(447 days)
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.
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).
The provided FDA 510(k) summary for the Clicky Cross™ device details its substantial equivalence to a predicate device, the Safeport Manifold™ (K111016). It primarily focuses on demonstrating that the new device is as safe and effective as the predicate.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" in a typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device by meeting established performance and safety standards for medical devices of this type.
The reported device performance is indicated by its compliance with various ISO and ASTM standards relevant to infusion equipment and biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Functional Performance | ISO 8536-4:2019 | Meets standard for Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed |
| ISO 80369-7:2016 | Meets standard for Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | |
| Biocompatibility | ISO 10993-3 | Meets standard for genotoxicity, carcinogenicity, and reproductive toxicity |
| ISO 10993-5 | Meets standard for irritation and skin sensitization | |
| ISO 10993-11 | Meets standard for systemic toxicity | |
| ISO 10993-12 | Meets standard for sample preparation and reference materials | |
| USP <788> | Meets standard for Particulate Matter in Injection (Particulate testing) | |
| Sterility | ISO 11135:2014 | Meets standard for Sterilization of healthcare products - Ethylene Oxide (Overkill Approach (Half-cycle) validation method; residuals EO <0.01mg/device, ECH <0.04mg/device) |
| Packaging Integrity | ASTM F88/F88M-15 | Meets standard for Seal strength |
| ASTM F1929-12 | Meets standard for Dye penetration test | |
| Shelf Life | ASTM F1980-16 | 3 years validated using accelerated aging |
2. Sample size used for the test set and the data provenance:
The document does not specify a "test set" sample size in the context of an AI/ML algorithm. The performance testing refers to physical device testing according to established medical device standards. Therefore, there is no information about data provenance like country of origin or retrospective/prospective nature as this device is a physical medical device, not a software algorithm relying on clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a physical medical instrument (stopcock) and its performance is evaluated against engineering, materials, and biological safety standards, not against "ground truth" established by clinical experts for a diagnostic or prognostic AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for a physical medical device being evaluated against engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The Clicky Cross™ is a physical stopcock, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Clicky Cross™ device is defined by compliance with the referenced international and national standards (ISO, ASTM, USP) for medical devices of its type. This involves objective measurements of physical properties, material characteristics, and biological interactions, rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device is not an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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)
| 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 TaipeiCity 244, TaiwanWeb: www.yomura.com.twPhone: 02-86013839Fax: 02-86013833Establishment Registration No.: 1st | |
| Contact Person | Mrs. Anita Chen/ Regulatory Adviser of YomuraTechnologies 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 | |
|---|---|---|
| SpecificationandDifference | A barb connector ismade and held inplace by one ormore continuousradial serrations orridges surroundinga hollow tubethrough which fluidand air flow cantake place. | A Luer connector isa small-boreconnector thatcontains a conicalmating surface witha 6% taper. Thethreads containmale type andfemale type. |
| Usage | Intravascular orhypodermicapplications of | Intravascular orhypodermicapplications of |
Types of Fitting end
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| medical devices | medical devices |
|---|---|
| and related | and related |
| accessories. | accessories. |
-
- Substantial
Equivalence
- Substantial
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.
-
- 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
- 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:
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| CLICKY CROSS | Safeport ManifoldTM | ||
| Productcode | FMG | FPA | |
| DeviceName | 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 typesof fitting end (Barb/Luer) for normalI.V. infusion sets. Inorder to meet therequirement of I.V.infusion set, here weprovide twodifferent types offitting end(Barb/Luer). | |||
|---|---|---|---|
| MedicalSpecialty | General Hospital | General Hospital | Same |
| Reg.Number | 880.5440 | 880.5440 | Same |
| Class | 2 | 2 | Same |
| Materials | PC, POM, TPE | PC, TPE, PP | DifferentComment# 1 |
| Design | Stopcocks have abody and core, and asmall amount oflubricate is appliedbetween stopcockbody and core. Thisdevice has twostyles. One is thefemale lock and themale lockconnection, the otherone is barbconnector fitting. | Stopcocks have a bodyand core, and a smallamount of lubricate isapplied betweenstopcock body andcore. This device havethe female lock and themale lock connection. | DifferentComment# 2 |
| Indicationsfor Use | Clicky Cross serveas a flow control anda conduit device forI.V fluid delivery tothe patient's vascularsystem. The productis intended fordelivering of I.V.drugs or fluids,allowing gravityfeed, sampling bolusinjection andelimination or refluxof fluid duringoperation. | New modifiedSafePort Manifold(Stopcock) serve as aflow control and aconduit device for I.Vfluid delivery to thepatient's vascularsystem. The product isintended for deliveringof I.V. drugs or fluids,allowing gravity feed,sampling bolusinjection andelimination or reflux offluid during operation. | Same |
| Sterility | EO Sterilization | EO Sterilization | Same |
| Utility | Single use | Single use | Same |
| Mechanism | Using ratchet andspring, this devicefollows the rules ofClick pen, forlocking andreleasing the switchto control the flow. | Using handle androtator, this device cancontrol the flow viarotating the handle toswitch on and off. | DifferentComment# 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.
§ 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.