(139 days)
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the manufacturer for the appropriate device.
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a 3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.
The provided document (K231363) is a 510(k) summary for Hantech Pre-filled 0.9% Normal Saline Flush Syringes. This type of device is a sterile medical product, not an AI/ML-driven diagnostic or image analysis tool.
Therefore, the concepts of acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets do not apply in the context of this device and the information provided in the 510(k) summary.
The document describes non-clinical bench testing to demonstrate the substantial equivalence of the Hantech Pre-filled 0.9% Normal Saline Flush Syringes to a legally marketed predicate device. The "acceptance criteria" here refer to the predefined standards and limits for the physical, chemical, and biological properties of the syringe and its contents, as well as the sterilization process, which are based on recognized international and national standards (e.g., ISO, USP).
Here's an interpretation of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table summarizing the non-clinical testing performed. The "Acceptance criteria" column lists the standards/criteria the device must meet, and the "Conclusion" column indicates "Pass" for all tests, meaning the device met these criteria.
| NO. | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing of syringe | ISO7886-1, ISO80369-7 | ISO7886-1, ISO80369-7 (specific parameters for appearance, scale, sliding, dimension, dead space, acidity/alkalinity, chemical performance) | Pass |
| 2 | Sodium Chloride Injection, USP Testing | USP40-<791>, USP-<191>, USP, USP6-471, USP40-<241>, USP<233>, USP<232> | pH: 4.5-7.0, Positive identification for Sodium/Chlorine, 95% ~ 105% content, limits for oxidizable substances, iron, ammonium salt, calcium salt, carbonate, sulfate, and extractable metals (Cd≤2 μg/L, Pb≤5 μg/L, As≤15 μg/L, Hg≤3 μg/L) | Pass |
| 3 | Particulate matter | USP<788> | ≥10um, ≤6000; ≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | ISO10993-11, ISO10993-10, ISO10993-5, ISO10993-4, ASTM F756-17 | No systemic toxicity, Non-irritant, Non-pyrogen, Non-sensitizer, Non-cytotoxic, Non-hemolytic | Pass |
| 5 | Sterilization | USP<85>, USP31-<71> | Bacterial endotoxins ≤0.5EU/mL, Sterility (conformance to USP31-<71>) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states "Summary of clinical Testing: N/A," meaning no clinical trials were conducted. The testing described is bench testing (laboratory-based, non-human, non-animal testing) of the physical product, its components, and its contents. The sample sizes for each specific test (e.g., how many syringes were tested for dimensions, or how many batches for chemical composition) are not provided in this summary document. Data provenance would be the manufacturer's internal testing facilities in China. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set:
This question is not applicable. The "ground truth" for a medical device like a syringe is established by validated measurement methods and recognized standards, not by expert consensus on clinical findings. For example, the pH of the saline is measured by a pH meter against a standard, not by an expert's opinion.
4. Adjudication Method for the Test Set:
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, like image reading, not for objective bench testing of a physical product.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where the performance of human readers, with and without AI assistance, is compared. This device is a pre-filled saline syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this concept is entirely irrelevant for a medical device such as a pre-filled saline syringe. This applies to AI/ML algorithms.
7. The Type of Ground Truth Used:
The "ground truth" (or more accurately, the reference standard) for this device's performance is based on:
- Recognized consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series)
- United States Pharmacopeia (USP) monographs and general chapters: (e.g., USP<791> for pH, USP<191> for identification tests, USP<788> for particulate matter, USP<85> for Bacterial Endotoxins, USP31-<71> for Sterility tests, USP monographs for Sodium Chloride Injection)
- Manufacturer's internal specifications: Which must meet or exceed these recognized standards.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2023
Hantech Medical Device Co., Ltd. Arnold Yang Vice President of Quality No 288 Sanheng Road, Changhe Industrial Park, Cixi Ningbo, Zhejiang 315326 China
Re: K231363
Trade/Device Name: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005. PFS-1010) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: August 31, 2023 Received: August 31, 2023
Dear Arnold Yang:
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.
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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).
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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Bifeng Qian -S" in a large, sans-serif font. The text is black against a white background. There is a faint watermark in the background, but it does not obscure the text.
Bifeng Qian, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231363
Device Name
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Indications for Use (Describe)
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to 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 (K231363)
l Submitter
Device submitter: Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industrial Park, Cixi 315326, Ningbo PEOPLE'S REPUBLIC OF CHINA
Contact person: Name: Rachel Jin Title: Regulatory Affairs Phone: +86 180 5829 7039 Fax: +86 574 5899 5557 E-mail: rachel@hantechmedical.com
Date: 09/25/2023
II Device
Trade Name of Device: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) Common Name: Pre-filled 0.9% Normal Saline Flush Syringes Regulation Number: 21 CFR 880.5200 Classification: II Classification Name: Saline, vascular access flush Product code: NGT Review Panel: General Hospital
III Predicate Devices
| Trade name: | AMSafe® Pre-Filled Normal Saline Flush Syringe |
|---|---|
| Common name: | Pre-Filled Normal Saline Flush Syringe |
| Classification: | Class II, 21 CFR 880.5200 |
| Product Code: | NGT |
| Premarket Notification: | K213522 |
| Manufacturer: | Amsino International Inc. |
IV Device description
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a
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| Specification and Model | Syringe Size (mL) | Content of 0.9% sodium chloride injection, USP (mL) |
|---|---|---|
| PFS-1003 | 10 | 3 |
| PFS-1005 | 10 | 5 |
10
10
3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.
V Indications for use
PFS-1010
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are 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 Comparison of technological characteristics with the predicate devices
The Hantech Pre-filled 0.9% Normal Saline Flush Syringes have the same intended use, technology and design as the predicate device, and performance specifications are either identical or similar to the existing legally marketed predicate device. The device will be marketed as 10mL syringe with a 3mL, 5mL or 10mL fill volume of 0.9% Sodium chloride injection, USP according to the market needs. The differences between the Pre-filled 0.9% Normal Saline Flush Syringes and predicate device do not alter suitability of the proposed device for its intended use.
| Devicefeature | Subject Device | Predicate Device K213522 | Comments |
|---|---|---|---|
| Indicationsfor use | The Hantech Pre-filled 0.9%Normal Saline FlushSyringes, are intended foruse in flushing compatibleintravenous administrationsets and indwellingintravenous access devices.Use according to therecommendations of themanufacturer for theappropriate device. | The AMSafe® Pre-FilledNormal Saline Flush Syringeis intended for use in flushingcompatible intravenousadministration sets andindwelling intravenousaccess devices. Useaccording to therecommendations of themanufacturer for theappropriate device. | Same |
| Product code | NGT | NGT | Same |
| Regulationnumber | 21 CFR 880.5200 | 21 CFR 880.5200 | Same |
| Class | CLASS II | CLASS II | Same |
| Prescription/over-the | For Rx only | For Rx only | Same |
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| Devicefeature | Subject Device | Predicate Device K213522 | Comments |
|---|---|---|---|
| counter use | |||
| Principle ofoperation | The product is a three-piece,sterile, single use syringewith a 6% (Luer) connectorpre-filled with 0.9% SodiumChloride Injection, USP, andsealed with a protective cap. | The AMSafe® Pre-FilledNormal 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. | Same |
| Chemicalcomposition | 0.9% Sodium chlorideinjection, USP | 0.9% Sodium chlorideinjection, USP | Same |
| Syringematerial | Barrel and plunger:polypropylenePlunger Stopper: Butylrubber (not made withnatural rubber latex)Protective cap:polypropylene | Barrel and plunger:polypropyleneStopper: Chlorobutyl rubber(not made with natural rubberlatex)Tip cap: polypropylene withwhite colorant | DifferentComment 1 |
| Syringe Sizeand FillVolumes | Fill 3ml, 5ml, 10ml in 10ccsyringe | Fill 3ml, 5ml, 10ml in 10ccsyringeFill 3ml, 5ml in 5cc syringe | Same |
| Syringepackaging | PP wrap | PP wrap | Same |
| Sterilizationmethod andSAL Level | Terminally sterilized bysteam, 10-6SAL | Terminally sterilized bysteam, 10-6 SAL | Same |
| Single useonly | Yes | Yes | Same |
| Shelf life | 1 years based on real timeaging study | 3 years | DifferentComment 2 |
Discussion:
Comment 1
The materials of plunger stopper and protective cap are different between the subject device and predicate device. The cap materials of subject device and predicate device are all polypropylene, the only difference is that the cap material of the predicate device has white colorant while the subject device does not. The biocompatibility test of the subject device was conducted to demonstrate that the subject device met the biocompatibility requirements. So these differences do not raise any safety and effectiveness problems.
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Comment 2
The shelf life is different between the subject device and predicate device. The subject device has a shelf life of 1 years and meets all acceptance criteria. Results from shelf life testing conducted on the subject device demonstrate that differences (if any) between the shelf life of the predicate device and the subject device shelf life do not raise different questions of safety and effectiveness.
VII Summary of Non-clinical Testing (Bench):
The non-clinical testing for Hantech Pre-filled 0.9% Normal Saline Flush Syringes were performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
| NO. | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing ofsyringe | ISO7886-1ISO80369-7 | ISO7886-1ISO80369-7 | Pass |
| Appearance | ISO7886-1 | ISO7886-1 | ||
| Scale and label | ISO7886-1 | ISO7886-1 | Pass | |
| Sliding performance test | ISO7886-1 | ISO7886-1 | Pass | |
| Dimension test | ISO80369-7 | ISO80369-7 | Pass | |
| Dead space test | ISO7886-1 | ISO7886-1 | Pass | |
| Limits of acidity oralkalinity of syringe | ISO7886-1 | ISO7886-1 | Pass | |
| Chemical performance | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | |||
| pH value | USP40-<791> | PH: 4.5-7.0 | Pass | |
| Sodium identification | USP-<191> | USP-<191> | Pass | |
| Chlorine identification | USP-<191> | USP-<191> | Pass | |
| Content determination | USP<SodiumChlorideInjection> | 95% ~ 105% (g/l) | Pass | |
| Oxidizablesubstance test | USP6-471 | USP6-471 | Pass | |
| Iron test | USP<SodiumChlorideInjection>USP40-<241> | <2ppm | Pass | |
| Ammonium salt | USP-<191> | USP-<191> | Pass | |
| Calcium salt | USP-<191> | USP-<191> | Pass | |
| Carbonate | USP-<191> | USP-<191> | Pass | |
| Sulfate | USP-<191> | USP-<191> | Pass | |
| Limits of extractablemetals | USP<233>USP<232> | Cd≤2 μg/LPb≤5 μg/LAs≤15 μg/LHg≤3 μg/L | Pass | |
| 3 | Particulate matter | USP<788> | ≥10um, ≤6000≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | |||
| Acute systemic toxicity | ISO10993-11 | No systemic toxicity | Pass | |
| Intracutaneousreactivity | ISO10993-10 | Non-irritant | Pass | |
| Pyrogen test | ISO10993-11 | Non-pyrogen | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| In vitro hemolysisproperties | ISO 10993-4ASTM F756-17 | Non-hemolytic | Pass | |
| 5 | Sterilization | |||
| Bacterial endotoxinstest | USP<85> | Bacterial endotoxins≤0.5EU/mL | Pass | |
| Sterility tests | USP31-<71> | USP31-<71> | Pass |
The following performance testing was conducted on the proposed device:
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The sterilization method has been validated according to ISO17665-1, which has thereby determined the routine control and monitoring parameters. The shelf life of the Hantech Pre-filled 0.9% Normal Saline Flush Syringes are determined based on stability study which includes ageing test. The shelf life of the final finished sterilized
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device was evaluated based on real time aging study to verify that the subject device will remain within specification during the prescribed shelf life when stored under the labeled storage conditions.
Summary of clinical Testing: N/A
VIII Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Hantech Prefilled 0.9% Normal Saline Flush Syringes proposed in this 510(k) is as safe, as effective, performs as well as or better than the legally marketed device.
§ 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).