(322 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device is used to treat a disease or condition. This device is used to inject or withdraw fluids, which are diagnostic or procedural actions, not therapeutic treatments.
No
The device is purely for injecting or withdrawing fluids, which is a therapeutic or procedural function, not for diagnosing a condition. While the withdrawn fluids might be used for diagnostic purposes later, the syringe itself does not perform any diagnostic function.
No
The device description clearly outlines physical components (graduation lines, barrel, plunger, etc.) and mentions bench performance testing on these physical attributes, 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 is a direct interaction with the patient's body for therapeutic or diagnostic purposes (like withdrawing fluid for analysis, but the device itself isn't performing the analysis).
- Device Description: The description focuses on the mechanical function of the syringe for fluid handling.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, analyzers, or other components designed for laboratory testing of biological samples.
The device is a medical device used for direct patient care, specifically for fluid management. While it can be used to withdraw fluids that might later be used for in vitro diagnostic testing, the syringe itself is not performing the diagnostic function.
N/A
Intended Use / Indications for Use
INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)
Product codes
PUR
Device Description
The INT Vacuum Locking Syringe is used to inject or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g., thrombus, abscess fluid, bile, urine etc.). The Syringe consists of graduation lines, zero line, luer connector, nozzle lumen, seals, barrel, plunger, push-button, barrel flanges, locking column, locking piece and fiducial line. When the Syringe is used, it can be divided into two situations: normal suction in normal state and vacuum suction in locked state. Vacuum Locking Syringe is placed in a soft blister box which is composed of Tyvek 2FS and PE. The proposed device is sterilized by EO and intended for single use. The packaging form is sealed packaging and guarantees that the product is sterile until opening. The packaging can ensure the sterilized finished device during its shelf life of 3 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
Adult patient
Intended User / Care Setting
physicians who has been trained in this device and/or has the clinical use experiences.
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 non-clinical bench performance testing was conducted on the subject device. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Testing included the following from these standards:
- Appearance
- Graduated scale
- Barrel
- Luer connector
- Nozzle lumen
- Force to operate the piston
- Freedom from air and liquid leakage past plunger stopper
- Tolerance on graduated capacity
- Dead space
- Push-button distance
- Matching of seals and plunger
- Matching of barrel and Piston
- Tensile strength
- Particulate Matter (USP Particulate Matter in Injections)
- Titration acidity or alkalinity
- Limits for extractable metals
- Reducing (oxidizable) matter
Sterile barrier packaging testing were performed on the proposed device, which included visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15), dye penetration test (ASTM F1929-15) and Durability of markings test (ISO 20417:2021). The test result showed that the device package can maintain its integrity.
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Vacuum Locking Syringe is three (3) years, determined based on stability studies which includes accelerated aging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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February 23, 2024
Shanghai Kindly Medical Instruments Co., Ltd Xu Jianhai, RA Manager No.925, Jinyuan yi Road Shanghai, 201803, China
Re: K230999
Trade/Device Name: INT Vacuum Locking Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: PUR Dated: January 19, 2024 Received: January 23, 2024
Dear Jianhai Xu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Shruti N. Mistry -S
Shruti Mistry, MS Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230999
Device Name INT Vacuum Locking Syringe
Indications for Use (Describe)
INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)
| 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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K230999- 510(k) summary
I. Submitter
Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan yi Road, Shanghai, 201803, China Establishment Registration Number: 3009605245 Contact Person: Xu Jianhai Position: RA Manager Tel .: +86-21-59140056 Fax: +86-21-59140056 Email: xujianhai(@kdl-int.com
Date of Preparation: February 23, 2024
II. Proposed Device
| Device Trade Name: | INT Vacuum Locking Syringe |
|---|---|
| Common name: | Vacuum Locking Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulatory Class: | Class II |
| Product code: | PUR |
| Review Panel: | General Hospital |
III. Predicate Devices
Primary predicate device
510(k) Number: K163597 VacLok™ AT Vacuum Syringe Trade name:
IV. Device description
The INT Vacuum Locking Syringe is used to inject or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g., thrombus, abscess fluid, bile, urine etc.). The Syringe consists of graduation lines, zero line, luer connector, nozzle lumen, seals, barrel, plunger, push-button, barrel flanges, locking column, locking piece and fiducial line. When the Syringe is used, it can be divided into two situations: normal suction in normal state and vacuum suction in locked state. Vacuum Locking Syringe is placed in a soft blister box which is composed of Tyvek 2FS and PE. The proposed device is sterilized by EO and intended for single use. The packaging form is sealed packaging and guarantees that the product is sterile until opening. The packaging can ensure the sterilized finished
4
device during its shelf life of 3 years.
V.Indication for use
INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)
VI. Comparison of technological characteristics with the predicate devices
Comparisons of subject device and the predicate devices shows that technological characteristics of the subject device such as components, design, sterilization, shelf life and operating principle are substantially equivalent to the currently marketed predicate device.
Table 1 summarizes the proposed device technological characteristics with compared to the predicate device under K163597.
| Item | Proposed device | Primary predicate
device
(K163597) | Discussion |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | INT Vacuum Locking
Syringe | VacLok™ AT Vacuum
Syringe | - |
| Product Code | PUR | PUR | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Indications for
Use | INT Vacuum Locking
Syringe is intended for
only use by physician
for adult patient to
inject fluids into or
withdraw fluids from
the body. It can also be
used in cases where a
Vacuum Syringe is
preferred (e.g.,
thrombus, abscess
fluid, bile, urine, etc.) | VacLok™ AT Vacuum
Syringe is used to
inject fluids into or
withdraw fluids from
the body. It can also be
used in cases where a
vacuum syringe is
preferred (e.g.,
thrombus, abscess
fluid, bile, urine, etc.). | Similar |
| Intended user | The device is intended
to be used only by
physicians who has | Unknown | The different intended
user populations do not
alter the intended use
of the device, nor do |
| | been trained in this
device and/or has the
clinical use
experiences. | | they affect the
performance of the
device. |
| Intended Patient
Population | Adult patient | Unknown | This difference does
not alter suitability of
the proposed device
for its intended use. |
| Contraindications | There are no
contraindications. | There are no
contraindications or
warnings for this
product | The proposed device
contains warnings,
which are to remind
users to use the product
safely, so this
difference does not
raise new or different
questions of safety and
effectiveness of the
subject device when
compared to the
predicate device. |
| Design | The proposed INT
Vacuum Locking
Syringe consists of
plunger, barrel, seals
and locking column.
Fitting offered with
male luer lock
connector. | Standard piston
syringe constructed
with a clear hollow
barrel into which is
inserted a closely
fitting movable
plunger and tip/seal.
Fitting offered with
male luer lock
connector. | The subtle differences
in design does not
affect the function of
the product and the
design principles are
consistent. Differences
in design between the
predicate device and
subject device were
addressed through
performance testing
accordingly. |
| Material | The barrel is
constructed from PC.
The plunger and
locking column from
ABS material; Seals
are made of silicone
material. | The barrel is
constructed from clear
polycarbonate; the
plunger from ABS
material; the seal is
made of silicone
material. | The materials of the
proposed device is
similar to the predicate
device and the
biocompatibility test
results show that the
proposed device does
not raise new biological
issues regarding safety
when compared to the
predicate device. |
| Principle of
Operation | Manually operated by
advancing and
withdrawing the
plunger within the
barrel. | Manually operated by
advancing and
withdrawing plunger
within the barrel. | Same |
| Vacuum
Technology | Fixed stop position
technology | Variable camlock
technology | The difference in the
Vacuum Technology
does not raise new or
additional questions of
safety and effectiveness
of the subject device
when compared to the
predicate device.
Differences in Vacuum
Technology between
the predicate device
and subject device were
addressed through
performance testing
accordingly. |
| Operational Volume | 1mL, 3mL, 5mL,
10mL, 20mL, 30mL,
50mL and 60mL | 20 and 30 mL | The difference in the
Operational Volume
does not raise new or
different questions of
safety and effectiveness
of the subject device
when compared to the
predicate device.
Differences in
Operational Volume
between the predicate
device and subject
device were addressed
through performance
testing accordingly. |
| Tip (nozzle) type | Fixed male luer lock
connector | Fixed male luer lock
connector | Same |
| Graduation | Printed with accurate
graduation lines that
are compliant with
ISO 7886-1. | Printed with accurate
graduation lines that
are compliant with ISO
7886-1. | Same |
| Environment of
use | Professional medical
conditions | Professional medical
conditions | Same |
| Accessories | No | No | Same |
| Performance
Standards Used | ISO 7886-1:2017
ISO 80369-7:2021 | ISO 7886-1
ISO 594-2 | Same |
| Sterile | Yes | Yes | Same |
| Single for Use | Yes | Yes | Same |
| Prescription (Rx
Only) | Yes | Yes | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf life | 3 years | 3 years | Same |
Table 1 Technological Characteristics Comparison
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6
7
VII. Non-Clinical Testing
The non-clinical tests were conducted to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
8
Biocompatibility testing >
The biocompatibility evaluation for proposed device was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"." All tests prescribed in guidance for an external communicating device with limited exposure ( Particulate Matter in
Injections |
| Titration acidity or alkalinity
Limits for extractable metals
Reducing (oxidizable) matter | In-house standards |
9
Sterile Barrier Packaging Test >
Sterile barrier packaging testing were performed on the proposed device, which included visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15), dye penetration test (ASTM F1929-15) and Durability of markings test (ISO 20417:2021). The test result showed that the device package can maintain its integrity.
Sterilization and Shelf Life >
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Vacuum Locking Syringe is three (3) years, determined based on stability studies which includes accelerated aging.
| 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 |
Sterilization and shelf-life testing listed were performed on the proposed device.
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposed device has the same indications and has similar design features and technological characteristics as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.