(175 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard material/sterility testing, with no mention of AI or ML.
No
The device, a hypodermic needle, is intended for aspiration and injection of fluids, which are procedures, but it does not directly treat a disease or condition itself.
No
Explanation: The device is a sterile safety hypodermic needle intended for the aspiration and injection of fluids, which are procedural actions, not diagnostic ones. Its purpose is to physically introduce or remove fluids, and it does not interpret data or provide diagnostic information.
No
The device description clearly outlines physical components (Needle, Safety shield, Protective Cap, Needle Hub) and the performance studies focus on physical and material properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration and injection of fluids for medical purpose" and to "minimize risk of accidental needlestick." This describes a device used for administering or withdrawing substances from the body, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of a needle and safety mechanism, consistent with a device used for injection/aspiration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process related to diagnosing a condition based on testing samples in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely related to the physical act of accessing the body for fluid transfer and safety.
N/A
Intended Use / Indications for Use
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Sterile Safety 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 1) Needle, 2) Safety shield, 3) Protective Cap, 4) Needle Hub. The proposed device is available in a variety needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
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 Test Conclusion: The device described in this summary the Sterile Safety Hypodermic Needles for Single Use were tested and demonstrated to be in conformance with the following FDA recognized standards: ISO 80369-7: 2016, ISO 80369-20:2015, ISO 7864: 2016, ISO 9626:2016.
Simulated Clinical Study: A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test: The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the proposed device and predicate device meet the acceptance criteria.
Biocompatibility testing: In accordance with ISO10993-1, testing was conducted for Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, and Material Mediated Toxicity. Particulate matter testing was conducted in accordance with USP and met the USP acceptance criteria.
Sterility, Shipping, and Shelf-life: The sterilization process was validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below 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. Simulated transportation testing was in accordance to ASTM D4169-16. Sterile Barrier Packaging performance was evaluated via Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88-15), and Dye penetration (ASTM F1929-15). Shelf-life of 5-years is validated using FDA recognized standard ASTM F1980-16.
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
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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: K221080
Trade/Device Name: Sterile Safety 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 25, 2022 Received: September 6, 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
1
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 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 (OS) 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) K221080
Device Name
Sterile Safety Hypodermic Needles for Single Use
Indications for Use (Describe)
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
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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3
K221080 -510(k) Summary
- Date of Preparation: 10/08/2022 1.
-
- 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 Safety Hypodermic Needles for Single Use Common Name: Safety Needle
Regulatory Information
Classification Name: Hypodermic, Syringe Lumen Classification: II Product Code: FMI Regulation Number: 21CFR 880.5570 Review Panel: General Hospital
- Identification of Predicate Device న్.
510(k) Number: K180417 Product Name: Sterile Safety Hypodermic Needles for Single Use
Device Description 6.
The Sterile Safety 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 1) Needle, 2) Safety shield, 3) Protective Cap, 4) Needle Hub. The proposed device is available in a variety needle length and needle gauge. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification:
| 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 |
5
| 19mm | 23G | TW |
|---|---|---|
| 25mm | 23G | TW |
| 32mm | 23G | TW |
| 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 Safety Hypodermic Needles for | |||
| Single Use K221080 | Sterile Safety Hypodermic Needles for | ||
| Single Use K180417 | |||
| Indication for Use | The Sterile Safety Hypodermic Needles | ||
| for Single Use are intended to be used | |||
| with a luer slip or luer lock syringe for | |||
| aspiration and injection of fluids for | |||
| medical purpose. After withdrawal of the | |||
| needle from the body, the attached needle | |||
| safety shield can be manually activated | |||
| to cover the needle immediately after use | |||
| to minimize risk of accidental | |||
| needlestick. | The Sterile Safety Hypodermic Needles | ||
| for Single Use are intended to be used | |||
| with a luer slip or luer lock syringe for | |||
| aspiration and injection of fluids for | |||
| medical purpose. After withdrawal of | |||
| the needle from the body, the attached | |||
| needle safety shield can be manually | |||
| activated to cover the needle | |||
| immediately after use to minimize risk | |||
| of accidental needlestick. | |||
| Prescription or OTC | |||
| (over the counter) | Prescription use | Prescription use | |
| Proposed Device | Predicate Device | ||
| Technological | |||
| Characteristic | Sterile Safety Hypodermic Needles | ||
| for Single Use | |||
| K221080 | Sterile Safety Hypodermic Needles | ||
| for Single Use | |||
| K180417 | Remark | ||
| Configuration | Needle hub | Needle hub | Same |
| Protective cap | Protective cap | ||
| Needle | Needle | ||
| Safety shield | Safety shield | ||
| 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 | 18G, 19G, 20G, 21G, 22G, 23G, | ||
| 24G, 25G, 26G, 27G | See comment # | ||
| 1 | |||
| Needle Length | 13mm, 16mm, 19mm, 25mm, | ||
| 32mm, 38mm | 12mm, 13mm, 16mm, 20mm, | ||
| 25mm, 30mm, 32mm, 38mm, | |||
| 40mm | See comment # | ||
| 2 | |||
| Wall type | TW: 16G, 18G, 19G, 20G, 21G, | ||
| 22G, 23G | TW: 18G, 19G, 20G, 21G, 22G, | ||
| 23G | See comment # | ||
| 3 | |||
| RW: 24G, 25G, 26G, 27G, 28G, | |||
| 29G, 30G | RW: 20G, 21G, 22G, 23G, 24G, | ||
| 25G, 26G, 27G | |||
| Material | |||
| Needle | Stainless Steel SUS304 | Stainless Steel SUS304 | Same |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same |
| Needle cap | Polypropylene (PP) | Polypropylene (PP) | Same |
| Safety shield | Polypropylene (PP) | Polypropylene (PP) | Same |
| Lubricants | Polydimethylsiloxane | Polydimethylsiloxane | Same |
6
Technological Characteristics 8.
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
7
Discussions of differences in technological characteristics
Comment # 1- Needle Gauge
The proposed device has the additional gauge 16G, 28G, 29G and 30G compared to the predicate device, while other gauges can be covered by the predicate device. The differences do not impact the intended use and do not raise new questions of safety and effectiveness. The needle performance has been evaluated and test results comply with ISO 7864 and ISO 9626.
Comment #2 – Needle Length
The proposed device has less needle lengths compared to the predicate device and the proposed needle length specifications can be covered by 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 needle gauge of the proposed device and the predicate device is different under the same wall thickness. However, all the wall type and needle gauge of proposed device has been tested and results demonstrate that the needle meets 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 the intended use and does not raise new questions of safety and effectiveness. Biocompatibility testing has been conducted on the proposed device and the test results do not show any adverse effect.
9. Non-Clinical Test Conclusion
The device described in this summary the Sterile Safety Hypodermic Needles 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
- A ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods
- ISO 7864: 2016, Sterile Hypodermic Needles for Single Use. A
- ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices >
Simulated Clinical Study
A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
8
Safety Feature Test
The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the proposed device and predicate device meet the acceptance criteria.
Biocompatibility testing
In accordance with ISO10993-1 the syringe and needle are classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( 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.
Simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and . sterile device.
- . Sterile Barrier Packaging performed on the proposed device:
- ○Visual Inspection ASTM F1886 / F1886M-16
- o Seal Strength ASTM F88/F88-15
- o Dye penetration ASTM F1929-15
. 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.
- Clinical Test Conclusion
No clinical study is included in this submission.
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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 Safety Hypodermic Needles for Single Use is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K180417.