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 Description

The applicant device-JT series disposable infusion set is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Male conical fitting is used for connecting with vein needle for medical solution transfusion. The proposed device is provided sterilized.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Disposable Infusion Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list specific acceptance criteria with numerical targets for the device's performance. Instead, it states that the device "comply[s] with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission" (which are not included in the provided text).

The reported device performance is indirect and qualitative:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with voluntary standards	Device complies with voluntary standards as detailed in Sections 9, 11, and 17 of the premarket submission (details not provided here).
Safety	Considered "as safe" as the predicate device(s).
Effectiveness	Considered "as effective" as the predicate device(s).
Performance	Performance is "substantially equivalent" to the predicate device(s).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document states "Testing on unit level (Module verification)", "Integration testing (System verification)", "Final acceptance testing (Validation)", "Performance testing (Verification)", and "Safety testing (Verification)" were performed, but no sample sizes are given for these tests.
Data Provenance: Not specified. However, the manufacturer is Shanghai Jinta Medical Co., Ltd. in China, so it's likely the testing occurred in China. The study type is non-clinical testing, which implies lab-based testing rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. This was a non-clinical study, so there was no "ground truth" established by medical experts for a test set of patient data. The ground truth would be based on engineering specifications and compliance with standards.
Qualifications of Experts: Not applicable.

4. Adjudication Method:

Adjudication Method: Not applicable, as this was a non-clinical study without human interpretation of clinical cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Disposable infusion set, did not require clinical studies to support substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: Yes, this essentially describes the non-clinical performance and safety testing conducted. The device (Disposable Infusion Set) itself is a physical medical device, not an algorithm. The testing described ("Risk Analysis," "Requirements Reviews," "Design Reviews," "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," "Safety testing") demonstrates its standalone performance against design specifications and voluntary standards. There is no "human-in-the-loop" aspect to the function of this specific device to be evaluated.

7. Type of Ground Truth Used (for the test set):

Ground Truth Type: For this non-clinical submission, the "ground truth" for the test set would be derived from engineering specifications, design requirements, and voluntary standards. Performance was measured against these predefined technical benchmarks and safety requirements for medical devices of this type.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This document describes the submission for a physical medical device (infusion set), not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The device is designed and manufactured based on established engineering principles and materials.

9. How Ground Truth for the Training Set Was Established:

Ground Truth Establishment: Not applicable, as there is no training set for this type of device. The device's design and manufacturing are based on established engineering and material science principles, guided by regulatory standards for medical devices.

Summary

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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: +86-20-62321333Fax: +86-20-86330253
Secondary Contact Person:	Mr. Wang Changqing
	Vice General Manager
	Shanghai Jinta Medical Co., Ltd.
	+86-21-67361700
	NOV 2 6 2013
Device:Trade Name:	Disposable infusion set
Common/Usual Name:	Disposable infusion set
Classification Names:	Class II per Code of Federal Regulations,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,single-use, sterile disposable infusion device, which is intendedto be used to administer fluids from a container to a patient'svascular system through a needle or catheter inserted into thevein.The protective cap is intended to protect the needle; Thepuncturing needle is made of Polyethylene and used to piercethe container; the catheter is made of Polyvinyl chloride andused to connect various components; the drip is transparent sothat the user can observe the dropping condition of the medicalsolution, and it has a filtration mesh which can prevent the microparticle with diameter larger than 200 um to from enteringhuman vessel; Flow regulator is used to adjust the flow rate fromzero to maximum; Male conical fitting is used for connectingwith vein needle for medical solution transfusion.The proposed device is provided sterilized.
Intended Use:	JT series Disposable infusion set is used to administer fluids froma container to a patient's vascular system through a needle orcatheter 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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Image /page/4/Picture/12 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in black and white and is made up of the letters "FDA". The letters are stylized and have a thick, outlined appearance. The logo is simple and recognizable.

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.

Regulation Number and Section

§ 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.