(297 days)
The Bella-mu is indicated for intradermal injections of FDA approved drugs for patients 18 years of age and older. The Bella-mu is to be inserted in the dermis of the suprascapular, deltoid, waist, or thigh regions.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Bella-mu" device does not contain information about acceptance criteria or the study that proves the device meets the acceptance criteria in the way you have described for an AI/ML medical device.
This document is a standard FDA 510(k) clearance letter, which typically confirms that a device is substantially equivalent to a predicate device and can be legally marketed. It focuses on regulatory aspects like product codes, regulations, general controls, and good manufacturing practices.
For a device like "Bella-mu" which is described as a "Hypodermic Single Lumen Needle" for "intradermal injections," the types of studies performed (e.g., biocompatibility, sterility, needle pull-off force, flow rates, sharpness, patient comfort, etc.) and their acceptance criteria are generally found in the full 510(k) submission, which is not publicly released in its entirety in this clearance letter.
Therefore, I cannot provide the detailed information requested in your prompt based on the provided text. The prompt's questions (e.g., number of experts, MRMC studies, standalone performance, training/test set sample sizes, ground truth establishment) are highly relevant for AI/ML device submissions, but not applicable to the information contained within this specific 510(k) clearance letter for a medical needle.
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February 3, 2020
U-Needle B.V. % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K190962
Trade/Device Name: Bella-mu Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: January 22, 2020 Received: January 22, 2020
Dear Robert Packard:
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,
For 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) K190962
Device Name Bella-mu
Indications for Use (Describe)
The Bella-mu is indicated for intradermal injections of FDA approved drugs for patients 18 years of age and older. The Bella-mu is to be inserted in the dermis of the suprascapular, deltoid, waist, or thigh regions.
X 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).