Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical fluid flow control device and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device is described as a flow control switch and access port for administering solutions, not as a device that directly treats or prevents a disease or condition. It is an accessory for fluid administration.

Diagnostic

No
Explanation: The device description clearly states its purpose is for "fluid flow control and for providing access port(s) for administration of solutions." It mentions uses like "pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids," which are actions related to administering or controlling fluids, not diagnosing conditions. The performance studies also focus on equipment standards rather than diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical medical device (flow control switch, stopcock system, fitting ends) and performance studies related to physical standards (ISO 8536-4, ISO 80369-7). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, the Clicky Cros™ device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used for fluid flow control and providing access ports for administering solutions directly into the patient's vascular system. This is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
Device Description: The description reinforces its use in I.V. sets and pressure infusion systems, which are used for administering substances to a patient.
Anatomical Site: The specified anatomical site is the "Vascular system," which is inside the body.
Performance Studies: The performance studies mentioned (ISO 8536-4 and ISO 80369-7) relate to infusion equipment and connectors for intravascular applications, further supporting its in-vivo use.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Clicky Cros™ does not perform any such analysis on bodily specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

Product codes (comma separated list FDA assigned to the subject device)

FMG

Device Description

Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.
Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).
A barb connector is made and held in place by one or more continuous radial serrations or ridges surrounding a hollow tube through which fluid and air flow can take place.
A Luer connector is a small-bore connector that contains a conical mating surface with a 6% taper. The threads contain male type and female type.
Stopcocks have a body and core, and a small amount of lubricate is applied between stopcock body and core. This device has two styles. One is the female lock and the male lock connection, the other one is barb connector fitting.

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)

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device:

ISO 8536-4:2019, Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
ISO 80369-7:2016 Small -bore connectors for liquids and gases in healthcare . applications-Part 7: Connectors for intravascular or hypodermic applications.

Biocompatibility evaluation and testing was conducted in accordance with:

ISO 10993-3 Biological evaluation of medical device Part3: Test for . genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-5 Biological evaluation of medical device-Part 10: Test for irritation and skin sensitization
ISO 10993-11, Biological evaluation of medical device-Part 11: Test for . systemic toxicity.
ISO 10993-12 Biological evaluation of medical device -Part 12: sample preparation and reference materials
Particulate testing using USP Particulate Matter in Injection

Sterility, Shipping, and shelf Life:

Evaluated for sterility using ISO 11135:2014 - Sterilization of healthcare products - Ethylene Oxide
Validation method is Overkill Approach (Half-cycle) and residuals of EO

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Summary

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May 16, 2022

Yomura Technologies Inc. % Anita Chen Official Correspondent ZhengCheng Consulting Corporation No.19, 335 Lane, Fu-Xi Road, Shulin District New Taipei City, 23871 Taiwan

Re: K210516

Trade/Device Name: Clicky Cross™ Regulation Number: 21 CFR 880.5440 Regulation Name: Stopcock, I.V set Regulatory Class: Class II Product Code: FMG Dated: March 22, 2022 Received: April 14, 2022

Dear Anita Chen:

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,

David Wolloscheck For Payal Patel 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210516

Device Name Clicky Cross™

Indications for Use (Describe)

Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

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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K210516.510K Summary

	Date Prepared	May 16, 2022
1.	Manufacturer
	Mailing Address	Yomura Technologies Inc.
Address: No.8, Gong 8th Rd., LinKou Dist., New Taipei
City 244, Taiwan
Web: www.yomura.com.tw
Phone: 02-86013839
Fax: 02-86013833
Establishment Registration No.: 1st
	Contact Person	Mrs. Anita Chen/ Regulatory Adviser of Yomura
Technologies Inc.
	Phone:	+886(0) 939-855-759
	E-mail:	m9104303@gmail.com
2	Device Name
	Proprietary Name:	Clicky Cross™
	Common or usual name	I.V. Set Stopcock
	Product Code	FMG
	Device	Clicky Cross™
	Regulation Number	21 CFR 880.5440
	Regulation Name	Intravascular administration set
	Device Class	II
	Classification Panel	General Hospital
3	Predicate Device
	510(k) number:	K111016
	Trade or proprietary	Safeport Manifold™

4

or model name:

4 Device Description: Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.
Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).

	Barb	Luer
Specification
and
Difference	A barb connector is
made and held in
place by one or
more continuous
radial serrations or
ridges surrounding
a hollow tube
through which fluid
and air flow can
take place.	A Luer connector is
a small-bore
connector that
contains a conical
mating surface with
a 6% taper. The
threads contain
male type and
female type.
Usage	Intravascular or
hypodermic
applications of	Intravascular or
hypodermic
applications of

Types of Fitting end

5

medical devices	medical devices
and related	and related
accessories.	accessories.

1. Substantial
  Equivalence

Discussion

Characteristic Predicate Device Subject Device Safeport Device Name Manifold™ K210516 K111016 Indication for New Clicky Cross™ is modified Use SafePort indicated for fluid (Stopcock) serve as flow control and a flow control and a for providing conduit device for access port(s) for I.V fluid delivery to administration of solutions the patient's in a vascular system. limited contact The product is duration (24 hours or less). Typical intended for delivering of I.V. uses include drugs pressure fluids, allowing gravity monitoring, feed, sampling intravenous fluid bolus injection and administration, elimination transfusion or and reflux fluid infusion of during operation. nutritive or medicinal fluids. Prescription Prescription Only Prescription Only Only or Over the counter

Clicky Cross™ has the same intended use as the claimed predicate device, Safeport Manifold™ (K111016). Although there is a slightly different technological design, as compared to the predicate, the performance data

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demonstrates the proposed device performs as safely and effectively as the predicate device. There are only editorial differences to the indications for use statement between the predicate and the subject device which do not change the indications.

Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Clicky Cross™ is substantially equivalent to the predicate device and raises no new questions of safety or effectiveness.

Stopcocks have a body and core, and a small amount of lubricate is applied between stopcock body and core. This device has two styles. One is the female lock and the male lock connection, the other one is barb connector fitting.

1. Technological A comparison of the device features, intended use, and other Characteristics and information demonstrates that the Product name is Substantial substantially equivalent to to the predicate device as Equivalence summarized in Table 1. The differences raise no new question Comparison with of safety and effectiveness. Predicate:
  Table 1 Comparison table

	Subject Device	Predicate Device
	CLICKY CROSS	Safeport ManifoldTM
Product
code	FMG	FPA
Device
Name	Clicky CrossTM	Safeport ManifoldTM

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Clicky Cross™ is	SAFEPORT is an	The design is for
indicated for fluid	intuitive manifold	management the fluid.
flow control and for	designed for one-way	The intended use is
providing access	or two-way fluid flow.	totally the same as:
port(s) for	It is available in 2 and	Clicky Cross™ serve
administration of	3 port configurations,	as a flow control and a
solutions. Typical	with or without	conduit device for I.V
uses include	swabable valves.	fluid delivery to the
pressure monitoring,		patient's vascular
intravenous fluid		system.
administration,
transfusion and
infusion of nutritive
or medicinal fluids.
Yomura Clicky
Cross™ is a new
medical device using
as flow control
switch and is
developed by
Yomura
Technologies Inc.

Click-release
process via one-
handed operation
Less leakage issues.
Stopcock system for
I.V. set and other
application
Suitable for all_
current pressure
infusion system

8

| | There are two types
of fitting end (Barb
/Luer) for normal
I.V. infusion sets. In
order to meet the
requirement of I.V.
infusion set, here we
provide two
different types of
fitting end
(Barb/Luer). | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Medical
Specialty | General Hospital | General Hospital | Same |
| Reg.
Number | 880.5440 | 880.5440 | Same |
| Class | 2 | 2 | Same |
| Materials | PC, POM, TPE | PC, TPE, PP | Different
Comment# 1 |
| Design | Stopcocks have a
body and core, and a
small amount of
lubricate is applied
between stopcock
body and core. This
device has two
styles. One is the
female lock and the
male lock
connection, the other
one is barb
connector fitting. | Stopcocks have a body
and core, and a small
amount of lubricate is
applied between
stopcock body and
core. This device have
the female lock and the
male lock connection. | Different
Comment# 2 |
| Indications
for Use | Clicky Cross serve
as a flow control and
a conduit device for
I.V fluid delivery to
the patient's vascular
system. The product
is intended for
delivering of I.V.
drugs or fluids,
allowing gravity
feed, sampling bolus
injection and
elimination or reflux
of fluid during
operation. | New modified
SafePort Manifold
(Stopcock) serve as a
flow control and a
conduit device for I.V
fluid delivery to the
patient's vascular
system. The product is
intended for delivering
of I.V. drugs or fluids,
allowing gravity feed,
sampling bolus
injection and
elimination or reflux of
fluid during operation. | Same |
| Sterility | EO Sterilization | EO Sterilization | Same |
| Utility | Single use | Single use | Same |
| Mechanism | Using ratchet and
spring, this device
follows the rules of
Click pen, for
locking and
releasing the switch
to control the flow. | Using handle and
rotator, this device can
control the flow via
rotating the handle to
switch on and off. | Different
Comment# 3 |

9

Discussions of differences in technological characteristics

Comment 1

The different materials POM are use in crenelated bottom as an non-contact part. All materials used in Clicky Cross™ are well known biomaterials with long history of human use. Human contact parts from final device of Clicky Cross™ were evaluated using the FDA 2020 guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management

10

process". The test results demonstrate that all materials used to construct Clicky Cross™ are biocompatible and safe for human body.

Comment 2

A minor technological difference between the predicate device and subject device is single port for single use. The design is only for management the fluid. The intended use is totally the same as: Clicky Cross™ serve as a flow control and a conduit device for I.V fluid delivery to the patient's vascular system. The product is intended for delivering of I.V. drugs or fluids, allowing gravity feed, sampling bolus injection and elimination or reflux of fluid during operation.

Comment 3

Different design for lock method, but all pass the safety and ISO standards. Lock by switch like a plug in and plug out for lock and open.

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7. Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device.

. ISO 8536-4:2019, Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed
ISO 80369-7:2016 Small -bore connectors for liquids and gases in healthcare . applications-Part 7: Connectors for intravascular or hypodermic applications.

8. Biocompatibility

The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:

ISO 10993-3 Biological evaluation of medical device Part3: Test for . genotoxicity, carcinogenicity, and reproductive toxicity
. ISO 10993-5 Biological evaluation of medical device-Part 10: Test for irritation and skin sensitization
ISO 10993-11, Biological evaluation of medical device-Part 11: Test for . systemic toxicity.
. ISO 10993-12 Biological evaluation of medical device -Part 12: sample preparation and reference materials

Particulate testing using USP Particulate Matter in Injection

9. Sterility, Shipping, and shelf Life

The proposed device was evaluated for sterility using ISO 11135:2014 - Sterilization of healthcare products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The validation methos is Overkill Approach (Half-cycle) and residuals of EO