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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove performance against specific acceptance criteria in the way an AI/ML device study would.

Therefore, the document does not contain the acceptance criteria or a study design in the context of an AI/ML device. Instead, it presents a summary of non-clinical testing performed to demonstrate that the device meets the safety and performance requirements expected of such a device and is substantially equivalent to existing devices.

Here's an attempt to answer the questions based on the non-clinical information provided, acknowledging the different context:

1. A table of acceptance criteria and the reported device performance

The document refers to the FDA consensus standard ASTM F623-99 (2013), "Standard Performance Specification for Foley Catheter," as the basis for nonclinical functional performance testing. While the standard serves as the acceptance criteria, the specific numerical targets and the detailed reported performance are not explicitly provided in the summary.

Acceptance Criteria (Based on ASTM F623-99)	Reported Device Performance
Functional Performance (e.g., balloon inflation/deflation, drainage, strength, biocompatibility, etc.)	Met the requirements of ASTM F623-99 (2013) for functional performance. Specific numerical results are not detailed in this summary.
Biocompatibility (according to ISO 10993-1:2009 and FDA Guidance)	Passed evaluation according to ISO 10993-1:2009 and FDA Guidance for mucosal contacting surfaces with prolonged exposure. Specific test results are not detailed.
Sterility Assurance Level (SAL)	Achieved SAL of 1 x 10⁻⁶ via validated EtO sterilization cycle.
Accelerated Aging/Shelf Life (simulating 1, 2, and 3 years)	Conformance to ASTM F623-99 (2013) after accelerated aging at 55°C for 1, 2, and 3 years. Specific performance metrics post-aging are not detailed.
Packaging Integrity (visual integrity, dye penetration, seal integrity)	Passed packaging tests (visual integrity of seals and package, dye penetration test, and seal integrity). Specific results are not detailed.

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

The document describes non-clinical testing rather than a study with a "test set" of patient data. The sample sizes for the various non-clinical tests (functional performance, accelerated aging, packaging) are not specified in this summary. The "data provenance" is derived from laboratory testing of the device itself.

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

This question is not applicable to the provided document. The ground truth for device performance in this context is established by adherence to recognized engineering standards (like ASTM F623-99) and validated testing methodologies, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

This question is not applicable. There is no "test set" in the context of human interpretation requiring adjudication.

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

This question is not applicable. The device is a physical medical catheter, not an AI/ML algorithm that assists human readers.

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

This question is not applicable. The device is a physical medical catheter, not an AI/ML algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is derived from:

Engineering specifications and standards: Adherence to defined performance limits within ASTM F623-99.
Biocompatibility standards: Compliance with ISO 10993-1.
Sterilization validation standards: Achieving a predetermined SAL (1 x 10⁻⁶).
Packaging integrity tests: Meeting established criteria for seal strength and integrity.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of an AI/ML device. The device is a physical product designed and tested against established engineering and medical standards.

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

This question is not applicable, as there is no training set.

Summary

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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.

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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)

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, LLC1095 Jupiter Park DriveSuite 10Jupiter, FL 33458
Submission Contact:	Grace Powers, MS, MBA, RACFounder/Principal ConsultantPowers Regulatory ConsultingTel: 404-931-8730
Submission Date:	November 14, 2017
Subject Device:	Trade Name: Duette™ 100% Silicone Dual-Balloon, Temperature-SensingCatheterCommon Name: Catheter, Retention Type, Balloon (Urological Catheter)Classification Name: Urological catheter and accessoriesRegulation: 21 CFR §876.5130Regulatory Classification: IIProduct 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

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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

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

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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.

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.