Disposable Infusion Needle, Safelock Disposable Infusion Needle

K152323 · Jiangyin Caina Technology Co., Ltd. · FPA · Dec 14, 2015 · General Hospital

Device Facts

• Record ID: K152323
• Device Name: Disposable Infusion Needle, Safelock Disposable Infusion Needle
• Applicant: Jiangyin Caina Technology Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Dec 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein. Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.

Device Story

Disposable infusion needle; used to administer fluids to patient vascular system via gravity-fed infusion set. Device features female luer lock connector for attachment to administration sets. Safelock variant includes integrated safety sheath; clinician manually withdraws needle handle backward into sheath to lock and prevent accidental needlesticks. Used in clinical settings by healthcare professionals. Benefits include reliable fluid delivery and sharps injury prevention.

Clinical Evidence

Bench testing only. Simulated clinical study performed per FDA guidance 'Medical Devices with Sharps Injury Prevention Feature' (2005) to evaluate safety mechanism; results met pre-established criteria. Biocompatibility, sterility, and mechanical integrity verified via ISO 10993, ISO 11135, ISO 11737, ASTM F88, and ASTM F1140 standards.

Technological Characteristics

Stainless steel needle tubing (ISO 9626:1991); female luer lock connector; EO sterilization (ISO 11135-1:2007). Safety mechanism: manual retraction into sheath. Biocompatibility per ISO 10993. Packaging integrity per ASTM F88/F1140.

Indications for Use

Indicated for patients requiring intravenous fluid administration via infusion set and needle insertion into the vein. The Safelock version includes a safety sheath to prevent accidental needlesticks.

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

• SURFLO Winged Infusion Set (K070362)

Reference Devices

• SafeTouch PSV winged Infusion Set with/without filter (K132153)

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

December 14, 2015

Jiangyin Caina Technology Co., Ltd c/o Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152323

Trade/Device Name: Disposable Infusion Needle, Safelock Disposable Infusion Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration set Regulatory Class: II Product Code: FPA Dated: November 10, 2015 Received: November 13, 2015

Dear Ms. 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 vours.

Tina Kiang -S

for Erin I. Keith, M.S. 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) K152323

Device Name Safelock Disposable Infusion Needle Disposable Infusion Needle

#### Indications for Use (Describe)

Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.

Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CER 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### K152323 510(k) Summary

### 510(k) Submitter

# Jiangyin Caina Technology Co., Ltd.

No.2, Taifu Road, Huashi Town, Jiangyin, Jiangsu, 214421, China Contact Person: Jun Lu Tel: [phone] Fax: [phone] Email: [e-mail]

Date of Preparation: 10/20/2015

#### Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

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

## Device Name

Trade Name: Disposable Infusion Needle Safelock Disposable Infusion Needle Common Name: Intravenous Infusion Needle

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

#### Predicate Device

Predicate Device 510(k) Number: K070362 Product Name: SURFLO Winged Infusion Set

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Reference Device 510(k) Number: K132153 Product Name: SafeTouch PSV winged Infusion Set with/without filter

#### Device Description

The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.

## Intended Use

Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.

Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the safety sheath is designed to prevent accidental needle sticks.

#### Technological Characteristics

| Table 1 Comparison of Technology Characteristics | | | |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device<br>K070362 | Reference Device<br>K132153 |
| Product | Disposable Infusion<br>Needle<br>Safelock Disposable<br>Infusion Needle | SURFLO ® Winged<br>Infusion Set | SafeTouch PSV<br>winged Infusion Set<br>with/without filter |
| Product Code | FPA | FPA | FOZ |
| Regulation<br>Number | 880.5440 | 880.5440 | 880.5200 |
| Indications for<br>Use | Disposable Infusion Needle<br>is intended to administer<br>fluid by using an infusion set<br>to a patient' s vascular<br>system through the needle<br>inserted into the vein.<br>Safelock Disposable Infusion<br>Needle is intended to<br>administer fluid by using an<br>infusion set to a patient's | The Surflo Winged Infusion<br>Set is intended to access the<br>peripheral vascular system,<br>for intravenous<br>administration of fluids<br>and/or withdrawal of blood<br>specimens using a syringe,<br>luer adapter, or other<br>compatible/appropriate<br>devices | The Safe Touch PSV<br>Winged Infusion Set<br>with/without filter is<br>intended to be used for<br>insertion into a<br>patient's vascular<br>system for single use<br>as an indwelling device<br>to administer fluids<br>intravenously |

#### Table 1 Comparison of Technology Characteristics

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| | vascular system through the<br>needle inserted into the vein,<br>and the safety sheath is<br>designed to prevent<br>accidental needle sticks. | | Secondly it is designed<br>with an active sharp<br>feature that requires<br>physical action by the<br>clinician to prevent<br>accidental needle<br>sticks. |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To administer fluid into the<br>vein | To administer fluid into the<br>vein and withdraw blood<br>specimens | To administer fluids<br>into the vein |
| Safety Feature | The Safelock Disposable<br>Infusion needle is locked<br>in safety sheath by<br>withdraw safety needle<br>handle backward | None | The Safe Touch PSV<br>Winged infusion set<br>needle is locked in<br>safety sheath by<br>withdraw safety<br>needle handle<br>backward |
| Sterile | EO sterilized | EO sterilized | EO sterilized |
| Blood sampling | None | Yes | None |
| Single Use | Single use | Single use | Single Use |
| Performance | Complied with ISO<br>9626:1991,<br>AMENDMENT 1 2001<br>and ISO 7864:1993 | Complied with ISO<br>9626:1991, AMENDMENT<br>1 2001 and ISO 7864:1993 | Complied with ISO<br>9626:1991, AMENDMENT<br>1 2001 and ISO 7864:1993 |
| Biocompatibility | Conform with ISO 10993 | Conform with ISO 10993 | Conforms with ISO<br>10993 |

The subject devices are equivalent to the predicate devices with respect to technological characteristics. They shared the same operational principle, intended use, materials, biocompatibility, and sterilization.

### 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 results demonstrated that the proposed device complies with the following standards:

- > ISO 9626:1991+AMENDMENT 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;

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- > ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
- > ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
- > USP37-NF32 <85> Bacterial Endotoxins Limit.
- ♪ ISO 11135-1:2007 Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- A ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
- 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. The test provided in this submission include:

Simulated Clinical Study performed on the proposed device:

A simulated clinical study was performed according to FDA Guidance for Industry and FDA Staff. Medical Devices with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

#### Conclusion

Based on the non-clinical tests above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.