(134 days)
No
The description focuses on the physical components and basic functions of a catheter for urine drainage and temperature sensing, with no mention of AI or ML capabilities.
No.
The device is used for drainage/collection and temperature monitoring, which are diagnostic and supportive functions, not therapeutic treatments.
Yes
The device is intended for "simultaneous monitoring of the body core temperature," indicating that it provides information about a patient's physiological state, which is a diagnostic function.
No
The device description clearly outlines a physical catheter with multiple lumens, balloons, and a temperature sensing capability, all made of silicone. The performance studies focus on physical and biological properties of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage/collection of urine and simultaneous monitoring of body core temperature. This is a direct interaction with the patient's body for therapeutic (drainage) and monitoring purposes.
- Device Description: The description details a physical catheter inserted into the bladder for drainage and temperature sensing.
- Lack of In Vitro Testing: The description of performance studies focuses on functional performance of the catheter itself, biocompatibility, sterilization, and packaging. There is no mention of testing biological samples (like urine) outside of the body to diagnose a condition or provide information about a patient's health status.
- No Mention of Analyzing Samples: The device collects urine, but it doesn't perform any analysis on the urine itself to provide diagnostic information. The temperature sensing is a measurement of the patient's body temperature, not an analysis of a biological sample.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter 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.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter 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. The device is a Foley Catheter that is used for simultaneous monitoring of the body core temperature during surgical intervals. It is composed of 100% silicone.
The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter comes in two sizes (16Fr and 18Fr). The catheters consist of a shaft with eyelets near the tip, two (2) balloons, drainage funnel and two (2) inflation arms with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. When inflated the balloons retains the catheter within the bladder. There are four (4) lumens in each catheter: one (1) for urine drainage, two (2) for individual balloon inflation/deflation and one (1) for the temperature sensing capability. The device is EtO sterilized and is a single-use device.
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)
Nonclinical functional performance testing was performed based on the FDA consensus standard ASTM F623-99 (2013), Standard Performance Specification for Foley Catheter.
The biocompatibility evaluation of the subject device was based on:
- ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- FDA Guidance Document: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 16, 2016.
The subject device is considered as a mucosal contacting surface device with prolonged exposure.
The Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter is provided sterile and intended for single-use only. The finished device is sterilized via a validated EtO sterilization cycle and provide a Sterility Assurance Level (SAL) of 1 x 10 °.
The subject device was aged at a temperature of 55°C for three (3) time periods simulating one (1), two (2) and three (3) years of aging. After accelerated aging, the subject devices were evaluated for conformance to the FDA consensus standard ASTM F623-99 (2013), Standard Performance Specification for Foley Catheter.
The subject device is packaged in a Tyvek pouch and was subject to the following packaging tests: visual integrity of seals and package, dye penetration test and seal integrity.
Conclusion: The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Cath is substantially equivalent to the legally marketed predicate device as demonstrated by the same intended use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 29, 2018
Poiesis Medical, LLC % Grace Powers, MS, MBA, RAC Founder/Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE, Suite 3740 Atlanta, GA 30339
Re: K173533
Trade/Device Name: Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: February 23, 2018 Received: February 26, 2018
Dear Grace Powers:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173533
Device Name
Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Indications for Use (Describe)
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter 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.
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)
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Section 5 510(k) Summary - K173533 Traditional 510(k) - Poiesis Medical, LLC Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Image /page/3/Picture/3 description: The image shows the logo for Poiesis Medical LLC. The word "Poiesis" is written in a large, blue, sans-serif font. A green graphic of leaves is placed in the middle of the word. Below "Poiesis" is the word "MEDICAL" in a smaller, teal, sans-serif font, and below that is "LLC" in an even smaller font.
Section 5 510(k) Summary - K173533
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Poiesis Medical, LLC
1095 Jupiter Park Drive
Suite 10
Jupiter, FL 33458 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
Tel: 404-931-8730 |
| Submission Date: | November 14, 2017 |
| Subject Device: | Trade Name: Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing
Catheter
Common Name: Catheter, Retention Type, Balloon (Urological Catheter)
Classification Name: Urological catheter and accessories
Regulation: 21 CFR §876.5130
Regulatory Classification: II
Product Code: EZL |
| Predicate Device:
Reference Device: | Legally marketed device to which substantial equivalence is claimed:
Poiesis Medical Duette™ 100% Silicone Dual-Balloon Catheter (K941488)
Well Lead Silicone Foley Catheter with Temperature Sensor (K091516) |
Device Description
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter 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. The device is a Foley Catheter that is used for simultaneous monitoring of the body core temperature during surgical intervals. It is composed of 100% silicone.
The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter comes in two sizes (16Fr and 18Fr). The catheters consist of a shaft with eyelets near the tip, two (2) balloons, drainage funnel and two (2) inflation arms with cap and valve. The eyelets allow for drainage of urine from the tip of the
4
Section 5 510(k) Summary - K173533
catheter through the drainage lumen. When inflated the balloons retains the catheter within the bladder. There are four (4) lumens in each catheter: one (1) for urine drainage, two (2) for individual balloon inflation/deflation and one (1) for the temperature sensing capability. The device is EtO sterilized and is a single-use device.
Table 1: Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter Product Offerings
| Catheter French Size | Product Reorder Number |
|---|---|
| 16Fr | D-10016T |
| 18Fr | D-10018T |
Figure 2 below shows a schematic of the Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter.
Image /page/4/Figure/7 description: This image shows a medical device with labels and a table describing the components. The device has a catheter shaft (3) with a base balloon (4) and a tip balloon (6) at the end. There are also balloon inflation valves (1), a drainage funnel (2), a drainage eye (5), and a temperature sensing connector (7).
Figure 2: Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter
Intended Use
Drainage of urine from the urinary bladder.
Indications for Use
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter 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.
Technological Characteristics
The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Cath has similar technological characteristics as the predicate device, Poiesis Medical Duette™ 100% Silicone Dual-Balloon cleared via K941488. The predicate device was cleared under a different name (DEVMED doubleballoon urinary catheter) but was acquired by the sponsor of this submission (Poiesis Medical) and has been marketed under the name Poiesis Medical Duette™ 100% Silicone Dual-Balloon Catheter since
5
Section 5 510(k) Summary - K173533 Traditional 510(k) — Poiesis Medical, LLC Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
- Both devices have the same intended use (to drain urine). They also have similar design features in that they are both 100% silicone multi-lumen Foley catheters with dual balloons and are composed of biocompatible materials. Additionally, they are both provided sterile in similar packaging for single-use.
The subject device differs from the predicate device as it incorporates a temperature-measuring feature for user convenience. The additional feature does not affect the intended use (to drain urine). A reference device, Well Lead Silicone Foley Catheter with Temperature Sensor, is included as this is a similar silicone Foley catheter made by the same manufacturer with the temperature sensing feature. The subject device has the same indications for use as the reference device.
Summary of Non-Clinical Testing
Nonclinical functional performance testing was performed based on the FDA consensus standard ASTM F623-99 (2013), Standard Performance Specification for Foley Catheter.
The biocompatibility evaluation of the subject device was based on:
- . ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- FDA Guidance Document: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" June 16, 2016.
The subject device is considered as a mucosal contacting surface device with prolonged exposure.
The Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter is provided sterile and intended for single-use only. The finished device is sterilized via a validated EtO sterilization cycle and provide a Sterility Assurance Level (SAL) of 1 x 10 °.
The subject device was aged at a temperature of 55°C for three (3) time periods simulating one (1), two (2) and three (3) years of aging. After accelerated aging, the subject devices were evaluated for conformance to the FDA consensus standard ASTM F623-99 (2013), Standard Performance Specification for Foley Catheter.
The subject device is packaged in a Tyvek pouch and was subject to the following packaging tests: visual integrity of seals and package, dye penetration test and seal integrity.
Conclusion
The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Cath is substantially equivalent to the legally marketed predicate device as demonstrated by the same intended use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.