(175 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterility, and biocompatibility of a standard syringe and needle, with no mention of AI or ML.
No
The device is described as intended for the aspiration and injection of fluids, which are diagnostic or supportive functions, not primarily therapeutic.
No
The device is described as a "Sterile Hypodermic Syringes for Single Use with Needles" intended for "aspiration of fluids" and to "inject of fluids for medical purpose." This describes a tool for administering or withdrawing substances, not for diagnosing conditions.
No
The device description clearly states it consists of physical components (piston, barrel, plunger, needle) and the performance studies focus on physical and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aspiration of fluids for medical purpose" and "aspirate and inject of fluids for medical purpose". This describes a physical action of moving fluids into or out of the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical components of a syringe and needle, which are tools for fluid handling within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on the aspirated fluid.
- Performance Studies: The performance studies focus on the physical and biological safety of the device itself (sterility, biocompatibility, strength, shelf-life), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe and needle set is used in vivo (within the body) for fluid management.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration of fluids for medical purpose.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI
Device Description
The Sterile Hypodermic Syringes for Single Use with Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle. The proposed device is available in a variety combination of syringe volume and needle size.
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 device described in this summary Sterile Hypodermic Syringes for Single Use with Needles, were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 7886-1: 2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
- 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 liquids 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 A
Biocompatibility testing: Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Material Mediated Toxicity.
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 10th. 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
- Seal Strength ASTM F88/F88-15
- 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.
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).
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: K221068
Trade/Device Name: Sterile Hypodermic Syringes for Single Use with Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (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 Injection Team Devision of Drug Delivery and General Hospital and General Hospital Devices Office of GastroRenal , OBGYN, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221068
Device Name
Sterile Hypodermic Syringes for Single Use with Needles
Indications for Use (Describe)
The Sterile Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration of fluids for medical purpose.
| 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
K221068 -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
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Identification of Proposed Device 4.
Trade Name: Sterile Hypodermic Syringes for Single Use with Needles Common Name: Syringe with Needle
Regulatory Information Classification Name: Syringe, Piston Classification: II; Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;
Classification Name: Hypodermic, Syringe Lumen Classification: II; Product Code: FMI; Regulation Number: 21CFR 880.5570; Review Panel: General Hospital;
-
- Identification of Predicate Device
Predicate Device 510(k) Number: K211329 Product Name: Sterile Disposable Syringes with Needles
- Identification of Predicate Device
-
Device Description 6.
The Sterile Hypodermic Syringes for Single Use with Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle. The proposed device is available in a variety combination of syringe volume and needle size.
| Syringe Volume | Needle Sizes | ||
|---|---|---|---|
| Needle Length (mm) | Needle gauge | Wall | |
| 1ml, | 32 | 16G | TW |
| 2ml, | 38 | 16G | TW |
| 3ml, | 32 | 18G | TW |
| 5ml, | 38 | 18G | TW |
| 10ml, | 32 | 19G | TW |
| 20ml, | 38 | 19G | TW |
| 30ml, | 32 | 20G | TW |
| 50ml, | 38 | 20G | TW |
5
| 60ml,
| 100ml | 32 | 21G | TW |
|---|---|---|---|
| 38 | 21G | TW | |
| 32 | 22G | TW | |
| 38 | 22G | TW | |
| 19 | 23G | TW | |
| 25 | 23G | TW | |
| 32 | 23G | TW | |
| 19 | 24G | RW | |
| 25 | 24G | RW | |
| 32 | 24G | RW | |
| 16 | 25G | RW | |
| 19 | 25G | RW | |
| 25 | 25G | RW | |
| 13 | 26G | RW | |
| 16 | 26G | RW | |
| 19 | 26G | RW | |
| 13 | 27G | RW | |
| 16 | 27G | RW | |
| 19 | 27G | RW | |
| 13 | 28G | RW | |
| 16 | 28G | RW | |
| 13 | 29G | RW | |
| 16 | 29G | RW | |
| 13 | 30G | RW | |
| 16 | 30G | RW |
All gauges can be used with 1mL, 2mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL, 100mL syringe.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
-
- Indication for Use:
| Characterization | Proposed device | Predicate Device |
|---|---|---|
| Sterile Hypodermic Syringes for | ||
| Single Use with Needles | ||
| K221068 | Sterile Disposable Syringe with | |
| Needle | ||
| K211329 | ||
| Indication for Use | The Sterile Hypodermic Syringes | |
| for Single Use with Needles is | The Sterile Disposable Syringe with | |
| Needle is intended for use in the |
6
| intended for use in the aspiration | aspiration and injection of fluids for | |
|---|---|---|
| and injection of fluids for medical | medical purpose. | |
| purpose. | ||
| Prescription or OTC (over | ||
| the counter) | Prescription use | Prescription use |
Technology Characteristics 8.
The table below includes a comparison of the technological characteristics between the new device and those of the predicate.
| Technological
| Characteristic | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Sterile Hypodermic Syringes | |||
| for Single Use with Needles | Sterile Disposable Syringe | ||
| with Needle | |||
| K221068 | K211329 | ||
| Configuration | Barrel | Barrel | Same |
| Plunger | Plunger | ||
| Piston | Piston | ||
| Needle hub | Needle hub | ||
| Protective cap | Protective cap | ||
| Needle | Needle | ||
| Operation | |||
| Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Volume | 1ml, 2ml, 3ml, 5ml, 10ml, | ||
| 20ml, 30ml, 50ml, 60ml, | |||
| 100ml | 1ml, 2ml, 3ml, 5ml, 10ml, | ||
| 20ml, 30ml, 50ml, 60ml | Different | ||
| See | |||
| comment | |||
| #1 | |||
| Connector | |||
| Type | Luer Lock/ Luer Slip | Luer Lock/ Luer Slip | Same |
| Syringe | |||
| Performance | Complied with | ||
| ISO 7886-1 | Complied with | ||
| ISO 7886-1 | Same | ||
| Luer | |||
| Connector | |||
| Performance | Complied with | ||
| ISO 80369-7 | Complied with | ||
| ISO 80369-7 | Same | ||
| Needle | |||
| Performance | Complied with | ||
| ISO 7864, | |||
| ISO 9626 | Complied with | ||
| ISO 7864, | |||
| ISO 9626 | Same | ||
| Needle Gauge | 16G, 18G, 19G, 20G, 21G, | 23G | Different |
Table 1 Comparison of Technology Characteristics
7
| 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | See comment #2 | ||
|---|---|---|---|
| Needle Length | 13mm, 16mm, 19mm, 25mm, 32mm, 38mm | 13mm, 16mm, 20mm, 25mm, 32mm, 38mm | Different See comment #3 |
| Wall type | TW: 16G, 18G, 19G, 20G, 21G, 22G, 23G | ||
| RW: 24G, 25G, 26G, 27G, 28G, 29G, 30G | TW | Different See comment #4 | |
| Bevel Design | LB/SB | LB/SB | Same |
| Syringe Hubs | Central/Eccentric | Central/Eccentric | Same |
| Material | |||
| Barrel | Polypropylene (PP) | Polypropylene (PP) | Same |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | Same |
| Piston | Polyisoprene | Polyisoprene | Same |
| Needle | Stainless Steel SUS304 | Stainless Steel SUS304 | Same |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same |
| Needle cap | Polypropylene (PP) | Polypropylene (PP) | Same |
| Lubricants | Polydimethylsiloxane | Silicone oil | Different See comment #5 |
| Adhesive | Epoxy adhesive | UV adhesive | Different See comment #5 |
Discussions of differences in technological characteristics
Comment #1 – Syringe Volume
The proposed device has the additional 100ml syringe volume which is out of the volume range of predicate device. This does not change the intended use and does not raise new questions of safety and effectiveness. In addition, the syringe performance has been tested and test results demonstrate that the syringe meets the requirements of ISO 7886.
Comment #2 – Needle Length
The range of needle lengths is the same as the predicate. The predicate device does not have a 19mm needle length. This difference is not a new intended use and does not raise new questions of safety and
8
effectiveness. 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 – Needle Gauge
The subject device has the more gauges compared to the predicate device. This difference is not a new intended use and does not raise new questions of safety and effectiveness. In addition, all the needle gauges of proposed device has been tested. The needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.
Comment #4- Wall Type
The proposed device is available in thin wall and normal wall two types, the predicate device only has thin wall type. This difference is not a new intended use and does not raise new questions of safety and effectiveness. In addition, the all the wall type of proposed device has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626.
Comment #5 - Material of Lubricants and Adhesive
The proposed device has different adhesive and lubricants material compared to the predicate device However, biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. This difference is not a new intended use and does not raise new questions of safety and effectiveness.
9. Non-Clinical Test Conclusion
The device described in this summary Sterile Hypodermic Syringes for Single Use with Needles, were tested and demonstrated to be in conformance with the following FDA recognized standards:
-
ISO 7886-1: 2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
-
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 liquids 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 A
Biocompatibility
In accordance with ISO10993-1 the device are classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Cytotoxicity
- Irritation A
- A Skin Sensitization
9
-
Acute Systemic Toxicity
-
Pyrogenicity
-
Hemolysis
-
Material Mediated Toxicity
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 10th. 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 Syringes for Single Use with Needles is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K211329.