(137 days)
Not Found
No
The summary describes a standard Foley catheter and does not mention any AI or ML capabilities.
Yes
The device is intended for "bladder drainage" and "bladder irrigation," which are medical interventions performed to treat or manage a patient's health condition.
No
The device is a catheter used for bladder drainage and irrigation, which are therapeutic and management functions, not diagnostic. While a radiopaque version allows for visualization, this is for placement and monitoring, not for diagnosing a condition itself.
No
The device description clearly describes a physical catheter with a tube, drainage eye, and balloon, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Urethral catheterization for bladder drainage and bladder irrigation." This is a procedure performed on the patient's body to manage bodily fluids.
- Device Description: The device is a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device described is a medical device used for a therapeutic or diagnostic procedure performed directly on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
78 EZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to predicate device, Safety and Effectiveness. 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"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- 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
-
- Equivalent legally marketed device: All Silicone Foley Catheters, Rochester Medical Corp. K981612.
-
- 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.
-
- 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.
1
Element of Comparison | ||
---|---|---|
All Silicone | ||
Foley Catheters, | ||
Rochester Medical Corp. | ||
K 981612 | ALL SILICONE | |
FOLEY BALLOON | ||
CATHETER | ||
Sewoon 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, 30cc | |
3 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, 26Fr | ||
3 way: 16Fr, 18Fr, 20Fr, 22Fr, | ||
24Fr, 26Fr | 2 way: 6Fr, 8Fr, 10Fr, 12Fr, | |
14Fr, 16Fr, 18Fr, | ||
20Fr, 22Fr 24Fr, | ||
26Fr | ||
3 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"
2
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.
3
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
4
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
OR