(156 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a standard hypodermic syringe, with no mention of AI or ML capabilities.
No.
The device description indicates its use for injecting or withdrawing fluids, which is a delivery mechanism, not a therapeutic action itself.
No
The device description clearly states its intended use is "to inject fluids into or withdraw fluids from the body," which are treatment-oriented actions, not diagnostic ones. There is no mention of analysis, interpretation, or detection of diseases or conditions.
No
The device description clearly outlines physical components (barrel, plunger, piston) and mentions testing related to materials, packaging, and sterilization, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes on the body, not for testing samples outside the body.
- Device Description: The description focuses on the physical components of a syringe (barrel, plunger, piston, connectors) used for fluid transfer. This aligns with a general medical device, not specifically an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological specimens in vitro.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This syringe's function is to deliver or remove substances from the body itself.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Sterile Hypodermic Syringe for Single Use is intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.
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
Adult and pediatric population
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 Performance Testing:
- 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
Biocompatibility Testing:
In accordance with ISO 10993-1, the syringe is classified as: Externally communicating Device. Blood Path Indirect, Limited Contact ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterile Barrier Packaging Test:
Performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and Shelf Life Test:
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile Hypodermic Syringe for Single Use is 5 years, determined based on stability studies which includes accelerated aging.
Sterilization and shelf life testing listed were performed on the proposed device.
- EO residue (ISO 10993-7:2008)
- ECH residue (ISO 10993-7:2008)
- Bacteria Endotoxin Limit (USP )
- Shelf Life Evaluation: Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device
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 shows 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.
May 12, 2022
BERPU MEDICAL TECHNOLOGY CO., LTD Buxin Yu Management Representative No.14 Xingii Road, Yongxing Street Longwan District, 325000, Wenzhou, Zhejiang Province
Re: K213811
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: February 2, 2022 Received: April 4, 2022
Dear Buxin Yu:
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,
For 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213811
Device Name
Sterile Hypodermic Syringe for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the 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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3
K213811 510(k) Summary
1. Date of Preparation: May 7, 2022
2. Sponsor Identification
BERPU MEDICAL TECHNOLOGY CO., LTD NO.14 Xingji Road, Yongxing Street, Longwan District, 325000, Wenzhou, Zhejiang Province
Establishment Registration Number: 3004496829
Contact Person: Buxin Yu Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: zhc@berpu.com
3. Identification of Proposed Device
Trade Name: Sterile Hypodermic Syringe for Single Use
Regulatory Information Classification Name: Piston Syringe Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
4. Identification of Predicate Devices
Predicate Device 510(k) Number: K210227 Product Name: Sterile syringe for single use with/without needle
5. Device Description
The Sterile Hypodermic Syringe for Single Use is intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.
4
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Sterile syringe for single use | ||
| with/without needle | ||
| K210227 | Sterile Hypodermic Syringes for Single | |
| Use | ||
| K213811 | ||
| Indication for Use | The Sterile Syringes for Single Use | |
| with/without needle are intended to be | ||
| used for medical purposes on adult | ||
| and inject inject fluids into or withdraw | ||
| fluids from the body. | The Sterile Hypodermic Syringes for | |
| Single Use are intended to be used for | ||
| medical purposes on adult and pediatric | ||
| population to inject fluids into or | ||
| withdraw fluids from the body. |
6. Indication for Use
The indications for use of the subject device are slightly different from the predicate device. The difference is the intended population is included in the indications of subject device. This difference is does not affect safety and effectiveness of the proposed device.
Substantially Equivalent (SE) Comparison 7.
Table 2 Comparison of Technology Characteristics of Sterile Hypodermic Syringes for Single Use
| Item | Proposed Device
K213811 | Predicate Device
K210227 | Remark |
|-------------------------------|------------------------------------------------------------|---------------------------------------------------------------|------------|
| Product name | Sterile Hypodermic Syringes
for Single Use | Sterile syringe for single use
with/without needle | - |
| Product Code | FMF | FMF | same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | CLASS II | CLASS II | same |
| Syringe volume | 10ml, 20ml, 30ml, 50mL, 60ml | 1ml, 2ml, 3ml, 5ml, 10ml,
20ml, 30ml, 50ml, 60ml,
100ml | Analysis 1 |
| Nozzle type | Luer slip; Luer lock | Luer slip; Luer lock | same |
| Configuration and
material | Barrel
Polypropylene
(PP) | Barrel
Polypropylene
(PP) | |
| | Plunger
Polypropylene
(PP) | Plunger
Polypropylene
(PP) | Analysis 2 |
| | Piston
Polyisoprene
Rubber | Piston
Silicone
Rubber | |
| Operation Mode | For manual use only | For manual use only | same |
| Syringe Performance | Complied with ISO
7886-1:2017 | Complied with ISO
7886-1:2017 | same |
| Biocompatibility | Comply with ISO 10993 series
standards, which includes: | Comply with ISO 10993 series
standards, which includes: | same |
5
| ISO 10993-5: 2009; | ISO 10993-5: 2009; | ||
|---|---|---|---|
| ISO 10993-10: 2010 | ISO 10993-10: 2010 | ||
| ISO 10993-4: 2017 | ISO 10993-4: 2017 | ||
| ISO 10993-11: 2017 | ISO 10993-11: 2017 | ||
| OTC use | No | No | same |
| Single for Use | Yes | Yes | same |
| Patient population | Adult and children | unknown | Analysis 3 |
| Shelf-life | 5 years | 3 years | Analysis 4 |
| Sterilization | EO Sterilization | EO Sterilization | same |
| SAL | 10-6 | 10-6 | same |
| Label/Labeling | Complied with 21 CFR part | ||
| 801 | Complied with 21 CFR part | ||
| 801 | same |
Analysis 1- Syringe volume
The proposed has less specification of syringe volume compared to predicate device. However, the different syringe volume will be selected by physician per injection requirement and this difference does not affect intended use. In addition, the syringe volume for proposed device is covered by predicate device. The performance of the proposed devices has been performed on the final finished device. The test results shows passed the requirements of standard of ISO 7886-1. Therefore, this difference is not considered to affect the Substantially Equivalency (SE) between the proposed and predicate devices.
Analysis 2-Configuration and material
The configurations for both proposed device and predicate device are similar, the difference is just in component material. However, the biocompatibility test result does not show any adverse effect which can demonstrate the safety of proposed device. Therefore, this difference is not considered to affect substantially equivalence.
Analysis 3-Paptient population
This difference does not alter suitability of the proposed device for its intended use
Analysis 4-Shelf-life
The shelf life of the proposed device is 5 years, which is longer than the predicated device. The product performance after 5 years has been determined based on accelerated aging study. The packaging integrity test of proposed device was conducted on the proposed device. The results can demonstrate that the packaging was able to maintain sterility of the sterilized finished device during its shelf life of 5 years.
8. Non-Clinical Test Performance Testing
The Sterile Hypodermic Syringe for Single Use described in this summary 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
6
- . ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility Testing:
In accordance with ISO 10993-1, the syringe is classified as: Externally communicating Device. Blood Path Indirect, Limited Contact ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterile Barrier Packaging Test
Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and Shelf Life Test
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile Hypodermic Syringe for Single Use is 5 years, determined based on stability studies which includes accelerated aging.
Sterilization and shelf life testing listed were performed on the proposed device.
| Item | Standard |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performed on |
| aging samples to verify the claimed shelf life of the device |
9. 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 substantially equivalent to the Sterile Syringe for Single Use with/without Needle with respect to the indications for use, target populations, treatment method, and technological characteristics.