(30 days)
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
This document is a 510(k) summary for a medical device called "Safety Winged Blood Collection Sets" (K243806) from Promisemed Hangzhou Meditech Co., Ltd. It declares substantial equivalence to a predicate device (K211293).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/ML performance. This is because the device is a physical medical device (blood collection set), not an AI/ML diagnostic system. The "acceptance criteria" here are implied by adherence to recognized international standards and successful completion of non-clinical tests.
However, based on the provided text, we can infer some "acceptance criteria" and "performance" statements related to the modifications made (specifically the addition of model RBC and changes in needle sizes/materials).
| Acceptance Criteria (Implied by Standards & Testing) | Reported Device Performance (as stated in the document) |
|---|---|
| Compliance with ISO 6009:2016 for needle color coding. | "Color system is in accordance with ISO 6009 requirement." |
| Compliance with ISO 8536-4:2019 for infusion sets (gravity feed). | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. |
| Compliance with ISO 9626:2016 for stainless steel needle tubing. | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. |
| Compliance with ISO 23908:2011 for sharps injury protection. | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. The device's "safety mechanism" is a key feature and its function is maintained. |
| Model RBC visual inspections for correct labeling. | "Visual inspections were conducted on unit packaging to ensure RBC labeling is correct." |
| Full performance testing (appearance, dimension, safety mechanism, labeling) for new needle sizes, colors, and schematic diagrams. | "Full performance was tested, including appearance, dimension, safety mechanism, labeling, etc. and found to comply with drawing requirements." |
| Biocompatibility of new material (PP for safety protective mechanism in RBC model). | "Material of RBC is PP which it is only contact intact skin as limited exposure (A), does not introduce new risks about biocompatibility safety." It also references K230715's biocompatibility testing per ISO 10993-1 (External communicating device, in contact with circulating blood with prolonged exposure B) to support this change, including In vitro cytotoxicity testing in accordance with ISO 10993-5:2009. |
| Overall device safety and effectiveness equal to predicate. | "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: The document does not specify a numerical sample size for any of the non-clinical tests conducted. Statements like "Visual inspections were conducted on unit packaging" and "Full performance was tested" indicate tests were performed but don't provide the number of units tested.
- Data provenance: The data provenance is from the manufacturer's internal non-clinical testing. It is implicitly "prospective" in the sense that the tests were conducted specifically to demonstrate the performance of the modified device for this 510(k) submission. No specific country of origin for the data is mentioned other than the manufacturer's location in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is a 510(k) for a physical medical device (blood collection set), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling in that sense. The "ground truth" for these types of devices is established by adherence to engineering specifications and international performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as above. No "adjudication" or consensus reading by experts is required for the non-clinical performance and design verification tests reported.
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
This is not applicable as the device is not an AI/ML system, nor does it involve human readers or cases in an interpretive diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is adherence to established technical specifications, engineering drawings, and relevant international performance standards (ISO 6009, ISO 8536-4, ISO 9626, ISO 23908). Biocompatibility is "ground-truthed" by ISO 10993 series testing (e.g., in vitro cytotoxicity).
8. The sample size for the training set
This is not applicable as there is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.
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Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, 311121 China
Re: K243806
Trade/Device Name: Safety Winged Blood Collection Sets Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FPA Dated: December 6, 2024 Received: December 11, 2024
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"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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-devices/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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
David Walloschek
David Wolloscheck, Ph.D. 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) K243806
Device Name Safety Winged Blood Collection Sets
Indications for Use (Describe)
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
| 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 logo is blue and green, with the word "Promisemed" in a stylized font. The "P" is green, and the rest of the word is blue. There is a green molecule graphic above the "P". There is a registered trademark symbol in the upper right corner of the logo.
K243806-510(k) Summary
Date prepared: 2025-01-09
| 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 | +86 571 88772985 |
| Fax | +86 571 88772985 |
| zearou.yang@promisemed.ca | |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | Safety Winged Blood Collection Sets |
| Common Name | Safety Blood Collection Device for Single Use |
| Classification Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Regulation Number | 21 CFR 880.5570 |
| Class | Class II |
| Product Code | FMI, FPA |
| 3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)] | |
| Predicate Name | Safety Winged Blood Collection Sets |
| 510(k) Number | K211293 |
| Product Code | FMI, FPA |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] |
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
5. Indication for use [21 CFR 807.92 (a) (5)]
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
6. Indications for Use Comparison [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 green and the word "med" is in blue. There is a blue molecular structure above the "o" in "Promise" with a green circle at the top. There is a registered trademark symbol in the upper right corner of the image.
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.
The indication of subject device is same as the predicate device.
7. Comparison of Technological Characteristic [21 CFR 807.92 (q) (6)]
The subject device has the same 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 ofdescription | Cleared device(K211293) | Modified device | Comments onSimilarities/Differences | Safety/EffectivenessStatement |
|---|---|---|---|---|
| Commonname | Safety Blood CollectionDevice for Single Use | No change | N/A | No new concerns.Common name issame. |
| Classificationname | NEEDLE, HYPODERMIC,SINGLE LUMEN (21 CFR880.5570) | No change | N/A | No new concerns. Theclassification nameremains consistent. |
| Device class | Class II | No change | N/A | No new concerns. Thedevice remains inClass II, indicating nochange in risk level. |
| ProductCode | FMI, FPA | No change | N/A | No new concerns. Theproduct code remainsthe same, reflectingno change in devicefunctionality. |
| Generaldescription | The Promisemed Safety BloodCollection sets are single-use,sterile, venipuncture needlesused for blood collection orshort-term infusion ofintravenous fluids (up to 2hours under direct clinicalsupervision). The blood-collection needle is designedto be covered with a safetymechanism, which can beactivated to cover the needleimmediately followingvenipuncture to aid in theprotection against accidentalneedlestick injury. | No change | N/A | No new concerns.The change to add anew model (RBC) doesnot introduce newrisks as thefundamentaltechnology andoperation remain thesame. |
| Principle ofoperation | When the Safety wingedblood collection set is usedfor venous blood collection.The principle is that thedevice is connected with thevacuum blood collection tube(met with EN 14820), thenegative pressure generatedby the vacuum bloodcollection tube draws humanblood out, and the bloodenters the vacuum bloodcollection tube, and theneedle is pulled out tocomplete the bloodcollection. | No change | N/A | No new concerns.The principles ofoperation remainunchanged, ensuringconsistentperformance. |
| Indication ofuse | When the Safety wingedblood collection set is usedfor short-term infusion. Theprinciple is that the device isconnected with IV set throughby Luer connector, andmedicinal solution enters thehuman body through theinfusion set (met with ISO8536-4) under the action ofgravity or thrust, and theneedle is pulled out tocomplete the injection.The safety winged bloodcollection set is single-use,sterile, winged venipunctureneedle bonded to a flexibletubing with or without a lueradaper and/or tube holder.The device is used for bloodcollection and/or the short-term infusion of intravenousfluids (up to 2 hours underdirect clinical supervision).The blood-collection needle isdesigned to be covered with asafety mechanism, which canbe activated to cover theneedle immediately followingvenipuncture to aid in theprotection against accidentalneedlestick injury. | No change | N/A. | No new concerns.The change to add anew model (RBC) doesnot introduce newindications as thefundamentaltechnology andoperation remain thesame. |
| Model | SBC | RBC is added. | Model RBC isadded. | No new concerns.The change to add a newmodel (RBC) does notintroduce newindications as thefundamental technologyand operation remainthe same. |
| Type | SBC: Type H, A, SRemain no change | RBC: Type H, A, S | Model RBC isadded. | No new concerns.The addition of a newmodel (RBC) does notaffected the safety andeffectiveness which typeis remain same. |
| Needle size | 21G, 23G, 25G | RBC: 21G, 22G, 23G,24G, 25G | 22G, 24G isadded. | No new concerns.The broader needlegauge expands optionswithout altering thedevice's safety oreffectiveness. |
| Needlelength | 10cm, 19cm, 30cm | No change | N/A | No new concerns.The addition of a newmodel (RBC) does notaffected the safety andeffectiveness whichneedle length is remainsame. |
| Color | SBC: Remain no change | RBC:Gauge Color | Color of 22G,24G is added. | No new concerns.The broader needlegauge expands optionswithout altering thedevice's safety oreffectiveness. The colorsystem is in accordancewith ISO 6009requirement. |
| Tubinglength | Remain no change | No change. | N/A | No new concerns.The addition of a newmodel (RBC) does notaffected the safety andeffectiveness which typeis remain same. |
| Schematicdiagram | SBC: Remain no change | RBC is same with SBCexempt the safetyprotective mechanism. | Theconfiguration issimilar thatoperationmethod issame. | No new concerns.The addition of a newmodel (RBC) does notintroduce new risks asthe fundamentaltechnology andoperation remain thesame. |
| Material | Remain no change.Safetyprotectivemechanism is ABS. | RBC: Safety protectivemechanism is PP.Others component aresame with SBC exemptthe safety protectivemechanism. | Safetyprotectivemechanismmaterial isdifferencewhich it is onlycontact intactskin as limitedexposure (A). | No new concerns.Material of RBC is PPwhich it is only contactintact skin as limitedexposure (A), does notintroduce new risksabout biocompatibilitysafety. |
| Sterility | SAL of 10-6Remain no change | No change. | N/A | No new concerns.The addition of a newmodel (RBC) does notintroduce new risks asthe fundamentaltechnology andoperation remain thesame. |
| Shelf life | 3 yearsRemain no change | No change. | N/A | No new concerns.The addition of a newmodel (RBC) does notintroduce new risks asthe shelf life remain thesame. |
| 21G Deepgreen22G Black23G Deepblue24G Mediumpurple25G Orange |
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Image /page/6/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is written in green and the word "med" is written in blue. Above the "P" in "Promise" is a green and blue graphic that looks like a chemical structure. To the right of the word "Promisemed" is a circled R, indicating that the logo is a registered trademark.
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 "P" is green, while the rest of the letters are blue. There is a molecule graphic above the word "Promisemed" and a registered trademark symbol to the right of the word.
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Canggian Community, Yuhang District, Hanazhou City 311121 Theiland P R China
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:
- � Model RBC: Visual inspections were conducted on unit packaging to ensure RBC labeling is correct.
- � Needle size, color and schematic diagram: Full performance was tested, including appearance, dimension, safety mechanism, labeling, etc. and found to comply with drawing requirements.
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Image /page/8/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 molecule graphic above the "o" in "Promise". There is a registered trademark symbol to the right of the word "Promisemed".
Applicable standards:
- ISO 6009:2016, Hypodermic needles for single use Colour coding for identification. -
- ISO 8536-4: 2019, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed.
- -ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
- -ISO 23908:2011, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
- Material: the material of the subject device (RBC) safety protective mechanism has been changed to PP � from polypropylene (ABS), which only contacts the intact skin as limited exposure (A). Material PP has been used in the PROMISEMED's own legally marketed device (K230715) wing hub. K230715's biocompatibility testing (Externally communicating device, in contact with circulating blood with prolonged exposure B) was performed in accordance with ISO 10993-1 to support this change and does not raise new or different questions of safety and effectiveness, e.g. In vitro cytotoxicity testing in accordance with ISO 10993-5:2009.
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).