BAIXIN INTRAVASCULAR ADMINISTRATION SET

K083687 · Anhui Kangda Medical Products Co., Ltd. · FPA · Jun 11, 2009 · General Hospital

Device Facts

• Record ID: K083687
• Device Name: BAIXIN INTRAVASCULAR ADMINISTRATION SET
• Applicant: Anhui Kangda Medical Products Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Jun 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

BAIXIN™ Intravascular Administration Set facilitates fluid delivery from a container to a patient's venous system. The device consists of a closure-piercing device, drip chamber, fluid filter, tubing, flow regulator, and male conical fitting. It operates via gravity feed. The device is sterile, single-use, and intended for clinical use. Healthcare providers use the flow regulator to adjust fluid delivery rates. The device ensures controlled fluid administration, benefiting patients requiring intravenous therapy.

Clinical Evidence

Bench testing only. Testing included sterility, pyrogenicity, haemolysis, toxicity, chemical extractables (metal ions, reducing matter), EO residue, particulate contamination, leakage, tensile strength, flow rate, and mechanical performance of components (closure-piercing device, air-inlet, tubing, filter, drip chamber, flow regulator, and fittings) per ISO 8536-4-2007.

Technological Characteristics

Gravity-fed intravascular administration set. Components include closure-piercing device, drip chamber, fluid filter, tubing (min 1500mm), flow regulator, and male conical fitting (ISO 594-1/2 compliant). Materials evaluated for biocompatibility (toxicity, haemolysis, pyrogenicity). Sterilized for single use. Conforms to ISO 8536-4-2007.

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 a 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.

Submission Summary (Full Text)

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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: [phone]

[phone] 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: [phone]

US Agent: ROBERTJ. EDWARDS BOCA MEDICAL PRODUCTS, INC. 3550 nw 126th ave coral springs, FL 33065 Phone: 954 346 Fax: 954 346 Email: [e-mail]

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:

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, so the following precautions shall be observed during use:

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

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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 [phone] or [phone] 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

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