(123 days)
No
The device description and performance studies focus on the mechanical properties and function of a suprapubic catheter and introducer set, with no mention of AI or ML.
Yes.
The device is indicated for drainage of the bladder, which is a therapeutic intervention.
No
The device is indicated for drainage and irrigation of the bladder, which are therapeutic functions, not diagnostic.
No
The device description explicitly lists multiple hardware components (Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire) and the performance studies focus on testing these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Suprapubic Catheter and Introducer Set is a medical device used for the direct drainage of the bladder through a surgical procedure. It is used within the body (in vivo).
- Intended Use: The intended use clearly states "drainage of the bladder," which is a therapeutic or management function, not a diagnostic test performed on a sample.
- Device Description: The description details the components used for insertion and drainage, not for analyzing a biological sample.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activities typically associated with IVDs.
Therefore, this device falls under the category of a surgical or drainage device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.
Product codes (comma separated list FDA assigned to the subject device)
KOB
Device Description
Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip,
The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, sub-acute settings
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 Summary -
We have performed testing of the balloon per ASTM F623 for Foley catheters for balloon burst, Volume maintenance and Deflation as well as testing per ISO 11070 for guidewires and Introducers for fracture, flexion, tensile strength, and corrosion.
Discussion - The catheter balloon and guidewire met the performance requirements of the standards.
We performed non-clinical testing comparing the Mediplus guidewire to the predicate Cook Urological Guidewires (K082536). Additionally we tested the guidewires per ISO 11070 for tensile strength, fracture flexion, and corrosion. The results demonstrated that they were equivalent.
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.
Fortune Medical - Suprapubic catheter - K014002, Fortune Medical – Foley Catheters - K980919, Rusch Suprapubic Catheter Kits - K970021
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.
Cook Medical Urological Guidewires - K082536
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
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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
JAN 17 2014
510(k) Summary Page 1 of 9
Date Prepared:
19-Dec-2013
Mediplus Ltd. Unit 7, The Gateway Centre Coronation Road, Cressex Business Park High Wycombe, Bucks, HP12 3SU UK
.
Tel - +44 (0) 1494 551299 Fax - +44 (0) 1494 536333
| Official Contact: | Tim Ward
Operations Manager |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Suprapubic Catheter and Introducer set |
| Common/Usual Name: | catheter, suprapubic (and accessories) |
| Classification Name: | catheter, suprapubic (and accessories)
KOB – CFR 876.5090
Class II |
| Predicate Devices: | Fortune Medical - Suprapubic catheter - K014002
Fortune Medical – Foley Catheters - K980919
Rusch Suprapubic Catheter Kits - K970021
Cook Medical Urological Guidewires - K082536 |
Device Description:
Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip,
The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire
Indications for Use:
The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.
Environment of Use:
Hospitals, sub-acute settings
1
510(k) Summary
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| Attribute | Proposed Mediplus
Suprapubic | Predicate
Fortune Suprapubic Catheter
K014002 | Predicate
Rusch Suprapubic Kits
K970021 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Suprapubic Catheter and Introducer Set is
indicated for drainage of the bladder through a
needle puncture or stab wound over the
bladder. | Intended for drainage of the bladder
through a needle or stab wound over the
bladder | Suprapubic kit/tray is used for
suprapubic bladder catheterization and
drainage of fluids to and from the
urinary tract |
| Environments of use | Hospitals and sub-acute setting | Hospitals and sub-acute setting | Hospitals and sub-acute setting |
| Patient Population | Patients requiring bladder irrigation and / or
drainage | Patients requiring bladder irrigation and /
or drainage | Patients requiring bladder irrigation
and / or drainage |
| Indwelling Time | No greater than 29 days | No greater than 29 days, though not
specified | No greater than 29 days, though not
specified |
| Single patient use,
disposable | Yes | Yes | Yes |
| Basic Foley Catheter
design | Foley Catheter with inflatable balloon and
multiple drainage eyelets | Foley Catheter with inflatable balloon and
multiple drainage eyelets | Foley Catheter with inflatable balloon
and multiple drainage eyelets |
| Size range of Foley | Open Tip style
12 to 16 Fr | Open Tip style
12 to 24 Fr | Tip style – 2 kinds mentioned
8 to 16 Fr |
| Components of a kit or
Tray | Syringe
Scalpel
Needle
Tocar / peelaway sheath
Guidevire | This was a catheter only | Syringe
Scalpel
Needle
Tocar / peelaway sheath
Catheter plug |
2
510(k) Summary Page 3 of 9 19-Dec-2013
Substantial Equivalence Discussion
Indications for Use -
The indications for use for the Suprapubic Catheter and Introducer Set that is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder are identical for the proposed device when compared to the predicate - Fortune Medical Suprapubic catheter (K014002).
The indications for use for the Suprapubic Catheter and Introducer Set that is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder and includes various components to assist with the catheter placement are identical for the proposed device when compared to the predicate - Rusch Suprapubic catheter tray / kit (K970021).
Discussion - The proposed device and the identified predicates have the identical indications for use and thus can be found substantially equivalent.
Technology and construction -
The design, manufacturing, shape, sizes, and materials are identical to the predicate - Fortune Medical Suprapubic catheter (K014002).
Discussion - The catheter utilized in the Mediplus device are purchased from Fortune Medical on an OEM basis in their finished final form except sterilization.
Environment of Use -
The environments of use of Hospitals and sub-acute setting are identical to predicates - Fortune Medical Suprapubic catheter (K014002) and Rusch Suprapubic catheter tray / kit (K97002)). Discussion - The environments of use are identical to the predicate - Fortune Medical Suprapubic catheter (K014002) and Rusch Suprapubic catheter tray / kit (K970021).
Patient Population -
The patient population of Patients requiring bladder irrigation and / or drainage is identical to the predicates - Fortune Medical Suprapubic catheter (K014002) and Rusch Suprapublic catheter tray / kit (K970021).
Discussion - The patient populations are identical to the predicates - Fortune Medical Suprapubic catheter (K014002) and Rusch Suprapubic catheter tray / kit (K970021).
Indwelling Time -
The indwelling time of no greater than 29 days is identical to the predicate - Fortune Medical Suprapubic catheter (K014002).
Discussion - The indwelling time is identical to the predicate - Forume Medical Suprapubic catheter (K014002).
Convenience Kit -
Offering suprapubic catheters with components which assist in the placement of the catheter is equivalent to the predicate - Rusch Suprapubic catheter tray / kit (K970021).
3
510(k) Summary Page 4 of 9 19-Dec-2013
The components offered are either identical or equivalent and include: svringes, trocar / sheaths, needles, scalpels. The differences of including a guidewire for placement are not substantially different.
Discussion - Offering a convenience kit is equivalent to the predicate - Rusch Suprapubic catheter tray / kit (K970021).
Non-Clinical Testing Summary -
We have performed testing of the balloon per ASTM F623 for Foley catheters for balloon burst, Volume maintenance and Deflation as well as testing per ISO 11070 for guidewires and Introducers for fracture, flexion, tensile strength, and corrosion.
Discussion - The catheter balloon and guidewire met the performance requirements of the standards.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent.
Comparison to Predicates - Suprapubic Catheter - Closed Tip style and Kits
Table 5,2 below compares the key features of the proposed Mediplus Suprapybic catheter and Introducer Set with the identified predicates.
Indications for Use -
The indications for use for the Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder which is similar when compared to the predicate - Fortune Medical Foley catheter (K980919).
The indications for use for the Suprapubic Catheter with Introducer Set that is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder and includes various components to assist with the catheter placement are identical for the proposed device when compared to the predicate - Rusch Suprapubic catheter tray / kit (K970021), Discussion - The indications for use for the Suprapubic vs. a Foley Catheter are that the placement is different, i.e. needle puncture or stab wound over the bladder vs. inserted in the urethra, but the catheters are identical in design and function which is for drainage of the bladder. The proposed device and the identified predicate have similar indications for use and thus can be found substantially equivalent.
Technology and construction -
The design, manufacturing, shape, sizes, and materials are identical to the predicate -- Forune Medical Foley catheter (K980919).
Discussion - The catheter utilized in the Mediplus device are purchased from Fortune Medical on an OEM basis in their finished final form except sterilization.
PDF Page 104 of 109
4
510(k) Summary Page 5 of 9 19-Dec-2013
Environment of Use -
The environments of use of Hospitals and sub-acute setting are identical to predicates - Fortune Medical Foley catheter (K980919) and Rusch Suprapubic catheter tray / kit (K970021). Discussion - The environments of use are identical to the predicate - Fortune Medical Foley catheter (K980919) and Rusch Suprapubic catheter tray / kit (K970021).
Patient Population -
The patient population of Patients requiring bladder irrigation and / or drainage is identical to the predicates -- Fortune Medical Foley catheter (K980919) and Rusch Suprapubic catheter tray / kit (K970021).
Discussion - The patient populations are identical to the predicates - Fortune Medical Foley catheter (K980919) and Rusch Suprapubic catheter tray / kit (K970021).
Indwelling Time –
The indwelling time of no greater than 29 days is identical to the predicate - Fortune Medical Foley catheter (K980919).
Discussion - The indwelling time is identical to the predicate - Fortune Medical Foley catheter (K980919).
Convenience Kit -
Offering suprapubic catheters with components which assist in the placement of the catheter is equivalent to the predicate - Rusch Suprapubic catheter tray / kit (K970021).
The components offered are either identical or equivalent and include: syringes, trocar / sheaths, needles, scalpels.
Discussion - Offering a convenience kit is equivalent to the predicate - Rusch Suprapubic catheter tray / kit (K970021).
Non-Clinical Testing Summary -
We have performed testing of the balloon per ASTM F623 for Foley catheters for balloon burst, Volume maintenance and Deflation as well as testing per ISO 11070 for guidewires and Introducers for fracture, flexion, tensile strength, and corrosion.
Discussion - The catheter balloon and guidewire met the performance requirements of the standards.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent.
5
SIO(k) Summary
able 2 - Comparison to Predicates - Suprapubic Catheter - Closed Tip style and Kits
| Attribute | Proposed Mediplus
Suprapubic | Predicate
Fortune Foley Catheter
K980919 | Predicate
Rusch Suprapubic Kits
K970021 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Suprapubic Catheter and Introducer Set is
indicated for drainage of the bladder through a
needle puncture or stab wound over the
bladder. | Intended for as urinary catheters to pass
fluids to and from the urinary bladder | Suprapubic kit/tray is used for
suprapubic bladder catheterization and
drainage of fluids to and from the
urinary tract |
| Environments of use | Hospitals and sub-acute setting | Hospitals and sub-acute setting | Hospitals and sub-acute setting |
| Patient Population | Patients requiring bladder irrigation and / or
drainage | Patients requiring bladder irrigation and /
or drainage | Patients requiring bladder irrigation
and / or drainage |
| Indwelling Time | No greater than 29 days | No greater than 29 days, though not
specified | No greater than 29 days, though not
specified |
| Single patient use,
disposable | Yes | Yes | Yes |
| Basic Foley Catheter
design | Foley Catheter with inflatable balloon and
multiple drainage eyelets
Closed Tip style | Foley Catheter with inflatable balloon and
multiple drainage eyelets
Closed Tip style | Foley Catheter with inflatable balloon
and multiple drainage eyelets
Tip style - 2 kinds mentioned |
| Size range of Foley | 12 to 16 Fr | 12 to 24 Fr | 8 to 16 Fr |
| Components of a kit or
Tray | Syringe
Scalpel
Needle
Tocar / peelaway sheath
Guidewire | This was a catheter only | Syringe
Scalpel
Needle
Tocar / peelaway sheath
Catheter plug |
6
510(k) Summary Page 7 of 9
19-Dec-2013
Table 3 - Comparison to Predicate - Suprapubic Guidewire
| Attribute | Proposed Mediplus
Suprapubic Guidewire | Predicate
Cook Urological Guidewires
K082536 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Suprapubic Guidewire is used to establish
a tract and assist in the placement of a
suprapubic catheter | Urological Guidewires are used for ureteral
access, to establish a tract, and assist in the
placement, replacement, and exchange of
devices during urological procedures |
| Environments of use | Hospitals and sub-acute setting | Hospitals and sub-acute setting |
| Indwelling Time | None | None |
| Single patient use,
disposable | Yes | Yes |
| Basic design | Wound wire that allows for flexibility
Design has 3 sections of flexibility
Rigid to assist in placement
Semi-rigid
Flexible tip, straight but deflects / curves with
any resistance | Wound wire that allows for flexibility
Design has 3 sections of flexibility
Rigid to assist in placement
J-shaped tip, deflects with any resistance |
| Dimensions | 425mm long
0.93mm wide | Not available |
| Markings | Markings on the shaft to guide the user as to
depth of insertion when used with Needle and
Trocar | No markings |
| Performance testing | Tensile Strength
Flexion
Fracture
Corrosion | Tensile Strength
Flexion and deflection |
Substantial Equivalence Discussion ,
Table 5.3 above compares the key features of the proposed Mediplus Suprapubic guidewire with the identified predicate.
Indications for Use -
The indications for use for the Suprapubic Guidewire is indicated to establish a tract and assist in the placement of a suprapubic catheter which is similar when compared to the predicate - Cook Urological Guidewires (K082536).
Discussion - The proposed device and the identified predicate have the identical indications for use and thus can be found substantially equivalent.
7
510(k) Summary Page 8 of 9 19-Dec-2013
Technology and construction -
The design, manufacturing, shape, size, and materials are substantially equivalent to the predicate - Cook Urological Guidewires (K082536).
Discussion - The Guidewire is substantially equivalent, the only difference is that the Mediplus Guidewire have a flexible tip vs. the predicate has a pre-formed "J" tip, however both are designed to deflect when the tip comes into contact with tissue.
Environment of Use -
The environments of use of Hospitals and sub-acute setting are identical to predicate - Cook Urological Guidewires (K082536).
Discussion - The environments of use are identical to the predicate - Cook Urological Guidewires (K082536).
Patient Population -
The patient population is identical to the predicate - Cook Urological Guidewires (K082536). Discussion - The patient populations are identical to the predicate -- Cook Urological Guidewires (K082536).
Convenience Kit -
Offering suprapubic guidewire as a component to assist in the placement of the catheter is equivalent to the predicate - Cook Urological Guidewires (K082536). Discussion - Offering a convenience kit is equivalent to the predicate - Cook Urological Guidewires (K082536).
Non-Clinical Testing Summary -
We performed non-clinical testing comparing the Mediplus guidewire to the predicate Cook Urological Guidewires (K082536). Additionally we tested the guidewires per ISO 11070 for tensile strength, fracture flexion, and corrosion. The results demonstrated that they were equivalent.
Materials -
All of the components of the suprapubic catheters are identical to the predicates. Per ISO 10993-1 and G95-1 these would be considered as:
- For the parts which are in the fluid pathway (indirect)
- External Communicating (indirect) .
- . Tissue contact
- Prolonged duration of use (> 24 hours but 24 hours but Trade/Device Name: Suprapubic Catheter and Introducer Set Regulation Number: 21 CFR§ 876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: II Product Code: KOB Dated: December 19, 2013 Received: December 20, 2013
Dear Paul E. Dryden,
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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
10
Page 2 – Paul E. Dryden
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -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
11
Indications for Use Statement
Page 1 of 1
510(k) Number:
K132890 (To be assigned)
Suprapubic Catheter and Introducer Set Device Name:
Indications for Use:
The Suprapubic Catheter and Introducer Set are indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.
Environment of use - hospital and sub-acute settings.
Patient population - Patients requiring bladder irrigation and / or drainage.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)