Infusion Set for Single Use

K162601 · Shinva Ande Healthcare Apparatus Co., Ltd. · FPA · May 31, 2017 · General Hospital

Device Facts

• Record ID: K162601
• Device Name: Infusion Set for Single Use
• Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: May 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for the delivery of fluids from a container to a patient's vascular system.

Device Story

Gravity-fed infusion set; delivers fluids from container to patient vascular system. Components include protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp, and luer lock connector. Used in clinical settings for fluid administration. Operated by healthcare professionals. Provides controlled fluid delivery path. Benefits patient by enabling sterile, regulated intravenous therapy.

Clinical Evidence

No clinical data; bench testing only. Compliance demonstrated via ISO 8536-4 (gravity feed), ISO 8536-12 (check valves), ISO 594-1/2 (luer fittings), ISO 10993 (biocompatibility/sterilization), ASTM F88 (seal strength), ASTM F838 (bacterial retention), and internal specifications for flow regulation and filtration.

Technological Characteristics

Gravity-fed infusion set. Components: spike, air/fluid filters, drip chamber, flexible tubing, clamps, injection sites, luer lock. Materials evaluated per ISO 10993 (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogenicity). Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 8536-4, ISO 8536-12, ISO 594-1/2, ASTM F88, ASTM F756, ASTM F838.

Indications for Use

Indicated for delivery of fluids from a container to a patient's vascular system via IV catheter or infusion needle.

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

• Intravascular Administration Set (K121803)

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

May 31, 2017

SHINVA ANDE Healthcare Apparatus Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai 200120 CHINA

Re: K162601

Trade/Device Name: Infusion Set for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: April 26, 2017 Received: April 28, 2017

Dear Ms. 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 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 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/Resourcesfor You/Industry/default.htm. 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 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,

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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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# Change Control Table, Change History

# Change Control Table

| Version | Document Author | Document Approver | Date Approved |
|---------|---------------------|---------------------|---------------|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |

Complete Change Control Table (all versions) retained in SWIFT Docs.

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# Indications for Use

510(k) Number (if known) K162601

Device Name Infusion Set for Single Use

Indications for Use (Describe)

The device is indicated for the delivery of fluids from a container to a patient's vascular system.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 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: K162601

- Date of Preparation: 05/25/2017 1.
- 2. Sponsor Identification

## SHINVA ANDE Healthcare Apparatus Co., Ltd.

No.77 Development Zone North Road, Zibo, Shandong, 255086 China

Contact Person: Xiaolei Tian Position: R&D Director 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]

- 4. Identification of Proposed Device
Trade Name: Infusion Set for Single Use

Regulatory Information Regulation Name: Intravascular administration set Classification: II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital

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#### Indications for Use:

The device is indicated for the delivery of fluids from a container to a patient's vascular system.

### Device Description

The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.

- 5. Identification of Predicate Device
510(k) Number: K121803 Product Name: Intravascular Administration Set 510k Holder: Acta Medical

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to determine that the proposed device met all design specifications to claim Substantially Equivalence (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > ISO 8536-4:2010 AMD 1 2013 Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed
- > ISO 8536-12:2007 AMD 1 2012 Infusion equipment for medical use- Part 12: Check valves.
- > ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 1: General requirements
- > ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
- > ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals:
- > ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
- > USP38-NF33 <85> Bacterial Endotoxins Test.
- > ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- > ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- > ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- > ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
- A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
- A USP 38-NF 33<151> Pyrogen Test
- > Microbial Ingress Testing (Needleless Valve-Y Injection Site)

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- > ASTM F838-15-Standard Test for Determining Bacterial Retention of Membrane Filter (0.2 Micron Filter test)
- > Flow Regulator Performance (Internal Specification)
- > 1.2 Micron Filter Test (Internal Specification)
- Clinical Test Conclusion 7.

No clinical study is included in this submission.

- 8. Substantially Equivalent (SE) Comparison

| | Table 1 Comparison of Technology Characteristics | |
|--|--------------------------------------------------|--|
| | | |
| | | |

| Item | Proposed Device | Predicate Device | |
|--------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Product Code | FPA | Same | |
| Regulation Number | 21 CFR 880.5440 | Same | |
| Indication for Use | The device is indicated for the<br>delivery of fluids from a container<br>to a patient's vascular system. | Acta Medical Intravascular administration set<br>intended use is to deliver sterile, infusion fluid<br>from a container to the patient with or without<br>flow control features. Acta Medical infusion<br>tubing may act as an extension of other infusion<br>tubing in delivering intravenous fluids from a<br>container to patient. | |
| | Configuration | Protector Cap of Spike<br>Spike<br>Air Vent<br>Air Filter<br>Drip Chamber<br>Fluid Filter<br>Flexible Tube<br>Check Valve<br>Needle Free Y Injection Site<br>Roller Clamp<br>Y Injection Site<br>Precision Filter<br>Pinch Clamp<br>Luer Lock Connector<br>Protector Cap of Luer Lock<br>Connector | Similar, except for the additional model<br>Minibore extension set |
| | | Sterile | EO sterilized |
| SAL 10-6 | | | Same |
| Single Use | | Single Use | Same |

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| Biocompatibility | | |
|---------------------------|-------------------------------------|-------------------------------------|
| Cytotoxicity | Conform with ISO 10993 requirements | Conform with ISO 10993 requirements |
| Intracutaneous Reactivity | | |
| Skin Sensitization | | |
| Acute Systemic Toxicity | | |
| Hemolysis Test | | |
| Pyrogen Test | | |

Device Comparison: The predicate device and subject device are similar in model configurations except the predicate device has an additional model, an extension set. The indications for use for the subject device and predicate device are similar except the predicate device has additional language to include the extension set and some models will come with or without a flow control feature. These minor differences in device design and indications for use do not raise different questions of safety or effectiveness.

#### 9. Substantially Equivalent (SE) Conclusion

Based on the non clinical performance testing, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.