Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set

K161898 · Beijing Fert Technology Co., Ltd. · FPA · Mar 8, 2017 · General Hospital

Device Facts

• Record ID: K161898
• Device Name: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
• Applicant: Beijing Fert Technology Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Mar 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Disposable gravity-fed infusion sets; components include air filter, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter, and infusion needle with luer adaptor. Burette-type sets include a burette for quantitative infusion; precision filter sets include a membrane for filtration. Used in clinical settings for fluid administration; operated by healthcare professionals. Device delivers fluids from container to patient vascular system; flow controlled by manual regulator. Benefits include controlled, sterile fluid delivery.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ISO 8536-4/5, ISO 594-1/2, ISO 9626, ISO 7864, ISO 10993 (cytotoxicity, irritation, sensitization, systemic toxicity), ASTM F88/F1140, ASTM F756 (hemolysis), and USP <85> (endotoxins).

Technological Characteristics

Gravity-fed infusion set. Materials: stainless steel (ISO 9626), medical-grade plastics. Components: air filter, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter, luer adaptor, needle. Burette-type includes burette; precision filter-type includes membrane. Sterilization: Ethylene Oxide (EO) to 10^-6 SAL. Connectivity: None. Software: None.

Indications for Use

Indicated for the delivery of fluids from a container to a patient's vascular system via gravity-fed infusion.

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)

Reference Devices

• PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion (K972839)

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

March 8, 2017

Beijing Fert Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K161898

Trade/Device Name: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 28, 2017 Received: March 3, 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 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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# Indications for Use

510(k) Number (if known)

K161898

Device Name

Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set

Indications for Use (Describe)

The devices are 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: K161898

- 1. Date of Preparation: 03/07/2017
- 2. Sponsor Identification

## Beijing Fert Technology Co., Ltd.

No. 9, Zhangguozhuang Village, Changxindian Town, Feng Tai District, Beijing, 100072, China

Contact Person: Meng Zhang Position: Quality 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]

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#### 4. Identification of Proposed Device

Trade Name: Burette-type Infusion Sets for Single Use Disposable Infusion Sets with Precision Filters Disposable Infusion Set Common Name: Disposable Infusion Set

#### Regulatory Information

Classification Name: Set, Administration, Intravascular

Classification: Class II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital;

Indications for Use:

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

Device Description:

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.

5. Identification of Predicate Device

510(k) Number: K112204 Product Name: KDL Disposable Infusion Set

6. Identification of Reference Device

510(k) Number: K972839 Product Name: PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion

Non-Clinical Test Conclusion 7.

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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 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 8536-5:2004 Infusion equipment for medical use- Part 5: Burette 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 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
- > ISO 9626:1991 AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
- > ISO 7864: 1993 Sterile hypodermic needles for single use
- > ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
- > ASTM F 88/88M-09 Standard test method for seal strength of flexible barrier materials;
- > ASTM F1140/1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages
- > USP38-NF33 <85> Bacterial Endotoxins Tests.
- > 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
- 8. Clinical Test Conclusion

No clinical study is included in this submission.

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## 9. Substantially Equivalent (SE) Comparison

| Item | Proposed Device | Predicate Device | Reference Device |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA | FPA | FPA |
| Regulation Number | 21CFR 880.5440 | 21CFR 880.5440 | 21CFR 880.5440 |
| Indications for Use | The devices are indicated for the delivery of fluids from a container to a patient's vascular system. | 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 | For the delivery of I.V. solutions by on the order of a physician or other licensed practitioner. |
| Configuration | Protective Cap of Closure-piercing Device<br>Air Filter<br>Closure-piercing Device<br>Flexible Tubing<br>Clamp Hook<br>Injection Site<br>Burette<br>Fluid Filter<br>Drip Chamber<br>Flow Regulator<br>Y-shape Injection Site<br>Conical Fitting<br>Needle Seat<br>Wing | Protective Cap of Closure-piercing Device<br>Air Filter<br>Closure-piercing Device<br>Flexible Tubing<br>Clamp Hook<br>Site Drip<br>Chamber Fluid<br>Filter Flow<br>Regulator<br>Injection Site<br>Conical Fitting<br>Needle Seat<br>Wing<br>Infusion Needle<br>Protective Cap of Infusion Needle | Protective Cap of Closure-piercing Device<br>Air Filter<br>Closure-piercing Device<br>Flexible Tubing<br>Clamp Hook<br>Injection Site<br>Burette<br>Fluid Filter<br>Drip Chamber<br>Flow Regulator<br>Y-shape Injection Site<br>Conical Fitting<br>Needle Seat<br>Wing |
| | Infusion Needle<br>Protective Cap of Infusion Needle | Check valve | Infusion Needle<br>Protective Cap of Infusion Needle |
| Sterile | EO sterilized | EO sterilized | EO sterilized |
| | 10-6 | 10-6 | 10-6 |
| Single Use | Single Use | Single Use | Single Use |
| Biocompatibility | | | |
| Cytotoxicity | No Cytotoxicity | Conform with ISO 10993 series<br>standards | Conform with ISO 10993 series<br>standards |
| Intracutaneous Reactivity | No intracutaneous Reactivity | | |
| Skin Sensitization | No Sensitization | | |
| Acute Systemic Toxicity | No Systemic Toxicity | | |
| Hemolysis | No Hemolysis | | |

Table 1 Comparison of Technology Characteristics

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- Differences between the subject device indication for use are not identical word. However, the minor differences do . not raise new questions of safety and effectiveness of the reference device K972839 PROTOS® Burette Infusion Set was leveaged for the burette component of the subject device.
10. Substantially Equivalent (SE) Conclusion

Based upon the indications for use, technological characteristics, and the results of the subject devices have been demonstrated to be substantially equivalent to the predicate.