(120 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, and biocompatibility of a simple mechanical needle, with no mention of AI or ML.
No.
A therapeutic device is typically used to treat a disease or condition, whereas this device is used for administering vaccines or epidermal allergens, which are preventive or diagnostic applications, not treatments.
No
The device is intended for administering vaccines and allergens, which are therapeutic or administrative functions, not diagnostic.
No
The device description clearly describes a physical needle with prongs, sterilization, and packaging, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for administering vaccines or epidermal allergens by scarification. This is a direct application to the patient's skin for therapeutic or diagnostic purposes (in the case of allergen testing), not for examining specimens in vitro (outside the body).
- Device Description: The description details a physical needle used for puncturing the skin. This is a medical device used for direct patient interaction, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like reagents, assays, or detection methods).
IVD devices are used to examine specimens (like blood, urine, or tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. This bifurcated needle does not fit that description.
N/A
Intended Use / Indications for Use
The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
Product codes
LDH
Device Description
The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five 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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing of the Bifurcated Needle 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 (
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
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December 6, 2022
Anhui Tiankang Medical Technology Co., Ltd. Zhang Yong Management No.228,Weiyi Road, Economic Development Zone Tianchang, Anhui 239300 China
Re: K222385
Trade/Device Name: Bifurcated Needle Regulatory Class: Unclassified Product Code: LDH Dated: November 10, 2022 Received: November 10, 2022
Dear Zhang Yong:
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 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
1
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,
Alan M.
Stevens -
S3
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222385
Device Name Bifurcated Needle
Indications for Use (Describe)
The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
| 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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K222385 510(k) Summary
l Submitter
Device submitter: Anhui Tiankang Medical Technology Co., Ltd. No.228, Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China.
Contact person: Name: Zhang yong Title: Management representative Phone: +86-13705505106 Fax: +86-550-7309158 E-mail: zy@tkmedical.com
Preparation Date: December 6, 2022
II Device
Trade Name of Device: Bifurcated Needle Common Name: System, Delivery, Allergen And Vaccine Regulation Name: None Requlatory Class: Unclassified Product code: LDH Review Panel: General Hospital
III Predicate Devices
| Trade name: | BD Bifurcated Needle |
|---|---|
| Common name: | Bifurcated Needle |
| Classification: | Unclassified |
| Product Code: | LDH |
| Premarket Notification: | K020523 |
| Manufacturer: | BECTON, DICKINSON & CO. |
IV Device description
The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five years.
4
V Indications for use
The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
VI Comparison of technological characteristics with the predicate devices
The Bifurcated Needle has the same intended use, technology, design and biocompatibility is either identical or substantially equivalent to existing legally marketed predicate devices. The comparison between the subject device and the predicate devices are listed in below tables:
| Device
feature | Subject Device
K222385 | Predicate Device
K020523 | Comment |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product | Bifurcated Needle | BD Bifurcated Needle | / |
| Indications
for use | The Bifurcated Needle is
intended for use in
administering vaccines by
the scarification method or
administering epidermal
allergens. | The BD Bifurcated Needle is
intended for use in
administering vaccines by
the scarification method or
administering epidermal
allergens. | Same |
| Product code | LDH | LDH | Same |
| Principle of
operation | For Manual Use Only, For
Single Use Only | For Manual Use Only, For
Single Use Only | Same |
| Models | BFN001 | 301754; 301755; 301756;
301757 | Difference
comment 1 |
| Needle Length | $64mm\pm0.3mm$ Needle | 60.325mm | |
| Needle
dimension | $2mm\pm0.05mm$ | 1.905mm | |
| Materials | Bifurcated needle-(SUS
304)
Needle tip protector-(PVC
MT) | Stainless steel | Difference
comment 2 |
| Sterilization | EO Sterilization | Sterilization | Difference
comment 3 |
Table 6-1 Substantial equivalence discussion for Bifurcated Needle
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| Device
feature | Subject Device
K222385 | Predicate Device
K020523 | Comment |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Biocompatibility | Contact level: blood path,
indirect, limited contact (