DISPOSABLE INFUSION SET

K131646 · Shanghai Jinta Medical Co., Ltd. · LHI · Nov 26, 2013 · General Hospital

Device Facts

• Record ID: K131646
• Device Name: DISPOSABLE INFUSION SET
• Applicant: Shanghai Jinta Medical Co., Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JT series Disposable infusion set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Device Story

The JT series Disposable infusion set is a sterile, single-use plastic device for intravenous fluid administration. It consists of a puncturing needle (polyethylene) for container access, a drip chamber with a 200 µm filtration mesh to prevent micro-particle entry, a flow regulator for manual rate adjustment, and a male conical fitting for connection to a vein needle or catheter. The device is operated by healthcare professionals in clinical settings. The transparent drip chamber allows visual monitoring of flow. The device facilitates controlled fluid delivery to the patient's vascular system.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, risk analysis, design reviews, and verification/validation testing.

Technological Characteristics

Constructed of high-grade extruded Polyvinyl Chloride (PVC). Features include a polyethylene puncturing needle, a drip chamber with a 200 µm filtration mesh, a manual flow regulator, and a male conical fitting. The device is provided sterile.

Indications for Use

Indicated for the administration of fluids from a container to a patient's vascular system via a needle or catheter inserted into the vein.

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.

Predicate Devices

• K083687

Submission Summary (Full Text)

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# 510(k) Summary

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 27, 2012 |
| Submitter: | Shanghai Jinta Medical Co., Ltd. |
| | No. 18, Jianding Road, Fengjing Town, Jinshan District, Shanghai, |
| | China |
| Primary Contact Person: | Mike Gu |
| | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Consulting Co., Ltd |
| | Tel: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Mr. Wang Changqing |
| | Vice General Manager |
| | Shanghai Jinta Medical Co., Ltd. |
| | [phone] |
| | NOV 2 6 2013 |
| Device:<br>Trade Name: | Disposable infusion set |
| Common/Usual Name: | Disposable infusion set |
| Classification Names: | Class II per Code of Federal Regulations,<br>Title 21, 880.5440, Intravascular Administration Sets |
| Product Code: | FPA |
| Predicate Device(s): | K083687 |
| Device Description: | The applicant device-JT series disposable infusion set is plastic,<br>single-use, sterile disposable infusion device, which is intended<br>to be used to administer fluids from a container to a patient's<br>vascular system through a needle or catheter inserted into the<br>vein.<br>The protective cap is intended to protect the needle; The<br>puncturing needle is made of Polyethylene and used to pierce<br>the container; the catheter is made of Polyvinyl chloride and<br>used to connect various components; the drip is transparent so<br>that the user can observe the dropping condition of the medical<br>solution, and it has a filtration mesh which can prevent the micro<br>particle with diameter larger than 200 um to from entering<br>human vessel; Flow regulator is used to adjust the flow rate from<br>zero to maximum; Male conical fitting is used for connecting<br>with vein needle for medical solution transfusion.<br>The proposed device is provided sterilized. |
| Intended Use: | JT series Disposable infusion set is used to administer fluids from<br>a container to a patient's vascular system through a needle or<br>catheter inserted into the vein. |

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#### Technology:

Shanghai Jinta JT series Disposable infusion set is Constructed of high grade extruded Polyvinyl Chloride (PVC). The primary components of Jinta Disposable infusion set are manufactured to identical or similar specifications of the predicated devices listed above. The intended use, basic design, function and materials used are identical or similar to the predicated devices. The technical characteristic is substantially equivalent to the predicate devices. For details refer to the SE section in the application package.

#### Determination of Substantial Equivalence:

### Summary of Non-Clinical Tests:

The Disposable infusion set and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- . Risk Analysis
- Requirements Reviews
- . Design Reviews
- o Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- . Performance testing (Verification)
- . Safety testing (Verification)

#### Summary of Clinical Tests:

The subject of this premarket submission, Disposable infusion set, did not require clinical studies to support substantial equivalence.

- Conclusion: Shanghai Jinta Medical Co., Ltd considers the JT series Disposable infusion set to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue ocument Control Center - WO66-G609 Silver Spring MD 20993-0002

#### November 26, 2013

Shanghai Jinta Medical Company, Limited C/O Mike Gu Guangzhou Osmunda Medical Device Consulting Co., Ltd. Guangzhou, Guangdong CHINA 510420

Re: K131646

Trade/Device Name: Disposable Infusion Set, Models JT-DST1 and JT-DST2 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: August 20, 2013 Received: August 30, 2013

Dear Mr. Gu:

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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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 (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Safety/ReportalProblem/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,

for

Erin Keith M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation 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) K 13 1646

Device Name

Disposable Infusion Set, Models JT-DST1 and JT-DST2

Indications for Use (Describe)

IT series Disposable infusion set is used to adminer to a patient's vascular system through a needle or catheter inserted into the vein.

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Digitally signed by Richard C. Chapman Date: 2013.11.26 12:25:02 -05'00'

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.