(251 days)
Not Found
No
The summary describes a standard medical device (Foley catheter with temperature sensor) and its materials, intended use, and performance testing related to MR compatibility. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies.
No.
The device is intended for drainage/collection of urine and simultaneous monitoring of body core temperature, which are diagnostic and supportive functions, not therapeutic.
No.
Explanation: The device is primarily for drainage/collection of urine and simultaneous monitoring of body core temperature, which are functions related to treatment and general physiological monitoring, not diagnosing a specific disease or condition.
No
The device description clearly states it is a physical catheter made of silicone with a temperature sensor, balloon, and other hardware components. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The description clearly states the device is a Foley catheter used for the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature. These are functions performed within the body (in vivo).
- No Sample Analysis: The device collects urine, but it doesn't perform any analysis on the urine sample itself to diagnose a condition. The temperature sensor monitors the body's core temperature, which is also an in vivo measurement.
The device is a medical device used for therapeutic (drainage) and monitoring (temperature) purposes within the patient's body.
N/A
Intended Use / Indications for Use
All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The All Silicone Foley Catheter with Temperature Sensor is made from medical grade silicone, consists of temperature sensor for monitoring core body temperature and Foley catheter including a shaft, drainage funnel, inflation funnel, balloon, valve, and X-ray opaque line. The device is provided sterile by ethylene oxide and is for single use only. It is provided in a variety of sizes and color-coded by size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder
Indicated Patient Age Range
Not Found
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)
Bench-top testing was conducted to assure conformance to the following standards:
- ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced . Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182-19, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
The performance data support that the subject device can be labeled "MR Conditional."
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services logo. The FDA logo is in blue and features the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. The Department of Health & Human Services logo is on the left and features a stylized human figure.
April 8, 2021
Well Lead Medical CO., LTD. Jenny Zhu RA Specialist C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou. Guangdong 511434 China
Re: K202134
Trade/Device Name: All Silicone Foley Catheter with Temperature Sensor Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: March 5. 2021 Received: March 11, 2021
Dear Jenny Zhu:
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/cfpmr/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.
1
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); 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 (QS) 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,
Sharon M. Andrews -S
For Jessica K. Nguyen, Ph.D. Assistant 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) K202134
Device Name
All Silicone Foley Catheter with Temperature Sensor
Indications for Use (Describe)
All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (21 CFR 201.2) | ☐ Over-The-Counter Use (21 CFR 201.2) |
|---|---|
| ----------------------------------------------------------------------------------- | --------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K202134
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter Information
| Date Prepared: | April 6, 2021 |
|---|---|
| Submitter: | WELL LEAD MEDICAL CO., LTD. |
| Address: C-4 # Jinhu Industrial Estate, Hualong, Panyu, Guangzhou | |
| 511434, P.R. China | |
| Jenny Zhu | |
| RA Specialist | |
| Contact Person: | WELL LEAD MEDICAL CO., LTD. |
| Email: jenny_zhu@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Device Name: | All Silicone Foley Catheter with Temperature Sensor |
| Common Name: | Foley Catheter |
| Regulation Number: | 21 CFR 876.5130 |
| Regulation Name: | Urological catheter and accessories |
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| Product Code: | EZL (catheter, retention type, balloon) |
|---|---|
| Regulatory Class: | Class II |
| Predicate Device(s): | K091516-Well Lead All Silicone Foley Catheter with Temperature Sensor |
2. Intended Use
All Silicone Foley Catheter with Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
3. Device Description
The All Silicone Foley Catheter with Temperature Sensor is made from medical grade silicone, consists of temperature sensor for monitoring core body temperature and Foley catheter including a shaft, drainage funnel, inflation funnel, balloon, valve, and X-ray opaque line. The device is provided sterile by ethylene oxide and is for single use only. It is provided in a variety of sizes and color-coded by size.
4. Substantial Equivalence-Comparison to Predicate Device
The All Silicone Foley Catheter with Temperature Sensor has the same intended use as the predicate device. It is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals. The subject device uses the same design, materials, and manufacturing technique as the predicate device; and therefore, the subject and predicate device have technological characteristics.
The All Silicone Foley Catheter with Temperature Sensor differs from the predicate device in MR compatibility. The predicate device is labeled "Safety in MRI Not Evaluated" and the subject device is labeled "MR Conditional."
5. Summary of Non-Clinical Testing
Bench-top testing was conducted to assure conformance to the following standards:
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ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced . Displacement Force on Medical Devices in the Magnetic Resonance Environment
♦ ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
♦ ASTM F2182-19, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2503-13, Standard Practice for Marking Medical Devices and Other Items for Safety � in the Magnetic Resonance Environment
The performance data support that the subject device can be labeled "MR Conditional."
6. Conclusion
The All Silicone Foley Catheter with Temperature Sensor is substantially equivalent to predicate device.