MagiCath II is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for general patient with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Device Description

MagiCath II, safety IV catheter is inserted into the patient's blood vessel for short-term use to collect blood, monitor blood pressure, or inject drugs. It consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety shielding mechanism that will engage upon needle removal from the patient in order to prevent accidental needlestick injuries. The device is available in 18, 20, 22 and 24-gauge catheter.

MagiCath II is designed to allow users handling the device with single-hand, using the MagiGrip. In the MagiGrip, a vent fitting to regulate blood flow is placed. The needle hub is equipped with a vent filter which suppresses blood leakage, so the flashback can be more visible.

AI/ML Overview

The provided document is a 510(k) Summary for the MagiCath II, a safety IV catheter. It discusses the device's substantial equivalence to a predicate device but does not contain specific acceptance criteria, reported device performance metrics in a defined table, or detailed information about a clinical study involving a test set, expert adjudication, or human reader performance with or without AI assistance.

The document primarily focuses on:

Comparison of technological characteristics with the predicate device (BD Insyte™ Autoguard™ Intravascular Catheter).
Bench testing against various ISO standards to demonstrate performance and safety, particularly for sharps injury prevention and material compatibility.
Biocompatibility testing in accordance with ISO 10993 series.
Sterilization validation per ISO 11135:2014.

Therefore, many of the requested details cannot be extracted from this document as no clinical study with a test set, ground truth experts, or MRMC study is reported.

However, I can provide the acceptance criteria based on the standards cited for performance as these standards implicitly define performance requirements. The "reported device performance" would then be that the device conformed to these standards.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria/Standard	Reported Device Performance
Performance (Mechanical/Physical Characteristics):
- Conical fittings with 6% (Luer) taper for syringe, needles, and certain other medical equipment (ISO 594-1:1986, ISO 594-2:1998)	Device conforms to the requirements of ISO 594-1 and ISO 594-2. This implies acceptance of proper fitting, leak-tightness, and disconnection force.
- Intravascular catheter, general requirements (ISO 10555-1:2013)	Device conforms to the general requirements for intravascular catheters, covering aspects like sterility, freedom from defects, material compatibility, and certain physical attributes.
- Over-needle peripheral catheters (ISO 10555-5:2013)	Device conforms to specific requirements for over-needle peripheral catheters, addressing features like catheter tip design, flow rates, and insertion characteristics.
- Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:2016)	Device conforms to requirements for needle tubing, ensuring attributes like tensile strength, rigidity, and surface finish.
- Sterile hypodermic needles for single use (ISO 7864:2016)	Device conforms to requirements for hypodermic needles, including needle point geometry, resistance to corrosion, and freedom from manufacturing defects.
- Sharps injury protection features (ISO 23908:2011, FDA Guidance for Medical Devices with Sharps Injury Prevention Features)	Device conforms to sharps injury protection requirements, demonstrating that the passive safety mechanism performs as intended to prevent accidental needlestick injuries (as noted in "Note 2" of the submission summary, "Performance testing per ISO 23908:2011 demonstrated that the safety mechanism feature performs as intended.").
- Particulate Matter in Injections (USP <788>)	Device conforms to limits for particulate matter, ensuring safety when administered intravenously.
Biocompatibility (ISO 10993 Series):
- Cytotoxicity (ISO 10993-5)	Device materials are non-cytotoxic.
- Sensitization (ISO 10993-10)	Device materials do not cause sensitization.
- Intracutaneous (Intradermal) Reactivity (ISO 10993-10)	Device materials do not cause significant intracutaneous reactions.
- Acute, Subacute/Subchronic, and Material-Mediated Pyrogenicity (ISO 10993-11)	Device materials are not acutely toxic, do not cause subacute/subchronic toxicity, and are non-pyrogenic.
- Genotoxicity (ISO 10993-3/ISO 10993-33)	Device materials are not genotoxic (did not induce bacterial reverse mutation or mammalian chromosomal aberration).
- Hemocompatibility (ISO 10993-4/ASTM F756-17, F2382-18, F2888-19)	Device materials do not cause significant hemolysis, do not adversely affect partial thromboplastin time, do not cause significant changes in platelet/leukocyte counts or adherence, and do not cause undesired complement activation.
- Implantation (ISO 10993-6)	Device materials demonstrate appropriate tissue response upon implantation.
Sterilization (ISO 11135:2014):
- Sterilization process validation (Ethylene Oxide)	The Ethylene Oxide sterilization method is validated in accordance with ISO 11135:2014, ensuring sterility of the device.

Missing Information (Not found in the provided text):

Sample size used for the test set and the data provenance: Not applicable as no clinical study or specific test set for AI/human performance is detailed. The performance evaluations are bench tests against standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for a clinical test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for a test set is described.
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: Not applicable. This device is a physical medical device (catheter), not an AI-powered diagnostic tool, so an MRMC study comparing human readers with/without AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/clinical study. For the device's performance, the "ground truth" is defined by adherence to the cited international consensus standards (ISO, ASTM, USP).
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary of the Study Proving Device Meets Criteria:

The "study" proving the device meets the acceptance criteria is a comprehensive set of bench tests, biocompatibility tests, and sterilization validation performed according to recognized international and national standards (ISO, ASTM, USP, FDA guidance). The document asserts that these tests "demonstrate substantial equivalence to the predicate device" and that "no new safety and effectiveness questions are raised." The performance testing per ISO 23908:2011 specifically confirmed the sharps injury prevention feature performs as intended. The biocompatibility assessment was conducted per ISO 10993-1, and sterilization was validated per ISO 11135:2014.

Summary

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September 13, 2022

Woo Young Medical Co., Ltd. % Dave Kim President MTech Group 7505 Fannin St. Ste 610 Houston, Texas 77054

Re: K210929

Trade/Device Name: MagiCath II Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: September 12, 2022 Received: September 12, 2022

Dear Dave Kim:

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, Ph.D. 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210929

Device Name MagiCath II

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K210929

510(k) Summary

21 CFR Part §807.92

Date 510(k) summary prepared: September 12, 2022

I. Applicant
Company

Woo Young Medical Co., Ltd. 98, Sangsin 2-gil, Jincheon-eup, Jincheon-gun, Chungcheongbuk-do, Korea Tel.: +82 (43) 536 0291 / Fax.:+82 (43) 536 0290 Jenny Cho / RA Team Manager jennycho@wooyoungmed.com

II. Submission Correspondent

Contact person

Official Correspondent Dave Kim, MBA Company MTECH GROUP 7505 Fannin St. Suite 610 Houston TX 77054 Tel: 713-467-2607 Email: davekim@mtech-inc.net

III. Proposed Device Identification

Trade Name	MagiCath II
Common Name	Short-Term Less Than 30 Days Intravascular TherapeuticCatheter
Regulation Name	Intravascular catheter
Regulation Number	21 CFR §880.5200
Product Code	FOZ
Regulatory Class	Class II
510(k) Review Panel	General hospital

IV. Predicate Device

Trade Name	BD Insyte™ Autoguard™ Intravascular Catheter
510(k) Number	K013800
Regulation Number	21 CFR §880.5200
Product Code	FOZ
Regulatory Class	Class II
510(k) Review Panel	General hospital

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V. Device Description

VI. Indication for use

MagiCath II is inserted into the patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for the general patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure.

VII. Comparison of technological characteristics with the predicate device

Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject Safety IV Catheter MagiCath II achieves its intended use based on the same or similar technology and safety mechanism as the predicate device. The substantial equivalence comparison of the subject device to the predicate devices is provided in the table below.

	MagiCath II(K210929)	BD InsyteTMAutoguardTM(K013800)	Comparison
Indicationsfor Use	MagiCath II is inserted into thepatient's vascular system forshort-term use (less than 30days) to sample blood, monitorblood pressure, or administerfluids intravenously. Thesecatheters may be used for thegeneral patient population withconsideration given to theadequacy of vascular anatomyand appropriateness ofprocedure.	An intravascular catheter is adevice that is inserted into thepatient's vascular system forshort term use (less than 30days) to sample blood, monitorblood pressure, or administerfluids intravenously. Thesecatheters may be used forany patient population withconsideration given to adequacyof vascular anatomy andappropriateness of procedure.	Similar
Materials
	Catheter tubePolyurethane	Catheter tubeBD Vialon polyurethane	Differences are discussed in Note 1
	Catheter hubPolypropylene	Catheter hubPolypropylene
	Catheter WedgeStainless steel	Catheter WedgeStainless steel
	NeedleStainless steel	NeedleStainless steel
	Needle hubPolycarbonate	Needle hubPropionate
	Needle CoverPolypropylene	Needle CoverPolypropylene
	Vent filterPolyethylene with filter	Vent filterPolypropylene with filter
	Lubricant for needle & catheterPolydimethylsiloxane	Lubricant for needle & catheterPolydimethylsiloxane-based Lubricant
Safetymechanism	Passive_A needle shield passivelycovers the guide needle whenneedle is upright after beingwithdrawn from the catheter_Whole length cannulaincluding the cannula tip isshielded	Active_A needle is moved backactively by spring when thebutton is pushed_Whole length cannulaincluding the cannula tip isshielded	Thedifference isdiscussed inNote 2
Flashback	When the catheter and needleare properly placed inside thevessel, flashback can beconfirmed after blood flowthrough ditch on the cannulasurface.	When the catheter and needleare properly placed inside thevessel, flashback can beconfirmed after blood flowthrough ditch on the cannulasurface.	Identical
Sterilization	Ethylene Oxide	Ethylene Oxide	Identical
Shelf-life	3 years	3 years	Identical
Catheterspecification	Catheter Diameters:18G, 20G, 22G, 24GCatheter Lengths:0.75", 1.00", 1.16", 1.88"	Catheter Diameters:14G, 16G, 18G, 20G, 22G, 24GCatheter Lengths:0.75", 1.00", 1.16", 1.25",1.77",1.88"	Thedifference isdiscussed inNote 3
		Winged or Non-winged

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Note 1

MagiCath II is composed of different materials than the predicate device. These differences do not raise new or other questions of safety or effectiveness because all materials used in the subject device are widely used for the IV catheters and are considered minor differences. The biocompatibility was assessed in accordance with ISO10993 series to demonstrate the biological safety of the device.

Note 2

The difference between the subject device and the predicate device is the operation method of the needlestick safety function. The safety function of BD Insyte™ Autoguard™ is operated actively when the push-button is pushed. The safety function of MagiCath II is operated passively. The needle fully enters the shield when the device is placed upright after disconnecting from the catheter. As the needle enters the shield, it rotates 90 degrees along the specifically designed line inside Shield Bottom and connects with the Inners, and the needle is fully retracted within the housing of thedevice.

Even when turned upside down, the sharp prevention never is deactivated. These differences do not raise new or different questions of safety or effectiveness because the Safety IV catheters, including both subject and predicate device, are designed for the needle to be stored inside the shield when the safety function is activated in order to prevent accidental needlestick injuries. Performance testing per ISO 23908:2011 demonstrated that the safety mechanism feature performs as intended.

Note 3

The subject device has fewer models, and the diameter and lengths are within the predicate's configurations. And that these differences do not raise new or different questions of safety or effectiveness.

VIII. SAFETY & PERFORMANCE DATA

Bench testing was performed to ensure the safety and effectiveness of the MagiCath II, Safety IV Catheter. Verification testing conforming to the standards listed in this application demonstrate substantial equivalence to the predicate device. No new safety and effectiveness questions are raised with the testing performed. Therefore, the MagiCath II is substantially equivalent to the predicate device.

Performance

ISO 594-1:1986, "Conical fitting with 6% (Luer) taper for syringe, needles and certain other medical equipment - Part 1: General requirements"
ISO 594-2:1998, "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"
ISO 10555-1:2013, "Intravascular catheter Sterile and single-use catheter Part 1: General requirements"
ISO 10555-5:2013, "Intravascular catheter Sterile and single-use catheter Part 5: Overneedle peripheral catheters"
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 testmethods"
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

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VOO YOUNG MEDICAL CO., LTD.

FDA Guidance for Medical Devices with Sharps Injury Prevention Features Guidance for Industry and FDA Staff
USP <788> Particulate Matter in Injections test

Biocompatibility testing

The biocompatibility evaluation for the MagiCath II was conducted in accordance with the International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing included the following:

ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization
ISO 10993-10 Intracutaneous (Intradermal) Reactivity
ISO 10993-11 Acute Systemic Toxicity
ISO 10993-11 Material-Mediated Pyrogen
ISO 10993-11 Subacute/Subchronic Toxicity
ISO 10993-3/ISO 10993-33 Genotoxicity (Bacterial reverse mutation & In Vitro Mammalian chromosomal aberration)
ISO 10993-4/ASTM F756-17 In Vitro Hemolysis Test by Direct Contact and Indirect Contact Methods
ISO 10993-4/ASTM F2382-18 In Vitro Partial Thromboplastin Time
ISO 10993-4/ASTM F2888-19 In Vitro Hemocompatibility Assessment by Evaluating Platelet Leukocyte Counts and ItsAdherence
ISO 10993-4 In Vitro SC5b-9 Complement Activation
ISO 10993-6 Implantation

Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with 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."

IX. CONCLUSIONS

Based on the Indications for Use, technological characteristics, and performance testing, the subject device, MagiCath II safety IV catheter, does not raise different questions of safety and effectiveness when compared to the predicate. Therefore, it is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).