Huber Needle Infusion Set, Safety Huber Needle Infusion Set

K200463 · Jiangsu Caina Medical Co.,Ltd · PTI · Apr 7, 2021 · General Hospital

Device Facts

• Record ID: K200463
• Device Name: Huber Needle Infusion Set, Safety Huber Needle Infusion Set
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: PTI · General Hospital
• Decision Date: Apr 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G. The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Device Story

Single-use, sterile, non-pyrogenic Huber needle infusion sets; non-coring right-angle needle design. Used for accessing subcutaneously implanted ports for fluid/drug infusion and blood sampling. Safety models include a manually activated mechanism to lock the needle tip after removal to prevent accidental needlesticks. Available in various gauges (19G-25G) and lengths. 19G-22G models support power injection of contrast media at max 325psi. Includes Y-sites with needleless or needle adapters for secondary access. Operated by clinicians in clinical settings. Provides secure vascular access; safety mechanism reduces risk of sharps injury to healthcare personnel.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional performance (flow rates, pressure resistance, occlusion, leakage), mechanical integrity (tensile strength, wing flexibility), and biocompatibility (ISO 10993-1).

Technological Characteristics

Materials: MABS, PVC, PC, Silicone rubber, PE, Polydimethylsiloxane lubricant. Non-coring needle design. EO sterilized (SAL 10^-6). Connectivity: Luer fittings. Standards: ISO 10555-6, ISO 8536-4, ISO 23908, ISO 7864, ISO 9626, ISO 80369-7/20, ASTM F3212, ASTM F2182/F2052/F2119/F2213 (MRI).

Indications for Use

Indicated for insertion into the septum of a subcutaneously implanted port for infusion of fluids/drugs and blood sampling. 19G-22G needles are indicated for power injection of contrast media (max 325psi) into ports specifically indicated for power injection.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Surecan Safety II (K170897)

Submission Summary (Full Text)

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Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 CN

Re: K200463

Trade/Device Name: Huber Needle Infusion Set. Safety Huber Needle Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: February 1, 2021 Received: March 8, 2021

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. 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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/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.

# James M. Simpson Jr -S7

for Paval Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, 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

510(k) Number (if known) K200463

#### Device Name

Huber Needle Infusion Set Safety Huber Needle Infusion Set

## Indications for Use (Describe)

Huber Needle Infusion Set

The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port.

The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

#### Safety Huber Needle Infusion Set

The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks.

The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: K200463

- 1. Date of Preparation: 3/31/2021
- 2. Sponsor Identification Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town, Jiangyin city, Jiangsu, 214415, China. Establishment Registration Number: 3005670221 Contact Person: Jianwei Pan Position: Management Representative Tel: [phone]-8027 Fax: [phone]-8009 Email: [e-mail]
- 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (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: Huber Needle Infusion Set, Safety Huber Needle Infusion Set Common Name: Intravascular Administration Set Regulatory Information Classification Name: Hypodermic Single Lumen Needle Classification: II Product Code: PTI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;

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- 5. Identification of Predicate Device 510(k) Number: K170897 Product Name: Surecan Safety II
Indication for Use:

Huber Needle Infusion Set

The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port.

The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

#### Safety Huber Needle Infusion Set

The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle sticks.

The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

#### Device Description:

The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle

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Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s).

The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

- 6. Summary of Technological Characteristics

| Item | Proposed Device<br>Huber Needle<br>Infusion Set | Proposed Device<br>Safety Huber Needle<br>Infusion Set | Predicate Device<br>K170897 | Remake |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Product Code | PTI | PTI | PTI | Same |
| Regulation No. | 880.557 | 880.557 | 880.557 | Same |
| Class | II | II | II | Same |
| Indication for<br>Use | The Huber Needle<br>Infusion Set is a<br>device with a<br>non-coring right<br>angle needle intended<br>for insertion into the<br>septum of a<br>subcutaneously<br>implanted port and<br>for the infusion of<br>fluids and drugs, as<br>well as blood<br>sampling into the<br>port. | The Safety Huber Needle<br>Infusion Set is a device<br>with a non-coring right<br>angle needle intended for<br>insertion into the septum<br>of a subcutaneously<br>implanted port and for the<br>infusion of fluids and<br>drugs, as well as blood<br>sampling into the port.<br>The safety feature is<br>manually activated during<br>needle removal, and is<br>designed to aid in the<br>prevention of accidental<br>needle sticks. | The Surecan Safety II<br>power-injectable safety<br>non-coring needle is a<br>device intended for<br>insertion into the<br>septum of a<br>subcutaneously<br>implanted port for the<br>infusion of fluids and<br>drugs, as well as blood<br>sampling through the<br>port.<br>The Surecan Safety II<br>safety feature is<br>manually activated<br>during needle removal,<br>and is designed to aid in<br>the prevention of<br>accidental<br>needle-sticks. When<br>used with ports that are | Similar 1 |
| | The 19G-22G needles<br>of device are also<br>suitable for power<br>injection of contrast<br>media to a maximum<br>pressure of 325psi.<br>When used with ports | The 19G-22G needles of<br>device are also suitable<br>for power injection of<br>contrast media to a<br>maximum pressure of | | |
| Item | Proposed Device<br>Huber Needle<br>Infusion Set | Proposed Device<br>Safety Huber Needle<br>Infusion Set | Predicate Device<br>K170897 | Remake |
| | indicated for power<br>injection, the<br>maximum<br>recommended<br>infusion rate is<br>approximately 5ml/s<br>for 19G and 20G,<br>2ml/s for 22G. | 325psi. For power<br>injection of contrast<br>media, the maximum<br>recommended infusion<br>rate is approximately<br>5ml/s for 19G and 20G,<br>2ml/s for 22G. | indicated for power<br>injection of contrast<br>media into the central<br>venous system, the<br>Surecan Safety II<br>needle is also indicated<br>for power injection of<br>contrast media.<br>For power injection of<br>contrast media, the<br>maximum flow rates at<br>325 psi are 5mL/s for<br>19 gauge and 20 gauge<br>needles and 2mL/s for<br>the 22 gauge needles. | |
| | Non-coring needle | Non-coring needle | Non-coring needle | |
| | NA | Safety mechanism-hub | Safety mechanism-hub | |
| | PVC tube | PVC tube | PVC tube | |
| | Clamps | Clamps | Clamps | |
| Configuration | Female luer fitting | Female luer fitting | Female luer fitting | Similar 2 |
| | Male luer cap | Male luer cap | Male luer cap | |
| | Needleless connector | Needleless connector | Needleless connector | |
| | Y needleless adapters | Y needleless adapters | Y needleless adapters | |
| | Y needle adapters | Y needle adapters | Y needle adapters | |
| | NA | Safety Mechanism | Safety Mechanism | |
| Label/Labeling | Complied with 21<br>CFR part 801 | Complied with 21 CFR<br>part 801 | Complied with 21<br>CFR part 801 | |
| Needle gauge | 19G, 20G, 22G, 24G,<br>25G | 19G, 20G, 22G, 24G,<br>25G | 19G, 20G, 22G | Different 3 |
| Needle length | 0.5 ", 0.75 ", 1 ",<br>1.25 ", 1.5 " | 0.5 ", 0.75 ", 1 ",<br>1.25 ", 1.5 " | 0.5 ", 0.6 ", 0.8 "<br>1 ", 1.3 ", 1.5 " | Different 4 |
| Item | Proposed Device<br>Huber Needle<br>Infusion Set | Proposed Device<br>Safety Huber Needle<br>Infusion Set | Predicate Device<br>K170897 | Remake |
| Available for use<br>with contrast<br>media | 19G, 20G, 22G | 19G, 20G, 22G | 19G, 20G, 22G | Same |
| Infusion rate<br>with contrast<br>media | 5ml/s for 19G and<br>20G<br>2ml/s for 22G | 5ml/s for 19G and 20G<br>2ml/s for 22G | 5ml/s for 19G and 20G<br>2ml/s for 22G | Same |
| Needle bevel<br>design | Non-coring needle | Non-coring needle | Non-coring needle | Same |
| Priming volume | S-1: 0.4mL<br>S-2: 0.5mL<br>Y-1: 0.7mL<br>Y-2: 0.7mL<br>D-2: not applicable | S-1s: 0.4mL<br>S-2s: 0.5mL<br>Y-1s: 0.7mL<br>Y-2s: 0.7mL | 19ga (without<br>Caresite)- 0.32mL<br>20ga (without<br>Caresite)- 0.24mL<br>22ga (without<br>Caresite)- 0.18mL<br>19ga (with Caresite)-<br>0.62mL<br>20ga (with Caresite)-<br>0.53mL<br>22ga (with Caresite)-<br>0.46mL | Different 5 |
| Safety<br>Mechanism<br>Design | NA | The activation of the<br>safety device is manual.<br>After the infusion is<br>completed, hold the base<br>of the safety<br>mechanism-plate with one<br>hand, hold the double<br>wing with the other hand<br>and pull the needle out.<br>When the needle is<br>completely pulled out<br>until the click sound is<br>heard, the tip of the<br>needle is locked in the<br>safety mechanism-plate. | Manually activated<br>safety mechanism upon<br>removal of the needle<br>from the implanted<br>vascular port. Safety<br>mechanism locks<br>needle into place when<br>a firm stop is felt.<br>A green dot appears on<br>the clear bottom plate<br>when safety mechanism<br>is fully engaged. | Different 6 |
| Item | Proposed Device<br>Huber Needle<br>Infusion Set | Proposed Device<br>Safety Huber Needle<br>Infusion Set | Predicate Device<br>K170897 | Remake |
| Does the device<br>have wings? | NA | Yes | Yes | Same |
| Is the<br>engagement of<br>the safety<br>mechanism<br>visible to the<br>user? | NA | Yes | Yes | Same |
| Hub | Methyl methacrylate<br>acrylonitrile<br>butadiene styrene<br>plastics (MABS) | NA | | |
| Joint pipe | Polyvinyl chloride<br>(PVC) | NA | | |
| PVC tube | Polyvinyl chloride<br>(PVC) | Polyvinyl chloride (PVC) | | Non-clinical<br>testing<br>performed.<br>Does not<br>raise new<br>question of<br>safety and<br>effectiveness. |
| Female Luer<br>fitting | Methyl methacrylate<br>acrylonitrile<br>butadiene styrene<br>plastics (MABS);<br>Polypropylene (PP)<br>White Color | Methyl methacrylate<br>acrylonitrile butadiene<br>styrene plastics (MABS);<br>White Color | Unknown | |
| Needleless<br>connector | Polycarbonate<br>(PC)+Silicone rubber | Polycarbonate (PC)<br>+Silicone rubber | | |
| Y needleless<br>adapters | Polycarbonate (PC) +<br>Silicone rubber | Polycarbonate (PC) +<br>Silicone rubber | | |
| PVC extend tube | Polyvinyl chloride<br>(PVC) | Polyvinyl chloride (PVC) | | |
| Y needle<br>adapters-connect<br>or | Methyl methacrylate<br>acrylonitrile<br>butadiene styrene<br>plastics (MABS) | Methyl methacrylate<br>acrylonitrile butadiene<br>styrene plastics (MABS) | | |
| Y needle<br>adapters-injectio<br>n site | Silicone rubber | Silicone rubber | | |
| Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | | |
| Item | Proposed Device<br>Huber Needle<br>Infusion Set | Proposed Device<br>Safety Huber Needle<br>Infusion Set | Predicate Device<br>K170897 | Remake |
| Safety<br>mechanism-hub | NA | Polycarbonate (PC) | | |
| Protective pad | NA | Polyethylene (PE) | | |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | same |
| Sterilization | EO sterilization | EO sterilization | EO sterilization | Same |
| SAL | 10-6 | 10-6 | 10-6 | Same |
| Single use | Single use | Single use | Single use | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | 20 EU per device | Same |

Table 1 Comparison of Technological Characteristics with the Predicate Device

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## Similar 1- Indications for Use

Both the predicate and Huber Needle Infusion Set and Safety Huber Needle Infusion Set are intended for use with a non-coring right angle needle intended for insertion into the septum of a subcut…