SimPro™ Now is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

GentleCath™ Hydrophilic is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Device Description

The proposed devices: SimProTM Now and GentleCath™ Hydrophilic are a range of sterile, singleuse, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (Coudé tip) designs are available. Each catheter is individually packaged together with a sterile water sachet (packet) and an insertion guide. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing. The insertion guide is provided to minimize touching the catheter shaft directly during insertion and retraction.

AI/ML Overview

Acceptance Criteria and Device Performance for SimPro™ Now and GentleCath™ Hydrophilic Catheters

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical performance data for the SimPro™ Now and GentleCath™ Hydrophilic catheters. The acceptance criteria for these tests are generally stated as "All tests met the pre-determined acceptance criteria." While specific numerical acceptance criteria are not detailed in the provided text for each test, the document confirms that the device did meet these criteria. The table below summarizes the tests performed and the reported performance.

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Biocompatibility	Chemical characterization	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Cytotoxicity	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Irritation	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Sensitization	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Acute Systemic Toxicity	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Subacute Systemic Toxicity	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Genotoxicity	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
	Pyrogenicity	Met pre-determined acceptance criteria based on ISO 10993-1:2018(E) and FDA Guidance "Use of International Standard ISO 10993-1."
Sterile Barrier & Packaging	Packaging validation testing (e.g., ISO 11607-1, ISO 11607-2, ASTM F 1929-15)	Met pre-determined acceptance criteria. (Specifically mentioned: Sterile barrier systems confirmed, seal leaks by dye penetration, performance testing of shipping containers, conditioning, seal strength, packaging for terminally sterilized medical devices requirements).
Sterilization Validation	Sterilization process validation (e.g., ISO 11137-1, ISO 11137-2, ISO 11135, ISO 10993-7)	Met pre-determined acceptance criteria. (Specifically mentioned: Requirements for development, validation, and routine control of sterilization process, establishing sterilization dose, ethylene oxide sterilization, ethylene oxide sterilization residuals).
Shelf Life & Performance (ISO 20696:2018 & Internal Methods)	Flow rate (Annex E of ISO 20696:2018)	Met pre-determined acceptance criteria.
	Peak tensile force (Annex H of ISO 20696:2018)	Met pre-determined acceptance criteria.
	Connector security (internal test method)	Met pre-determined acceptance criteria.
	Kink stability (internal test method)	Met pre-determined acceptance criteria.
	Friction (internal test method)	Met pre-determined acceptance criteria.
	Water retention (internal test method)	Met pre-determined acceptance criteria.
	Coefficient of friction (internal test method)	Met pre-determined acceptance criteria.
	Packaging sterile integrity (internal test method)	Met pre-determined acceptance criteria.
	Primary package seal strength (internal test method)	Met pre-determined acceptance criteria.
	Catheter soaking time prior to use (internal test method)	Met pre-determined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for the test sets in each non-clinical performance test. However, it indicates that testing was performed according to various ISO and ASTM standards, which typically prescribe minimum sample sizes for their respective tests.

The data provenance is non-clinical bench testing. There is no information provided about the country of origin of the data, as it relates to laboratory testing rather than patient data. The tests are inherently prospective in nature for device qualification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The study described is a non-clinical bench study, not involving human interpretation or ground truth established by experts in a clinical context. The "ground truth" for these tests is defined by the technical specifications and requirements outlined in the referenced ISO and ASTM standards.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment of data. Since this is a non-clinical bench study, such methods are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No data from human clinical studies has been included to support the substantial equivalence of the proposed SimPro™ Now and GentleCath™ Hydrophilic." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance was done as this is a physical medical device (catheter) and not an AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by:

International Standards: ISO 10993 series for biological safety, ISO 11607 series and ASTM standards for packaging, ISO 11137 and ISO 11135 for sterilization, and ISO 20696:2018 for urethral catheters.
Internal Test Methods: Developed by the manufacturer to verify specific performance properties (e.g., connector security, kink stability, friction, water retention, coefficient of friction, packaging sterile integrity, primary package seal strength, catheter soaking time). These internal methods would have their own defined acceptance criteria.

8. The Sample Size for the Training Set

This question is not applicable. As stated, this is a non-clinical bench study for a physical medical device and does not involve AI or machine learning, and therefore no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of device qualification.

Summary

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May 4, 2023

Dentsply Sirona Laura Sobrin Corporate Regulatory Affairs Manager 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K223756

Trade/Device Name: SimPro™ Now, GentleCath™ Hydrophilic Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter And Accessories Regulatory Class: II Product Code: EZD Dated: December 15, 2022 Received: April 4, 2023

Dear Laura Sobrin:

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/cfpmn/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. 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

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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-regulatory-information/postmarketing-safety-reportingcombination-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,

Jessica K. Nguyen -S

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

Submission Number (if known)

K223756

Device Name

SimPro™ Now

GentleCath™ Hydrophilic

Indications for Use (Describe)

GentleCath™ Hydrophilic is for Clean Intermittent Catheterization-ClC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

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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510(k) SUMMARY for SimPro™ Now and GentleCath™ Hydrophilic K223756

Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404

Contact Person: Laura Sobrin Telephone Number: 717-849-4434 Fax number: 717-849-4343

Date Prepared: April 3, 2023

2. Device Name:

Proprietary Name: SimPro™ Now and GentleCath™ Hydrophilic ●
Intermittent urinary catheter ● Common Name:
Classification Name: Urological catheter and accessories ●
CFR Number: 21 CFR 876.5130 ●
Device Class: Class II
Product Code: EZD, Catheter Straight ●

3. Predicate and Reference Devices:

Type	Device Name	510(k)	Company Name
Predicate device	Hi-Slip® Plus	K062444	OASIS MEDIKAL A.S.
Reference device	GentleCath Glide Catheter	K161344	ConvaTec Limited

4. Description of Device:

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న. Indications for Use:

6. Intended use population

SimPro™ Now and GentleCath™ Hydrophilic catheters are intended for male, female and pediatric patients (children, adolescents and transitional adolescents B (18 years old to less than 22 years old but treated like and adult)).

7. Comparison of Technological Characteristics:

The purpose of this Traditional 510(k) is to gain U.S. premarket clearance for the modification to the predicate device Hi-Slip® Plus (K062444).

The proposed and predicate devices have the same intended use, patient population and ● indications for use.
The proposed and predicate devices are sterile, single use, hydrophilic coated catheters, use the . same operational principle, incorporate the same basic design, and have similar materials.
. The proposed and predicate devices have similar packaging configuration and are sterilized using the same method and processes.

The key differences between the predicate device (K062444) and the proposed devices are:

Additional sizes and diameters .
Addition of insertion guide for non-touch technique .
. Change in plasticizer material used in catheter body and funnel
Updates made to Instructions for Use for reduction of soaking time and other minor updates ●
Change in packaging materials supplier but similar materials and same configuration ●

An overview of the similarities and differences between the proposed devices and predicate device is given in Table FS-1.

8. Non-Clinical Performance Data

Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence includes:

a) Qualification of biological safety assessment according to ISO 10993-1:2018(E), Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1". Testing performed included Chemical characterization, Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subacute Systemic Toxicity, Genotoxicity, and Pyrogenicity.

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b) Test methods for confirmation of sterile barrier systems and packaging validation testing following requirements in:
- . ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F 1929-15, Standard test method for detecting seal leaks in porous medical packaging by . dye penetration.
- ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and ● Systems
- ASTM D4332-14, Standard Practice for Conditioning Containers Packages or Packaging Components for Testing
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials ●
- EN 868-5:2018, Packaging for terminally sterilized medical devices Part 5- Sealable pouches ● and reels of porous materials and plastic film construction – Requirements and test methods.
c) Sterilization validation was performed according to
- . ISO 11137-1:2006/(R)2015, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013, Sterilization of health care products Radiation Part 2: Establishing the . sterilization dose.
- ISO 11135:2014. Sterilization of health-care products Ethylene oxide Requirements for the . development validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide . sterilization residuals.
d) Shelf life and Performance bench testing was performed per applicable sections of ISO 20696:2018. Sterile urethral catheters for single use, and internal test methods to document the following properties of the catheters:
- Flow rate was verified by the test method in Annex E of ISO 20696:2018. .
- Peak tensile force was verified by the test method in Annex H of ISO 20696:2018. .
- Connector security was verified by internal test method. ●
- Kink stability was verified by internal test method. ●
- Friction was verified by internal test method. ●
- Water retention was verified by internal test method. ●
- . Coefficient of friction was verified by internal test method.
- Packaging sterile integrity was verified by internal test method. ●
- Primary package seal strength was verified by internal test method.
- Catheter soaking time prior to use according to the Instructions for Use was verified by internal test method.

All tests met the pre-determined acceptance criteria.

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The results of the testing show substantial equivalence in performance of the proposed device when compared to the predicate device (K062444) and reference device (K161344).

9. Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of the proposed SimPro™ Now and GentleCath™ Hydrophilic.

10. Conclusion

The proposed devices and the predicate device (K062444) have the same intended use and indications for use, are sterile, single use catheters, incorporate the same basic design, incorporate the same or very similar materials, and have similar packaging configuration. Performance data are included to address the safety and effectiveness of the proposed devices. The results of non-clinical bench testing, combined with the design, biocompatibility, and intended use comparison to the predicate device (K062444) demonstrate that the proposed devices are as safe, as effective and perform as well as the legally marketed device.

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	Proposed Devices		Predicate Device	Reference Device	Discussion
Element	SimPro™ Now	GentleCath™Hydrophilic	Hi-Slip® Plus (K062444)	GentleCath GlideIntermittent Catheter(K161344)
Product Code	EZD	EZD	EZD	GBM	Same as predicate device
Device forPrescription use	Yes	Yes	Yes	Yes	Same
Indications for Use	SimPro™ Now is for CleanIntermittent Catheterization-CICtreatment and is indicated for use bypatients with chronic urine retention.The catheter is inserted into thebladder through the urethra foremptying the bladder.	GentleCath™ Hydrophilic is forClean Intermittent Catheterization-CIC treatment and is indicated for useby patients with chronic urineretention. The catheter is inserted intothe bladder through the urethra foremptying the bladder.	Hi-Slip® Plus is launched forClean IntermittentCatheterization-CIC treatmentand is indicated for use bypatients with chronic urineretention. The catheter isinserted into the bladder throughthe urethra for emptying thebladder.	Intermittent catheters areindicated for routinetransient intermittentdrainage of the bladder.The catheter is insertedthrough the urethra.GentleCath Glideintermittent catheter isintended for adult useonly.	Same as predicate device
Anatomical site	Bladder through the Urethra		Bladder through the Urethra	Bladder through theUrethra	Same
Patient population	Intended for male, female andpediatric patients (children,adolescents and transitionaladolescents B (18 years old to lessthan 22 years old but treated like andadult)).		Intended for male, female andpediatric patients (children,adolescents and transitionaladolescents B (18 years old toless than 22 years old but treatedlike and adult)).	Intended for male andfemale patients	Same as predicate device
Principal ofoperation	• Squeeze water pocket• Peel pack open• Insert catheter• Empty bladder• Withdraw catheter	• Squeeze water pocket• Peel pack open• Insert catheter• Empty bladder• Withdraw catheter	• Squeeze water pocket• Peel pack open• Insert catheter• Empty bladder• Withdraw catheter	• Squeeze waterpocket• Peel pack open• Insert catheter• Empty bladder• Withdraw catheter	Same
	Proposed Devices		Predicate Device	Reference Device	Discussion
Element	SimPro™ Now	GentleCath™Hydrophilic	Hi-Slip® Plus (K062444)	GentleCath GlideIntermittent Catheter(K161344)
	• Dispose device		• Dispose device	• Dispose device
Catheter tipConfiguration	Nelaton (Straight) tip &Tiemann (Coudé tip) tip		Nelaton (Straight) tip &Tiemann (Coudé tip) tip	Nelaton (Straight) tip &Tiemann (Coudé tip) tip	Same
Type/Sizes	NelatonCH.8, 10, 12, 14,16 & 18in 15cm lengthNelatonCH.6, 8, 10, 12,14, 16 & 18in 20cm lengthNelatonCH.6, 8 & 10in 30cm lengthNelatonCH.8, 10, 12, 14,16, 18, 20 & 22in 40cm length	NelatonCH.8, 10, 12,14 & 16in 20cm lengthNelatonCH.8, 10, 12,14, 16 & 18in 40cm length	NelatonCH.6, 8, 10, 12, 14, 16 & 18in 20cm lengthNelatonCH.6, 8 & 10in 30cm lengthNelatonCH.8, 10, 12, 14, 16, 18, 20, 22& 24in 40cm length	NelatonCH.8, 10, 12, 14, 16in 15cm lengthNelatonCH.8, 10, 12, 14, 16 &18in 20cm length	SimilarTo facilitate handling by femaleusers, a shorter catheter (15cm)has been added to the proposedSimPro™ Now.With the exception of the 40cmTiemann tip catheter which hasbeen expanded to include anadditional diameter of CH20,all other sizes are within therange of predicate device Hi-Slip Plus (K062444).
	TiemannCH.10, 12, 14, 16,18 & 20in 40cm length	TiemannCH.10, 12, 14,16 &18in 40cm length	TiemannCH.10, 12, 14, 16 &18in 40cm length	TiemannCH.8, 10, 12, 14, 16&18in 40cm length
Catheter tubeMaterial	Polyvinylchloride (PVC) +Dioctyl terephthalate (DEHT)		Polyvinylchloride (PVC) +Di(2-ethylhexyl) (DEHP)	Polyolefin BasedSynthetic ThermoplasticElastomer (POBE)	Same base material, differentplasticizer as predicate deviceThe proposed device iscomposed of identical basematerial (PVC) with a non-
	Proposed Devices		Predicate Device	Reference Device	Discussion
Element	SimPro™ Now	GentleCath™Hydrophilic	Hi-Slip® Plus (K062444)	GentleCath GlideIntermittent Catheter(K161344)
					phthalate plasticizer (DEHT).Biocompatibility testing wasperformed to address materialformulation differencesbetween the proposed andpredicate device in support ofsubstantial equivalence.
Hydrophilic surfacecoating	Polyvinylpyrrolidone (PVP) & NaCl		Polyvinylpyrrolidone (PVP) &NaCl	Hydrophilic additivewithin the base material(unknown)	Same as predicate device
Hydrophilic coatingactivation	Integrated water sachet with sterilewater		Integrated water sachet withsterile water	Integrated water sachetwith sterile water	Same
Catheter funnel	Color coded end-funnel withinsertion guide		Color coded end-funnelNo insertion guide	Color coded end-funnelwith insertion sleeve	Similar to predicate andreference devicesThe proposed devices areprovided with insertion guide tominimize touching the cathetershaft directly during insertionand retraction. This has thesame functionality as theinsertion sleeve in the referencedevice.Both predicate and proposeddevices are composed of thesame base material for thecatheter funnel. The proposedfunnel material contains a non-phthalate plasticizer.
Single Package	Paper and film peel pack		Paper and film peel pack	Paper and film peel pack	SimilarSame packaging configurationand similar materials.Packaging testing has beenconducted and included toaddress material formulation
Element	Proposed Devices		Predicate Device	Reference Device	Discussion
	SimPro™ Now	GentleCath™ Hydrophilic	Hi-Slip® Plus (K062444)	GentleCath Glide Intermittent Catheter (K161344)
					and sterility integrity in supportof substantial equivalence.
Sterilization method	Ethylene Oxide &gamma irradiation (water sachet)	Ethylene Oxide &gamma irradiation (water sachet)	Ethylene Oxide	Same as predicate device
Condition of Use	Single Use	Single Use	Single Use	Same
Shelf Life	3 years	3 years	18 months	Same as predicate device

Table FS-1: Comparison of technological characteristics between proposed, predicate, and reference devices

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K223756

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K223756
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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.