KDL DISPOSABLE INFUSION SET by SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD.

KDL Disposable Infusion Set is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Device Description

The proposed device, KDL Disposable Infusion Set, is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The proposed device consists of protective cap, air filtration membrane, air-inlet set, closure-piercing device, drip chamber, medicine fluid filter, locked clamp, tubing, check valve, flow regulator, clamp, injection sites, two-part luer lock connector, infusion needle.

The protective cap is intended to protect the needle; the closure-piercing device is used to pierce the container; the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution; the locked clamp is used to control the flow of the medicine solution; the tubing is used to connect various components; the check valve is used to make the medicine solution flow in one direction; the flow regulator is used to adjust the flow rate from zero to maximum; there are two injection sites, one is needleless and the other is needle access, which are used to inject solution into the tubing; two-part luer lock connector is used to connect the infusion needle with the tubing; infusion needle is inserted into human vessel for medical solution transfusion and it is made of stainless steel.

It is provided EO sterilized.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KDL Disposable Infusion Set:

Based on the provided 510(k) Summary (K112204), the device is a KDL Disposable Infusion Set, which is a typically low-risk medical device. For such devices, "acceptance criteria" are usually met by demonstrating compliance with recognized international standards and proving substantial equivalence to a predicate device through non-clinical (bench) testing. There isn't typically a "study" involving human subjects or complex statistical analysis for performance metrics in the same way one would find for diagnostic AI.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance)
ISO 8536-4: 2010: Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed	Device complies with this standard.
ISO 594-1:1986: Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment, Part 1: General requirements	Device complies with this standard.
ISO 594-2 Second edition 1998-09-01: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.	Device complies with this standard.
Design Specifications: Ensure the device meets all specified design requirements.	"Bench tests were conducted to verify that the proposed device met all design specifications."
Substantial Equivalence: Demonstrate that the proposed device is as safe and effective as the predicate device.	"The proposed device...is determined to be Substantially Equivalent (SE) to the predicate device, BAIXINTM Intravascular Administration Set, in respect of safety and effectiveness."

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

Test Set Sample Size: The document does not specify a numerical sample size for the "bench tests." For medical devices like infusion sets, bench testing typically involves a sufficient number of units to ensure statistical confidence in the results for each specific test (e.g., fluid flow rate, leakage, strength of connections).
Data Provenance: The tests were non-clinical (bench tests) conducted to assess compliance with international standards. The country of origin for the data generation would likely be China, where the manufacturer (Shanghai Kindly Enterprise Development Group Co., Ltd) is located, although this is not explicitly stated for the testing itself. The data is prospective for the device being tested but not in the context of human subject data.

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

This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts, especially clinical experts like radiologists, is relevant for diagnostic devices or AI algorithms where clinical interpretations are being evaluated. For an infusion set, the "ground truth" for its performance is determined by meeting the objective criteria set forth in the international standards through physical and mechanical testing.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods involving multiple experts (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretations, particularly in clinical studies for diagnostic tools. For bench testing of a physical device, the results are typically quantitative measurements and either pass or fail predetermined criteria, not subject to expert adjudication of interpretation in the same manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable. MRMC studies are specifically designed for evaluating the performance of diagnostic imaging devices or AI algorithms used in conjunction with human readers. The KDL Disposable Infusion Set is a mechanical device for fluid administration, not a diagnostic tool or an AI-powered system that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The KDL Disposable Infusion Set is a physical medical device; it does not contain an algorithm or AI component to be evaluated in a standalone performance study.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is objective compliance with established international engineering and medical device standards (ISO standards). This is confirmed through physical and mechanical bench testing, where quantifiable parameters (e.g., material strength, dimensions, flow rates, luer lock integrity) are measured against predefined specifications within the standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of evaluating the device's basic functional performance for 510(k) submission.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" for the KDL Disposable Infusion Set as it is not an AI/machine learning device. The design, development, and testing process does not involve training an algorithm on a dataset.

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

This question is not applicable for the same reasons as #8.

Summary

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K11 2204

Section III 510(k) Summary.

Project #:M0112011Ab

SEP 10 2012

510(k) Summary Section III

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

The assigned 510(k) Number:

Date of Submission: Jul 10, 2011 1.

1. Sponsor
  Shanghai Kindly Enterprise Development Group Co., Ltd: No. 18 Lane 668 Huajiang Road, Jiading Shanghai, 201803, China Establishment Registration Number: 3005405146 Contact Person: Cailiang Wang Position: General Manager Tel: +86-21-59140045 Fax: +86-21-59118500-78 Email: wangcl@kdIchina.net
Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification 4.

Proposed Device Name: KDL Disposable Infusion Set Classification: II Product Code: FPA Regulation Number: 21 CFR 880.5440 Review Panel: General Hospital Intended Use Statement: K.DL Disposable Infusion Set is intended to administer fluids from a container to a patient's vascular

system through a needle or catheter inserted into the vein.

Predicate Device Identification ર્ .

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510(k) Number: K083687

Product Name: BAIXINTM Intravascular Administration Set Manufacturer: Anhui Kangda Medical Products Co., Ltd.

Device Description 6.
The proposed device, KDL Disposable Infusion Set, is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

It is provided EO sterilized.

1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 8536-4: 2010, Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed

ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment, Part 1 : General requirements

ISO 594-2 Second edition 1998-09-01, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.

Substantially Equivalent Conclusion 8.
III-2

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The proposed device, KDL Disposable Infusion Set, is determined to be Substantially Equivalent (SE) to the predicate device, BAIXIN™ Intravascular Administration Set, in respect of safety and effectiveness.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

1 0 2012

SEP

Shanghai Kindly Enterprise Development Group Company, Limited
C/O Mid-Link Consulting Company, Limited
Ms. Diana Hong
General Manager
P.O. Box 237-023
Shanghai, China 200237

Re: K112204

Trade/Device Name: KDL Disposable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 31, 2012 Received: September 4, 2012

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. 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 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/Safety/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

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Section II Indications for Use

510(k) Number: Device Name: KDL Disposable Infusion Set

Indications for Use:

KDL Disposable Infusion Set is indicated to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USE (2 1 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)

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Ald C. Chapa 9/10/12

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

510(k) Number: K112204

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.