(123 days)
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.
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
This is a 510(k) summary for a medical device and does not contain information about a clinical study with detailed acceptance criteria and performance metrics in the way you've requested for an AI/ML device.
Here's an explanation of why the requested information cannot be fully provided based on the provided text, and what can be extracted:
- Device: Suprapubic Catheter and Introducer Set
- Submission Type: 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials as might be required for a PMA or for an AI/ML device.
Analysis of the Provided Text (and why it doesn't fit the AI/ML study request)
The document describes a conventional medical device (catheter and introducer set) and its comparison to predicate devices, focusing on demonstrating substantial equivalence based on:
- Indications for Use: Identical or similar to predicates.
- Technology and Construction: Identical or substantially equivalent materials, design, manufacturing, shape, and sizes, with the catheter often being an OEM product from a predicate manufacturer.
- Environments of Use: Identical to predicates.
- Patient Population: Identical to predicates.
- Indwelling Time: Identical to predicates.
- Convenience Kit: Comparison of kit components.
- Non-Clinical Testing Summary: This is the only area where "testing" is mentioned, but it's for physical performance of the device components (balloon burst, volume maintenance, deflation, guidewire fracture, flexion, tensile strength, corrosion) against established standards (ASTM F623, ISO 11070). This is not a study assessing diagnostic accuracy or clinical outcomes in humans, nor does it involve AI/ML.
- Materials: Biocompatibility testing per ISO 10993-1 and G95-1.
Therefore, many of your specific requests are not applicable to this 510(k) submission:
- A table of acceptance criteria and the reported device performance: The "performance" reported here is adherence to physical/material standards, not diagnostic accuracy. The acceptance criteria are "met the performance requirements of the standards" (ASTM F623, ISO 11070).
- Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an algorithm. The testing is material/device-specific.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a clinical sense.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted device.
- Standalone (algorithm only) performance: Not applicable. There's no algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. No training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
What can be extracted (re-interpreting "acceptance criteria" for a 510(k) of a conventional device):
For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices and meeting relevant recognized standards for the device's physical and material properties.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Focus)
| Acceptance Criteria (Demonstrates Equivalence / Meets Standards) | Reported Device Performance |
|---|---|
| Indications for Use (Identical/Similar to predicates) | Identical/Similar to Fortune Medical Suprapubic catheter (K014002), Rusch Suprapubic catheter tray/kit (K970021), Fortune Medical Foley catheter (K980919). |
| Technology & Construction (Identical/Equivalent to predicates) | Identical/Equivalent to Fortune Medical Suprapubic catheter (K014002) and Fortune Medical Foley catheter (K980919). Guidewire is substantially equivalent to Cook Urological Guidewires (K082536). |
| Environments of Use (Identical to predicates) | Identical to Fortune Medical (K014002, K980919) and Rusch (K970021) predicates. |
| Patient Population (Identical to predicates) | Identical to Fortune Medical (K014002, K980919) and Rusch (K970021) predicates. |
| Indwelling Time (Identical to predicates) | Identical to Fortune Medical (K014002, K980919) predicates (no greater than 29 days). |
| Convenience Kit Components (Equivalent to predicates) | Equivalent to Rusch Suprapubic catheter tray/kit (K970021) and Cook Urological Guidewires (K082536). Components are identical or equivalent (syringes, scalpel, needle, trocar/peelaway sheath, guidewire). |
| Catheter Balloon Performance (ASTM F623) | Met performance requirements for balloon burst, volume maintenance, and deflation. |
| Guidewire/Introducer Performance (ISO 11070) | Met performance requirements for fracture, flexion, tensile strength, and corrosion. |
| Materials/Biocompatibility (ISO 10993-1, G95-1) | Considered for prolonged use (>24 hours but <30 days) with external communicating (indirect) tissue contact and surface communicating (direct) mucosal membrane contact. Implies materials are acceptable for this duration and contact. |
Summary regarding AI/ML related questions:
- None of the AI/ML specific questions (2-9) are applicable because the submission is for a conventional, non-AI/ML medical device where substantial equivalence is demonstrated through comparative analysis with predicates and non-clinical engineering/material testing against recognized standards. There is no algorithm, no training/test sets of patient data, and no ground truth in the context of diagnostic accuracy being established by experts.
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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 WardOperations 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 876.5090Class II |
| Predicate Devices: | Fortune Medical - Suprapubic catheter - K014002Fortune Medical – Foley Catheters - K980919Rusch Suprapubic Catheter Kits - K970021Cook 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
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510(k) Summary
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| Attribute | Proposed MediplusSuprapubic | PredicateFortune Suprapubic CatheterK014002 | PredicateRusch Suprapubic KitsK970021 |
|---|---|---|---|
| Indications for Use | The Suprapubic Catheter and Introducer Set isindicated for drainage of the bladder through aneedle puncture or stab wound over thebladder. | Intended for drainage of the bladderthrough a needle or stab wound over thebladder | Suprapubic kit/tray is used forsuprapubic bladder catheterization anddrainage of fluids to and from theurinary 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 / ordrainage | Patients requiring bladder irrigation and /or drainage | Patients requiring bladder irrigationand / or drainage |
| Indwelling Time | No greater than 29 days | No greater than 29 days, though notspecified | No greater than 29 days, though notspecified |
| Single patient use,disposable | Yes | Yes | Yes |
| Basic Foley Catheterdesign | Foley Catheter with inflatable balloon andmultiple drainage eyelets | Foley Catheter with inflatable balloon andmultiple drainage eyelets | Foley Catheter with inflatable balloonand multiple drainage eyelets |
| Size range of Foley | Open Tip style12 to 16 Fr | Open Tip style12 to 24 Fr | Tip style – 2 kinds mentioned8 to 16 Fr |
| Components of a kit orTray | SyringeScalpelNeedleTocar / peelaway sheathGuidevire | This was a catheter only | SyringeScalpelNeedleTocar / peelaway sheathCatheter plug |
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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).
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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
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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.
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SIO(k) Summary
able 2 - Comparison to Predicates - Suprapubic Catheter - Closed Tip style and Kits
| Attribute | Proposed MediplusSuprapubic | PredicateFortune Foley CatheterK980919 | PredicateRusch Suprapubic KitsK970021 |
|---|---|---|---|
| Indications for Use | The Suprapubic Catheter and Introducer Set isindicated for drainage of the bladder through aneedle puncture or stab wound over thebladder. | Intended for as urinary catheters to passfluids to and from the urinary bladder | Suprapubic kit/tray is used forsuprapubic bladder catheterization anddrainage of fluids to and from theurinary 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 / ordrainage | Patients requiring bladder irrigation and /or drainage | Patients requiring bladder irrigationand / or drainage |
| Indwelling Time | No greater than 29 days | No greater than 29 days, though notspecified | No greater than 29 days, though notspecified |
| Single patient use,disposable | Yes | Yes | Yes |
| Basic Foley Catheterdesign | Foley Catheter with inflatable balloon andmultiple drainage eyeletsClosed Tip style | Foley Catheter with inflatable balloon andmultiple drainage eyeletsClosed Tip style | Foley Catheter with inflatable balloonand multiple drainage eyeletsTip style - 2 kinds mentioned |
| Size range of Foley | 12 to 16 Fr | 12 to 24 Fr | 8 to 16 Fr |
| Components of a kit orTray | SyringeScalpelNeedleTocar / peelaway sheathGuidewire | This was a catheter only | SyringeScalpelNeedleTocar / peelaway sheathCatheter plug |
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510(k) Summary Page 7 of 9
19-Dec-2013
Table 3 - Comparison to Predicate - Suprapubic Guidewire
| Attribute | Proposed MediplusSuprapubic Guidewire | PredicateCook Urological GuidewiresK082536 |
|---|---|---|
| Indications for Use | The Suprapubic Guidewire is used to establisha tract and assist in the placement of asuprapubic catheter | Urological Guidewires are used for ureteralaccess, to establish a tract, and assist in theplacement, replacement, and exchange ofdevices 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 flexibilityDesign has 3 sections of flexibilityRigid to assist in placementSemi-rigidFlexible tip, straight but deflects / curves withany resistance | Wound wire that allows for flexibilityDesign has 3 sections of flexibilityRigid to assist in placementJ-shaped tip, deflects with any resistance |
| Dimensions | 425mm long0.93mm wide | Not available |
| Markings | Markings on the shaft to guide the user as todepth of insertion when used with Needle andTrocar | No markings |
| Performance testing | Tensile StrengthFlexionFractureCorrosion | Tensile StrengthFlexion 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.
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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 < 30 days) .
and
(2) for the parts which contact the patient's mucosal membrane (direct)
- Surface Communicating (direct) .
- Mucosal Membrane contact .
- . Prolonged duration of use (> 24 hours but < 30 days)
PDF Page 108 of 109
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510(k) Summary Page 9 of 9 19-Dec-2013
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 substantially equivalent.
.
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
Mediplus Ltd. Paul E. Dryden Regulatory Consultant Unit 7, The Gateway Centre High Wycombe, Bucks UK HP123SU
Re: K132890
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)
Herbert P. Lerner -S 2014.01.17 14:57:54 -05'00'
§ 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.