(147 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, sterility, and safety mechanisms, with no mention of AI or ML.
No
The device is described as injecting or withdrawing fluids, which are typically diagnostic or procedural functions, not therapeutic. The predicate device is a hypodermic syringe, which is also generally considered a diagnostic or procedural tool.
No
This device is described as a "Verifine Safety Syringe with Fixed Needle" intended to "inject fluids into or withdraw fluids from the body for medical purposes." It is an instrument for delivering or withdrawing substances, not for identifying a medical condition or disease.
No
The device description clearly outlines a physical syringe with a needle, barrel, plunger, and safety mechanism made of plastic and silicone materials. The performance studies also focus on physical and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluids into or withdraw fluids from the body for medical purposes." This describes a device used on the body for therapeutic or diagnostic procedures, not a device used in vitro (outside the body) to examine specimens.
- Device Description: The description details a syringe with a needle, designed for injecting and withdrawing fluids directly from a patient. This aligns with the intended use and is characteristic of a medical device used for direct patient care.
- Lack of IVD Indicators: There is no mention of analyzing specimens, performing tests on samples, or any other activities typically associated with in vitro diagnostics.
Therefore, the Verifine Safety Syringe with Fixed Needle is 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 inject fluids into or withdraw fluids from the body for medical purposes.
Product codes (comma separated list FDA assigned to the subject device)
FMF, MEG
Device Description
Verifine Safety Syringe with Fixed Needle is a sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end. It is made of plastic and silicone materials. It includes an attached needle with a safety mechanism. The protective shield covers the needle. After injection, the shield is permanently locked in place by pushing axially until a click is heard, reducing risk of needle sticks and rendering the device unusable. It can be used by health care personnel. This is a single-use device.
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
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
- 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
- USP Bacterial Endotoxin Test
Biocompatibility
In accordance with ISO 10993-1 the device is classified as Externalcommunicating device, Blood path, indirect, with limited contactduration (≤ 24h). The biosafety tests that required consideration were validated:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- USP42-NF37 Pyrogen Test
- USP Particulate matter in injections
Sterility, Shipping, and Shelf-Life
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, 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 proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33 C71
- 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
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 5, 2022
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: K213560
Trade/Device Name: Verifine Safety Syringe with Fixed Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: March 17, 2022 Received: March 17, 2022
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 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
1
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,
CAPT Alan M. 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) K213560
Device Name Verifine Safety Syringe with Fixed Needle
Indications for Use (Describe)
It is intended to inject fluids into or withdraw fluids from the body for medical purposes.
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) |
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
1 Date Prepared
April 3rd, 2022
2 Submitter's Information
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:
3 Trade Name, Common Name, Classification
Trade/Product Name: Verifine Safety Syringe with Fixed Needle Common Name: Piston Syringe Classification name: Piston Syringe Regulation Number: 21 CFR 880.5860 Device Class: Class II Product Code: FMF, MEG
- 4 ldentification of Predicate Device K211242; Sterile Hypodermic Syringes
4
5 Description of the Device
Verifine Safety Syringe with Fixed Needle is a sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end.
It is made of plastic and silicone materials.
It includes an attached needle with a safety mechanism. The protective shield covers the needle. After injection, the shield is permanently locked in place by pushing axially until a click is heard, reducing risk of needle sticks and rendering the device unusable.
It can be used by health care personnel.
This is a single-use device.
| Capacity | Gauge | Needle Length | Packaging Configuration |
|---|---|---|---|
| 0.5 ml | 28G | 12mm, 16mm, 25mm, 32mm, 38mm | Polypropylene/ |
| Polyethylene | |||
| composite | |||
| membrane (XPP-B) | |||
| and Dialyzer paper | |||
| 27G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 26G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 25G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 24G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 23G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 22G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 21G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 1.0 ml | 28G | 12mm, 16mm, 25mm, 32mm, 38mm | Polypropylene/ |
| Polyethylene | |||
| composite | |||
| membrane (XPP-B) | |||
| and Dialyzer paper | |||
| 27G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 26G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 25G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 24G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 23G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 22G | 12mm, 16mm, 25mm, 32mm, 38mm | ||
| 21G | 12mm, 16mm, 25mm, 32mm, 38mm |
6 Indication
lt is intended to inject fluids into or withdraw fluids from the body for medical purposes.
5
- 7 Similarities and Differences of the Proposed Devices to the Predicate Devices
The Verifine Safety Syringe with fixed Needle is substantially equivalent to the predicate device, the Sterile Hypodermic Syringes (K211242) 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 intended use or raise new questions of safety and effectiveness.
| Subject Device | Predicate Device (K211242) | ||
|---|---|---|---|
| Trade Name | Verifine Safety Syringe with Fixed Needle | Sterile Hypodermic Syringes | |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd | Promisemed Hangzhou Meditech Co., Ltd | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF, MEG | FMF | Similar |
| Regulation number | 880.5860 | 880.5860 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/ Indications for Use | It is intended to inject fluids into or withdraw fluids from the body for medical purposes. | 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. The protective shield will permanently be locked in place by pulling forward till click, providing protection against needle sticks. | Plunger is used to fill syringe as well as discharge the fluid. | Different |
| The subject device has additional safety shield to prevent sharp injury. | |||
| 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 | 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G | Same |
| Needle Length | 12mm, 16mm, 25 mm, 32mm, 38mm | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | Different |
| The needle length range of subject device is within that of predicate device. | |||
| Gradations | Legible | Legible | Same |
| legibility | |||
| Lubricant | Silicone oil | Silicone oil | 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 | 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 | Same |
| Configuration
and
Materials | Needle: Stainless Steel
(X5CrNi18-10)
Barrel/push-button:
Polypropylene
Plunger: Polypropylene
Needle cap: Polyethylene
Piston: Polyisoprene
rubber
Sliding Sleeve, Cover:
Polypropylene
Plunger stopper, Tight
ring: Acrylonitrile
Butadiene Styrene | Needle: Stainless Steel
(X5CrNi18-10)
Barrel/push-button:
Polypropylene
Plunger: Polypropylene/
Acrylonitrile Butadiene
Styrene
Needle cap:
Polyethylene/
Polypropylene
Piston: Polyisoprene
rubber | 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
biocompatility testing per
ISO 10993. |
| Performance | Complied with ISO 7886-1,
ISO 9626, ISO 7864, ISO
23908 | Complied with ISO 7886-
1, ISO 9626, ISO 7864 | Different
The subject device has
additional safety shield to
prevent sharp injury. The
difference is addressed
through testing per
ISO23908. |
| Sterilization
method and SAL | EO Sterilization
$SAL = 10^{-6}$ | EO Sterilization
$SAL = 10^{-6}$ | Same |
A detailed comparison to the predicate is provided in Table 1.
6
Discussions of differences in technological characteristics
-The needle length of subject device is within the range of predicate device. The difference needle length does not affect the effectiveness and safety of the device.
7
-
The syringe bodies of subject device and predicate device have material differences. This difference does not affect the effectiveness and safety of the device. The biocompatibility tests conducted demonstrate the safety of subject device.
-
The operating procedure is the same as predicate device. The subject device has additional safety shield to protect against sharps injury. The sharps protection feature is addressed through testing per ISO23908. This difference does not impact the safety and effectiveness 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
- •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
- •USP Bacterial Endotoxin Test
Biocompatibility
In accordance with ISO 10993-1 the device is classified as Externalcommunicating device, Blood path, indirect, with limited contactduration (≤ 24h). The biosafety tests that required consideration were validated:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
8
- ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- USP42-NF37 Pyrogen Test
- · USP Particulate matter in injections
Sterility, Shipping, and Shelf-Life
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, 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 proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33 C71
- 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
の Conclusion
Based on the information provided within this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.