Pre-filled Syringe with Saline

K220060 · Jiangsu Caina Medical Co.,Ltd · NGT · Jun 10, 2022 · General Hospital

Device Facts

• Record ID: K220060
• Device Name: Pre-filled Syringe with Saline
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: NGT · General Hospital
• Decision Date: Jun 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Pre-filled Syringe with Saline is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

Device Story

Pre-filled Syringe with Saline is a sterile, single-use device containing saline solution. It is used by healthcare professionals in clinical settings to flush intravenous (IV) administration sets and indwelling IV access devices. The device facilitates the maintenance of IV line patency by clearing residual medication or blood. It is a manual, mechanical device; no electronic or software components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, single-use pre-filled syringe containing saline. Materials and design are consistent with standard medical-grade syringes used for IV flushing. No electronic components, software, or energy sources.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices in patients requiring IV therapy.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Submission Summary (Full Text)

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June 10, 2022

Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O Box 120-119 Shanghai, 200120 China

Re: K220060

Trade/Device Name: Pre-filled Syringe with Saline Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: December 31, 2021 Received: January 10, 2022

Dear Diana Hong:

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.

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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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K220060

Device Name

Pre-filled Syringe with Saline

Indications for Use (Describe)

The Pre-filled Syringe with Saline is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

Type of Use (Select one or both, as applicable)

| | <span> <svg height="16" width="16"> <rect fill="black" height="16" width="16"></rect> <rect fill="white" height="12" width="12" x="2" y="2"></rect> <path d="M4 8 L6 11 L12 5" fill="none" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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