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 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.

This submission is new design primarily involve changes to addition of new needle lengths and specifications.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Promisemed Safety Huber Needles details a medical device that is a physical product (a needle), not a software-based AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) does not apply to this specific device.

The 510(k) submission for the Promisemed Safety Huber Needles focuses on demonstrating substantial equivalence to a predicate device (K243332) primarily through non-clinical performance testing for physical and mechanical properties, and a comparison of technological characteristics.

Here's a breakdown of the relevant information provided in the document:

Device Description and Purpose:

The Promisemed Safety Huber Needle is a non-coring intravascular infusion set with a right-angle needle and a manually activated needle-stick prevention safety mechanism. It is used to access surgically implanted vascular ports and, for the high-pressure resistant model, can be used for high-pressure injection of contrast media for CT imaging. It is for adult use only.

Nature of This Submission:

This 510(k) submission is for a device modification that primarily involves:

Addition of new needle lengths (16mm, 17mm, 20mm) for Type D and Type E needles.
Addition of a new specification: "without lubrication" for the needle tip.

The manufacturer asserts that these changes "do not introduce new risks as the fundamental technology and operation remain the same" and that the device remains "substantially equivalent" to its predicate device.

Acceptance Criteria and Study for This Device:

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are based on meeting established performance specifications and international standards for hypodermic needles and infusion sets. The "study" that proves the device meets these criteria is the suite of non-clinical (bench) tests performed.

1. A table of acceptance criteria and the reported device performance:

The document lists the types of tests performed and the standards they adhere to, implying that the acceptance criteria are successful completion according to these standards. It does not provide specific quantitative acceptance thresholds (e.g., "puncture force must be X-Y Newtons") nor the raw performance data, but rather states that "All verification and validation tests passed without deviations."

No.	Test Item	Standard	Reported Device Performance
1.	Appearance and cleanliness	ISO 7864:2016	Passed without deviations. Conforms to specified appearance and cleanliness requirements.
2.	Dimension of needle tube	ISO 9626:2016	Passed without deviations. Conforms to specified dimensional tolerances.
3.	Needle point	ISO 7864:2016	Passed without deviations. Conforms to specified needle point characteristics.
4.	Fragment	ASTM F3212-16	Passed without deviations. No fragments detected.
5.	Needle sheath and cap	/ (Internal)	Passed without deviations. Conforms to specified design and functionality.
6.	Puncture force of needle	ISO 7864:2016	Passed without deviations. Conforms to specified puncture force requirements.
Overall	Verification & Validation	Various / Internal	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.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the 510(k) summary. For physical device performance testing, sample sizes are typically determined by statistical methods based on specified confidence levels or are prescribed by the testing standards themselves (e.g., a certain number of units per lot).
Data Provenance: The tests were conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests"). This is a retrospective collection of data for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This concept applies to AI/ML device ground truth establishment, often involving clinical image interpretation. For a physical device like a needle, "ground truth" is established by adherence to engineering specifications and international standards, tested by qualified engineers and technicians using calibrated equipment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. This concept relates to human expert consensus in clinical data annotation for AI/ML validation. Physical device testing relies on objective measurements against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. An MRMC study is for evaluating the impact of AI assistance on human diagnostic performance. This device is a physical medical instrument, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This pertains to AI algorithm performance. The device here is a standalone physical needle.

7. The type of ground truth used:

Engineering Specifications and International Standards: For a physical device, "ground truth" is adherence to predefined engineering specifications (e.g., dimensions, material properties, force resistance) and compliance with internationally recognized standards (like ISO 7864, ISO 9626, ASTM F3212). The testing confirms that the device's physical properties and functionality meet these established objective benchmarks.

8. The sample size for the training set:

N/A. This concept is relevant for AI/ML model development. This device does not involve a "training set" in the computational sense.

9. How the ground truth for the training set was established:

N/A. As above, this applies to AI/ML.

Summary of Key Takeaways from the Document:

The 510(k) submission successfully demonstrated substantial equivalence by confirming through non-clinical testing that the modified Promisemed Safety Huber Needles:

Maintain the same intended use, technological characteristics, and principle of operation as the predicate device.
The added needle lengths and the "without lubrication" option do not introduce new safety or effectiveness risks.
All required performance tests (appearance, dimensions, needle point, fragment, sheath/cap, puncture force) passed without deviations, confirming adherence to relevant ISO and ASTM standards.
No clinical testing was deemed necessary for this type of modification, reinforcing that the changes were not considered to impact fundamental safety or effectiveness parameters requiring human clinical data.

Summary

FDA 510(k) Clearance Letter - Promisemed Safety Huber Needles

Page 1

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

Doc ID # 04017.07.05

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).

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K251138 - Zearou Yang
Page 2

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K251138 - Zearou Yang
Page 3

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

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 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.

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
PRAStaff@fda.hhs.gov

"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."

Page 5

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

Page 1 of 5

K251138-510(k) Summary

Date prepared: 2025-05-08

1. Manufacturer [21 CFR 807.92 (a) (1)]

Field	Details
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	+86 571 88772985
Fax	+86 571 88772985
Email	zearou.yang@promisemed.ca

2. Device [21 CFR 807.92 (a) (2)]

Field	Details
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)]

Field	Details
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)]

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.

Page 6

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

Page 2 of 5

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.

Page 7

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

Page 3 of 5

Item of description	Cleared device (K243332)	Modified device	Comments on Similarities/Differences	Safety/Effectiveness Statement
Principle of operation	The Safety Huber Needle is for insertion 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.	No change	N/A	No new concerns. 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. 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 operation remain the same.

Page 8

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

Page 4 of 5

Item of description	Cleared device (K243332)	Modified device	Comments on Similarities/Differences	Safety/Effectiveness Statement
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: 19G Cream, 20G Yellow, 22G Black	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.
Schematic diagram (safety mechanism)	Type B: [diagram], Type D: [diagram], Type E: [diagram]	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.
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 requirements	Remain no change	No change	N/A	No new concerns. 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.

Page 9

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

Page 5 of 5

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.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).