(139 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a pre-filled saline syringe, with no mention of AI or ML.
No.
The device is used for flushing intravenous administration sets and indwelling intravenous access devices, which is a maintenance task, not a therapeutic intervention that directly treats a disease or condition.
No
The device is a pre-filled syringe containing saline solution used for flushing intravenous lines and devices. Its purpose is to clear the lines and prepare them for subsequent medication administration or to maintain patency, not to diagnose a medical condition.
No
The device description clearly states it is a physical syringe made of polypropylene plastic, filled with saline, and terminally sterilized. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "flush compatible intravenous administration sets and indwelling intravenous access devices." This is a direct interaction with the patient's circulatory system and medical devices used for administering substances, not for testing samples in vitro (outside the body).
- Device Description: The device is a pre-filled syringe containing saline solution. This is a medical device used for flushing, not for performing diagnostic tests on biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to maintaining the patency of intravenous lines.
N/A
Intended Use / Indications for Use
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.
Product codes
NGT
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 3mL, 5mL or 10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 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
Not Found
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)
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. Tests included: Physical testing of syringe (ISO7886-1, ISO80369-7), Sodium Chloride Injection, USP Testing (USP40-, USP-, USP, USP6-471, USP40-, USP, USP), Particulate matter (USP), Biocompatibility testing (ISO10993-11, ISO10993-10, ISO10993-5, ISO 10993-4, ASTM F756-17), and Sterilization (USP, USP31-). All tests passed their respective acceptance criteria. The sterilization method has been validated according to ISO17665-1. The shelf life was determined based on a real-time aging study to verify that the device remains within specification.
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
§ 880.5200 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).
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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.
1
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).
2
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
3
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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4
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
5
| 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.
| Device
| feature | Subject Device | Predicate Device K213522 | Comments |
|---|---|---|---|
| Indications | |||
| for use | 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. | The AMSafe® 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. | Same | ||
| Product code | NGT | NGT | Same |
| Regulation | |||
| number | 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 |
6
| Device
| feature | Subject Device | Predicate Device K213522 | Comments |
|---|---|---|---|
| counter use | |||
| Principle of | |||
| operation | The product is a three-piece, | ||
| sterile, single use syringe | |||
| with a 6% (Luer) connector | |||
| pre-filled with 0.9% Sodium | |||
| Chloride Injection, USP, and | |||
| sealed with a protective cap. | The AMSafe® Pre-Filled | ||
| Normal Saline Flush Syringe | |||
| is a three-piece, sterile, | |||
| single use syringe with a 6% | |||
| (Luer) connector pre-filled | |||
| with 0.9% Sodium Chloride | |||
| Injection, USP, and sealed | |||
| with a tip cap. | Same | ||
| Chemical | |||
| composition | 0.9% Sodium chloride | ||
| injection, USP | 0.9% Sodium chloride | ||
| injection, USP | Same | ||
| Syringe | |||
| material | Barrel and plunger: | ||
| polypropylene | |||
| Plunger Stopper: Butyl | |||
| rubber (not made with | |||
| natural rubber latex) | |||
| Protective cap: | |||
| polypropylene | Barrel and plunger: | ||
| polypropylene | |||
| Stopper: Chlorobutyl rubber | |||
| (not made with natural rubber | |||
| latex) | |||
| Tip cap: polypropylene with | |||
| white colorant | Different | ||
| Comment 1 | |||
| Syringe Size | |||
| and Fill | |||
| Volumes | Fill 3ml, 5ml, 10ml in 10cc | ||
| syringe | Fill 3ml, 5ml, 10ml in 10cc | ||
| syringe | |||
| Fill 3ml, 5ml in 5cc syringe | Same | ||
| Syringe | |||
| packaging | PP wrap | PP wrap | Same |
| Sterilization | |||
| method and | |||
| SAL Level | Terminally sterilized by | ||
| steam, 10-6SAL | Terminally sterilized by | ||
| steam, 10-6 SAL | Same | ||
| Single use | |||
| only | Yes | Yes | Same |
| Shelf life | 1 years based on real time | ||
| aging study | 3 years | Different | |
| Comment 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.
7
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 of | |||
| syringe | ISO7886-1 | |||
| ISO80369-7 | ISO7886-1 | |||
| ISO80369-7 | 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 or | ||||
| alkalinity of syringe | ISO7886-1 | ISO7886-1 | Pass | |
| Chemical performance | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | |||
| pH value | USP40- | PH: 4.5-7.0 | Pass | |
| Sodium identification | USP- | USP- | Pass | |
| Chlorine identification | USP- | USP- | Pass | |
| Content determination | USP | 95% ~ 105% (g/l) | Pass | |
| Oxidizable | ||||
| substance test | USP6-471 | USP6-471 | Pass | |
| Iron test | USP | |||
| USP40- | USP- | Pass | ||
| Calcium salt | USP- | USP- | Pass | |
| Carbonate | USP- | USP- | Pass | |
| Sulfate | USP- | USP- | Pass | |
| Limits of extractable | ||||
| metals | USP | |||
| USP | Cd≤2 μg/L | |||
| Pb≤5 μg/L | ||||
| As≤15 μg/L | ||||
| Hg≤3 μg/L | Pass | |||
| 3 | Particulate matter | USP | ≥10um, ≤6000 | |
| ≥25um, ≤600 | Pass | |||
| 4 | Biocompatibility testing | |||
| Acute systemic toxicity | ISO10993-11 | No systemic toxicity | Pass | |
| Intracutaneous | ||||
| reactivity | 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 hemolysis | ||||
| properties | ISO 10993-4 | |||
| ASTM F756-17 | Non-hemolytic | Pass | ||
| 5 | Sterilization | |||
| Bacterial endotoxins | ||||
| test | USP | Bacterial endotoxins | ||
| ≤0.5EU/mL | Pass | |||
| Sterility tests | USP31- | USP31- | Pass |
The following performance testing was conducted on the proposed device:
8
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
9
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.