(86 days)
Indicated for subcutaneous delivery of medicine, including insulin, from an external infusion pump.
Not Found
I'm sorry, but your document, which is an FDA 510(k) clearance letter, does not contain the specific information needed to answer your request about acceptance criteria and a study proving device performance.
This document primarily states that the FDA reviewed Medx-Set Limited's LIGHTY DD INFUSION SET and determined it to be "substantially equivalent" to legally marketed predicate devices. This is a regulatory finding that focuses on equivalence, not on detailed performance studies or specific acceptance criteria and their fulfillment via a study report.
Here's a breakdown of why the requested information isn't available in your provided text:
- Acceptance Criteria and Reported Device Performance (Table): The document does not define any specific performance metrics (e.g., flow rate accuracy, leak rate, biocompatibility results) or numerical acceptance criteria for those metrics. It also doesn't report any device performance results against such criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method: These details are typical of a clinical or performance study report, which is not what this FDA clearance letter is. The letter doesn't mention any specific test sets, ground truth establishment, or expert involvement.
- MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case study, human reader improvement with AI, or AI assistance. The device is an infusion set, not an AI-powered diagnostic tool.
- Standalone (Algorithm Only) Performance: As the device is an infusion set, there is no "algorithm" or standalone performance of an AI system to report.
- Type of Ground Truth: This concept is relevant for AI or diagnostic devices where a "true" condition needs to be established. An infusion set's performance is typically evaluated through engineering tests, physical properties, and safety assessments rather than ground truth against a clinical diagnosis.
- Training Set Sample Size and Ground Truth Establishment (for Training Set): These are again concepts specific to machine learning or AI model development, which is not applicable to a physical medical device like an infusion set.
In summary, the provided FDA 510(k) clearance letter is a regulatory document confirming substantial equivalence, not a detailed performance study report. Therefore, it does not contain the information you are seeking regarding acceptance criteria and performance study details.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name arranged in a circular pattern around a stylized eagle-like symbol. The eagle is depicted with three curved lines forming its body and wings, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medx-Set Limited C/O Mr. Raymond Kelly Regulatory Affairs Quality Assurance Specialist Arazy Group 56B Shawdow Drive Hudson, New Hampshire 03051
APR 2 7 2011
Re: K110282
Trade/Device Name: LIGHTY DD INFUSION SET Regulation Number: 21 CFR 880 5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 7, 2011 Received: January 31, 2011
Dear Mr. Kelly:
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. 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.
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Page 2- Mr. Kelly
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jams I terso
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the logo for MEDX-SET, a company that produces innovative medical devices. The logo is in black and white, with the company name in large, bold letters. Below the company name is the tagline "Innovative Medical Devices" in a smaller font. The logo is simple and professional, and it conveys the company's focus on innovation and medical technology.
Office: 3 Hasadna, Industrial Zone, Tirat Carmel 39032 Tel- 972-4-8550652 Fax - 972-4-8500297 E-Mail: info@Nilimedix.com
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: LIGHTY DD INFUSION SET
Indications for Use: Indicated for subcutaneous delivery of medicine, including insulin, from an external infusion pump.
Prescription Use (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhd C Chapa 4/26/16
(Version Sign-Off)
"Westing (1) 4nesthesiology. General Hospital Intection Control. Dental Devices
510(k) Number: K110282
§ 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.