(322 days)
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.)
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.
The provided text is a 510(k) summary for a medical device (INT Vacuum Locking Syringe) seeking FDA clearance. It describes non-clinical testing performed to establish substantial equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission."
Therefore, I cannot provide information regarding:
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Effect size of human readers improving with AI vs. without AI assistance
- Standalone (algorithm only without human-in-the-loop performance) study
I can, however, extract information about the non-clinical acceptance criteria and testing that was performed.
Here's the breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance testing conducted on the subject device against recognized standards. It states: "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." However, the specific quantitative acceptance criteria and the exact reported performance values (e.g., specific force in N, leakage volume) are not detailed in this summary. The summary only lists the items tested and the methodology/standards used.
| Item Tested | Methodology/Standard | Reported Device Performance (as stated in document) |
|---|---|---|
| Appearance | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Graduated scale | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Barrel | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Luer connector | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Nozzle lumen | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Force to operate the piston | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Freedom from air and liquid leakage past plunger stopper | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Tolerance on graduated capacity | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Dead space | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Push-button distance | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Matching of seals and plunger | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Matching of barrel and Piston | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Tensile strength | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Particulate Matter | USP <788> Particulate Matter in Injections | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Titration acidity or alkalinity | In-house standards | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Limits for extractable metals | In-house standards | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Reducing (oxidizable) matter | In-house standards | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Toxicity, Acute Systemic Toxicity, Pyrogen, In Vitro Hemolytic Properties) | FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1..." | All tests performed and passed. |
| Sterile Barrier Packaging (Visual inspection, Seal strength, Dye penetration, Durability of markings) | ASTM F1886/F1886M-16, ASTM F88/F88-15, ASTM F1929-15, ISO 20417:2021 | Test result showed that the device package can maintain its integrity. |
| Sterilization (EO residue, ECH residue, Bacteria Endotoxin Limit) | ISO 10993-7:2008, USP <85> | Met acceptance criteria. |
| Shelf-Life Evaluation (Physical, Mechanical, Chemical, Package Tests) | Stability studies including accelerated aging | Verified the claimed shelf life of 3 years. |
2. Sample size used for the test set and the data provenance:
The document mentions "non-clinical bench performance testing was conducted on the subject device" and lists various tests. However, it does not specify the sample sizes used for any of these tests.
Regarding data provenance, the testing was performed by the manufacturer, Shanghai Kindly Medical Instruments Co., Ltd., based in China, as part of their 510(k) submission. This is retrospective testing done to support the premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document explicitly states "No clinical study is included in this submission" and the testing described is non-clinical bench testing. Ground truth for clinical studies typically involves expert assessment of patient data.
4. Adjudication method for the test set:
This information is not applicable as it pertains to clinical studies and expert consensus, which were not part of this submission.
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:
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "No clinical study is included in this submission." The device is a physical medical instrument (syringe), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone study (in the context of AI algorithm performance) was not done. The device is a physical syringe, and the testing described is bench performance testing for a medical instrument, not a software algorithm.
7. The type of ground truth used:
For the non-clinical performance and biocompatibility testing, the "ground truth" is defined by the acceptance criteria specified within the referenced international standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993-1, ASTM standards, USP standards) and the manufacturer's own in-house standards. Compliance with these established technical specifications and biological safety requirements serves as the ground truth for device performance and safety.
8. The sample size for the training set:
This information is not applicable as there is no "training set" in the context of this device and the non-clinical testing performed. This usually refers to machine learning models, which are not involved here.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
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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 predicatedevice(K163597) | Discussion |
|---|---|---|---|
| Product name | INT Vacuum LockingSyringe | VacLok™ AT VacuumSyringe | - |
| Product Code | PUR | PUR | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Indications forUse | INT Vacuum LockingSyringe is intended foronly use by physicianfor adult patient toinject fluids into orwithdraw fluids fromthe body. It can also beused in cases where aVacuum Syringe ispreferred (e.g.,thrombus, abscessfluid, bile, urine, etc.) | VacLok™ AT VacuumSyringe is used toinject fluids into orwithdraw fluids fromthe body. It can also beused in cases where avacuum syringe ispreferred (e.g.,thrombus, abscessfluid, bile, urine, etc.). | Similar |
| Intended user | The device is intendedto be used only byphysicians who has | Unknown | The different intendeduser populations do notalter the intended useof the device, nor do |
| been trained in thisdevice and/or has theclinical useexperiences. | they affect theperformance of thedevice. | ||
| Intended PatientPopulation | Adult patient | Unknown | This difference doesnot alter suitability ofthe proposed devicefor its intended use. |
| Contraindications | There are nocontraindications. | There are nocontraindications orwarnings for thisproduct | The proposed devicecontains warnings,which are to remindusers to use the productsafely, so thisdifference does notraise new or differentquestions of safety andeffectiveness of thesubject device whencompared to thepredicate device. |
| Design | The proposed INTVacuum LockingSyringe consists ofplunger, barrel, sealsand locking column.Fitting offered withmale luer lockconnector. | Standard pistonsyringe constructedwith a clear hollowbarrel into which isinserted a closelyfitting movableplunger and tip/seal.Fitting offered withmale luer lockconnector. | The subtle differencesin design does notaffect the function ofthe product and thedesign principles areconsistent. Differencesin design between thepredicate device andsubject device wereaddressed throughperformance testingaccordingly. |
| Material | The barrel isconstructed from PC.The plunger andlocking column fromABS material; Sealsare made of siliconematerial. | The barrel isconstructed from clearpolycarbonate; theplunger from ABSmaterial; the seal ismade of siliconematerial. | The materials of theproposed device issimilar to the predicatedevice and thebiocompatibility testresults show that theproposed device doesnot raise new biologicalissues regarding safetywhen compared to thepredicate device. |
| Principle ofOperation | Manually operated byadvancing andwithdrawing theplunger within thebarrel. | Manually operated byadvancing andwithdrawing plungerwithin the barrel. | Same |
| VacuumTechnology | Fixed stop positiontechnology | Variable camlocktechnology | The difference in theVacuum Technologydoes not raise new oradditional questions ofsafety and effectivenessof the subject devicewhen compared to thepredicate device.Differences in VacuumTechnology betweenthe predicate deviceand subject device wereaddressed throughperformance testingaccordingly. |
| Operational Volume | 1mL, 3mL, 5mL,10mL, 20mL, 30mL,50mL and 60mL | 20 and 30 mL | The difference in theOperational Volumedoes not raise new ordifferent questions ofsafety and effectivenessof the subject devicewhen compared to thepredicate device.Differences inOperational Volumebetween the predicatedevice and subjectdevice were addressedthrough performancetesting accordingly. |
| Tip (nozzle) type | Fixed male luer lockconnector | Fixed male luer lockconnector | Same |
| Graduation | Printed with accurategraduation lines thatare compliant withISO 7886-1. | Printed with accurategraduation lines thatare compliant with ISO7886-1. | Same |
| Environment ofuse | Professional medicalconditions | Professional medicalconditions | Same |
| Accessories | No | No | Same |
| PerformanceStandards Used | ISO 7886-1:2017ISO 80369-7:2021 | ISO 7886-1ISO 594-2 | Same |
| Sterile | Yes | Yes | Same |
| Single for Use | Yes | Yes | Same |
| Prescription (RxOnly) | Yes | Yes | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf life | 3 years | 3 years | Same |
Table 1 Technological Characteristics Comparison
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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.
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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 (< 24hrs) to blood path, indirect were done. The following tests were performed and passed:
- In Vitro Cytotoxicity
- Skin Sensitization
- Intracutaneous Toxicity
- Acute Systemic Toxicity
- Pyrogen
- In Vitro Hemolytic Properties
A Performance testing
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:
| Items | Methodology/Standards |
|---|---|
| Appearance | ISO 7886-1:2017,ISO 80369-7:2021 |
| Graduated scale | |
| Barrel | |
| Luer connector | |
| Nozzle lumen | |
| Force to operate the piston | |
| Freedom from air and liquid leakage pastplunger 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<788> Particulate Matter inInjections |
| Titration acidity or alkalinityLimits for extractable metalsReducing (oxidizable) matter | In-house standards |
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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 <85> |
| 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.
§ 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).