Disposable infusion set with needle

K232475 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · FPA · May 10, 2024 · General Hospital

Device Facts

• Record ID: K232475
• Device Name: Disposable infusion set with needle
• Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: May 10, 2024
• 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 under the action of gravity.

Device Story

Disposable infusion set for gravity-fed fluid administration; consists of closure-piercing device, drip chamber with fluid filter, tubing, flow regulator, and needle. Input: fluid from container; Output: fluid delivered to patient vascular system. Used in clinical settings by healthcare professionals. Device components include PVC, ABS, and stainless steel. Output allows controlled fluid therapy; benefits patient by enabling intravenous delivery of medications or hydration. Device is single-use and EO sterilized.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified via physical, mechanical, and chemical testing per ISO 8536-4, ISO 7864, ISO 9626, ISO 80369-7, and USP <788>. Biocompatibility confirmed per ISO 10993 series (cytotoxicity, sensitization, systemic toxicity, irritation, hemocompatibility). Sterility and shelf-life validated per ISO 11135 and ISO 11607.

Technological Characteristics

Gravity-fed infusion set. Materials: PVC, ABS, PE, stainless steel, polyethersulfone (PES) filter. Tubing diameter: 4mm. Filter sizes: 2µm, 3µm, 5µm. Needle gauges: 18G-27G. Sterilization: Ethylene Oxide (EO) to 10^-6 SAL. Connectors: Luer lock. Standards: ISO 8536-4, ISO 7864, ISO 9626, ISO 80369-7.

Indications for Use

Indicated for patients requiring gravity-fed intravenous fluid administration via needle or catheter.

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

• sterile single-use infusion set (K163160)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2024

Shandong Zhushi Pharmaceutical Group Co., Ltd % Bruce Cai Technical Manager Humiss Inc. RM62, No. 236, Renmin Road, Qingcun Town, Fengxian District Shanghai. 201414 China

Re: K232475

Trade/Device Name: Disposable infusion set with needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 2, 2024 Received: April 11, 2024

Dear Bruce Cai:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices,

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and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K232475

Device Name

Disposable infusion set with needle

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 under the action of gravity.

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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## 510(k) SUMMARY

The assigned 510(k) number: K232475 Date prepared: May. 10, 2024

# I. SUBMITTER

Manufacturer name: Shandong Zhushi Pharmaceutical Group Co., Ltd. Address; No. 6, Shande Road, Shan County, Heze City, Shandong Province, 274300, China Contact Person: Junhui Zhu Title: Manager Tel: [phone] Fax: [phone] E-mail: [e-mail]

## II. Correspondent Contact Information

Bruce Cai (Contact Person) Humiss Inc. Tel: [phone] E-mail: [e-mail]

## III. DEVICE

| Trade Name: | - Disposable infusion set with needle |
|---------------------|---------------------------------------|
| Common Name | - Intravascular Administration Set |
| Classification Name | - Intravascular administration set |
| Regulation Number | - 21CFR 880.5440 |
| Regulation Number | - FPA |

## IV.PREDICATE DEVICE

Predicate Device 510k number: K163160

Predicate device trade name: sterile single-use infusion set Predicate device common name: Intravascular Administration Set Predicate Device Manufacturer: JiangXi HongDa Medical Equipment Group Ltd. (No. 39 South Shengli Road, Jinxian County, Nanchang, CN 331700)

## V. Device Description

#### Table 5.1. Device Description Summary for Disposable infusion set with needle

| Models | Subject Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Disposable infusion set with needle |
| Indications for use | The device is intended to administer fluids from a container to a<br>patient's vascular system through a needle or catheter inserted into<br>the vein under the action of gravity. |

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| Model name | SY03 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Configuration | Protective Cap of Closure-piercing Device<br>Closure-piercing Device<br>Clamp<br>Fluid channel (tubing)<br>Drip chamber upper cover (including the dropper)<br>Drip chamber<br>Drip chamber base (including Fluid Filter membrane)<br>Flow regulator<br>Regulator wheel<br>Luer Lock Connector<br>Infusion needle hub<br>Needle tube<br>Plastic needle handle<br>Infusion needle protector<br>Integral air-inlet with air filter and closure<br>Tubing<br>Lubricant<br>Adhesives |
| Tubing Diameter | 4 mm |
| Filter Characteristics | 15µm |
| Needle Gauge and<br>Lengths | 0.4mm(27G) x13.5mm, 0.45 mm (26 G) x13.5 mm, 0.45 mm<br>(26 G) x15 mm, 0.5mm (25 G) x17.5mm, 0.55mm (24G) x17.5<br>mm, 0.55mm (24 G) x20 mm, 0.6 mm (23 G) x22.5 mm, 0.6<br>mm (23 G) x25 mm, 0.7 mm (22 G) x19 mm, 0.7 mm (22 G)<br>x22.5 mm, 0.7 mm (22 G) x25 mm, 0.8 mm (21 G) x19 mm, 0.8<br>mm (21 G) x28 mm, 0.9 mm (20 G) x26 mm, 0.9 mm (20 G)<br>x28 mm, 1.1 mm (19G ) x 38 mm, 1.2mm (18 G) x19 mm,<br>1.2mm (18 G) x26 mm, 1.2mm (18 G) x30 mm, 1.2mm (18 G)<br>x38 mm |

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# VI. Predicate Comparison

| Item | Predicate Device K163160 | Subject Device | Comparison | | |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------|
| Product Code | FPA | FPA | Same | | |
| Regulation<br>Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same | | |
| Indication for<br>Use | The device is intended to<br>administer fluids from a<br>container to a patient's<br>vascular system through a<br>needle or catheter inserted<br>into the vein. | The device is intended to<br>administer fluids from a<br>container to a patient's<br>vascular system through<br>a needle or catheter<br>inserted into the vein<br>under the action of<br>gravity. | Same | | |
| | Compon<br>ent name<br>Protector<br>Cap of<br>Spike | Material<br>HDPE | Compon<br>ent name<br>Protector<br>Cap of<br>Spike | Material<br>PE | |
| | Spike | ABS | Spike | ABS | |
| | Air Vent | PVC | Air Vent | PVC | |
| Configuration<br>and material | Drip<br>Chamber | PVC | Drip<br>chamber | PVC | |
| | Fluid<br>Filter | ABS | Drops of<br>bucket | ABS, Fluid<br>Filter<br>membrane<br>made by<br>Polyethersulf<br>one filtration<br>membrane<br>(PES) | Difference 1 |
| | Flexible<br>Tube | PVC | Flexible<br>Tube | PVC | |
| | Roller<br>Clamp | HDPE | Regulati<br>ng wheel | ABS | |
| | Latex<br>Tube | Polyisoprene | Latex<br>Tube | N/A | |
| | Y<br>Injection<br>Site | ABS | Y<br>Injection<br>Site | N/A | |
| | Luer<br>Lock<br>Connect<br>or | ABS | Luer<br>lock<br>Connect<br>or | PVC | |
| | Protector<br>Cap of<br>Luer<br>Lock<br>Connect<br>or | HDPE | Protector<br>Cap of<br>Luer<br>Lock<br>Connect<br>or | | |
| | Needle<br>Hub | PP | Needle<br>hub | PVC | |
| | Needle<br>Tube | Stainless<br>Steel | Needle<br>tube | Stainless<br>steel | |
| Tubing<br>Diameter | 3.9mm | | 4 mm | | Difference 2 |
| Filter<br>Characteristics | 15μm | | 2µm, 3µm, 5µm | | Difference 3 |
| Needle Gauge | 21G | | 18G, 19G, 20G, 21G,<br>22G, 23 G, 24G, 25G,<br>26G, 27G | | Difference 4 |
| Sterile | EO sterilized | | EO sterilized | | Same |
| | 10-6 | | 10-6 | | Same |
| Single Use | Single Use | | Single Use | | Same |
| Infusion Set Performance | | | | | |
| Particulate<br>contamination | Contamination index limit<br>is less than 90 | | Contamination index<br>limit is less than 90 | | |
| Leakage | No leakage | | No leakage | | |
| Tensile<br>strength | Withstand a static tensile<br>force of not less than 15N<br>for 15s | | Can withstand a static<br>tensile force of 15 N for<br>15s | | |
| Closure<br>piercing device | Comply the dimension of<br>ISO 8536-4 | | Comply the dimension of<br>ISO 8536-4 | | |
| Air-inlet device | Flow of fluid is reduced<br>less than 20% of that from<br>a freely ventilated<br>container | | Flow of fluid is reduced<br>less than 20% of that<br>from a freely ventilated<br>container | | Same |
| Fluid filter | Retention of latex particles<br>is not less than 80% | | Retention of latex<br>particles is not less than<br>80% | | |
| Drip chamber<br>and drip tube | 20 drops of distilled water<br>delivered by the drip are<br>equivalence to a volume of<br>(1±0.1) ml (1±0.1) g | | 20 drops of distilled<br>water delivered by the<br>drip are equivalence to a<br>volume of (1±0.1) ml<br>(1±0.1) g | | |
| Flow rate | Deliver not less than<br>1000ml | | Deliver not less than<br>1000ml | | |
| Construction | | The clamps can resist the | | The clamps can resist the | |

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| | flow of fluid and air at an<br>applied pressure of 50 kPa<br>when closed. | flow of fluid and air at an<br>applied pressure of 50 kPa when closed. | |
|--------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------|------|
| Needle Performance | | | |
| Cleanliness | Free from particles and<br>extraneous matter | Free from particles and<br>extraneous matter | Same |
| Needle length | 38mm (meet ISO<br>7864:2016 Clause 4.10 of<br>21G needle) | 20.72mm (meet ISO<br>7864:2016 Clause 4.10<br>of 23G needle) | Same |
| Bond of hub<br>and needle tube | Not broken by the<br>minimum force | Not broken by the<br>minimum force | Same |
| Stiffness | Deflection is less than<br>0.50mm | Deflection is less than<br>0.50mm | Same |
| Dimensions of<br>needle tubing | 0.8mm (meet ISO<br>9626:2016 Clause 5.6 of<br>21G needle) | 0.627mm (meet ISO<br>9626:2016 Clause 5.6 of<br>23G needle) | Same |
| Resistance to<br>breakage | The tubing is not break | No breakage | Same |
| Resistance to<br>corrosion | No evidence of corrosion | No corrosion | Same |
| Biocompatibility | | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| Intracutaneous<br>Reactivity | No Intracutaneous<br>Reactivity | No Intracutaneous<br>Reactivity | |
| Skin<br>Sensitization | No Skin Sensitization | No Skin Sensitization | Same |
| Acute Systemic<br>Toxicity | No Acute Systemic<br>Toxicity | No Acute Systemic<br>Toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No pyrogen | No pyrogen | |

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#### VII Substantial Equivalence Discussion

The indications for use statement for the Disposable infusion set with needle subject device is equivalent to the predicate device. There are no technological differences between the predicate and subject devices except for the following: Components and materials, Tubing Diameter, Filter Characteristics, and Needle Gauge.

- Difference 1: The subject device has different components and materials compared to the predicate device, such as the predicate device's Injection Site, which the subject device doesn't have. These differences have no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4 and ISO 10993. The requirements of the standards are met.
- Difference 2: The subject device has a different Tubing Diameter compared to the predicate device; predicate device's Tubing Diameter is 3.9 mm, subject device's Tubing Diameter is 4 mm. This slight difference has no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4. The requirements of the standards are met.
- Difference 3: The subject device has different Filter Characteristics compared to the predicate device; predicate device's Filter size is 15um, subject device's Filter size is 2um, 3um, 5um. This difference has no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4, and USP NF <788>. The requirements of the standards are met.
- Difference 4: The subject device has different Needle Gauges compared to the predicate device, predicate device's Needle Gauge is 21 G, subject device's Needle Gauges are 18G, 19G, 20G, 21G, 22G, 23 G, 24G, 25G, 26G, 27G. This difference has no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4, ISO 7864, ISO 9626 which is same as predicate device. The requirements of the standards are met.

# VIII. Performance Testing

The Disposable infusion set with needle described in this summary were tested and demonstrated to be in conformance with the following standards:

- ISO 8536-4:2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- . ISO 7864:2016 Fourth Edition: Sterile hypodermic needles for single use - Requirements and test methods
- . ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods;
- . ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- . USP NF <788> Particulate Matter in Injections
- . USP NF <161> Bacterial endotoxin test
- . ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood

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- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- . ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- . ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- . ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- . ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- . ASTM F1980:2011 Standard Guide or Accelerated Aging of Sterile Barrier Systems for Medical Devices
- F1140/F1140M-13 (Reapproved 2020) e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

The Disposable infusion set with needle is considered in the category of "External Communicating Devices" and are in contact for a period less than 24 hours with "Indirect blood path" or "Circulating blood" (needles). Thus, hemocompatibility (ISO 10993-4:2017), cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), acute systemic toxicity (ISO 10993- 11:2017), irritation (ISO 10993-23:2021) were carried out for the device in question.

#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the subject device met all design specifications as Substantially Equivalent (SE) to the predicate device. The tests conducted for this submission include:

Physical, Mechanical and Chemical Tests performed on the subject devices:

ISO 8536-4:2019 ISO 8536-14:2016 ISO 7864:2016 ISO 9626:2016 ISO 80369-7:2021

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Particulate matter: USP-NF<788> Sterile Barrier Packaging Testing performed on the subject device: Seal strength ASTM F88/F88-09 Internal pressure ASTM F1140/F1140M-13 Dye Penetration ASTM F 1929-15 Sterilization and Shelf-Life Testing performed on the subject device: EO residue ISO 10993-7:2008 ECH residue ISO 10993-7:2008 Bacteria Endotoxin Limit USP NF <161> Shelf-Life Evaluation Physical, Mechanical, Chemical, Package and Sterility Tests were performed on accelerated aged samples to 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.

#### IX. Clinical Test Conclusion

No clinical trials were conducted in support of this 510(k).

## X. Conclusion

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