Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Device Description

BAIXIN™ Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. This device is sterile and for single use only.

AI/ML Overview

The provided text describes the acceptance criteria and the summary of testing for the "BAIXIN™ Intravascular Administration Set". However, it does not detail a study in the context of AI/ML devices or clinical trials that would typically involve a "test set," "training set," "ground truth experts," or "MRMC comparative effectiveness studies." The document is a 510(k) summary for a medical device that conforms to recognized consensus standards, specifically ISO 8536-4-2007.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and review process described.

Here's the information that can be extracted or inferred:

Acceptance Criteria and Reported Device Performance

Test Items	Requirements	Reported Device Performance
Sterility	No evidence of growth of BI	Conforms (Implied)
Pyrogenicity	Free from pyrogenicity (Bacterial endotoxin test)	Conforms (Implied)
Haemolysis	The infusion set shall be free from haemolytic reactions	Conforms (Implied)
Toxicity	Free from toxicity	Conforms (Implied)
Reducing (oxidizable) matter	The total amount of potassium permanganate solution used [c(KMnO4)=0.002mol/l] shall not exceed 2.0ml	Conforms (Implied)
Metal ions	The extract shall not contain in total more than 1µg/ml of cadmium, chromium, copper, lead and tin. Not more than 0.1µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or equivalent method.	Conforms (Implied)
Titration acidity or alkalinity	Not more than 1ml of either standard volumetric solution shall be required for the indicator to change to the colour grey.	Conforms (Implied)
Residue on evaporation	The total amount of dry residue shall not exceed 5 mg.	Conforms (Implied)
UV absorption of extract solution	The extract solution S, shall not show absorption greater than 0.1.	Conforms (Implied)
EO residue	Less than 0.5mg/set	Conforms (Implied)
Particulate contamination	Contamination index < 90	Conforms (Implied)
Leakage	Immerse the infusion set, with one end blocked, in water at 20°C to 30°C and apply an internal air pressure of 50kPa above atmospheric pressure for 15s. Examine the infusion set for air leakage. Apply an internal excess pressure of -20kPa at (23±1) °C and (40±1) °C for 15s. Inspect whether air enters the infusion set.	Conforms (Implied)
Tensile strength	Withstand a static tensile force of not less than 15N for 15s.	Conforms (Implied)
Closure-piercing device	The closure-piercing device shall be capable of piercing and penetrating the closure without prepiercing. No coring should occur during this procedure.	Conforms (Implied)
Air-inlet device	The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container. Air went through rate ≥ 90%. The air-inlet device shall be separate from, or integral with, the closure-piercing device. The air admitted into the container shall not become entrained in the liquid outflow. The flow rate of fluid is not reduced by more than 20% of that from a freely ventilated container.	Conforms (Implied)
Tubing	The tubing shall be transparent or sufficiently translucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision. The tubing length distal to the drip chamber shall be not less than 1500mm in length.	Conforms (Implied)
Fluid filter	The retention of latex particles on the filter shall be not less than 80%.	Conforms (Implied)
Dimensions of the drip chamber	There shall be a distance of not less than 40mm between the drip tube and fluid filter. The wall of the drip chamber shall not be closer than 5mm to the end of the drip tube. The drip tube shall be such that 20 drops of distilled water or 60 drops of distilled water at: 23±2°C and at a flow rate of 60 drops/min±10drops/min deliver a volume of 1ml±0.1ml (1g±0.1g).	Conforms (Implied)
Flow regulator	The flow regulator shall adjust the flow of the infusion solution between zero and maximum. The regulation length should be no less than 30mm.	Conforms (Implied)
Flow rate	20 drops, 10min > 1000ml	Conforms (Implied)
Injection port	There shall be no leakage of more than one falling drop of water.	Conforms (Implied)
Male conical fitting	In accordance with ISO594-1 or ISO594-2	Conforms (Implied)
Protective cap	The protective caps shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the infusion set.	Conforms (Implied)
Individual package	The infusion set and/or the air-inlet device shall be individually packed so that they remain sterile during storage. The unit container shall be sealed in a tamper-evident manner.	Conforms (Implied)
No flattened portions and kinks	The infusion set and/or the air-inlet devices shall be packed and sterilized in such a way that there are no flattened portions or kinks when they are ready for use.	Conforms (Implied)

Note on Reported Device Performance: The document states, "Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes conform to the FDA recognized consensus standard, ISO 8536-4-2007, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd." The "Summary of Testing" lists the requirements, implying that the device met these requirements without explicitly providing numerical results for each test within this summary. Therefore, "Conforms (Implied)" is used as the reported performance.

1. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The document refers to "All materials used in the fabrication... were evaluated," but does not give a specific sample size for each test.
Data Provenance: Not explicitly stated, but the manufacturer is Anhui Kangda Medical Products Co., Ltd. in P. R. China. The testing was conducted to conform to ISO 8536-4-2007. The tests are likely performed by the manufacturer or a contracted lab in China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and submission. The "ground truth" for this device is defined by the technical specifications and performance criteria outlined in the ISO standard, and demonstrated through physical, chemical, and biological testing, rather than expert interpretation of medical images or data.

3. Adjudication method for the test set:

Not applicable. This concept relates to disagreement resolution among experts in medical image interpretation or clinical diagnosis, which is not relevant for the conformance testing of an intravascular administration set.

4. 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:

No, this was not done. MRMC studies are used for evaluating diagnostic or screening devices, particularly those involving human readers (e.g., radiologists) and potentially AI assistance. This device is a fluid administration set, not an AI/ML diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:

The "ground truth" for this device is established by technical specifications, chemical analysis, physical testing, and biological assays (e.g., sterility, pyrogenicity, toxicity, dimensional correctness) as defined by the international consensus standard ISO 8536-4-2007.

7. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

Not applicable. There is no "training set" as this is not an AI/ML device.

Summary

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K083687

510(K) SUMMARY

Submitted by:

Anhui Kangda Medical Products Co., Ltd

88 Zhenxing Road,

Yangcun Town,

Tianchang City,

Anhui Province

P. R. China

Phone: +86 0550 7093893

+86 0550 7093800 Fax:

Preparation Date: Jun. 10. 2008

Contact Person/Prepared by:

Official Correspondent: bian wei giang SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. 1707 vingiao bldg 58 jinxin road jinqiao, pudong, shanghai, CHINA 201206 Phone: 86-21-50324423

US Agent: ROBERTJ. EDWARDS BOCA MEDICAL PRODUCTS, INC. 3550 nw 126th ave coral springs, FL 33065 Phone: 954 346 Fax: 954 346 Email: bob@bocapharmacal.com

510(K) Summary of Safety and Effectiveness for the:

Trade/Proprietary Name: BAIXIN™ Intravascular Administration Set

Common Name: INTRAVASCULAR ADMINISTRATION SET

Classification Name: set, administration, intravascular

Class: Il

JUN 1 1 2009

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Procodes: FPA - set, administration, intravascular

Device Description:

(1) Don't use when visual damage on its packaging is detected or the
protective cap is found not in position.
(2) Only for single use, discard after use.
(3) Use before expiration date.
(4) It shall be used immediately after the individual package is opened.

Intended Use:

The intended use of the BAIXINTM Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Statement to conform to ISO 8536-4-2007:

Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes corm to the FDA recognized consensus standard, ISO 8536-4-2007, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Ltd.

Summary of Testing:

All materials used in the fabrication of the Anhui Kangda piston syringe and hypodermic needles were evaluated for:

Test items	Requirements
Sterility	No evidence of growth of BI
Pyrogenicity	Free from pyrogenicity (Bacterial endotoxin test)
Haemolysis	The infusion set shall be free from haemolytic reactions
Toxicity	Free from toxicity
Reducing(oxidizable) matter	The total amount of potassium permanganate solution used[c(KMnO4)=0.002mol/l]shall not exceed 2.0ml;
Metal ions	The extract shall not contain in total more than 1µg/ml of cadmium, chromium, copper, lead and tin.
	Not more than 0.1µg/ml of cadmium, when determined by atomicabsorption spectroscopy (AAS) or equivalent method.
Titration acidity oralkalinity	Not more than 1ml of either
	standard volumetric solution
	shall be required for the
		indicator to change to thecolour grey
Residue onevaporation		The total amount of dryresidue shall not exceed 5 mg.
UV absorption ofextract solution		The extract solution S, shallnot show absorption greaterthan 0.1.
EO residue		Less than 0.5mg/set
Particulatecontamination		Contamination index<90
Leakage		Immerse the infusion set, with one end blocked, in water at 20°C to30°C and apply an internal air pressure of 50kPa above atmosphericpressure for 15s. Examine the infusion set for air leakage. Apply aninternal excess pressure of -20kPa at (23±1) °C and (40±1) °C for 15s.inspect whether air enters the infusion set.
Tensile strength		Withstand a static tensile force of not less than 15N for 15s;Dimensions
Closure-piercingdevice		The closure-piercing deviceshall be capable of piercingand penetrating the closurewithout prepiercing. No coring should occur during thisprocedure.
Air-inlet device		The air-inlet device shall beprovided with an air filter toprevent the ingress ofmicroorganisms into thecontainerAir went trough rate≥90%The air-inlet device shall be separate from, or integral with, theclosure-piercing device.The air admitted into thecontainer shall not becomeentrained in the liquid outflow.The flow rate of fluid is notreduced by more than 20% ofthat from a freely ventilatedcontainer.
Tubing		The tubing shall be transparent or sufficiently translucent so that theinterface of air and water during the passage of air bubbles can beobserved with normal or corrected vision.The tubing length distal to the drip chamber shall be not less than1500mm in length.
Fluid filter		The retention of latex particleson the filter shall be not lessthan 80%
Dimensions of thedrip chamber		There shall be a distance ofnot less than 40mm betweenthe drip tube and fluid filterThe wall of the drip chambershall not be closer than 5mmto the end of the drip tubeThe drip tube shall be suchthat 20 drops of distilled water
	or 60 drops of distilled water at:23±2°C and at a flow rate of 60drops/min±10drops/mindeliver a volume of$1ml±0.1ml(1g±0.1g)$
Flow regulator	The flow regulator shall adjustthe flow of the infusion solutionbetween zero and maximum.The regulation length should be no less than 30mm.
Flow rate	20 drops, 10min>1000ml
Injection port	There shall be no leakage ofmore than one falling drop ofwater.
Male conical fitting	In accordance with ISO594-1 or ISO594-2
Protective cap	The protective caps shallmaintain the sterility of theclosure-piercing device, themale conical fitting and theinterior of the infusion set.
Individual package	The infusion set and/or the air-inlet device shall be individually packedso that they remain sterile during storage. The unit container shall besealed in a tamper-evident manner.
no flattened portionsand kinks	The infusion set and/or the air-inlet devices shall be packed andsterilized in such a way that there are no flattened portions or kinkswhen they are ready for use

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이 지원 기준

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K08368

Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use. :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.

JUN 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Anhui Kangda Medical Products Company, Limited C/O Mr. Bian Wei Qiang Shanghai Carelife International Trading Company, Limited 1707 Yingiao Building 58 Jinxin Road, Jinqiao Pudong, Shanghai CHINA 201206

K083687 Re:

Trade/Device Name: BAIXINTM Intravascular Administration Set (BAIXINTM) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 3, 2009 Received: June 3, 2009

Dear Mr. Qiang:

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Page 2- Mr. Oiang

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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/Centers_Offices/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 yours,

Anthony, is mistaken for
Susan Dunner, D.D.S., M.S.

Susan Runner, D.D.S., M. 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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K083687

Indications for Use

510(k) Number (if known): _ K083687

Device Name: BAIXIN™ Intravascular Administration Set (BAIXIN™)

Indications for Use: Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sta all

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

510(k) Number: K083687

VIII

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.