(136 days)
Not Found
No
The device description and performance studies indicate a manually operated syringe with no mention of AI/ML capabilities or data-driven performance metrics.
No
This device is a syringe, which is used for injecting or withdrawing fluids (like medication) but does not have a direct therapeutic effect on the body itself.
No
The device is described as a "sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas ... to/from a medical device or the body." This functionality is for therapeutic or procedural purposes (injecting or withdrawing fluids), not for identifying a disease or condition. The "Intended Use" also states it is "to inject fluids into or withdraw fluids from the body," which is a treatment or procedural action.
No
The device description clearly states it is a sterile device made of stainless steel, plastic, and silicone materials, and is manually operated, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a syringe with a needle, designed for injecting or withdrawing fluids/gas. This is a physical tool for manipulating substances within or from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living organism) to provide information about a physiological state, health, disease, or congenital abnormality. The provided description does not mention any such use or interaction with patient specimens outside the body.
- Performance Studies: The performance studies focus on the physical and biological properties of the syringe and needle (sterility, biocompatibility, mechanical strength, etc.), not on the analytical performance of testing patient specimens.
Therefore, this device falls under the category of a medical device used for direct patient care, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
A sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both). It is made of stainless steel needle, plastic and silicone materials, and is manually operated. It is intended for various medical applications and is not dedicated to medication administration.
It is intended be used by health-care personnel (doctors, nurses, etc.). The needle is lubricated with silicone. Product is sterile and sterilization process is validated according to ISO 11135:2014.
| Capacity | Gauge | Length |
|---|---|---|
| 0.5ml | 28G | |
| 27G | ||
| 26G | ||
| 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | |
| 23G | ||
| 22G | ||
| 21G | ||
| 1.0 ml | 28G | |
| 27G | ||
| 26G | ||
| 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | |
| 23G | ||
| 22G | ||
| 21G |
This is a single-use device without any accessory.
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
health-care personnel (doctors, nurses, etc.).
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)
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ISO 7886-1:2017, Sterile hypodermic syringes for single use. Part 1: Syringes for manual use
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
- ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
- USP Bacterial Endotoxin Test
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(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.
September 9, 2021
Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China
Re: K211242
Trade/Device Name: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 9, 2021 Received: August 9, 2021
Dear Wei Hsu:
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 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).
Sincerely,
For CAPT Alan Stevens 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) K211242
Device Name
Promisemed Sterile Hypodermic Syringes Verifine Sterile Hypodermic Syringes
Indications for Use (Describe)
It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K211242 510(k) Summary
1 Date Prepared
Sep 9th, 2021
Submitter's Information 2
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
Trade Name, Common Name, Classification ന
Trade/Product Name: Promisemed Sterile Hypodermic Syringes
Verifine Sterile Hypodermic Syringes
Common Name: Sterile Hypodermic Syringes
Classification name: Syringe, Piston
Regulation Number: 21 CFR 880.5860
Device Class: Class II
Product Code: FMF
- ldentification of Predicate Device ব K153537: Sol-M TB Syringe
4
Description of the Device ഗ
A sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both). It is made of stainless steel needle, plastic and silicone materials, and is manually operated. It is intended for various medical applications and is not dedicated to medication administration.
It is intended be used by health-care personnel (doctors, nurses, etc.). The needle is lubricated with silicone. Product is sterile and sterilization process is validated according to ISO 11135:2014.
| Capacity | Gauge | Length |
|---|---|---|
| 0.5ml | 28G | |
| 27G | ||
| 26G | ||
| 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | |
| 23G | ||
| 22G | ||
| 21G | ||
| 1.0 ml | 28G | |
| 27G | ||
| 26G | ||
| 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | |
| 23G | ||
| 22G | ||
| 21G |
This is a single-use device without any accessory.
Indications for use statement 6
lt is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
- 7 Similarities and Differences of the Proposed Devices to the Predicate Devices
5
The Sterile Hypodermic Syringes is substantially equivalent to the predicate device, the Sol-M TB Syringe (K153537) in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not affect the basic design principle and usage.
| | Subject Device | Predicate Device
(K153537) | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed Sterile
Hypodermic Syringes
Verifine Sterile
Hypodermic Syringes | Sol-M TB Syringe | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Sol-Millennium Medical,
Inc. | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF | FMF | Same |
| Regulation number | 880.5860 | 880.5860 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/
Indications for Use | It is intended to be used
for medical purposes to
inject fluids into or
withdraw fluids from the
body. | It is intended to be used
for medical purposes to
inject fluids into or
withdraw fluids from the
body. | Same |
| Operating
Principle | Plunger is used to fill
syringe as well as
discharge the fluid. | Plunger is used to fill
syringe as well as
discharge the fluid. | Same |
| Volume | 0.5ml,1.0ml | 0.5ml,1.0ml | Same |
| Tip type | Fixed Needle | Fixed Needle | Same |
| Gauge | 28G, 27G, 26G, 25G,
24G, 23G, 22G, 21G | 23G, 26G, 27G | Different
Subject device
has wider gauge
size than
predicate device.
Differences are
addressed through
testing per ISO
9626:2016 and ISO
7864:2016. |
| Needle Length | 10mm, 12mm, 16mm,
20mm, 25mm, 32mm,
38mm, 50mm | 1/2" (12.5mm), 3/8"
(9.6 mm) | Different
Subject device
has wider needle
length than
predicate device.
Differences are
addressed through |
| | | | testing per ISO
9626:2016 and ISO
7864:2016. |
| Gradations
legibility | Bold markings | Bold markings | Same |
| Lubricant | Silicone | Silicone | Same |
| Barrel
transparency | Transparent | Transparent | Same |
| Reuse durability | Single Use | Single Use | Same |
| Biocompatibility | Complied with ISO10993
series standards, and the
following tests are
performed
- Cytotoxicity: No
cytotoxicity - Skin Irritation: No
evidence of skin irritation - Skin Sensitization: No
evidence of sensitization - Acute Systemic Toxicity:
No systemic toxicity - Hemolysis: No evidence
of hemolysis - Pyrogen: Non pyrogenic
- USP Particulate
matter | Per ISO 10993-1 | Same |
| Materials | Needle: Stainless Steel
(X5CrNi18-10)
Barrel: Polypropylene
Plunger: Polypropylene/
Acrylonitrile Butadiene
Styrene
Needle cap:
Polyethylene/
Polypropylene
Piston: Polyisoprene
rubber | Needle: Stainless Steel
Barrel: Polypropylene
Plunger: Polypropylene
Needle cap:
Polypropylene
Gasket: Santoprene | The needle of
both devices is
made of stainless
steel.
The syringe bodies
of subject device
and predicate
device have
material
differences.
Differences are
addressed through
biocompatibility
testing per ISO
- |
| Performance | Complied with
ISO 7886-1, ISO 9626, ISO
7864 | Complied with
ISO 7886-1, ISO 9626, ISO
7864 | Same |
| Sterilization
method | EO Sterilization | EO Sterilization | Same |
A detailed comparison to the predicate is provided in Table 1.
6
7
Discussions of differences in technological characteristics
· The subject device has wider gauge size and needle length than predicate device. Differences are addressed through testing per ISO 9626:2016 and ISO 7864:2016. The difference in gauge size and needle length does not affect the effectiveness and safety of the device.
· The syringe bodies of subject device and predicate device have material differences. The biocompatibility tests conducted demonstrate the safety of subject device. Difference do not affect the effectiveness and safety of the device.
8 Performance Testing Summary
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- · ISO 7886-1:2017, Sterile hypodermic syringes for single use. Part 1: Syringes for manual use
- · ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
- · ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
- USP Bacterial Endotoxin Test
Sterility, Shipping and Shelf-Life
The sterilization of the product is achieved using ethylene oxide sterilization. Sterilization condition is validated per ISO 11135: 2014 overkill half-cycle approach. The sterility assurance level (SAL) is 10-6. The amount of ethylene oxide and chlorohydrin residual levels are within the limit and in compliance with ISO 10993-7: 2008 requirement.
The device is non-pyrogenic. Endotoxin is tested per USP and is conducted on every batch. Endotoxin limit for the subject device is less than 20 EU/Device.
8
- . Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the subject device: . Seal strength ASTM F88/F88-15 Dye penetration ASTM F1929-15
- . Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- · Biocompatibility
In accordance with ISO 10993-1 the device is classified as External communicating device, Blood path, indirect, with limited contact duration (≤ 24h). The biosafety tests that required consideration were validated:
- a. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- b. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- c. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- d. USP42-NF37 Pyrogen Test
- e. USP Particulate matter in injections
- f. ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- g. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
9
Conclusion 9
Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.