For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.

Device Description

The Sewoon Medical Device Corp. Ltd. catheter has a tube with a single drainage eye on the proximal tip. The catheter has an additional eye for irrigation purposes. The catheters are available with a radiopaque option. The catheter is available in a combination of French sizes, capacities and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths are 29 and 41 cm. French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.

AI/ML Overview

The provided text describes the Sewoon All-silicone Foley Balloon Catheter and its substantial equivalence to a predicate device, Rochester Medical Corp. K981612. The data focuses on the physical and performance characteristics of the catheter, rather than an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or cannot be extracted from the given document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ASTM F623-99)	Reported Device Performance
Clause 4.1 "Flow Rate Through the Drainage Lumen"	Meets ASTM F623-99 Standard
Clause 4.2 "Balloon Integrity, Resistance to Rupture"	Meets ASTM F623-99 Standard
Clause 4.3 "Inflated Balloon Response to pullout"	Meets ASTM F623-99 Standard
Clause 4.4 "Balloon Volume Maintenance"	Meets ASTM F623-99 Standard
Clause 4.5 "Balloon size and Shaft size"	Meets ASTM F623-99 Standard
Clause 4.6 "Deflation Reliability"	Meets ASTM F623-99 Standard
Clause 4.7 "Biocompatibility"	Meets ASTM F623-99 Standard

2. Sample size used for the test set and the data provenance:

Not Applicable. The device is a physical medical device (Foley catheter), not an AI/ML powered device that would typically use a "test set" in the context of data. The "testing" referred to is for physical performance criteria of the catheter.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing was conducted to meet ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This information pertains to studies for AI/ML devices where human experts establish ground truth for diagnostic or prognostic tasks. For a physical device like a catheter, the "ground truth" is defined by the objective physical and functional standards set by ASTM F623-99.

4. Adjudication method for the test set:

Not Applicable. As mentioned above, this applies to AI/ML device studies involving human interpretation and disagreement resolution. The catheter's performance is objectively measured against a standard.

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:

Not Applicable. This is a physical medical device. There is no AI component or human reader interaction described in the context of its performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This section describes an AI/ML algorithm's performance without human intervention. The device is a physical catheter, not an algorithm.

7. The type of ground truth used:

Objective Standards: The "ground truth" for the device's performance is established by the ASTM F623-99 Standard Performance Specifications for Foley Catheters. This standard defines the acceptable physical and functional characteristics of such devices.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML powered device.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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FEB 1 5 2002

EXHIBIT 2

Sewoon Medical Device Corp. Ltd. 238-108, Yongdoo-dong Dongdaemoon-gu, Seoul, KOREA Telephone : 82-2-922-6555 Fax: 82-2-922-6558 Contact Person: Gil Whan Lee September 10, 2001 Rev February 8, 2002 510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Sewoon All-silicone Foley Balloon Catheter. (Two way Three way, Radiopaque) Classification Name: Urological Catheter 78 EZL Common/Usual Name: Foley Balloon Catheter
1. Equivalent legally marketed device: All Silicone Foley Catheters, Rochester Medical Corp. K981612.
1. Indications for Use (intended use) For Urological Use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.
1. Description of the Device: The Sewoon Medical Device Corp. Ltd. catheter has a tube with a single drainage eye on the proximal tip. The catheter has an additional eye for irrigation purposes. The catheters are available with a radiopaque option. The catheter is available in a combination of French sizes, capacities and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths are 29 and 41 cm. French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.

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Element of Comparison
	All SiliconeFoley Catheters,Rochester Medical Corp.K 981612	ALL SILICONEFOLEY BALLOONCATHETERSewoon Medical Corp., ltd
Intended Use	For urological only	For urological only (SAME)
Material	Silicone Elastomer	Silicone Elastomer (SAME)
Lumen	2 way, 3way	2 way, 3way (SAME)
Balloon size	2 way: 1.5cc, 3cc, 5cc, 30cc3 way: 5cc, 30cc	2 way: 1.5cc, 3cc, 5cc, 30cc (SAME)3 way: 5cc, 30cc (SAME)
French size	2 way: 6Fr, 8Fr, 10Fr, 12Fr,14Fr, 16Fr, 18Fr,20Fr, 24Fr, 26Fr3 way: 16Fr, 18Fr, 20Fr, 22Fr,24Fr, 26Fr	2 way: 6Fr, 8Fr, 10Fr, 12Fr,14Fr, 16Fr, 18Fr,20Fr, 22Fr 24Fr,26Fr3 way: 16Fr, 18Fr, 20Fr, 22Fr,24Fr, 26Fr (SAME)
Lengths available	"Male and Female Lengths"(Actual lengths not published)	SAME: 29 and 41 cm
Sterilization	ETO	SAME

5. Safety and Effectiveness, comparison to predicate device:

Conclusion: In all respects, the All-Silicone Foley Balloon Catheters are substantially equivalent to one or more silicone balloon catheters that are legally marketed and/or were marketed prior to 1976. Testing and certifications demonstrate that the device meets the ASTM standard referenced above. All Silicone Foley Balloon catheters have been tested to and meet the following test requirements of ASTM F623-99 Standard Performance Specifications for Foley Catheters:

Clause 4.1 " Flow Rate Through the Drainage Lumen"

Clause 4.2 " Balloon Integrity, Resistance to Rupture

Clause 4.3 " Inflated Balloon Response to pullout"

Clause 4.4 "Balloon Volume Maintenance"

Clause 4.5 "Balloon size and Shaft size"

Clause 4.6 "Deflation Reliability"

Clause 4.7 "Biocompatibility"

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Sewoon Medical Device Corp. Ltd. c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K013276 Trade/Device Name: All-Silicone Foley Balloon Catheter (Two way; Three way, Radiopaque) Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: December 24, 2001 Received: December 26, 2001

Dear Mr. Kamm:

Dour MI. Hallini.
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(L) premaited is substantially equivalent (for the indications
referenced above and have determined the device is substantialy interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regally manced tecated Device Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Rederal Food Drug commerce prior to May 28, 1976, the enaculiers with the provisions of the Federal Food, Drug, devices that have been recrassilled in accordance was as a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate or aparal controls provisions of the Act. The You may, therefore, market the device, subject of annual registration, listing of
general controls provisions of the Act include requirements for annual registrating and general controls provisions of the Act monde roquilibitions against misbranding and and the production of the states adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), a
nd be If your device is classified (see above) more regulations affecting your device can be
it may be subject to additional controls. Existing major regulation EDA may it may be subject to additional controls. Latisting major 1990. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Tarts 800 to 898. In addition, FDA found in the Code of I ederal Rogalations, Four device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ing Active and Please be advised that FDA s issualice of a subscunser of the requirements of the Act
that FDA has made a determination that your device Force agencies. You must that FDA has made a delemination und your areas by other Federal agencies. You must or any Federal statutes and regulations anninisco, by on limited to: registration and listing
comply with all the Act's requirements, including, but no arcestion requirement comply with all the Act s requirements, metall); good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice th (2) CFR Part 807); labeling (21 CFR Pair 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, forth in the quality systems (Q5) regulations (S1-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri inding of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific advice for your de rice on one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promote the regulation entitled, "Misbranding Office of Compilance at (301) 377-10577 - 10577 Part 807.97). Other general information on by reletence to premaired nothers (on the Division of Small Manufacturers, your responsibilities and Consumer & its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number K013276

Device Name: Sewoon Medical Device Corp. Ltd. All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)

Indications for Use:

Indications for Use:
For urological use only. Two-Way Catheter: Urethral cathererization for bladder drainere and his For urological use only. Two-Way Catheterization for bladder drainage and bladder
drainage. Three -Way Catheter: Urethral catheterization for bladder drainage with drainage. Three -Way Catheter. Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v

Over the Counter Use_ (Per 21 CFR 801.109)

David C. Ingram

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.