(13 days)
Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only
Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only
The Well Lead Latex and Silicone Foley catheters are two-way Foley catheters which are placed in the bladder throught the urethra. The urine drains out through the catheter into a collection device attached to the catheter.
Based on the provided text, here's a detailed analysis of the acceptance criteria and the study performed for the Well Lead Silicone and Latex Foley Catheters:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Conformance to ASTM F 623-99 | The dimensions, design, sterility, and packaging of the Well Lead Foley Catheters (silicone and latex) conform to ASTM F 623-99. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify a sample size used for a test set. It mentions conformance to an ASTM standard, which implies testing was conducted, but the details of that testing, including sample specifics, are not present. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" in the context of typical diagnostic device studies. The performance is assessed against an engineering standard (ASTM F 623-99), not through expert consensus on medical images or diagnoses.
4. Adjudication Method:
Not applicable. This device is a medical catheter, and its performance is evaluated against engineering and manufacturing standards, not through adjudication of diagnostic outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The provided text does not describe an MRMC comparative effectiveness study. This type of study is relevant for diagnostic AI devices where human readers interpret medical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is adherence to the specifications outlined in the ASTM F 623-99 standard. This standard likely covers physical dimensions, material properties, sterility, and packaging integrity. It's an engineering/manufacturing standard, not clinical pathology or outcomes data.
8. The Sample Size for the Training Set:
Not applicable. This section is relevant for AI/ML devices that require training data. The Well Lead Foley Catheters are physical medical devices.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This section is relevant for AI/ML devices.
Summary of Device Performance Study:
The "study" cited in the document is the claim that the device "conform[s] to ASTM F 623-99." This indicates that the manufacturer has performed internal testing and quality control procedures to ensure their Foley catheters meet the established specifications of this American Society for Testing and Materials (ASTM) standard. ASTM F 623-99, titled "Standard Specification for Foley Catheter," would define the precise requirements for aspects like catheter diameter, balloon volume, material strength, leakage, and other critical performance characteristics. The document does not provide a detailed report of the specific tests conducted, the sample sizes for those tests, or the raw data, but rather states the conclusion of conformance to the standard.
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510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Well Lead Medical InstrumentsA4-1# Jinhu Industrial EstateHualong, Pan YuGuangdong, China 511434 |
|---|---|
| Phone: 8620 84752978Fax: 8620 84758224 | |
| Contact Person: | Han Guang Yuan |
| Date of Summary: | 5/09/07 |
| Trade/Proprietary Name: | Well Lead All Silicone Foley CathetersWell Lead Latex Foley Catheters |
| Classification Name: | Silicone - Catheter, Retention Type, BalloonLatex - Urological catheter and accessories |
| Product Code: | Silicone - EZLLatex - MJC |
Intended Use:
Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only
Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only
Device Description:
The Well Lead Latex and Silicone Foley catheters are two-way Foley catheters which are placed in the bladder throught the urethra. The urine drains out through the catheter into a collection device attached to the catheter.
Device Performance:
The dimensions, design, sterility and packaging of the Well Lead Foley Catheters (silicone and latex) conform to ASTM F 623-99.
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Predicate Device:
Silicone - K981612 - Rochester Medical all Silicone Foley Catheter Latex - K040658 - Bard I.C
Substantial Equivalence:
Well Lead Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K981612 and K040658. Well Lead Medical Products claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles, and physical, operational specifications as compared to the predicate devices.
The similarities and differences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission. Additionally, this matrix is included as an attachment to the 510(k) Summary. These differences have no effect on safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2008
Well Lead Medical Instruments Co. % Mr. Jay Y. Kogoma Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K082815
Trade/Device Name: Well Lead Silicone and Latex Foley Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 24, 2008 Received: September 25, 2008
Dear Mr. Kogoma:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko82815
Device Name: Well Lead Silicone and Latex Foley Catheters
Indications for Use:
Two - Way Catheters - Urethral catheterization for bladder drainage for urological use only.
Three - Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi Heitner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
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§ 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.