(182 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven algorithms.
Yes.
The device is intended for the subcutaneous injection of insulin for diabetes treatment, which is a therapeutic intervention.
No
The device is described as an insulin syringe for subcutaneous injection, intended for administering insulin in the treatment of diabetes, not for diagnosing a condition.
No
The device description clearly outlines a physical medical device (syringe, barrel, plunger, needle, safety mechanism) and the performance studies focus on bench testing of physical properties and biocompatibility, 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 for the subcutaneous injection of insulin in the treatment of diabetes. This is a direct administration of a substance into the body for therapeutic purposes.
- Device Description: The device is described as a syringe with a needle and safety mechanism, designed for administering injections.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is clearly intended for the delivery of medication into the body, which falls under the category of a drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
It is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. The safety shield is intended to reduce the risk of sharp injuries.
Product codes
FMF, FMI
Device Description
Verifine Mechanical Safety Insulin Syringe is a sterile device consisting of a calibrated barrel with plunger intended to be used to administer an injection of insulin to a patient subcutaneously.
It includes an attached needle with a safety mechanism, i.e, after the injection, the protective shield will permanently be locked in place by pushing forward till click, providing protection against needle sticks and rendering the device unusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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
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 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 8537:2016, Sterile single-use syringes, with or without needle, for insulin
- 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
- Simulated clinical use testing was conducted as recommended in FDA guidance, Medical Devices with Sharps Injury Prevention Features.
Biocompatibility: In accordance with ISO 10993-1 the device is classified as External communicating device, Blood path, indirect, with prolonged contact duration (> 24h to 30d). It is leverage for the predicate the following testing;
- 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 and pyrogen test
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Subacute systemic toxicity
- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood, Hemocompatibility
- USP42-NF37 Pyrogen Test
- Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 8, 2021
Image /page/0/Picture/1 description: The image contains 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.
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: K210712
Trade/Device Name: Verifine Mechanical Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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) K210712
Device Name
Verifine Mechanical Safety Insulin Syringe
Indications for Use (Describe)
It is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. The safety shield is intended to reduce the risk of sharp injuries.
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
K210712 510(k) Summary
Date Prepared 1
Sep 7th, 2021
Submitter's Information 2
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Canggian 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: Verifine Mechanical Safety Insulin Syringe
Classification name: Syringe, Piston
Regulation Number: 21 CFR 880.5860
Device Class: Class II
Product Code: FMF, FMI (hypodermic needle)
ldentification of Predicate Device ব
K193273: Insulin Syringe
Classification name: Syringe, Piston
Regulation Number: 21 CFR 880.5860
Device Class: Class II
Product Code: FMF
4
5 Description of the Device
Verifine Mechanical Safety Insulin Syringe is a sterile device consisting of a calibrated barrel with plunger intended to be used to administer an injection of insulin to a patient subcutaneously.
It includes an attached needle with a safety mechanism, i.e, after the injection, the protective shield will permanently be locked in place by pushing forward till click, providing protection against needle sticks and rendering the device unusable.
| Gauge | Length | Wall Type |
|---|---|---|
| 29G | 6 mm | |
| 29G | 8 mm | |
| 29G | 10 mm | |
| 29G | 13mm | |
| 30G | 6 mm | |
| 30G | 8 mm | |
| 30G | 10 mm | Regular Wall |
| 30G | 13mm | Thin Wall |
| 31G | 4 mm | |
| 31G | 6 mm | |
| 31G | 8 mm | |
| 31G | 10 mm | |
| 31G | 13mm | |
| 32G | 4 mm |
It can be used by health care personnel. This is a single-use device.
Indication for Use 6
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Verifine Mechanical Safety | ||
| Insulin Syringe K210712 | Insulin Syringe | |
| K193273 |
5
| Indication for Use | It is intended for | Insulin Syringe is intended |
|---|---|---|
| subcutaneous injection of | for subcutaneous injection | |
| U-40 and U-100 insulin in | of U-40 and U-100 insulin | |
| the treatment of diabetes. | in the treatment of diabetes. | |
| The safety shield is | ||
| intended to reduce the | ||
| risk of sharp injuries. | ||
| Prescription Only or | ||
| Over the counter | Prescription Only | Prescription Only |
7 Similarities and Differences of the Proposed Devices to the Predicate Devices
The Verifine Mechanical Safety Insulin Syringe is substantially equivalent to the predicate device, the Insulin Syringe (K193273) 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 above between the subject device and predicate device do not affect the basic design principle, usage of the subject device.
| | Subject Device | Predicate Device
(K193273) | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Verifine
Mechanical
Safety Insulin Syringe | Insulin Syringe | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Promisemed Hangzhou
Meditech Co., Ltd | |
| 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 for
subcutaneous injection
of U-40 and U-100
insulin in the treatment
of diabetes. The safety
shield is intended to
reduce the risk of sharp
injuries. | Insulin Syringe is
intended for
subcutaneous injection
of U-40 and U-100 insulin
in the treatment of
diabetes. | Similar
The subject
device has
additional safety
shield to prevent
sharp injury. |
| Operating
Principle | The insulin is injected to
subcutaneous tissue by
pushing force generated | The insulin is injected to
subcutaneous tissue by
pushing force generated | Different
The subject
device has |
| | through pushing plunger
rod of the insulin
syringe. The protective
shield will permanently
be locked in place by
pulling forward till click,
providing protection
against needle sticks. | through pushing plunger
rod of the insulin
syringe. | additional safety
shield to prevent
sharp injury. |
| Volume | 0.3ml,0.5ml, 1.0ml | 0.3ml,0.5ml, 1.0ml | Same |
| Gauge | 32G, 31G, 30G, 29G | 32G, 31G, 30G, 29G, 28G | Different
The gauge range
of subject device
is within that of
predicate device. |
| Dead Space | Maximum dead space
0.01ml | Maximum dead space
0.01ml | Same |
| Wall Type | Regular wall, Thin wall | Regular wall, Thin wall | Same |
| Needle Length | 4mm, 6mm, 8mm, 10mm,
13mm | 6mm, 8mm, 12mm | Different
Subject device
has wider needle
length than
predicate
device. The
specification of
4mm and 13mm
meets the
requirement of
ISO9626, ISO7864
and ISO8537. |
| Needle tip
configuration | 3 bevels | 3 bevels | Same |
| Nozzle type | Not applicable | Not applicable | Same |
| Numbering of scale | At every five units for
the 0.3mL and 0.5mL
syringes, and at every 5
or 10units for 1.0mL
syringe | At every five units for
the 0.3mL and 0.5mL
syringes, and at every
10units for 1.0mL
syringe | Same |
| Gradations
legibility | Legible | Legible | Same |
| Needle cover color | Red (U-40) and orange
(U-100) | Red (U-40) and orange
(U-100) | Same |
| Lubricant | Silicone oil | Silicone oil | Same |
| Lubricant
amount/cm² | The lubricant is not form
pools of fluid on the
interior surface of the
syringe or outside
surfaces of the needle
tube | The lubricant is not form
pools of fluid on the
interior surface of the
syringe or outside
surfaces of the needle
tube | Same |
| Barrel
transparency | Transparent | Transparent | Same |
| Reuse durability | Single Use | Single Use | Same |
| Hub/needle
bond
strength | Bond between hub and
needle tube should be | Bond between hub and
needle tube should be | Same |
A detailed comparison to the predicate is provided in Table 1.
6
7
| | Nominal
outside
diameter
of needle
(mm) | Minimum
shearing
strength | Nominal
outside
diameter
of needle
(mm) | Minimum
shearing
strength | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------------------------------------------|---------------------------------|------|
| | ≥0.33 | 22N | ≥0.33 | 22N | |
| | 24h to 30d). It is leverage for the predicate the following testing;
- 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
9
- ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Subacute systemic toxicity
- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood, Hemocompatibility
- USP42-NF37 Pyrogen Test
- Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
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
10 Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Verifine Mechanical Safety Insulin Syringe is substantially equivalent to the Insulin Syringe with respect to the indications for use, target populations, treatment method, and technological characteristic.