(224 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and filtration function of a filter needle, with no mention of AI or ML.
No
The device is described as a "Filter Needle for Single Use" intended for the aspiration and preparation of medical fluid, specifically for the "extraction, filtration and configuration of medicinal solutions." Its function is related to preparing medications, not directly treating a disease or condition in a patient.
No
The device is a filter needle used for preparing medical fluid, not for diagnosing medical conditions. The "Intended Use" specifies "aspiration and preparation of medical fluid," and the "Device Description" details its use for "extraction, filtration and configuration of medicinal solutions." There is no mention of analysis, detection, or assessment for diagnostic purposes.
No
The device description clearly outlines physical components made of materials like polycarbonate, stainless steel, and polyamide, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "aspiration and preparation of medical fluid, not including injection." This describes a process involving the handling of fluids outside of the body for preparation or transfer, not for diagnostic testing of biological samples.
- Device Description: The description details a "Filter Needle for Single Use" designed for "extraction, filtration and configuration of medicinal solutions." This aligns with the preparation of medications or fluids for administration, not for analyzing biological specimens.
- Lack of Diagnostic Purpose: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of such samples.
- Predicate Device: The listed predicate device (K801343; B-D FILTER NEEDLE) is also a filter needle, which is a general medical device used for fluid handling, not an IVD.
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is related to the preparation and handling of medical fluids, which is a different category of medical device.
N/A
Intended Use / Indications for Use
This product is intended for the aspiration, filtration and preparation of medical fluid, not including injection.
Product codes (comma separated list FDA assigned to the subject device)
FPB
Device Description
The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).
The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
Biocompatibility of the Filter Needle for Single Use was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device -Blood path indirect" with a contact duration of "Limited () - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2024
Hangzhou Qiantang Longyue Biotechnology Co., LTD % Esther Zhang Regulatory Affairs Shanghai Ling Fu Technology Co., Ltd. 4F, No.585-2 Wanyuan Road, Minhang District Shanghai, Shanghai 201102 China
Re: K233277
Trade/Device Name: Filter Needle for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPB Dated: April 10, 2024 Received: April 11, 2024
Dear Esther Zhang:
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 (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"
1
(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 OS 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.
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233277
Device Name Filter Needle for Single Use
Indications for Use (Describe)
This product is intended for the aspiration and preparation of medical fluid, not including injection.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K233277_510(k) summary
I Submitter
| Device submitter: | Hangzhou Qiantang Longyue Biotechnology Co., LTD
104, 301, 302, building 12, building 1,619 WangMe
Road Linping street, Linping District, Hangzhou |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Chunyu Wang
Quality Assurance Manager
Phone: 0086-571-89150121
Email: chunyu_wang@nextech-x.com
Fax: 86-571-89150091 |
Prepare Date: May 10, 2024
II Correspondent
| Company | Shanghai Ling Fu Technology Co., Ltd.
4F, No.585-2 Wanyuan Road, Minhang District, Shanghai
P.R.China |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Contact person: | Esther ZHANG
Regulatory affairs
Phone: 0086-13771505757
Email: Esther.zhang@llins-tech.com |
III Device
Trade Name of Device: Filter Needle for Single Use Common Name: Infusion Line Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product code: FPB Review Panel: General Hospital
IV Predicate Devices
| Trade name: | B-D FILTER NEEDLE |
|---|---|
| Common name: | Infusion Line Filter |
| Classification: | Class II, 21 CFR 880.5440 |
| Product Code: | FPB |
| Premarket Notification: | K801343 |
| Manufacturer: | BD BECTON DICKINSON VACUTAINER SYSTEMS |
| PREANALYTIC |
5
V Device description
The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).
The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.
| Model Number | Description |
|---|---|
| FN-B1838RW | 18 Gauge, 38 mm length |
| FN-B1850RW | 18 Gauge, 50 mm length |
| FN-L1938TW | 19 Gauge, 38 mm length |
| FN-L1950TW | 19 Gauge, 50 mm length |
VI Indications for use
This product is intended for the aspiration, filtration and preparation of medical fluid, not including injection.
VII Comparison of technological characteristics with the predicate devices
The Filter Needle for Single Use has the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Filter Needle for Single Use and predicate devices do not alter suitability of the proposed device for its intended use.
| Device feature | Subject Device | Predicate Device
K801343 | Comments |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product code | FPB | FPB | Identical |
| Regulation
number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
| Class | CLASS II | CLASS II | Identical |
| Number of
uses | Single use Rx only | Single use Rx only | Identical |
| Material | Needle holder material of
polycarbonate
(PC),
needle tube material of
stainless steel (SUS304),
filter membrane material of
polyamide (PA) | Needle holder material
(PC),
Needle tube
material (SUS304),
Filter membrane
material (PA) | Identical |
| Device feature | Subject Device | Predicate Device
K801343 | Comments |
| Sheath | Image: Subject Device Sheath | Image: Predicate Device Sheath | Different
Comment
1 |
| Indications for
Use | This product is intended
for the aspiration, filtration
and preparation of medical
fluid, not including
injection. | The B-D FILTER
NEEDLE is intended
for the aspiration,
filtration and
preparation of medical
fluid, not including
injection. | Identical |
| Operating
principles | Manual | Manual | Identical |
| Design
specifications | Needle Gauge:
18G, 19G
Length:
38 mm,50 mm | Gauge: 18 G
Length (mm): 40
Length (inch): 1 1/2" | Different
Comment
2 |
| Performance | Conforms to the standard
requirements of ISO
7864:2016 and ISO
22413:2021 | Conforms to the
standard requirements
of ISO 7864:2016 and
ISO 22413:2021 | Identical |
| Biocompatibility | Biocompatible
The
finished device's patient
contacting parts were
assessed in accordance
with tests recommended in
the FDA Guidance - Use of
International Standard
ISO-10993- 1, "Biological
evaluation of medical
devices - Part 1:
Evaluation and testing
within a risk management
process." | Biocompatible
The
finished device's
patient contacting parts
were assessed in
accordance with tests
recommended in the
FDA Guidance - Use of
International Standard
ISO-10993- 1,
"Biological evaluation
of medical devices -
Part 1: Evaluation and
testing within a risk
management process." | Identical |
| Sterilization
method | Irradiation sterilization | Irradiation sterilization | Identical |
| Bacterial
endotoxin | USP | USP | Identical |
| Expiration Date | 4 years | 5 years | Different
Comment
3 |
6
Discussion:
7
Comment 1
Although there are differences in the size and design of the two sheaths of needle, their general forms are essentially the same. Since the structure and intended use of the body of the subject and predicate device remain unchanged, modifications to the sheath do not raise different safety concerns or new ones.
Comment 2
Needle length specification our needle length specification is 38mm and 50mm, and BD needle length specification is 40mm. Tests on the varying needle lengths of the subj are performed per ISO 7864:2016. These test results confirm that the differences in needle lengths do not impact the safety or effectiveness.
Comment 3
Our products are valid for 4 years and BD' products are valid for 5 years. We have implemented validation of our products, and the safety and validity of our products meet the requirements within the validity period.
In conclusion, there is no substantial difference between our products and similar products currently marketed in the United States.
8
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Filter Needle for Single Use was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device -Blood path indirect" with a contact duration of "Limited ( ASTM F1929-2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- A ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
9
Performance testing
| Performance testing Summary | |||
|---|---|---|---|
| Number | Item | Testing standard | Result |
| 1. | Exterior Condition | ISO 7864:2016 | Pass |
| 2. | Needle Length | ISO 7864:2016 | Pass |
| 3. | Needle Holder | ||
| Tapered Fittings | ISO 7864:2016 | Pass | |
| 4. | Uprightness | ISO 7864:2016 | Pass |
| 5. | Firmness of | ||
| Connection | ISO 7864:2016 | Pass | |
| 6. | Particulate | ||
| Contamination | ISO 22413-2021 | Pass | |
| 7. | Tightness | ISO 22413-2021 | Pass |
| 8. | Piercing Force | ISO 22413-2021 | Pass |
| 9. | Puncture Chip | ISO 22413-2021 | Pass |
| 10. | Filtration Rate | ISO 22413-2021 | Pass |
| 11. | Seat to Sheath | ||
| Mating | ISO 7864:2016 | Pass | |
| 12. | Chemical Property | ISO 7864:2016 | Pass |
| 13. | Sterility | United States Pharmacopeia | Pass |
| 14. | Bacterial Endotoxin | USP | Pass |
IX Conclusion
The Filter Needle for Single Use are substantially equivalent to its predicate device (B-D FILTER NEEDLE). The non-clinical testing demonstrates that the device is as safe and as effective as the legally marketed predicate device.