Disposable TPE 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 is 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 thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; 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; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel.

The proposed device is provided sterilized.

AI/ML Overview

The provided document is a 510(k) summary for a Disposable TPE Infusion Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report with performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods for establishing ground truth, which are typically found in studies relevant to AI/ML software.

The document states: "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This indicates that physical and functional tests were performed on the device to ensure it met pre-defined engineering and safety standards, rather than a clinical study evaluating an algorithm's performance.

Therefore, many of the requested details about acceptance criteria and study particulars for a software/AI device cannot be extracted from this document.

Here's a breakdown of what can be inferred or what is explicitly missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of specific thresholds for performance metrics (e.g., accuracy, sensitivity, specificity) for a software device. For this hardware device, acceptance criteria would typically relate to physical properties, flow rates, sterility, material biocompatibility, and mechanical integrity. The document only generally states the device "met all design specifications."
Reported Device Performance: No specific performance metrics (like accuracy, sensitivity, etc.) are reported in the document. The general statement is that it "met all design specifications" and was "substantially equivalent to the predicate device."

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. This document pertains to a physical medical device (infusion set), not a software algorithm. Testing would involve a certain number of manufactured units, but the count is not provided.
Data Provenance: Not applicable in the context of clinical "data provenance" for algorithm training/testing. The testing performed would be laboratory-based validation of the physical device.

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

Number of Experts: Not applicable. For a physical infusion set, ground truth is established through engineering specifications, validated test methods (e.g., flow rate testing, material testing, sterility testing), and adherence to standards, not expert clinical consensus on images or diagnoses.
Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication Method: Not applicable for a physical device. Test results are typically compared against pre-defined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. This is a physical medical device, not an AI/ML diagnostic tool requiring human reader comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: No. This refers to an algorithm's performance, which is not relevant here.

7. The Type of Ground Truth Used

Type of Ground Truth: For this device, ground truth would be established by validated engineering specifications, international standards (e.g., for sterility, biocompatibility, flow rate), and material properties testing. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI would be.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no software algorithm or "training set" mentioned or implied for this physical device.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable.

In summary, the provided 510(k) summary for the Disposable TPE Infusion Set is for a conventional physical medical device. It does not contain the type of information related to AI/ML software performance, acceptance criteria, study design (like sample sizes, expert involvement, and ground truth establishment) that your questions are designed to elicit. The "study" referenced is general laboratory testing to confirm the device meets its design specifications and is substantially equivalent to a predicate device.

Summary

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K090459

Chapter III 510(k) Summary

OCT 1 3 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number is:

Date Prepared: February 1, 2009
Sponsor Information

ShanDong WeiGao Group Medical Polymer Co., Ltd No.312 Shichang Road Weihai City, Shangdong, China

Contact Person: Mrs. Zhao Suxia, Quality Manager Tel: +86-631-5621632 Fax: +86-631-5620555 E-Mail: Zsx9001@sina.com

Submission Correspondent

Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Consulting Co., Ltd Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S) . Shanghai, 200030, China

Device Name and Classification:

Device Trade Name: Disposable TPE infusion set Device Common Name: Disposable infusion device Device Classification Name: Set, administration, intravascular Product Code: FPA Regulation Number: 880.5440 Device Class; II

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1. Predicate Device Identification: Tianjin Medis Disposable Infusion Set K-number: K060082
1. Intended Use:

Disposable TPE 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.

1. Device Description:
  The applicant device is 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 proposed device is provided sterilized.

1. Test Conclusion resignation
  Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device.
1. Substantially Equivalent Conclusion:
  The subject device, disposable infusion set is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

OCT 1 3 2009

Shan Dong Wei Gao Group Medical Polymer Products C/O Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Company, Limited Suite 8D, No. 19, Line 999, Zhongshan No.2 Road (S) Shanghai, 200030, CHINA

Re: K090459

Trade/Device Name: Disposable TPE Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 24, 2009 Received: September 28, 2009

Dear Ms. 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. 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.

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- Ms. Hong

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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runser

Susan Runner, D.D.S., M.A. Acting 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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Indication for Use

510(k) Number:

Device Name: Disposable TPE Infusion Set

Indications for Use:

Disposable TPE 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.

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antimony L.a. an

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(Division Sign-Off) (Division Olgh Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

1-494459 510(k) Number: J

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.