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. This is a single-use device.

AI/ML Overview

The provided text is a 510(k) summary for the "Verifine Safety Syringe with Fixed Needle." This document primarily focuses on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and bench testing. It does not contain information about a study that would involve acceptance criteria related to a statistical performance metric of a device, especially not an AI/ML powered device, assessed against a ground truth established by experts.

Here's why the requested information cannot be extracted from this document:

Device Type: The device is a "Verifine Safety Syringe with Fixed Needle," a hardware medical device (a physical syringe with a safety mechanism). It is not an AI/ML powered device.
"Study that proves the device meets the acceptance criteria": The document describes performance testing (bench testing) to show compliance with various ISO standards (e.g., ISO 7886-1 for syringes, ISO 23908 for sharps injury protection, ISO 10993 for biocompatibility) and packaging tests. These are engineering and material compliance tests, not clinical studies or performance studies involving human-in-the-loop or standalone AI performance evaluation.
"Acceptance criteria": The "acceptance criteria" for a physical device like a syringe are typically defined by these ISO standards (e.g., specific force required to activate safety, leakage rates, sterility levels, biocompatibility results like "no cytotoxicity"). These are quantitative engineering specifications rather than diagnostic performance metrics.

Therefore, I cannot provide the requested table and details because the device and the testing described in the document do not align with the nature of the questions, which are highly specific to the evaluation of AI/ML-powered medical devices.

To answer your request based on the provided document:

The acceptance criteria are implicitly met by demonstrating compliance with the referenced ISO standards. For example, for biocompatibility, the acceptance criteria would be "no evidence of cytotoxicity," "no evidence of skin irritation," etc. For sharps injury protection, the acceptance criteria would be that the device functions as intended to prevent sharps injury according to ISO 23908.

Since the information is not present in the provided text, I cannot fill out the requested table or answer points 2-9.

What the document does provide regarding performance testing:

Bench Testing: The device underwent bench testing to verify performance characteristics against the predicate device.
Standards Followed:
- ISO 7886-1:2017 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use)
- S ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices)
- ISO 7864:2016 (Sterile hypodermic needles for single use)
- ISO 23908:2011 (Sharps injury protection)
- USP<85> Bacterial Endotoxin Test
Biocompatibility Testing (per ISO 10993-1, -5, -10, -11, -4, -7, USP42-NF37<151>, USP<788>):
- 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 <788> Particulate matter
Sterility, Shipping, and Shelf-Life Testing:
- ISO 11135:2014 (Ethylene oxide sterilization)
- ASTM D4169-16 (Simulated transport)
- ASTM F88/F88-15 (Seal strength)
- ASTM F1929-15 (Dye penetration)
- USP38-NF33 C71 (Sterility test)
- ASTM F1980-16 (Accelerated aging for shelf life of 5 years)

In summary, the document details engineering and material testing to ensure the safety and effectiveness of a physical syringe, not the performance of an AI/ML algorithm.

Summary

{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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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:

zearou.yang@promisemed.ca

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/Polyethylenecompositemembrane (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/Polyethylenecompositemembrane (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.	DifferentThe 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	DifferentThe needle length range of subject device is within that of predicate device.
Gradations	Legible	Legible	Same
legibility
Lubricant	Silicone oil	Silicone oil	Same
Barreltransparency	Transparent	Transparent	Same
Reuse durability	Single Use	Single Use	Same
Biocompatibility	Complied with ISO10993series standards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skin irritation- Skin Sensitization: Noevidence of sensitization-Acute Systemic Toxicity:No systemic toxicity-Hemolysis: No evidenceof hemolysis-Pyrogen: Non pyrogenic-USP <788> Particulatematter	Complied with ISO10993series standards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skin irritation- Skin Sensitization: Noevidence of sensitization-Acute Systemic Toxicity:No systemic toxicity-Hemolysis: No evidenceof hemolysis-Pyrogen: Non pyrogenic-USP <788> Particulatematter	Same
ConfigurationandMaterials	Needle: Stainless Steel(X5CrNi18-10)Barrel/push-button:PolypropylenePlunger: PolypropyleneNeedle cap: PolyethylenePiston: PolyisoprenerubberSliding Sleeve, Cover:PolypropylenePlunger stopper, Tightring: AcrylonitrileButadiene Styrene	Needle: Stainless Steel(X5CrNi18-10)Barrel/push-button:PolypropylenePlunger: Polypropylene/Acrylonitrile ButadieneStyreneNeedle cap:Polyethylene/PolypropylenePiston: Polyisoprenerubber	The needle of both devicesis made of stainless steel.The syringe bodies ofsubject device and predicatedevice have materialdifferences. Differences areaddressed throughbiocompatility testing perISO 10993.
Performance	Complied with ISO 7886-1,ISO 9626, ISO 7864, ISO23908	Complied with ISO 7886-1, ISO 9626, ISO 7864	DifferentThe subject device hasadditional safety shield toprevent sharp injury. Thedifference is addressedthrough testing perISO23908.
Sterilizationmethod 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<85> 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<151> Pyrogen Test
· USP<788> 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.

Regulation Number and Section

§ 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).