LIGHTY DD INFUSION SET

K110282 · Medx-Set, Ltd. · FPA · Apr 27, 2011 · General Hospital

Device Facts

• Record ID: K110282
• Device Name: LIGHTY DD INFUSION SET
• Applicant: Medx-Set, Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Apr 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for subcutaneous delivery of medicine, including insulin, from an external infusion pump.

Device Story

The LIGHTY DD INFUSION SET is a medical device designed for the subcutaneous delivery of medications, such as insulin, from an external infusion pump. It functions as a conduit between the pump and the patient's subcutaneous tissue. The device is intended for use by patients or healthcare providers in clinical or home settings to facilitate continuous or intermittent drug administration. By providing a reliable pathway for medication delivery, the device supports the management of conditions requiring infusion therapy, such as diabetes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

The device is an infusion set designed for subcutaneous delivery. It is classified under 21 CFR 880.5440 as an intravascular administration set (Product Code: FPA).

Indications for Use

Indicated for subcutaneous delivery of medicine, including insulin, from an external infusion pump.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

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 [phone] or [phone] 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

{2}------------------------------------------------

K110282

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: [e-mail]

## 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