(60 days)
Not Found
No
The device description and intended use are for a mechanical blood collection set with a safety mechanism. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and sterilization properties.
No.
The device is used for blood collection and short-term infusion of intravenous fluids, which are diagnostic and procedural uses rather than therapeutic.
No
The device is a safety winged blood collection set used for blood collection and/or short-term intravenous fluid infusion. It is not described as being used to diagnose conditions or processes.
No
The device description clearly outlines a physical medical device (needle, tubing, luer adapter, tube holder, safety mechanism) used for blood collection and fluid infusion. It does not describe software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood collection and/or the short-term infusion of intravenous fluids." This describes a device used to obtain a biological sample (blood) or deliver a substance into the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body to analyze the sample.
- Device Description: The description focuses on the physical components of the device (needle, tubing, safety mechanism) and its function in the process of blood collection or fluid infusion. It doesn't mention any analytical or diagnostic function performed on the collected blood.
- Lack of Diagnostic Information: The text does not mention any analysis of the blood sample, detection of biomarkers, or any other diagnostic purpose.
- Performance Studies: The performance studies described relate to the physical safety and sterility of the device, not its ability to diagnose anything.
This device is a tool used in the process of obtaining a sample for potential subsequent in vitro diagnostic testing, but it is not an IVD itself.
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 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.
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)
Non-Clinical Summary:
The needle, tubing, hub, and luer connectors meet the following physical, chemical, biological requirements:
Sharps injury protection: Device meets safety mechanism activation requirements as per ISO 23908, internal protocol and test results
Sharps injury protection: Device meets safety overriding/unlocking force after activation requirements as per ISO 23908, internal protocol and test results
Sterilization: A Sterility Assurance Level (SAL) of 10-6 has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.
Clinical Summary: Not applicable. Substantial equivalence does not depend on clinical test data.
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 25, 2021
Promisemed Hangzhou Meditech Co., Ltd. % John Beasley Official Correspondent MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 89015
Re: K211293
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: April 16, 2021 Received: April 26, 2021
Dear John Beasley:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Payal Patel Acting 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
2
Indications for Use
510(k) Number (if known)
K211293
Device Name
Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - HOLDER, SBC-xxxxH, Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - ADAPTER, SBC-xxxx A: Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - W/O Puncture, SBC-
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 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.
| 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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3
Image /page/3/Picture/1 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 molecule graphic above the word "Promise" and a registered trademark symbol to the right of the word "med". There is a black line underneath the logo.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, China.
510(k) Summary
Updated: 06/18/2021
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | Promisemed Hangzhou Meditech Co., Ltd. | |
| Applicant Address | No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City, | |
| Zhejiang, 311121, CH | ||
| Applicant Telephone Number | 865-718-8772985 | |
| Applicant Contact | Mr. Zearou Yang | |
| Applicant Contact Email | zearou.yang@promisemed.ca | |
| Correspondent Name | MedTech Review, LLC | |
| Correspondent Address | 257 Garnet Garden Street, Henderson, NV, 89015, US | |
| Correspondent Telephone | ||
| Number | 1-612-889-5168 | |
| Correspondent Contact | Mr. John Beasley, RAC (US) | |
| Correspondent Contact Email | john@medtechreview.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Safety Winged Blood Collection Sets | |
| Common Name | Safety Blood Collection Device for Single Use | |
| Classification Name | NEEDLE, HYPODERMIC, SINGLE LUMEN | |
| Regulation Number | 880.5570 | |
| Product Code | FMI/FPA | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate [510(k)] # | Predicate Trade Name | Product Code |
| K170276 | Gemtier Medical (Shanghai) Inc. Safety Blood Collection Device | |
| for Single Use | FMI/FPA | |
| Device Description Summary | 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. | ||
| Intended Use/Indications 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. |
4
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. Above the word "Promise" is a green and blue atom-like structure. To the right of the word "Promisemed" is a circled R symbol.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Other than the difference in the name of the device and the fact that they are all connected to flexible tubing (these are sets), there are no differences in the indications for use of the subject device when compared to the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Compared with the predicate device, the subject device is identical in mechanism of action, materials, needle point, sterilization method, and biocompatibility. The subject device has the same performance specifications except for needle length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent.
| Specification | Predicate Device | Subject Device | Discussion of
Differences |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Safety Blood Collection
Device for Single Use | Safety Winged Blood
Collection Sets | The subject device brings
attention to the "wings" in
the device name, as well
as properly defines the
device as a "set".
The differences do not
introduce any new
concerns for safety or
efficacy. |
| K number | K170276 | K211293 | - |
| Product code and
classification name | FMI, Needle,
Hypodermic, Single
Lumen | FMI, Needle
Hypodermic, Single
Lumen | No difference |
| Indications for use | The SAFETY BLOOD
COLLECTION DEVICE
FOR SINGLE USE is a
single-use, sterile,
winged venipuncture
needle bonded to a
flexible tubing with or
without a luer adapter
and/or tube holder.
The SAFETY BLOOD
COLLECTION DEVICE
FOR SINGLE USE is
used for blood
collection and/or the
short-term infusion of
intravenous fluids (up
to 2 hours under direct
clinical supervision).
The venipuncture
needle is designed to | 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 | Difference in the name of
the device and the fact
that they are all
connected to flexible
tubing (these are sets).
The differences do not
introduce any new
concerns for safety or
efficacy. |
| Specification | Predicate Device | Subject Device | Discussion of
Differences |
| | be covered with a
safety mechanism,
which can be activated
to cover needle
immediately following
venipuncture to aid in
the protection against
accidental needlestick
injury. | the needle immediately
following venipuncture
to aid in the protection
against accidental
needlestick injury. | |
| Indicated for infusion | Yes | Yes | No difference |
| Single use | Yes | Yes | No difference |
| Mechanism of safety
blood collection | Latch mechanism:
press both sides of the
safety mechanism to
release the lock first
and then slide the
safety mechanism to
activate. | Latch mechanism:
Place the index finger
on the curved design to
press gently, hold the
two wings by the thumb
finger and middle finger
and withdraw the wings
back to activate the
safety mechanism until
hearing sound of
CLICK. The click is a
sign that the Safety
mechanism has been
correctly activated | The subject device
requires use of one finger
to press the release and
incorporates the wings for
activating the safety
mechanism.
The differences do not
introduce any new
concerns for safety or
efficacy. |
| Materials: | | | |
| Venipuncture Needle | Stainless Steel | Stainless Steel | No difference |
| Tubing | PVC | PVC | No difference |
| Wing | PVC | PVC | No difference |
| Sleeve | PE | ABS | No difference |
| Retractable Cartridge | PE | PE | No difference |
| Luer adapter | PP | PVC | No difference |
| Tube Holder | PP | ABS | No difference |
| Blood collection needle
protector | PP | PE | No difference |
| Rubber cover | Synthetic Rubber | Nitrile Rubber | Predicate device
unspecified.
The use of nitrile rubber
does not introduce any
new concerns for safety
or efficacy. |
| Specification | Predicate Device | Subject Device | Discussion of
Differences |
| Components: | | | |
| Tubing, Wing, Luer
connectors | Yes | Yes | No difference |
| Plastic sleeve,
venipuncture needle
stand | Yes | Yes | No difference |
| Luer adapter, tube
holder, blood collection
needle, protection
mechanism | Yes | Yes | No difference |
| Performance: | | | |
| Needle Gauge Sizes | 21G, 23G, 25G | 21G, 23G, 25G | No difference |
| Tubing Length | 10 cm to 35 cm | 10 cm, 19cm, 30 cm | No difference |
| Needle Length | 20mm | 19mm | The needle length of the
subject device is shorter
in length (19mm) as
compared to the
predicate device (20mm).
The short needle length
allows the phlebotomist to
insert it at a shallow angle
that can increase the
ease of use and
therefore, does not
introduce any new
concerns for safety or
efficacy. |
| Needle Point | 3-bevel | 3-bevel | No difference |
| Sterile | Ethylene Oxide | Ethylene Oxide | No difference |
| Non-pyrogen | Yes | Yes | No difference |
| Shelf life | 3 years | 3 years | No difference |
| Biocompatibility | Cytotoxicity, Skin
Sensitization, Irritation,
Acute Systemic
Toxicity, Hemolysis,
Pyrogenicity, Bacterial
Endotoxins testing
have passing results | Cytotoxicity, Skin
Sensitization, Irritation,
Acute Systemic
Toxicity, Hemolysis,
Pyrogenicity, Bacterial
Endotoxins testing
have passing results | No difference |
| Physical
performance | Needle appearance and cleanliness | ISO 7864:2016, clause 4.3 | |
| | Needle Size color code | ISO 6009:2016 | |
| | Needle Particulate contamination | USP, METHOD 1, Test 1.B | |
| | Bonding
strength: | Needle and hub | ISO 7864:2016, clause 4.12 |
| | | Tubing and hub | ISO 8536-4:2019, clause 7.3 |
| | | Tubing and double wings
luer adapter | ISO 8536-4:2019, clause 7.3 |
| | Infusion set leakage | ISO 8536-4:2019, clause 7.2 | |
| | Needle patency of lumen | ISO 7864 :2016, clause 4.13, a) | |
| | Dimension | Blood collection needle | ISO 9626 :20 16, clause 5.6, table 1, (TW) |
| | | Puncturing needle | ISO 9626 :2016, clause 4.10.2, table1 |
| | Needle point | ISO 7864:2016, clause 4.11 | |
| | Needle
Lubrication | Appearance | ISO 7864:2016, clause 4.10.4, |
| | | Quantity | ISO 7886-1:2017, Annex F |
| | Luer Connector | | ISO 80369-7:2016
ISO 80369-20:2015 |
| | Tubing kink stability | ISO 20696:2018, clause 6.7 | |
| | Puncture force of needle | ISO 7864:2016, clause 4.11 | |
| | Safety protection mechanism | ISO 23908:2011 | |
| | Stiffness of needle | ISO 9626 :2016, clause 5.8, table 2 (TW) | |
| | Toughness of needle | ISO 9626:2016, clause 5.9 | |
| | Resistance to corrosion of needle | ISO 9626 :2016, clause 5.10 | |
| Chemical
performance | Reducing matter | ISO 8536-4:2019, clause 8.1 | |
| | Metal ions | ISO 8536-4:2019, clause 8.2 | |
| | Limits for acidity or alkalinity | ISO 8536-4:2019, clause 8.3 | |
| | Residue on evaporation | ISO 8536-4:2019, clause 8.4 | |
| | Ethylene oxide residue (EO&ECH) | ISO 10993-7:2008, clause 4.3.4 | |
| Biological
performance | Bacterial endotoxin | USP | |
| | Sterility | USP | |
| | Pyrogen Test (Rabbit) | USP | |
| | Hemolytic Properties | ASTM F756-17 | |
| | Hematology | ISO 10993-4:2017 | |
| | Platelet Count | | |
| | Partial Thromboplastin Time | | |
| | Cytotoxicity | ISO 10993-5:2009 | |
| | Skin Sensitization | ISO 10993-10:2010 | |
| | Intracutaneous Reactivity | | |
| | Acute Systemic Toxicity | ISO 10993-11:2017 | |
5
Image /page/5/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a stylized font, with the "Pro" in green and the rest of the word in blue. Above the "m" is a graphic of two circles connected by a line, with a green circle at the top. To the right of the word is the registered trademark symbol.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, China.
6
Image /page/6/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. There is a green and blue graphic above the word, and a registered trademark symbol to the right of the word.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, 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. Above the word is a blue molecular structure with a green circle at the top right. There is a registered trademark symbol to the right of the word.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-Clinical Summary:
The needle, tubing, hub, and luer connectors meet the following physical, chemical, biological requirements:
8
Image /page/8/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 word is blue. There is a blue atom-like structure above the word, with a green circle at the top.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Sharps injury protection: Device meets safety mechanism activation requirements as per ISO 23908, internal protocol and test results
Sharps injury protection: Device meets safety overriding/unlocking force after activation requirements as per ISO 23908, internal protocol and test results
Sterilization: A Sterility Assurance Level (SAL) of 10-6 has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.
Clinical Summary: Not applicable. Substantial equivalence does not depend on clinical test data.
Conclusion:
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to the legally marketed predicate device (K170276).