(222 days)
Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.
Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.
Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.
Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.
This document is a 510(k) clearance letter for the Shina Safety Needle, a hypodermic single lumen needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, nor does it include details about AI/ML performance, ground truth, or study methodologies that are typically found in a clinical study report or a more detailed section of a 510(k) submission.
The document focuses solely on:
- The FDA's decision regarding substantial equivalence.
- General regulatory requirements for the device.
- Indications for Use for the Shina Safety Needle.
Therefore, I cannot provide the requested information based on the input text. The information requested typically comes from performance testing reports, clinical studies, or AI/ML validation studies, none of which are detailed in this regulatory clearance letter.
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March 20, 2023
Shina Corporation Seunggi Jeon Quality Assistant 8-26, Bojeokdong-gil Gongju, Chungcheongnam-do 32533 Korea, South
Re: K222417
Trade/Device Name: Shina Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 16, 2023 Received: February 16, 2023
Dear Seunggi Jeon:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Sincerely,
Alan St
CAPT Alan 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)
Device Name Shina safety needle
Indications for Use (Describe)
Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.
Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.
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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§ 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).