(120 days)
The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
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.
The provided document is a 510(k) summary for a "Bifurcated Needle" and primarily focuses on proving substantial equivalence to a predicate device based on material properties, manufacturing processes, and adherence to performance standards. It explicitly states that "No clinical study is included in this submission." Therefore, the document does not contain information regarding a study that proves the device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or clinical effectiveness.
The request asks for details typically found in submissions for AI/ML-driven medical devices or diagnostic tools, which involve evaluating algorithm performance, human-in-the-loop studies, and the establishment of "ground truth" for test and training sets. Since this document is for a physical, non-AI medical device (a bifurcated needle for administering vaccines), these types of studies were not conducted or presented.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy.
- Sample sizes for a test set for AI performance or data provenance.
- Number of experts or their qualifications for establishing ground truth for AI.
- Adjudication methods for AI test sets.
- MRMC comparative effectiveness studies.
- Standalone (algorithm only) performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for AI performance.
- Sample size for training set for AI.
- How ground truth for training set was established for AI.
The "performance data" section in the document refers to biocompatibility, sterilization, shelf life, and general physical performance testing for the needle itself, against standards like ISO 10993, ISO 11135, and ASTM standards. This is for the device's physical properties and safety, not for diagnostic or AI/ML performance.
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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
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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
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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.
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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:
| Devicefeature | Subject DeviceK222385 | Predicate DeviceK020523 | Comment |
|---|---|---|---|
| Product | Bifurcated Needle | BD Bifurcated Needle | / |
| Indicationsfor use | The Bifurcated Needle isintended for use inadministering vaccines bythe scarification method oradministering epidermalallergens. | The BD Bifurcated Needle isintended for use inadministering vaccines bythe scarification method oradministering epidermalallergens. | Same |
| Product code | LDH | LDH | Same |
| Principle ofoperation | For Manual Use Only, ForSingle Use Only | For Manual Use Only, ForSingle Use Only | Same |
| Models | BFN001 | 301754; 301755; 301756;301757 | Differencecomment 1 |
| Needle Length | $64mm\pm0.3mm$ Needle | 60.325mm | |
| Needledimension | $2mm\pm0.05mm$ | 1.905mm | |
| Materials | Bifurcated needle-(SUS304)Needle tip protector-(PVCMT) | Stainless steel | Differencecomment 2 |
| Sterilization | EO Sterilization | Sterilization | Differencecomment 3 |
Table 6-1 Substantial equivalence discussion for Bifurcated Needle
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| Devicefeature | Subject DeviceK222385 | Predicate DeviceK020523 | Comment |
|---|---|---|---|
| Biocompatibility | Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards | Contact level: blood path,indirect, limited contact (<24hours).Conforms to therequirement of ISO 10993series Standards | Same |
| Labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same |
Difference comment 1
The subject device is similar to the predicate device. There are minor differences in needle length and dimension. These differences do not affect intended use. In addition, differences were addressed through ISO 7864 and ISO 9626. Therefore, the differences on models and the specification of needle length and needle width will not raise different question of safety and effectiveness.
Difference comment 2
The material of the needle of the subject device is similar to the predicated device. They are both stainless steels. The differences on materials do not raise new questions about safety and effectiveness.
Difference comment 3
The sterilization of the predicate device was unknown while the subject device was sterilized by EO to achieve a SAL of 10-6 and it has been validated to ISO11135. Both devices are sterile.
Discussion:
From clinical aspect: The subject device has the same indication for use as the predicate.
From technological aspect: The subject device has the same principle of operation, and configuration.
From product performance. The main difference is that specification of models and l the specification of needle length and needle width. However, all of them will be selected by health care provider per injection requirement and this difference does not affect indication for use. Additionally, the performance of needle has been evaluated and the test results met the requirements of ISO 7886-1 and ISO 7864. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
From material perspective: The biocompatibility of the subject device was evaluated through tests according to the requirements of ISO10993 series standards. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
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From sterilization: The subject device was sterilized by EO to achieve a SAL of 10-6 and it has been validated to ISO11135. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility 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 (< 24 hours)". The following tests were performed, as recommended:
| In Vitro Cytotoxicity Test | ISO 10993-5: 2009 |
|---|---|
| Skin Sensitization Test | ISO 10993-10: 2010 |
| In Vitro Hemolysis Test | ISO 10993-4: 2017 |
| Intracutaneous Reactivity Test | ISO 10993-10: 2010 |
| Acute Systemic Toxicity Test | ISO 10993-11: 2017 |
| Pyrogen Test | ISO 10993-11: 2017 |
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters.
The testing is performed according to the following standards:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
The shelf life of 5 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16.
Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed acceptable for protection of product and sterility maintenance.
The testing is performed according to the following standards:
| Seal strength | ASTM F88/F88M-15 |
|---|---|
| Blue Dye Penetration | ASTM F 1929-2015 |
| Seal Integrity (Visual Inspection) | ASTM F 1886/ F 1886M-16 |
Performance testing
Performance testing is performed according to the following standards:
- A ISO 7864: 2016, Sterile hypodermic syringes for single use
- A ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices-Requirements and test methods.
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VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The Bifurcated Needle IS substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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).