(175 days)
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 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.
This document is a 510(k) Summary for a medical device called "Sterile Hypodermic Syringes for Single Use" (K221079). It focuses on demonstrating substantial equivalence to a predicate device (K180417) rather than providing detailed acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.
Therefore, many of the requested categories for acceptance criteria and study details for an AI/algorithm device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this submission.
However, I can extract the relevant information regarding the performance criteria and the non-clinical studies conducted to demonstrate its safety and effectiveness against recognized standards.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1: 2017 (Syringes for Manual Use) | Complied with (Test results demonstrate syringe meets requirements) |
| ISO 80369-7: 2016 (Connectors for intravascular or hypodermic applications) | Complied with |
| ISO 80369-20:2015 (Common test methods for small-bore connectors) | Complied with |
| Biocompatibility (ISO 10993-1, Externally Communicating Device, Blood Path Indirect, Limited Contact) | |
| Cytotoxicity | Testing conducted |
| Irritation | Testing conducted |
| Skin Sensitization | Testing conducted |
| Acute Systemic Toxicity | Testing conducted |
| Pyrogenicity | Testing conducted |
| Hemolysis | Testing conducted |
| Particulate Matter (USP <788>) | Met USP acceptance criteria |
| Sterility (ISO 11135:2014) | Achieved a Sterility Assurance Level (SAL) of 10^-6 |
| EO and ECH Residuals (ISO 10993-7:2008) | Below specified limits |
| Bacterial Endotoxin Levels (USP <85>) | Below 20EU/device |
| Packaging & Shelf-life | |
| Visual Inspection (ASTM F1886 / F1886M-16) | Performed |
| Seal Strength (ASTM F88/F88-15) | Performed |
| Dye penetration (ASTM F1929-15) | Performed |
| Simulated transportation testing (ASTM D4169-16) | Performed |
| Shelf-life (ASTM F1980-16) | 5-years validated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document pertains to a physical medical device (syringes), not an AI/algorithm. Performance is demonstrated through non-clinical laboratory testing of the manufactured product, not data analysis of a test set in the context of AI. The country of origin for the device manufacturer is China (Sichuan Prius Biotechnology Co., Ltd.). The studies are non-clinical, involving physical testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of AI/algorithm performance, is not relevant here. Performance is measured against recognized industry standards and validated laboratory methods for physical device characteristics (e.g., sterility, biocompatibility, mechanical performance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is a method for resolving discrepancies in expert labeling or diagnoses used in AI/algorithm studies. It is not relevant for the non-clinical testing of a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to the performance of an AI algorithm. This submission is for a physical syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance of this physical device, the "ground truth" is defined by compliance with established international and national standards (e.g., ISO for syringe performance, biocompatibility, sterility; USP for particulate matter and endotoxins) and validated test methodologies.
8. The sample size for the training set
- Not Applicable. Training sets are used for machine learning. This submission is for a sterile syringe.
9. How the ground truth for the training set was established
- Not Applicable. This question relates to AI/machine learning model development, which is not relevant to this medical device submission.
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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
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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
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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)
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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
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-
- 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 SingleUseK221079 | Sterile Hypodermic Syringes for SingleUseK180417 | |
| Indication for Use | The Sterile Hypodermic Syringes forSingle Use are intended to be used formedical purpose to inject fluid into orwithdraw fluid from body. | The Sterile Hypodermic Syringes forSingle Use are intended to be used formedical purpose to inject fluid into onwithdraw fluid from body. |
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| 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 | |||
|---|---|---|---|
| TechnologicalCharacteristic | Proposed deviceSterile Hypodermic Syringes forSingle UseK221079 | Predicate DeviceSterile Hypodermic Syringes forSingle UseK180417 | 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 |
| SyringePerformance | Complied with | Complied with | Same |
| ISO 7886-1 | ISO 7886-1 | ||
| Luer ConnectorPerformance | 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 | DifferentSee 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
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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 (< 24hrs). The following testing was conducted:
-
Cytotoxicity
-
Irritation
-
Skin Sensitization
- A Acute Systemic Toxicity
- A Pyrogenicity
- Hemolysis A
Particulate matter testing was conducted in accordance with USP <788> 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<85>. 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
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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.
§ 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).