Two-way and Three-way Disposable Silicone Foley Catheters are indicated for urethral catheterization for bladder drainage for urological use only. The Two-way Disposable Silicone Foley Catheters have an indwell time of no more than 30 days and are indicated for adult use only.

Device Description

This product is a Foley Balloon Catheter. It is a 'prescription only' device. It consists of a Manifold part and Shaft parts. The Manifold Part is equipped with a non-return valve for inflating the balloon and a band to fix the non-return valve and identify the catheter's size by its color. The Shaft parts have an x-ray opaque line for checking the position of the catheter by X-ray and a balloon to place the catheter in the bladder. After the catheter is inserted, distilled water or saline is injected to expand the balloon and fix the catheter in place. The shaft also contains drainage eyes for urine drainage, and a rounded tip to aid insertion of the catheter. This Foley Balloon Catheter will be provided in Two and Three-Way configurations. The Three-Way configuration contains an 'Irrigation Manifold' for washing the bladder with saline solution. The shaft and balloon of the catheter are made of silicone and zinc oxide. The tip and the manifold are made of silicone only. The proposed device is supplied in French sizes ranging from 12 to 24. It is available in 337(±15) mm and 345(±15) mm lengths with various balloon sizes. The devices for adults only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for disposable silicone Foley catheters, not an AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device, which involves comparing technological characteristics and presenting performance testing related to biocompatibility, sterilization, shelf-life, and functional testing per ASTM F623.

Since the prompt specifically asks about the study proving an AI/ML device meets acceptance criteria, and the document is about a physical medical device (Foley catheter) with no mention of AI/ML, I cannot extract the requested information.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 30, 2020

Apollon Co., Ltd. % Hvevoung Moon Assistant Manager TSD Life Sciences Co., Ltd. 211, Mallijae-ro, Jung-gu Seoul. 04508 Korea

Re: K201776

Trade/Device Name: Two-way and Three-way Disposable Silicone Foley Catheters Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: November 24, 2020 Received: November 24, 2020

Dear Hyeyoung Moon:

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.

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statutes and regulations administered by other Federal agencies.

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

You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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,

Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices 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) K201776

Device Name

Two-way and Three-way Disposable Silicone Foley Catheters

Indications for Use (Describe)

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows a logo for a company called APOLLON Co., Ltd. The logo features a stylized letter "A" in a dark blue color, enclosed within two concentric circles. The circles have small, solid black circles attached to them on either side of the letter "A". The company name, "APOLLON Co., Ltd.", is printed in black text below the circular logo.

510(k) Summary - K201776

[21 CFR 807.92]

1. Submitter Information

	Company Name	: APOLLON Co., Ltd.
	Company Address	: M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu, Incheon, Korea
	Company Phone	: +82-32-830-4724
	Contact Person	: Donghyuk Shin/ GeneralManagerdhshin@apollonmds.com
	Submission Correspondent	: Hyeyoung.moon/RAHyeyoung.moon@tsdls.co.krTel: +82-70-4224-9790
	Date Prepared	: December 28, 2020
2. Device Name
	Trade Device Name	: Two-way and Three-way Disposable Silicone Foley Catheters
	Common Name	: Foley Catheter
	Classification Name	: Urological Catheter and Accessories
	Classification Number	: 876.5130
	Regulatory Class	: II
	Product code(s)	: EZL
	Product code Name	: Catheter, Retention Type, Balloon
	Advisory Panel	: Gastroenterology/Urology
3. Predicate Device
	510(k) Number	: K130908:
	Device Name	: Disposable Silicone Foley Catheter
	Product Code	: EZL
	Manufacturer	: Guangdong Baihe Medical Technology Co., Ltd.

The predicate device is not the subject of a design related recall.

4. Device Description:

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Image /page/4/Picture/1 description: The image shows a logo for a company named APOLLON Co., Ltd. The logo features a stylized letter "A" in a dark blue color, enclosed within two concentric circles. The circles have small, circular extensions on either side, resembling electrical contacts. The company name "APOLLON Co., Ltd." is printed in a simple font below the circular logo.

510(k) Summary - K201776

[21 CFR 807.92]

balloon of the catheter are made of silicone and zinc oxide. The tip and the manifold are made of silicone only.

The proposed device is supplied in French sizes ranging from 12 to 24. It is available in 337(±15) mm and 345(±15) mm lengths with various balloon sizes. The devices for adults only.

5. Indication for use

Two-way and Three-way Disposable Silicone Foley Catheters are indicated for urethral catheterization for bladder drainage for urological use only. The Two-way and Three-way Disposable Silicone Foley Catheters have an indwell time of no more than 30 days and are indicated for adult use only.

6. Comparison of Technological Characteristics with Predicate Device

Features	Subject Device	Predicated Device
Device name	Two-way and Three-way DisposableSilicone Foley Catheters	Disposable Silicone Foley Catheter
510(k)Number	K201776	K130908
Manufacturer	APOLLON Co., Ltd.	Guangdong Baihe Medical Technology Co., Ltd.
Indication foruse	Two-way and Three-way Disposable SiliconeFoley Catheters are indicated for urethralcatheterization for bladder drainage forurological use only. The Two-way and Three-way Disposable Silicone Foley Catheters havean indwell time of no more than 30 days and areindicated for adult use only.	Two-way Disposable Silicone Foley Catheter:Urethral catheterization for bladder drainage forurological use only; the indwell time of theproposed device is no more than 30 days.Three-way Disposable Silicone Foley Catheter:Urethral catheterization for bladder drainage andbladder irrigation for urological use only; theindwell time of the proposed device is no morethan 30 days.
Population	Male and female (adult only)	Pediatric, male and female
Lumen	Two way and three way	Two way and three way
Indwell Time	No more than 30 days	No more than 30 days
Single Use	Yes	Yes
Size Range	Two way: 12,14,16,18,20,22,24FrThree way: 14,16,18,20,22,24Fr	Two way: 6,8,10,12,14,16,18,20,22,24 and 26FrThree way: 16,18,20,22,24 and 26Fr
Length	337( $\pm$ 15) and 345( $\pm$ 15) mm	310mm and 400mm
Balloon	Yes	Same
Balloon size	5cc and 30cc	1.5cc,3cc,5cc,10cc,15cc,20cc,30cc
Sterile	Yes	Same
Main ShaftMaterial	Silicone and Zinc Oxide	Silicone

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Image /page/5/Picture/1 description: The image shows a logo for Apollon Co., Ltd. The logo features a stylized letter "A" in blue, enclosed within two concentric circles. The circles have small extensions with dots on either side, resembling an electrical circuit. Below the circular logo, the text "APOLLON Co.,Ltd." is printed in a simple, sans-serif font.

510(k) Summary - K201776

[21 CFR 807.92]

Eyes in Tip	Yes	Same
Tip Shape	Rounded	Same
Performancetest	ASTM F623-99	Same

The subject and predicate device have the same intended by the above table, the subject and predicate device have different technological characteristics. The differences in technological characteristics do not raise different questions of safety or effectiveness.

7. Summary of Testing Performed

The sponsor provided the following performance testing to support substantial equivalence:

. Biocompatibility per ISO 10993 - cytotoxicity, sensitization, irritation or intracutaneous reactivity, material-mediated pyrogenicity, acute systemic toxicity, subacute toxicity, and implantation
Sterilization validation per ISO 11135:2014
. Shelf-life - transportation simulation, package integrity and functional testing
. Performance/Functional testing per ASTM F623

The protocol and results of the provided performance testing is acceptable.

8. Conclusion

The subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.