(175 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a standard syringe, with no mention of AI or ML capabilities.
No.
The device is a syringe used for injecting or withdrawing fluids, which is a delivery mechanism, not a therapeutic agent itself.
No
Explanation: The device, a sterile hypodermic syringe, is intended for injecting or withdrawing fluids from the body. This is a functional purpose, not a diagnostic one. Diagnostic devices are used to identify or characterize a disease or condition.
No
The device description clearly outlines physical components (barrel, plunger, piston) and manufacturing processes (sterilization, packaging), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Intended Use: The intended use of the Sterile Hypodermic Syringes is "to inject fluid into or withdraw fluid from body." This is a direct interaction with the body, not the testing of a specimen outside the body.
- Device Description: The description focuses on the physical components and function of a syringe for injection/withdrawal, not on analyzing biological samples.
The device described is a medical device used for direct patient care, specifically for administering or collecting substances from the body. It does not perform diagnostic testing on samples.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle. The proposed device is available in a variety syringe volume. Syringe volume: 1ml, 2ml, 3ml, 5ml, 20ml, 30ml, 50ml, 60ml, 100ml
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.
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 the Sterile Hypodermic Syringes for Single Use, 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
Biocompatibility
In accordance with ISO10993-1 the syringe 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 10t%. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20EU/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 ASTMD4169-16 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 two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
Sichuan Prius Biotechnology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China
October 4, 2022
Re: K221079
Trade/Device Name: Sterile Hypodermic Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF 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) K221079
Device Name
Sterile Hypodermic Syringes for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
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)
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."
3
K221079 -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
Trade Name: Sterile Hypodermic Syringes for Single Use Common Name: Syringe
- Identification of Proposed Device
Regulatory Information Classification Name: Syringe, Piston Classification: II; Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;
-
Identification of Predicate Device న్
510(k) Number: K180417 Product Name: Sterile Hypodermic Syringes for Single Use -
- Device Description
The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle. The proposed device is available in a variety syringe volume. Syringe volume: 1ml, 2ml, 3ml, 5ml, 20ml, 30ml, 50ml, 60ml, 100ml
- Device Description
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
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
- Indication for Use
| Characterization | Proposed device | Predicate Device |
|---|---|---|
| Sterile Hypodermic Syringes for Single | ||
| Use | ||
| K221079 | Sterile Hypodermic Syringes for Single | |
| Use | ||
| K180417 | ||
| Indication for Use | The Sterile Hypodermic Syringes for | |
| Single Use are intended to be used for | ||
| medical purpose to inject fluid into or | ||
| withdraw fluid from body. | The Sterile Hypodermic Syringes for | |
| Single Use are intended to be used for | ||
| medical purpose to inject fluid into on | ||
| withdraw fluid from body. |
5
| Prescription or OTC
| (over the counter) | Prescription use | Prescription use |
|---|---|---|
| ------------------------------------------- | ------------------ | ------------------ |
8. Technology Characteristics
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 | |||
|---|---|---|---|
| Technological | |||
| Characteristic | Proposed device | ||
| Sterile Hypodermic Syringes for | |||
| Single Use | |||
| K221079 | Predicate Device | ||
| Sterile Hypodermic Syringes for | |||
| Single Use | |||
| K180417 | Remark | ||
| Configuration | Barrel | Barrel | Same |
| Plunger | Plunger | ||
| Piston | Piston | ||
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Syringe | |||
| Performance | Complied with | Complied with | Same |
| ISO 7886-1 | ISO 7886-1 | ||
| Luer Connector | |||
| Performance | Complied with | Complied with | Same |
| ISO 80369-7 | ISO 80369-7 | ||
| Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, | ||
| 30ml, 50ml, 60ml, 100ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, | ||
| 30ml, 50ml | Different | ||
| See comment # | |||
| 1 | |||
| Connector Type | Luer Lock/ Luer Slip | Luer Lock/ Luer Slip | |
| Barrel | Polypropylene (PP) | Polypropylene (PP) | Same |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | Same |
| Piston | Polyisoprene | Polyisoprene | Same |
| Lubricants | Polydimethylsiloxane | Polydimethylsiloxane | Same |
Table 1 Comparison of Technology Characteristics
Discussions of differences in technological characteristics
Comment #1- Syringe Volume
The proposed device has the additional 60ml and 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.
-
- Non-Clinical Test Conclusion
6
The device described in this summary the Sterile Hypodermic Syringes for Single Use, 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
Biocompatibility
In accordance with ISO10993-1 the syringe are classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Cytotoxicity
-
Irritation
-
Skin Sensitization
- A Acute Systemic Toxicity
- A Pyrogenicity
- Hemolysis A
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 10t%. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20EU/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:
- O Visual Inspection ASTM F1886 / F1886M-16
- Seal Strength ASTM F88/F88-15 o
- o Dye penetration ASTM F1929-15
- . Simulated transportation testing in accordance to ASTMD4169-16 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.
-
- Clinical Test Conclusion
7
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 is as safe, as effective, and performs as well as the legally marketed predicative device cleared under K180417.