility test has been conducted on the proposed device and the test result does not show anv adverse effect. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.
9. Non- Clinical Testing
The device described in this summary the Sterile Hypodermic Needle for Single Use. were tested and demonstrated to be in conformance with the following FDA recognized standards:
-
ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
-
ISO 80369-20:2015 Small-bore connectors for liguids and gases in healthcare applications-Part 20: Common test methods
-
ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.
-
ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices
Biocompatibility
In accordance with ISO10993-1 the needle are classified as: Externally Communicating Device, Blood Path direct, Limited Contact ( Cytotoxicity
- A Irritation
- A Skin Sensitization
-
Acute Systemic Toxicity
-
Pyrogenicity
- Hemolvsis A
- A Material Mediated Toxicity
8
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping, and Shelf -life
The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 106. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP . Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 5 year shelf-life.
- . Sterile Barrier Packaging performed on the proposed device: ○ Visual Inspection ASTM F1886 / F1886M-16 0 Seal Strength ASTM F88/F88-15 o Dye penetration ASTM F1929-15
- . Simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and sterile device.
Shelf-life of 5-years is validated using FDA recognized standard ASTM F1980-16 Standard . Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Hypodermic Needles for Single Use is as safe, as effective, and performs as well as the legally marketed predicative device cleared under K180417.