(141 days)
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.
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 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), Yinjection 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 the type C name, the addition of new needle lengths and new type E.
The FDA 510(k) submission document for the Promisemed Safety Huber Needles details the device's characteristics and its substantial equivalence to a predicate device (K230715). The document does not describe a study involving an AI/software device that requires extensive acceptance criteria, an MRMC study, or the establishment of ground truth by multiple experts.
The provided document is a 510(k) premarket notification for a Class II medical device, specifically a hypodermic single lumen needle. This type of device approval primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than a clinical study with complex AI performance metrics.
Therefore, many of the requested details, such as the number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets, are not applicable to the content of this document.
However, based on the non-clinical testing described, we can extract information relevant to the device's acceptance criteria and how its performance was verified.
Here's an interpretation based on the provided document:
Acceptance Criteria and Device Performance for Promisemed Safety Huber Needles
The acceptance criteria for this device are primarily based on meeting established industry standards and design specifications, ensuring the new design (specifically Type D and Type E, and changes in needle lengths for Type D) is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Industry Standards/Design Specifications) | Reported Device Performance (Verification and Validation Activities) |
|---|---|
| Name and Labeling Compliance | Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 7864. Result: Complied. |
| Needle Dimensions (Type D) | The needle's dimensions, including outer diameter and length, were measured. Result: Complied with drawing requirements. This implies that the new needle lengths (13mm, 15mm, 19mm, 25mm, 32mm, 38mm) for Type D, previously Type C, and for the newly added Type E, met their specified dimensions. |
| Performance (Type E - newly added type)- Appearance- Dimension- Safety mechanism operation | Full performance was tested, including appearance, dimension, safety mechanism, etc., and found to comply with: - ISO 7864 (Sterile hypodermic needles for single use) - ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) - ASTM F3212-16 (Standard Test Method for Performance of Safety Mechanism on Needles Used for Accessing Implanted Ports) - ISO 23908 (Sharps injury protection features for single-use containers, sharps disposal containers and medical sharps)Result: Complied with all specified standards. |
| No New Risks (Safety and Effectiveness) | 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 Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of needles) used for each non-clinical test (visual inspections, dimensional measurements, and performance tests). It generally states "verification and validation tests passed without deviations."
- Data Provenance: The document implies that the testing was conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China."). The testing is described as "Nonclinical test," which typically refers to laboratory-based evaluations rather than human subject data. These tests are retrospective in the sense that they are performed on manufactured devices to prove compliance, not prospective data collection from clinical use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is not an AI/software device requiring human expert annotation or ground truth determination based on clinical interpretation. The "ground truth" here refers to compliance with engineering specifications and recognized international standards (ISO, ASTM).
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this isn't a study involving human interpretation or AI output that would require adjudication. Compliance is determined against quantitative and qualitative engineering specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- Not applicable. This is a physical medical device (needle), not an AI algorithm. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to international consensus standards (ISO, ASTM) and the manufacturer's internal design specifications and drawing requirements. This includes:
- Dimensional accuracy (e.g., outer diameter and length of needles).
- Functional performance of the safety mechanism.
- Material properties and biocompatibility (implied by compliance with standards for medical devices).
- Labeling accuracy.
8. The Sample Size for the Training Set
- Not applicable. There is no concept of a "training set" for a physical medical device in this context, as no AI model is being trained.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
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March 14, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City, 311121, China
Re: K243332
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: December 23, 2024 Received: February 12, 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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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 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.
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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
Sincerely,
Rong Guo --> Digitally signed
Rong Guo --> by Rong Guo -S for
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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Indications for Use
Submission Number (if known)
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 imaqing.
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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Image /page/4/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green and the word "med" is in blue. There is a blue and green molecule-like graphic above the word "Promise". There is a registered trademark symbol to the right of the word "med".
Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hanazhou City 311121 Zheiiana P R China
510(k) Summary
Date prepared: 2025-03-14
| 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, China. |
| Contact Person | Zearou Yang |
| Phone | +86 571 88772985 |
| Fax | +86 571 88772985 |
| zearou.yang@promisemed.ca | |
| 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 | K230715 |
| 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 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), Yinjection 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 the type C name, the addition of new needle lengths and new type E.
- Indication for use [21 CFR 807.92 (a) (5)]
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Image /page/5/Picture/0 description: The image shows the logo for Promisemed. The word "Promise" is in blue, except for the "P" which is in green. To the left of the "r" is a green circle connected to a blue circle. To the right of the word "Promisemed" is a circled R, indicating that the logo is registered.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hanazhou City 311121 Zheijana P R China
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.
Indications for Use Comparison [21 CFR 807.92 (a) (5)] 6.
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 or safety of the subject device when compared to the predicate device. 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 ofdescription | Cleared device(K230715) | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement | |
|---|---|---|---|---|---|
| Common name | Safety Huber Needles | No change | N/A | No new concerns.The commonname remainsunchanged,ensuringconsistency withthe intended use. | |
| Classificationname | Needle, Hypodermic, Single Lumen(21 CFR 880.5570) | No change | N/A | No new concerns.The classificationname remainsconsistent. | |
| Device class | Class II | No change | N/A | No new concerns.The deviceremains in Class II,indicating nochange in risklevel. | |
| Product Code | PTI | No change | N/A | No new concerns.The product coderemains the same,reflecting nochange in devicefunctionality. | |
| Generaldescription | Safety Huber Needle is a standardnon-coring intravascular infusion setwith a non-coring Huber type rightangle needle and a manuallyactivated needle-stick preventionsafety mechanism which reduces therisk of accidental needlestick injuriesby sheathing the needle.The device includes an integratedextension set consisting of a Huberneedle and safety mechanism (Type Band Type C), needle infusion tubing(pressure resistance or non-pressureresistance), Y-injection site, clampand female Luer lock adapter. Thepressure resistance tubing can beused for power injection up to 330psi. The device will be retained on | Safety Huber Needle is a standardnon-coring intravascular infusionset with a non-coring Huber typeright angle needle and a manuallyactivated needle-stick preventionsafety mechanism which reducesthe risk of accidental needlestickinjuries by sheathing the needle.The device includes an integratedextension set consisting of a Huberneedle and safety mechanism(Type B, Type D and Type E), needleinfusion tubing (pressure resistanceor non-pressure resistance), Y-injection site, clamp and femaleLuer lock adapter. The pressureresistance tubing can be used forpower injection up to 330 psi. The | Name of TypeC is changed toType D.Type E wasadded. | No new concerns.The change totype name and abroader type donot introducenew risks as thefundamentaltechnology andoperation remainthe same. | |
| patient for 24h to 7 days. | device will be retained on patientfor 24h to 7 days. | ||||
| Principle ofoperation | Type B and Type C:The Safety Huber Needle is forinsertion into the septum of asubcutaneously implanted port andfor the infusion of fluids into the port.It is designed with flexible wingswhich allow the user to securely holdthe device for insertion and removalof the needle. The protective baseand protective shield are made ofclear plastic that allow the user tovisualize placement of the needle. Afoam pad is present on the patient-contacting side of the protectivebase.The device include a safety designallowing the safety shield covers theneedle tip after usage. | Type B and Type D:No change | Name of TypeC is changed toType D. | No new concerns.The principles ofoperation remainunchanged,ensuringconsistentperformance. | |
| / | Type E:Same as Type D | Type E wasadded. | |||
| Indication of use | The needle is used to access surgicallyimplanted vascular ports.Safety Huber Needles is a standardnon coring intravascular infusion setwith a non-coring Huber type rightangle needle and a manuallyactivated needle stick preventionsafety mechanism which reduces therisk of accidental needlestick injuriesby sheathing the needle. This deviceis for adult use only.In addition, when used with portsthat are indicated for power injectionof contrast media into the centralvenous system, the high pressureresistant model is indicated for high-pressure injection of contrast mediafor CT imaging. | No change. | N/A | No new concerns.The change totype name and abroader type donot introducenew risks as thefundamentaltechnology andoperation remainthe same. | |
| Type | Type B, Type C | Type B, Type D and Type E | Name of TypeC is changed toType D.Type E wasadded. | No new concerns.The change totype name and abroader type donot introducenew risks as thefundamentaltechnology andoperation remainthe same. | |
| Needle size | 19G, 20G, 22G | No change | N/A | No new concerns.The needle sizeremainsunchanged. | |
| Needle length | Type B:19mm, 25mm, 38mm | No change | N/A | No new concerns.The needle lengthremainsunchanged. | |
| Type C:19mm, 25mm, 38mm | Type D: 13mm, 15mm, 19mm,25mm, 32mm, 38mm | Name of TypeC is changed toType D.New needlelength sizeswere added forType D. | No new concerns.The addition ofnew lengths donot introducenew risks as thefundamentaltechnology and | ||
| / | Type E: 13mm, 15mm,19mm,25mm, 32mm, 38mm | Type E wasadded. | operation remainthe same. | ||
| Needle beveldesign | Non-coring angled needle | No change | N/A | No new concerns.The addition ofnew lengths andnew type do not | |
| Color | Needle gauge19G20G22G | ColorCreamYellowBlack | Type B, Type D and Type E: No change; | Color designation system is remained no change.The color for Type E is indicated on the clamp. | introduce new risks as the fundamental technology and operation remain the same.No new concerns. The addition of new lengths and new type do not introduce new color system requirement as met with ISO 6009. |
| Schematic diagram(safety mechanism) | Image: Type B with wing hub, protective shield, and Huber Needle | No change | Name of Type C is changed to Type D.Type E was added.The difference of Type E and Type D is only the shape of hub which Type E is without wing. | No new concerns. The addition of new type do not introduce new risks as the fundamental technology and operation remain the same. | |
| Image: Type C with wing hub, protective shield, and Huber Needle | No change | ||||
| Image: Type E with Needle hub, protective shield, and Huber needle | / | ||||
| Material | Type B, Type C | Type B, Type D: No change Type E added. | Name of Type C is changed to Type D.Type E is without wing and other component material is same with type D. | No new concerns. Type E is without wing and other material is same with type D and does not affect safety. | |
| Performance requirements | Remain no change | No change | N/A | No new concerns. Performance requirements remained unchanged, ensuring consistent functionality. | |
| Labeling | Remain no change | Type B, Type D and Type E | Name of Type C is changed to Type D. Type E was added. | No new concerns. Labeling updates meet current standards and enhance the device's safety and usability. |
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Image /page/6/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. There is a green and blue atom-like graphic above the "o" in "Promise". There is a registered trademark symbol to the right of the word "Promisemed".
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
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Image /page/7/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. The "Pro" part of the word is green, while the rest of the word is blue. There is a green and blue graphic above the word, and a registered trademark symbol to the right of the word.
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green, while the word "med" is in blue. There is a green and blue atom-like structure above the "P" in "Promise". There is a registered trademark symbol to the right of the word "Promisemed".
No. 1388 Canaxing Street. Canagian Community. Yuhang District.
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:
- � Name and labeling: Visual inspections were conducted on unit packaging to ensure metric size labeling compliance with ISO 7864.
- ◆ Needle length (type D): The needle's dimensions, including outer diameter and length, were measured, and found to comply with drawing requirements.
- � Performance test (type E): Full performance was tested, including appearance, dimension, safety mechanism, etc. and found to comply with ISO 7864, ISO 9626, ASTM F3212-16 and ISO 23908.
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.
§ 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).