Promisemed Safety Huber Needles

K251138 · Promisemed Hangzhou Meditech Co., Ltd. · PTI · May 13, 2025 · General Hospital

Device Facts

• Record ID: K251138
• Device Name: Promisemed Safety Huber Needles
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: PTI · General Hospital
• Decision Date: May 13, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Device Story

Safety Huber Needles are non-coring intravascular infusion sets designed for accessing surgically implanted vascular ports. The device features a right-angle Huber needle, flexible wings for secure handling, and a manually activated safety mechanism that sheaths the needle post-use to prevent needlestick injuries. The assembly includes an integrated extension set with infusion tubing (pressure-resistant up to 330 psi or non-pressure-resistant), a Y-injection site, a clamp, and a female Luer lock adapter. A foam pad on the protective base provides patient comfort. Used in clinical settings by healthcare professionals, the device is retained for 24 hours to 7 days. The clear plastic construction allows for visualization of needle placement. By providing a secure, non-coring access point and a safety-shielding mechanism, the device facilitates fluid infusion and contrast media delivery while minimizing the risk of accidental injury to the clinician.

Clinical Evidence

No clinical data. Bench testing only, including appearance, dimensions, needle point integrity, fragment testing, and puncture force, performed per ISO 7864, ISO 9626, and ASTM F3212-16.

Technological Characteristics

Non-coring right-angle Huber needle; manually activated safety sheath; integrated extension set with Y-site, clamp, and Luer lock. Materials: clear plastic base, foam pad. Pressure-resistant models support up to 330 psi. Standards: ISO 7864:2016 (needle/point), ISO 9626:2016 (tube dimensions), ASTM F3212-16 (fragmentation).

Indications for Use

Indicated for adult patients requiring access to surgically implanted vascular ports for infusion. High-pressure resistant models are indicated for power injection of contrast media during CT imaging when used with compatible ports.

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

• Safety Huber Needles (K243332)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 13, 2025

Promisemed Hangzhou Meditech Co., Ltd.
Zearou Yang
Regulatory affairs manager
No. 1388 Cangxing Street
Cangqian Community, Yuhang District
Hangzhou City, 311121, China

Re: K251138
Trade/Device Name: Promisemed Safety Huber Needles
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: PTI
Dated: April 11, 2025
Received: April 14, 2025

Dear Zearou Yang:

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" (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).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251138 - Zearou Yang
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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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251138 - Zearou Yang
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Sincerely,

Shruti N. Mistry -S

Shruti Mistry
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251138 | |
| Device Name Promisemed Safety Huber Needles | |
| Indications for Use (Describe) The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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Promisemed

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District,

Hangzhou City, 311121 Zhejiang, P. R. China.

# K251138-510(k) Summary

Date prepared: 2025-05-08

| 1. Manufacturer[21 CFR 807.92 (a) (1)] | |
| --- | --- |
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P.R.China. |
| Contact Person | Zearou Yang |
| Phone | [phone] |
| Fax | [phone] |
| Email | [e-mail] |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | Promisemed Safety Huber Needles |
| Common Name | Safety Huber Needles |
| Classification Name | Needle, Hypodermic, Single Lumen |
| Regulation Number | 880.5570 |
| Class | Class II |
| Product Code | PTI |
| 3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)] | |
| Predicate Name | Safety Huber Needles |
| 510(k) Number | K243332 |
| Product Code | PTI |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] | |
| Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. This submission is new design primarily involve changes to addition of new needle lengths and specifications. | |
| 5. Indication for use [21 CFR 807.92 (a) (5)] | |
| The needle is used to access surgically implanted vascular ports. | |

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Promisemed

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District,

Hangzhou City, 311121 Zhejiang, P. R. China.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

# 6. Indications for Use Comparison [21 CFR 807.92 (a) (5)]

No difference.

# 7. Comparison of Technological Characteristic [21 CFR 807.92 (a) (6)]

The subject device has the same intended use and technological characteristics as the predicate device. The similarities above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding effectiveness and safety. We concluded the subject device is substantially equivalent to the identified predicate device.

At a high level, the subject and predicate devices are based on the following same technological elements:

| Item of description | Cleared device (K243332) | Modified device | Comments on Similarities/Differences | Safety/Effectiveness Statement |
| --- | --- | --- | --- | --- |
| Common name | Safety Huber Needles | No change | N/A | No new concerns. The common name remains unchanged, ensuring consistency with the intended use. |
| Classification name | Needle, Hypodermic, Single Lumen (21 CFR 880.5570) | No change | N/A | No new concerns. The classification name remains consistent. |
| Device class | Class II | No change | N/A | No new concerns. The device remains in Class II, indicating no change in risk level. |
| Product Code | PTI | No change | N/A | No new concerns. The product code remains the same, reflecting no change in device functionality. |
| General description | Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. | No change | N/A | No new concerns. There are no changes about general description as the fundamental technology and operation remain the same. |
| Principle of | The Safety Huber Needle is for insertion | No change | N/A | No new concerns. |

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Promisemed

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District,

Hangzhou City, 311121 Zhejiang, P. R. China.

| operation | into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. It is designed with flexible wings which allow the user to securely hold the device for insertion and removal of the needle. The protective base and protective shield are made of clear plastic that allow the user to visualize placement of the needle. A foam pad is present on the patient-contacting side of the protective base. The device include a safety design allowing the safety shield covers the needle tip after usage. | | | The principles of operation remain unchanged, ensuring consistent performance. |
| --- | --- | --- | --- | --- |
| Indication of use | The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging. | No change. | N/A | No new concerns. The change about needle length and new specifications do not introduce new risks as the fundamental technology and operation remain the same. |
| Type | Type B, Type D and Type E | No change | N/A | No new concerns. The change about needle length and new specifications do not introduce new risks as the fundamental technology and operation remain the same. |
| Needle size | 19G, 20G, 22G | No change | N/A | No new concerns. The needle size remains unchanged. |
| Needle length | Type B: 19mm, 25mm, 38mm. | No change | N/A | No new concerns. The needle length remains unchanged.. |
| | Type D and type E: 13mm, 15mm, 19mm, 25mm, 32mm, 38mm. | Type D and type E: 13mm, 15mm, 16mm, 17mm, 19mm, 20mm, 25mm, 32mm, 38mm. | New needle length sizes were added for type D and type E. | No new concerns. The addition of new lengths do not introduce new risks as the fundamental technology and operation remain the same. |
| Lubrication | With lubrication | With or without lubrication | New specification (without lubrication) was added. | No new concerns. The addition of new specification (without lubricant on the needle tip) do not introduce new risks as the fundamental technology and |

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Promisemed

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District,

Hangzhou City, 311121 Zhejiang, P. R. China.

| | | | | | operation remain the same. |
| --- | --- | --- | --- | --- | --- |
| Needle bevel design | Non-coring angled needle | | No change | N/A | No new concerns. The addition of new lengths do not introduce new risks as the fundamental technology and operation remain the same. |
| Color | Needle gauge | Color | No change | N/A | No new concerns. The change about needle length and new specifications do not introduce new risks as the fundamental technology and operation remain the same. |
| | 19G | Cream | | | |
| | 20G | Yellow | | | |
| | 22G | Black | | | |
| Schematic diagram (safety mechanism) | Type B: Wing hub Protective shield | | No change | N/A | No new concerns. The change about needle length and new specifications do not introduce new risks as the fundamental technology and operation remain the same. |
| | Type D: Wing hub Protective shield | | No change | | |
| | Type E: Needle hub Protective shield | | No change | | |
| | Type E: Hoods Hubs Protective shield | | No change | | |
| Material | Type B, Type D and Type E | | No change | N/A | No new concerns. The change about needle length and new specifications do not introduce new risks as the fundamental technology and operation remain the same. |
| Performance | Remain no change | | No change | N/A | No new concerns. |

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Promisemed

Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

| requirements | | | | Performance requirements remained unchanged, ensuring consistent functionality. |
| --- | --- | --- | --- | --- |
| Labeling | Remain no change | No change | N/A | No new concerns. Labeling updates meet current standards and enhance the device's safety and usability. |

# 8. Nonclinical test [21 CFR 807.92 (b) (1)]

To support substantial equivalence to the predicate device, Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.

Verification and Validation Activities - Design Changes:

- Addition needle lengths for type D and type E, and new specification (without lubrication): The addition of new needle length expands options, new specification (without lubrication) without altering the device's safety or effectiveness when compared to the predicate device.

Table- Test and performance specification for subject device

| No. | Test items | Standard |
| --- | --- | --- |
| 1. | Appearance and cleanliness | ISO 7864:2016 |
| 2. | Dimension of needle tube | ISO 9626:2016 |
| 3. | Needle point | ISO 7864:2016 |
| 4. | Fragment | ASTM F3212-16 |
| 5. | Needle sheath and cap | / |
| 6. | Puncture force of needle | ISO 7864:2016 |

This is a Device modification for 510K submission and it is not concerned about biocompatibility. All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.

# 9. Clinical test [21 CFR 807.92 (b) (2)]

No clinical test is included in this submission.

# 10. Conclusion [21 CFR 807.92 (b) (3)]

Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.

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