(140 days)
No
The device description and performance studies focus on the physical and material properties of the catheter, sterilization, packaging, and basic performance metrics like flow rate and friction. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML.
Yes
The device is used for Clean Intermittent Catheterization (CIC) treatment to empty the bladder in patients with chronic urine retention, which directly addresses a health condition.
No
Explanation: The device description states its purpose is for "drainage of the bladder," and the intended use indicates it's for "emptying the bladder" in patients with chronic urine retention. It is a therapeutic device, not a diagnostic one.
No
The device description clearly describes physical catheters, sterile water sachets, and insertion guides, which are hardware components. The performance studies also focus on the physical properties and sterilization of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Clean Intermittent Catheterization-CIC treatment" to empty the bladder. This is a physical procedure performed on the patient's body.
- Device Description: The device is a "urinary catheter" designed for "drainage of the bladder." This describes a physical tool used for a medical procedure.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The device is a medical device used for a therapeutic procedure (bladder drainage), not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
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-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.
Product codes
EZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bladder through the Urethra
Indicated Patient Age Range
patients (children, adolescents and transitional adolescents B (18 years old to less than 22 years old but treated like and adult)).
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)
Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence includes:
- 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.
- 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.
- 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.
- 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. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
1
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
2
Indications for Use
Submission Number (if known)
K223756
Device Name
SimPro™ Now
GentleCath™ Hydrophilic
Indications for Use (Describe)
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-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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3
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:
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.
4
న. Indications for Use:
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.
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.
5
- 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.
6
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.
7
| Proposed Devices | Predicate Device | Reference Device | Discussion | ||
|---|---|---|---|---|---|
| Element | SimPro™ Now | GentleCath™ | |||
| Hydrophilic | Hi-Slip® Plus (K062444) | GentleCath Glide | |||
| Intermittent Catheter | |||||
| (K161344) | |||||
| Product Code | EZD | EZD | EZD | GBM | Same as predicate device |
| Device for | |||||
| Prescription use | Yes | Yes | Yes | Yes | Same |
| Indications for Use | 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. | Hi-Slip® Plus is launched 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. | Intermittent catheters are | ||||
| indicated for routine | |||||
| transient intermittent | |||||
| drainage of the bladder. | |||||
| The catheter is inserted | |||||
| through the urethra. | |||||
| GentleCath Glide | |||||
| intermittent catheter is | |||||
| intended for adult use | |||||
| only. | Same as predicate device | ||||
| Anatomical site | Bladder through the Urethra | Bladder through the Urethra | Bladder through the | ||
| Urethra | Same | ||||
| Patient population | 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)). | 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)). | Intended for male and | ||||
| female patients | Same as predicate device | ||||
| Principal of | |||||
| operation | • 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 water | ||||
| • 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 Glide | |||
| Intermittent Catheter | |||||
| (K161344) | |||||
| • Dispose device | • Dispose device | • Dispose device | |||
| Catheter tip | |||||
| Configuration | Nelaton (Straight) tip & | ||||
| Tiemann (Coudé tip) tip | Nelaton (Straight) tip & | ||||
| Tiemann (Coudé tip) tip | Nelaton (Straight) tip & | ||||
| Tiemann (Coudé tip) tip | Same | ||||
| Type/Sizes | Nelaton | ||||
| CH.8, 10, 12, 14, | |||||
| 16 & 18 | |||||
| in 15cm length | |||||
| Nelaton | |||||
| CH.6, 8, 10, 12, | |||||
| 14, 16 & 18 | |||||
| in 20cm length | |||||
| Nelaton | |||||
| CH.6, 8 & 10 | |||||
| in 30cm length | |||||
| Nelaton | |||||
| CH.8, 10, 12, 14, | |||||
| 16, 18, 20 & 22 | |||||
| in 40cm length | Nelaton | ||||
| CH.8, 10, 12, | |||||
| 14 & 16 | |||||
| in 20cm length | |||||
| Nelaton | |||||
| CH.8, 10, 12, | |||||
| 14, 16 & 18 | |||||
| in 40cm length | Nelaton | ||||
| CH.6, 8, 10, 12, 14, 16 & 18 | |||||
| in 20cm length | |||||
| Nelaton | |||||
| CH.6, 8 & 10 | |||||
| in 30cm length | |||||
| Nelaton | |||||
| CH.8, 10, 12, 14, 16, 18, 20, 22 | |||||
| & 24 | |||||
| in 40cm length | Nelaton | ||||
| CH.8, 10, 12, 14, 16 | |||||
| in 15cm length | |||||
| Nelaton | |||||
| CH.8, 10, 12, 14, 16 & | |||||
| 18 | |||||
| in 20cm length | Similar | ||||
| To facilitate handling by female | |||||
| users, a shorter catheter (15cm) | |||||
| has been added to the proposed | |||||
| SimPro™ Now. | |||||
| With the exception of the 40cm | |||||
| Tiemann tip catheter which has | |||||
| been expanded to include an | |||||
| additional diameter of CH20, | |||||
| all other sizes are within the | |||||
| range of predicate device Hi- | |||||
| Slip Plus (K062444). | |||||
| Tiemann | |||||
| CH.10, 12, 14, 16, | |||||
| 18 & 20 | |||||
| in 40cm length | Tiemann | ||||
| CH.10, 12, 14, | |||||
| 16 &18 | |||||
| in 40cm length | Tiemann | ||||
| CH.10, 12, 14, 16 &18 | |||||
| in 40cm length | Tiemann | ||||
| CH.8, 10, 12, 14, 16 | |||||
| &18 | |||||
| in 40cm length | |||||
| Catheter tube | |||||
| Material | Polyvinylchloride (PVC) + | ||||
| Dioctyl terephthalate (DEHT) | Polyvinylchloride (PVC) + | ||||
| Di(2-ethylhexyl) (DEHP) | Polyolefin Based | ||||
| Synthetic Thermoplastic | |||||
| Elastomer (POBE) | Same base material, different | ||||
| plasticizer as predicate device | |||||
| The proposed device is | |||||
| composed of identical base | |||||
| material (PVC) with a non- | |||||
| Proposed Devices | Predicate Device | Reference Device | Discussion | ||
| Element | SimPro™ Now | GentleCath™ | |||
| Hydrophilic | Hi-Slip® Plus (K062444) | GentleCath Glide | |||
| Intermittent Catheter | |||||
| (K161344) | |||||
| phthalate plasticizer (DEHT). | |||||
| Biocompatibility testing was | |||||
| performed to address material | |||||
| formulation differences | |||||
| between the proposed and | |||||
| predicate device in support of | |||||
| substantial equivalence. | |||||
| Hydrophilic surface | |||||
| coating | Polyvinylpyrrolidone (PVP) & NaCl | Polyvinylpyrrolidone (PVP) & | |||
| NaCl | Hydrophilic additive | ||||
| within the base material | |||||
| (unknown) | Same as predicate device | ||||
| Hydrophilic coating | |||||
| activation | Integrated water sachet with sterile | ||||
| water | Integrated water sachet with | ||||
| sterile water | Integrated water sachet | ||||
| with sterile water | Same | ||||
| Catheter funnel | Color coded end-funnel with | ||||
| insertion guide | Color coded end-funnel | ||||
| No insertion guide | Color coded end-funnel | ||||
| with insertion sleeve | Similar to predicate and | ||||
| reference devices | |||||
| The proposed devices are | |||||
| provided with insertion guide to | |||||
| minimize touching the catheter | |||||
| shaft directly during insertion | |||||
| and retraction. This has the | |||||
| same functionality as the | |||||
| insertion sleeve in the reference | |||||
| device. | |||||
| Both predicate and proposed | |||||
| devices are composed of the | |||||
| same base material for the | |||||
| catheter funnel. The proposed | |||||
| funnel material contains a non- | |||||
| phthalate plasticizer. | |||||
| Single Package | Paper and film peel pack | Paper and film peel pack | Paper and film peel pack | Similar | |
| Same packaging configuration | |||||
| and similar materials. | |||||
| Packaging testing has been | |||||
| conducted and included to | |||||
| address 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 support | |||||
| of 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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