(30 days)
No
The description focuses on a mechanical safety mechanism for a blood collection needle and does not mention any computational or data-driven features.
No.
The device is used for blood collection and short-term infusion, which are diagnostic and procedural functions, not primarily therapeutic in nature.
No
The device is described as a blood collection set and for short-term infusion of intravenous fluids. Its primary function is to collect blood or infuse fluids, not to analyze or interpret data to diagnose a condition.
No
The device description clearly states it is a physical blood collection set with a needle and safety mechanism, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary uses described are "blood collection" and "short-term infusion of intravenous fluids." These are procedures performed on the patient, not on a sample of the patient's body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description focuses on the physical components and function of the needle and safety mechanism for venipuncture and infusion.
- Lack of IVD-specific language: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing a sample.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples to provide information for diagnosis, monitoring, or screening. This device is used for collecting the sample or administering fluids in vivo (within the body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMI, FPA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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"
1
(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).
2
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
3
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 of
description | Cleared device
(K211293) | Modified device | Comments on
Similarities/
Differences | Safety/Effectiveness
Statement |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
name | Safety Blood Collection
Device for Single Use | No change | N/A | No new concerns.
Common name is
same. |
| 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 | FMI, FPA | No change | N/A | No new concerns. The
product code remains
the same, reflecting
no change in device
functionality. |
| General
description | 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. | No change | N/A | No new concerns.
The change to add a
new model (RBC) does
not introduce new
risks as the
fundamental
technology and
operation remain the
same. |
| Principle of
operation | When the Safety winged
blood collection set is used
for venous blood collection.
The principle is that the
device is connected with the
vacuum blood collection tube
(met with EN 14820), the
negative pressure generated
by the vacuum blood
collection tube draws human
blood out, and the blood
enters the vacuum blood
collection tube, and the
needle is pulled out to
complete the blood
collection. | No change | N/A | No new concerns.
The principles of
operation remain
unchanged, ensuring
consistent
performance. |
| | | | | |
| Indication of
use | When the Safety winged
blood collection set is used
for short-term infusion. The
principle is that the device is
connected with IV set through
by Luer connector, and
medicinal solution enters the
human body through the
infusion set (met with ISO
8536-4) under the action of
gravity or thrust, and the
needle is pulled out to
complete the injection.
The safety winged blood
collection set is single-use,
sterile, winged venipuncture
needle bonded to a flexible
tubing with or without a luer
adaper 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. | No change | N/A. | No new concerns.
The change to add a
new model (RBC) does
not introduce new
indications as the
fundamental
technology and
operation remain the
same. |
| Model | SBC | RBC is added. | Model RBC is
added. | No new concerns.
The change to add a new
model (RBC) does not
introduce new
indications as the
fundamental technology
and operation remain
the same. |
| Type | SBC: Type H, A, S
Remain no change | RBC: Type H, A, S | Model RBC is
added. | No new concerns.
The addition of a new
model (RBC) does not
affected the safety and
effectiveness which type
is remain same. |
| Needle size | 21G, 23G, 25G | RBC: 21G, 22G, 23G,
24G, 25G | 22G, 24G is
added. | No new concerns.
The broader needle
gauge expands options
without altering the
device's safety or
effectiveness. |
| Needle
length | 10cm, 19cm, 30cm | No change | N/A | No new concerns.
The addition of a new
model (RBC) does not
affected the safety and
effectiveness which
needle length is remain
same. |
| Color | SBC: Remain no change | RBC:
Gauge Color | Color of 22G,
24G is added. | No new concerns.
The broader needle
gauge expands options
without altering the
device's safety or
effectiveness. The color
system is in accordance
with ISO 6009
requirement. |
| Tubing
length | Remain no change | No change. | N/A | No new concerns.
The addition of a new
model (RBC) does not
affected the safety and
effectiveness which type
is remain same. |
| Schematic
diagram | SBC: Remain no change | RBC is same with SBC
exempt the safety
protective mechanism. | The
configuration is
similar that
operation
method is
same. | No new concerns.
The addition of a new
model (RBC) does not
introduce new risks as
the fundamental
technology and
operation remain the
same. |
| Material | Remain no change.
Safety
protective
mechanism is ABS. | RBC: Safety protective
mechanism is PP.
Others component are
same with SBC exempt
the safety protective
mechanism. | Safety
protective
mechanism
material is
difference
which it is only
contact intact
skin as limited
exposure (A). | No new concerns.
Material of RBC is PP
which it is only contact
intact skin as limited
exposure (A), does not
introduce new risks
about biocompatibility
safety. |
| Sterility | SAL of 10-6
Remain no change | No change. | N/A | No new concerns.
The addition of a new
model (RBC) does not
introduce new risks as
the fundamental
technology and
operation remain the
same. |
| Shelf life | 3 years
Remain no change | No change. | N/A | No new concerns.
The addition of a new
model (RBC) does not
introduce new risks as
the shelf life remain the
same. |
| | | 21G Deep
green
22G Black
23G Deep
blue
24G Medium
purple
25G 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.
7
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.
8
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.