Clicky Cross
Device Facts
| Record ID | K210516 |
|---|---|
| Device Name | Clicky Cross |
| Applicant | Yomura Technologies, Inc. |
| Product Code | FMG · General Hospital |
| Decision Date | May 16, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Clicky Cross™ is a single-use stopcock device for IV infusion sets, designed for fluid flow control and vascular access. It features a click-release mechanism, operated one-handedly, functioning similarly to a click-pen (ratchet and spring) to lock/release flow, contrasting with the handle-rotation mechanism of traditional stopcocks. The device is used in clinical settings (General Hospital) by healthcare providers to manage IV lines, pressure monitoring, and fluid/drug delivery. It is available in two fitting configurations: barb connector or Luer lock. The device aims to reduce leakage issues compared to existing products. It is supplied sterile via ethylene oxide and is intended for short-term use (≤24 hours).
Clinical Evidence
Bench testing only. Performance testing included ISO 8536-4 (infusion sets) and ISO 80369-7 (small-bore connectors). Biocompatibility testing followed ISO 10993-3, -5, -11, and -12. Sterility validated per ISO 11135. Package integrity tested via ASTM F88/F88M-15 and ASTM F1929-12. Shelf life validated via ASTM F1980-16.
Technological Characteristics
Materials: PC, POM, TPE. Mechanism: Ratchet and spring (click-pen style) for flow control. Configurations: Barb or Luer (6% taper) connectors. Sterilization: Ethylene Oxide (EO). Single-use. Standards: ISO 8536-4, ISO 80369-7, ISO 10993, ISO 11135, ASTM F88, ASTM F1929, ASTM F1980.
Indications for Use
Indicated for patients requiring fluid flow control, pressure monitoring, IV fluid administration, transfusion, or infusion of nutritive/medicinal fluids via vascular access. Limited contact duration (≤24 hours).
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Safeport Manifold™ (K111016)
Submission Summary (Full Text)
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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
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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)
| <span style="font-size:10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|----------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# K210516.510K Summary
| | Date Prepared | May 16, 2022 |
|----|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Manufacturer | |
| | Mailing Address | Yomura Technologies Inc.<br>Address: No.8, Gong 8th Rd., LinKou Dist., New Taipei<br>City 244, Taiwan<br>Web: www.yomura.com.tw<br>Phone: 02-86013839<br>Fax: 02-86013833<br>Establishment Registration No.: 1st |
| | Contact Person | Mrs. Anita Chen/ Regulatory Adviser of Yomura<br>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™ |
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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<br>and<br>Difference | A barb connector is<br>made and held in<br>place by one or<br>more continuous<br>radial serrations or<br>ridges surrounding<br>a hollow tube<br>through which fluid<br>and air flow can<br>take place. | A Luer connector is<br>a small-bore<br>connector that<br>contains a conical<br>mating surface with<br>a 6% taper. The<br>threads contain<br>male type and<br>female type. |
| Usage | Intravascular or<br>hypodermic<br>applications of | Intravascular or<br>hypodermic<br>applications of |
Types of Fitting end
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| medical devices | medical devices |
|-----------------|-----------------|
| and related | and related |
| accessories. | accessories. |
- 5. 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.
- 6. 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 | Comment |
|-----------------|----------------|---------------------|---------|
| | CLICKY CROSS | Safeport ManifoldTM | |
| Product<br>code | FMG | FPA | |
| Device<br>Name | Clicky CrossTM | Safeport ManifoldTM | |
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| Description | | | |
|-------------|-----------------------|--------------------------|-------------------------|
| | 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 | | |
| | | | |
| | | | |
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| | There are two types<br>of fitting end (Barb<br>/Luer) for normal<br>I.V. infusion sets. In<br>order to meet the<br>requirement of I.V.<br>infusion set, here we<br>provide two<br>different types of<br>fitting end<br>(Barb/Luer). | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Medical<br>Specialty | General Hospital | General Hospital | Same |
| Reg.<br>Number | 880.5440 | 880.5440 | Same |
| Class | 2 | 2 | Same |
| Materials | PC, POM, TPE | PC, TPE, PP | Different<br>Comment# 1 |
| Design | Stopcocks have a<br>body and core, and a<br>small amount of<br>lubricate is applied<br>between stopcock<br>body and core. This<br>device has two<br>styles. One is the<br>female lock and the<br>male lock<br>connection, the other<br>one is barb<br>connector fitting. | Stopcocks have a body<br>and core, and a small<br>amount of lubricate is<br>applied between<br>stopcock body and<br>core. This device have<br>the female lock and the<br>male lock connection. | Different<br>Comment# 2 |
| Indications<br>for Use | Clicky Cross serve<br>as a flow control and<br>a conduit device for<br>I.V fluid delivery to<br>the patient's vascular<br>system. The product<br>is intended for<br>delivering of I.V.<br>drugs or fluids,<br>allowing gravity<br>feed, sampling bolus<br>injection and<br>elimination or reflux<br>of fluid during<br>operation. | New modified<br>SafePort Manifold<br>(Stopcock) serve as a<br>flow control and a<br>conduit device for I.V<br>fluid delivery to the<br>patient's vascular<br>system. The product is<br>intended for delivering<br>of I.V. drugs or fluids,<br>allowing gravity feed,<br>sampling bolus<br>injection and<br>elimination or reflux of<br>fluid during operation. | Same |
| Sterility | EO Sterilization | EO Sterilization | Same |
| Utility | Single use | Single use | Same |
| Mechanism | Using ratchet and<br>spring, this device<br>follows the rules of<br>Click pen, for<br>locking and<br>releasing the switch<br>to control the flow. | Using handle and<br>rotator, this device can<br>control the flow via<br>rotating the handle to<br>switch on and off. | Different<br>Comment# 3 |
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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
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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 <788> 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 <0.01mg/device and ECH <0.04mg/device
- . Package Integrity was done after environmental conditioning on final packaged, and sterile devices
- . Sterile Barrier Packaging testing performed on proposed device:
- Seal strength ASTM F88/F88M-15 o
- Dye penetration test- ASTM F1929 -12 O
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Shelf life of 3 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 Clicky Cross™ is substantially equivalent to the Safeport Manifold™(K111016) with respect to the indications for use, target populations, treatment method, and technological characteristics.
