(254 days)
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
The provided document is a 510(k) summary for a medical device called "Pre-Filled Normal Saline Flush Syringe." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not describe a study involving an AI/CADe device or human readers. Therefore, I cannot provide information regarding acceptance criteria and studies typical for AI/CADe devices, such as those related to multi-reader multi-case studies, effect size of AI assistance, expert qualifications, or ground truth establishment for training and test sets in an AI context.
However, I can extract the acceptance criteria and performance data for the non-clinical (bench) tests conducted on the Pre-Filled Normal Saline Flush Syringe to demonstrate its safety and effectiveness.
Here's the information based on the provided text, specifically from Section VII "Summary of Non-clinical Testing (Bench)":
1. Table of Acceptance Criteria and the Reported Device Performance
| ID# | Test | Method | Acceptance Criteria | Conclusion (Reported Device Performance) |
|---|---|---|---|---|
| 1.1 | Lubricant | ISO7886-1 | ISO7886-1 | Pass |
| 1.2 | Dead Space | ISO7886-1 | ISO7886-1 | Pass |
| 1.3 | Limits for acidity or alkalinity | ISO7886-1 | ISO7886-1 | Pass |
| 1.4 | Syringe Luer Performance | ISO 80369-7 | ISO 80369-7 | Pass |
| 1.5 | Sealing performance | ISO7886-1 | ISO7886-1 | Pass |
| 2.1 | pH value (Sodium Chloride Injection, USP) | USP<791> | PH: 4.5-7.0 | Pass |
| 2.2 | Oxidizable substance test | USP6-471 | USP6-471 | Pass |
| 2.3 | Carbonate (Sodium Chloride Injection, USP) | USP<191> | USP<191> | Pass |
| 2.4 | Sulfate (Sodium Chloride Injection, USP) | USP<191> | USP<191> | Pass |
| 2.5 | Calcium (Sodium Chloride Injection, USP) | USP<191> | USP<191> | Pass |
| 2.6 | Ammonium (Sodium Chloride Injection, USP) | USP<191> | USP<191> | Pass |
| 2.7 | Iron test (Sodium Chloride Injection, USP) | USP<241> | < 2ppm | Pass |
| 2.8 | Limits of extractable metals | USP<233>, USP<232> | USP<233>, USP<232> | Pass |
| 3 | Particulate Contamination | AAMI TIR42:2021 | ≥10μm, ≤6000; ≥25μm, ≤600 | ≥10μm, ≤361.5; ≥25μm, ≤0.0 |
| 4.1 | Bacterial Endotoxins Test | USP 43<85> | Bacterial endotoxins ≤ 0.5EU/mL | Pass |
| 4.2 | In Vitro Cytotoxicity | ISO 10995-5:2009 (should be ISO 10993-5) | Non-cytotoxic | Pass |
| 4.3 | Intracutaneous Reactivity Test | ISO 10995-23:2021 (should be ISO 10993-23) | Non-irritant | Pass |
| 4.4 | Skin Sensitization Test | ISO 10993-10:2021 | Non-sensitizer | Pass |
| 4.5 | Acute Systemic Toxicity Test | ISO 10993-11:2017 | No systemic toxicity | Pass |
| 4.6 | Pyrogen Test | ISO 10993-11:2017 | Non-pyrogen | Pass |
| 4.7 | In Vitro Hemolysis Test | ISO 10993-4:2017 | Non-hemolytic | Pass |
Note on ISO standards in the table: There appears to be a typo for test IDs 4.2 and 4.3 in the provided document (ISO 10995 instead of ISO 10993 for biocompatibility tests). I have kept the text as written but noted the likely correct standard.
2. Sample size used for the test set and the data provenance
- Sample Size: "Real time aged samples from three non-consecutive lots were tested for all performance criteria."
- Data Provenance: The document does not specify the country of origin for the test samples or explicitly state if the study was retrospective or prospective. It implies prospective testing of manufactured lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical, bench testing study for a physical medical device, not an AI/CADe device requiring expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is bench testing. The results are based on objective measurements against established standard criteria.
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, an MRMC comparative effectiveness study was not done. This device is not an AI/CADe device, and the study did not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "device" in this context is the physical syringe. The performance tests conducted are standalone tests of the device itself (its materials, chemical contents, physical properties, and biocompatibility), without specific human-in-the-loop performance measurement beyond standard laboratory procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by internationally recognized consensus standards (e.g., ISO, USP, AAMI TIR) which define the acceptable limits and test methodologies for the physical, chemical, and biological properties of the device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.
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Image /page/0/Picture/0 description: The image contains 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.
August 12, 2023
Anhui Tianyang Pharmaceutical Co., Ltd. Zhang Shunlin Quality Manager 46 Tiantong Road, Tianchang City, Anhui Province Tianchang. Anhui China
Re: K223584
Trade/Device Name: Pre-Filled Normal Saline Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: July 13, 2023 Received: July 14, 2023
Dear Zhang Shunlin:
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
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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 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 medical devices and radiation-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,
Bifeng Qian -S
Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K223584
Device Name Pre-Filled Normal Saline Flush Syringe
Indications for Use (Describe)
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
| 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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510(k) Summary (K223584)
l 510(k) Submitter
| Device Submitter: | Anhui Tianyang Pharmaceutical Co., LTD. |
|---|---|
| No.46, Tiantong Road, Tianchang City, Anhui Province |
| Contact Person: | Zhang Sunlin |
|---|---|
| Quality Manager | |
| Phone: | +86-15805509075 |
| E-mail: | 752322508@qq.com |
II Device
| Trade Name of Device: | Pre-Filled Normal Saline Flush Syringe |
|---|---|
| Regulation Number: | 21 CFR 880.5200 |
| Classification Name: | Saline, Vascular Access Flush |
| Product Code: | NGT |
| Regulation Number: | 21 CFR 880.5200 |
| Regulatory Class | II |
| Review Panel | General Hospital |
III Predicate Devices
| 510k Number | K213522 |
|---|---|
| Trade Name of Device: | AMSafe® Pre-Filled Normal Saline Flush Syringe |
| Regulation Number: | 21 CFR 880.5200 |
| Regulation Name: | Intravascular Catheter |
| Regulatory Class | II |
| Product Code: | NGT |
IV Device Description
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
V Indications for use
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
VI Technological Characteristics Comparison
VI-1: Comparison of Pre-Filled 0.9% Normal Saline Flush Syringe
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| DeviceCharacteristic | Subject Device(K223584) | Predicate Device(K213522) | Discussion |
|---|---|---|---|
| Indications forUse | Pre-Filled Normal Saline FlushSyringe is intended for use influshing compatibleintravenous administrationsets and indwellingintravenous access devices.Use according to therecommendations of themanufacturer for theappropriate device. | The AMSafe® PreFilledNormal Saline FlushSyringe, is intended for usein flushing compatibleintravenousadministration sets andindwelling intravenousaccess devices. Useaccording to therecommendations of themanufacturer for theappropriate device. | SimilarComment 1 |
| Prescription/over-the counteruse | For Rx only | For Rx only | Identical |
| OperationPrinciple | The Pre-Filled Normal SalineFlush Syringe is flushed afterthe locking connector isconnected to the medicalcatheter connector for clinicaluse the liquid medicine (0.9%sodium chloride injection) waspushed into the medicalcatheter and used to closeand flush the end of thecatheter in the gap betweendifferent drugs. | The AMSafe® PreFilledNormal Saline Flush Syringeis a three-piece, sterile,single use syringe with a 6%(Luer) connector pre-filledwith 0.9% Sodium ChlorideInjection, USP, and sealedwith a tip cap. | Identical |
| Design | The subject device with Luerlock connection fitting andnonvented, female Luer locktip cap. | The device has modified toadd an extra thread to theplunger rod and inside ofplunger stopper, the femaleLuer cap has Changed toscrew type. | DifferentComment 2 |
| Chemicalcomposition | 0.9% Sodium chlorideinjection, USP | 0.9% Sodium chlorideinjection, USP | Identical |
| Syringe material | Tip Cap, Barrel and Plunger:polypropylene;Piston: Bromobutyl rubber | Barrel and plunger:polypropyleneStopper: Butyl rubber (notmade with natural rubber | Identical |
| DeviceCharacteristic | Subject Device | Predicate Device(K213522) | Discussion |
| latex) | |||
| Tip cap: polypropylene withwhite colorant | |||
| Syringe Sizeand Fill Volumes | Fill 3ml, 5ml, 10ml in 10ccsyringe | Fill 3ml, 5ml, 10ml in 10ccsyringe | Identical |
| Fill 3ml, 5ml in 5cc syringe | Fill 3ml, 5ml in 5cc syringe | ||
| SyringePackaging | BOPP heat sealing film | PP wrap | DifferentComment 3 |
| Sterilizationmethod andSAL Level | Terminally sterilized by steam,10-6 SAL | Terminally sterilized bysteam, 10-6 SAL | Identical |
| Labelednonpyrogenic | Yes | Yes | Identical |
| Singe Use Only | Yes | Yes | Identical |
| Shelf Life | 2 Years | 3 Years | Similar |
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Comment 1: The Indications for Use of the predicate and subject device are same and the intended use is same, which does not affect the safety and effectiveness of the product.
Comment 2: The Luer cap of the predicate device has been modified, and the subject device is a standard Luer connector that meets the requirements of ISO 80369-7, so it does not affect the safety and effectiveness of the product.
Comment 3: The packaging materials of the subject and predicate are different, but the packaging of the subject device has been verified, and the sterility of the product can be guaranteed within the claimed shelf life of 2 years. Therefore, the safety and effectiveness of the product will not be affected.
VII Summary of Non-clinical Testing (Bench)
The non-clinical testing for Pre-Filled Normal Saline Flush Syringe was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. Real time aged samples from three non-consequtive lots were tested for all performance criteria.
| Table VII-1. Performance testing was conducted on the subject device | |||||
|---|---|---|---|---|---|
| ID# | Test | Method | Acceptance Criteria | Conclusion | |
| 1 | Physical Testing of Syringe | ||||
| 1.1 | Lubricant | ISO7886-1 | ISO7886-1 | Pass | |
| 1.2 | Dead Space | ISO7886-1 | ISO7886-1 | Pass | |
| 1.3 | Limits for acidity oralkalinity | ISO7886-1 | ISO7886-1 | Pass | |
| 1.4 | Syringe LuerPerformance | ISO 80369-7 | ISO 80369-7 | Pass | |
| 1.5 | Sealingperformance | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | ||||
| 2.1 | pH value | USP<791> | PH: 4.5-7.0 | Pass | |
| 2.2 | Oxidizablesubstance test | USP6-471 | USP6-471 | Pass | |
| 2.3 | Carbonate | USP<191> | USP<191> | Pass | |
| 2.4 | Sulfate | USP<191> | USP<191> | Pass | |
| 2.5 | Calcium | USP<191> | USP<191> | Pass | |
| 2.6 | Ammonium | USP<191> | USP<191> | Pass | |
| 2.7 | Iron test | USP<241> | < 2ppm | Pass | |
| 2.8 | Limits ofextractable metals | USP<233>USP<232> | USP<233>USP<232> | Pass | |
| 3 | ParticulateContamination | AAMI TIR42:2021 | ≥10μm, ≤6000≥25μm, ≤600 | ≥10μm, ≤361.5≥25μm, ≤0.0 | |
| 4 | Biocompatibility Testing | ||||
| 4.1 | BacterialEndotoxins Test | USP 43<85> | Bacterial endotoxins≤0.5EU/mL | Pass | |
| 4.2 | In Vitro Cytotoxicity | ISO 10995-5:2009 | Non-cytotoxic | Pass | |
| 4.3 | IntracutaneousReactivity Test | ISO 10995-23:2021 | Non-irritant | Pass | |
| 4.4 | Skin SensitizationTest | ISO 10993-10:2021 | Non-sensitizer | Pass | |
| 4.5 | Acute SystemicToxicity Test | ISO 10993-11:2017 | No systemic toxicity | Pass | |
| 4.6 | Pyrogen Test | ISO 10993-11:2017 | Non-pyrogen | Pass | |
| 4.7 | In Vitro HemolysisTest | ISO 10993-4:2017 | Non-hemolytic | Pass |
Table VII-1: Performance testing was conducted on the subject device
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VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject Pre-Filled Normal
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Saline Flush Syringe is as safe as effective, and performs as well as or better than the legally marketed device.
Date of Summary: August 8, 2023
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).