Sterile Single-use Infusion Set

K163160 · Jiangxi Hongda Medical Equipment Group , Ltd. · FPA · Apr 20, 2017 · General Hospital

Device Facts

• Record ID: K163160
• Device Name: Sterile Single-use Infusion Set
• Applicant: Jiangxi Hongda Medical Equipment Group , Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Apr 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Sterile, single-use infusion set; gravity-fed fluid delivery. Components: spike with protective cap, air vent, air filter, drip chamber, fluid filter, flexible PVC tubing, roller clamp, injection site, luer lock connector, and optional needle. Used in clinical settings by healthcare professionals to administer intravenous fluids. Device connects fluid container to patient venous access; flow controlled via roller clamp. Benefits include controlled, sterile fluid administration. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only, including physical, mechanical, chemical, biocompatibility, and sterility testing.

Technological Characteristics

Gravity-fed infusion set. Materials: HDPE, ABS, PVC, Polyisoprene, Stainless Steel. Standards: ISO 8536-4:2010, ISO 8536-14:2016, ISO 9626:1991, ISO 7864:1993, ISO 594-1/2, ISO 10993. Sterilization: Ethylene Oxide (EO) to 10^-6 SAL. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring fluid administration from a container to the 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.

Predicate Devices

• KDL Disposable Infusion Set (K112204)

Submission Summary (Full Text)

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

April 20, 2017

Jiangxi Hongda Medical Equipment Group, Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K163160

Trade/Device Name: Sterile Single-use Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 10, 2017 Received: March 21, 2017

Dear Diana 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang -S

Tina Kiang, Ph.D. Acting 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)

K163160

Device Name

Sterile Single-use Infusion Set

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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# Exhibit #2 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163160

- 1. Date of Preparation: 04/17/2017
- 2. Sponsor Identification

# JiangXi HongDa Medical Equipment Group Ltd.

No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China

Establishment Registration Number: Not yet registered.

Contact Person: Xiaohua Yang Position: Vice-general Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Sterile Single-use Infusion Set Common Name: Disposable Infusion Set

## Regulatory Information

Classification Name: Set, Administration, Intravascular; Classification: II; Product Code: FPA; Regulation Number: 21CFR 880.5440 Review Panel: General Hospital;

# Indication for Use:

The device 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 is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the action of gravity. The proposed device is provided with/without injection needle. It is comprised of protective cap of spike, air vent, air filter, drip chamber, fluid filter, flexible tube, injection site, roller clamp, luer lock connector, protector cap of luer lock connector. The devices are provided sterile and single use.

#### న్. Identification of Predicate Device

Premark Notification 510(k) Number: K112204 Trade Name: KDL Disposable Infusion Set Classification Name: Set, Administration, Intravascular Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd

#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include:

Physical, Mechanical and Chemical Tests performed on the proposed device

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Particulate contamination Leakage Tensile strength Closure-piercing device Air-inlet device Tubing Fluid filter Drip chamber and drip tube Flow regulator Flow rate of infusion fluid Injection site Male conical fitting Protective caps Reducing (oxidizable) matter Metal ions Titration acidity or alkalinity Residue on evaporation UV absorption of extract solution

Materials Tubing specifications Operating temperature Construction Flow rate

- Materials Surface finish Cleanliness Limits for acidity and alkalinity Size designation Dimensions Stiffness Resistance to breakage Resistance to corrosion
# Cleanliness Limits for acidity or alkalinity Limits for extractable metals

Clause 6.1 of ISO 8536-4:2010 AMD1 2013 Clause 6.2 of ISO 8536-4:2010 AMD1 2013 Clause 6.3 of ISO 8536-4:2010 AMD1 2013 Clause 6.4 of ISO 8536-4:2010 AMD1 2013 Clause 6.5 of ISO 8536-4:2010 AMD1 2013 Clause 6.6 of ISO 8536-4:2010 AMD1 2013 Clause 6.7 of ISO 8536-4:2010 AMD1 2013 Clause 6.8 of ISO 8536-4:2010 AMD1 2013 Clause 6.9 of ISO 8536-4:2010 AMD1 2013 Clause 6.10 of ISO 8536-4:2010 AMD1 2013 Clause 6.11 of ISO 8536-4:2010 AMD1 2013 Clause 6.12 of ISO 8536-4:2010 AMD1 2013 Clause 6.13 of ISO 8536-4:2010 AMD1 2013 Clause 7.1 of ISO 8536-4:2010 AMD1 2013 Clause 7.2 of ISO 8536-4:2010 AMD1 2013 Clause 7.3 of ISO 8536-4:2010 AMD1 2013 Clause 7.4 of ISO 8536-4:2010 AMD1 2013 Clause 7.5 of ISO 8536-4:2010 AMD1 2013

Clause 5 of ISO 8536-14:2016 Clause 6.1 of ISO 8536-14:2016 Clause 6.2 of ISO 8536-14:2016 Clause 6.3 of ISO 8536-14:2016 Clause 6.4 of ISO 8536-14:2016

Clause 3 of ISO 9626:1991/AMD-1:2001 Clause 4 of ISO 9626:1991/AMD-1:2001 Clause 5 of ISO 9626:1991/AMD-1:2001 Clause 6 of ISO 9626:1991/AMD-1:2001 Clause 7 of ISO 9626:1991/AMD-1:2001 Clause 8 of ISO 9626:1991/AMD-1:2001 Clause 9 of ISO 9626:1991/AMD-1:2001 Clause 10 of ISO 9626:1991/AMD-1:2001 Clause 11 of ISO 9626:1991/AMD-1:2001

Clause 4 of ISO 7864:1993 Clause 5 of ISO 7864:1993 Clause 6 of ISO 7864:1993

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| Size designation | Clause 7 of ISO 7864:1993 |
|------------------|----------------------------|
| Colour coding | Clause 8 of ISO 7864:1993 |
| Needle hub | Clause 9 of ISO 7864:1993 |
| Sheath | Clause 10 of ISO 7864:1993 |
| Needle tube | Clause 11 of ISO 7864:1993 |
| Needle point | Clause 12 of ISO 7864:1993 |
| Performance | Clause 13 of ISO 7864:1993 |

| Gauge | Clause 4.1 of ISO 594-1:1986 |
|--------------------------|--------------------------------|
| Liquid leakage | Clause 4.2.1 of ISO 594-2:1998 |
| Air leakage | Clause 4.2.2 of ISO 594-2:1998 |
| Separation force | Clause 4.3 of ISO 594-2:1998 |
| Unscrewing torque | Clause 4.4 of ISO 594-2:1998 |
| Ease of assembly | Clause 4.5 of ISO 594-2:1998 |
| Resistance to overriding | Clause 4.6 of ISO 594-2:1998 |
| Stress cracking | Clause 4.7 of ISO 594-2:1998 |

Sterile Barrier Packaging Testing performed on the proposed device:

| Seal strength | ASTM F88/F88-09 |
|-------------------|----------------------|
| Internal pressure | ASTM F1140/F1140M-13 |
| Dye Penetration | ASTM F 1929-12 |

Sterilization and Shelf Life Testing performed on the proposed device:

| EO residue | ISO 10993-7:2008 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 36-NF 31 <85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility<br>Tests were performed on accelerated aging samples to<br>verify the claimed shelf life of the device |

Biocompatibility Testing:

The patient-contact materials of blood collection sets are identified and biocompatibility testing is performed according to ISO 10993 standards.

# Transportation Testing

Transportation test is performed on the final product to verify its package integrity during transportation.

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- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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### 8. Substantially Equivalent (SE) Comparison

| Item | Proposed Device | | Predicate Device | |
|----------------------------|-------------------------------------------------------------------|-----------------|--------------------------------------------------------|----------|
| | | | K112204 | |
| Product Code | FPA | | Same | |
| Regulation Number | 21 CFR 880.5440 | | Same | |
| Indication for Use | The device is intended to administer fluids from a container to a | | KDL Disposable Infusion Set is intended to administer | |
| | patient's vascular system through a needle or catheter inserted | | fluids from a container to a patient's vascular system | |
| | into the vein. | | through a needle or catheter inserted into the vein. | |
| Configuration and material | Configuration | Material | Configuration | Material |
| | Protector Cap of Spike | HDPE | Protective Cap of Closure-piercing Device | |
| | Spike | ABS | Closure-piercing Device | |
| | Air Vent | PVC | Air Filter | |
| | Drip Chamber | PVC | Drip Chamber | |
| | Fluid Filter | ABS | Fluid Filter | |
| | Flexible Tube | PVC | Flexible Tube | |
| | Roller Clamp | HDPE | Roller Clamp | Unknown |
| | Latex Tube | Polyisoprene | Check Valve | |
| | Y Injection Site | ABS | Y Injection Set | |
| | Luer Lock Connector | ABS | Clamp | |
| | Protector Cap of Luer Lock Connector | HDPE | Injection Site | |
| | Needle Hub | PP | Luer Lock Connector | |
| | Needle Tube | Stainless Steel | Infusion Needle | |
| Tubing Diameter | 3.9mm | | Unknown | |
| Filter Characteristics | 15um | | 15um | |

# Table 1 Comparison of Technology Characteristics

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| Needle Gauge | 21G | Unknown |
|-----------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------|
| Sterile | EO sterilized<br>10-6 | Same |
| Single Use | Single Use | Same |
| Infusion Set Performance | | |
| Particulate contamination | Contamination index limit is less than 90 | Comply with ISO 8536-4 |
| Leakage | No leakage | |
| Tensile strength | Withstand a static tensile force of not less than 15N for 15s | |
| Closure piercing device | Comply the dimension of ISO 8536 | |
| Air-inlet device | Flow of fluid is reduced less than 20% of that from a freely<br>ventilated container | |
| Tubing | Length is not less than 1500mm | |
| Fluid filter | Retention of latex particles is not less than 80% | |
| Drip chamber and drip tube | 20 drops of distilled water delivered by the drip are equivalence<br>to a volume of (1±0.1)ml(1±0.1)g | |
| Flow rate | Deliver not less than 1000ml | |
| Injection site | No leakage | |
| Construction | The clamps can resist the flow of fluid and air at an applied<br>pressure of 50 kPa when closed. | |
| Needle Performance | | |
| Cleanliness | Free from particles and extraneous matter | Comply with ISO 7864 and ISO 9626 |
| Needle length | 38mm | |
| Bond of hub and needle tube | Not broken by the minimum force | |
| Stiffness | Deflection is less than 0.50mm | |
| Dimensions of needle tubing | 0.8mm | |
| Resistance to breakage | The tubing is not break | |
| Resistance to corrosion | No evidence of corrosion | |
| Biocompatibility | | |
| Cytotoxicity | No Cytotoxicity | |
| Intracutaneous Reactivity | No Intracutaneous Reactivity | |
| Skin Sensitization | No Skin Sensitization | Conform with ISO 10993 requirements |
| Acute Systemic Toxicity | No Acute Systemic Toxicity | |
| Hemolysis | No Hemolysis | |
| Pyrogen | No pyrogen | |

S001

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### Substantially Equivalent (SE) Conclusion 9.

Based on the performance testing, comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

S001