(90 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of the access sets, with no mention of AI or ML capabilities.
Yes
The device is used for introducing a drainage catheter into the bladder, which is a medical procedure aimed at addressing a patient's health condition (drainage). Instruments used for such procedures are considered therapeutic.
No
Explanation: The device is described as an "Access Set" used for "introducing a drainage catheter suprapubically into the bladder," indicating it is an interventional or procedural device, not one used for diagnosis.
No
The device description clearly outlines physical components like a peel-away sheath, dilator, trocar needle, and wire guide, and the performance studies focus on physical properties and testing of these components. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing a drainage catheter suprapubically into the bladder." This is a surgical/procedural device used to access an anatomical site within the body.
- Device Description: The description details physical components like sheaths, dilators, needles, and wire guides. These are instruments used for a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. There is no mention of reagents, calibrators, controls, or analytical methods typically associated with IVDs.
Therefore, this device falls under the category of a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The O'Brien Suprapubic Peel-Away Access Set is used for introducing a drainage catheter suprapubically into the bladder.
The Cook® SP Tube Introducer Set is used for introducing a drainage catheter suprapubically into the bladder.
Product codes (comma separated list FDA assigned to the subject device)
KOB
Device Description
The O'Brien Suprapubic Peel-Away Access Set includes a peel-away sheath, dilator, trocar needle and wire guide. The peel-away sheath is available in even-numbered French sizes ranging from 16.0 to 20.0 and measures 22 centimeters in length. Dual knobs allow the sheath, manufactured from thick wall radiopaque polytetrafluoroethylene material, to be peeled back and removed.
The Cook SP Tube Introducer Set is comprised of a 20 Fr sheath which is 15 cm in length, an introducer that fits within this sheath, two dilators, a wire guide and needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The subject devices, O'Brien Suprapubic Peel-Away Access Set and the Cook SP Tube Introducer Set, were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
- Radiopacity Testing ●
- Peel-Away Shaft Tensile Test ●
- Dilator Shaft Tensile Test ●
- Peel Force ●
- Rollback Testing ●
- Dilator Hub-to-Shaft Tensile Test ●
- Compatibility Testing
- Biocompatibility Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, ● and Acute Systemic Toxicity
- Sterilization
- Package integrity and stability
- Shelf-life
All predetermined acceptance criteria were met.
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.
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.
Not Found
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.
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October 30, 2018
Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K182066
Trade/Device Name: O'Brien Suprapubic Peel-Away Access Set, Cook® SP Tube Introducer Set Regulation Number: 21 CFR§ 876.5090 Regulation Name: Suprapubic Urological Catheter and Accessories Regulatory Class: II Product Code: KOB Dated: July 31, 2018 Received: August 1, 2018
Dear Carly Powell:
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. 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/tray. The general controls 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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Timothy Martin -S 2018.10.30 17:45:00 -04'00' for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name O'Brien Suprapubic Peel-Away Access Set
Cook® SP Tube Introducer Set
Indications for Use (Describe)
The O'Brien Suprapubic Peel-Away Access Set is used for introducing a drainage catheter suprapubically into the bladder.
The Cook® SP Tube Introducer Set is used for introducing a drainage catheter suprapubically into 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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Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller letters, also on a red background. The word "MEDICAL" is placed on a red banner that is angled.
2.0 510(k) Summary
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A 12 339 2235 TOLLEREE 800 457 4500 WWW.COOKMEDICAL.COM
O'Brien Suprapubic Peel-Away Access Set Cook SP Tube Introducer Set 21 CFR §807.5050 Date Prepared: July 31, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification | |
|---|---|---|
| Applicant: | Cook Incorporated | |
| Primary Contact: | Carly Powell | |
| Secondary Contact: | Karthik Pillai, Ph.D | |
| Applicant Address: | Cook Incorporated | |
| 750 Daniels Way | ||
| Bloomington, IN 47404 | ||
| Contact Phone Number: | (812) 335-3575 x104913 | |
| Contact Fax Number: | (812) 332-0281 | |
| Device Information: | ||
| Trade Names: | O'Brien Suprapubic Peel-Away Access Set | |
| Cook SP Tube Introducer Set | ||
| Common Name: | Catheter, Suprapubic (And Accessories) | |
| Classification Name: | Suprapubic Urological Catheter and Accessories | |
| Regulation: | 21 CFR §876.5090 | |
| Product Code: | KOB | |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
Predicate Devices:
The O'Brien Suprapubic Peel-Away Access Set and the Cook SP Tube Introducer Set are substantially equivalent to the following devices:
- Suprapubic Catheter and Introducer Set cleared under K132890 .
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Table 2.0-1 Comparison Table
| Predicate Device | Subject Device | |
|---|---|---|
| Suprapubic Catheter and Introducer Set | ||
| (K132890) | O'Brien Suprapubic Peel-Away Access Set | |
| Manufacturer | MediPlus Ltd. | Cook Inc. |
| Regulation | 876.5090 | Identical |
| Product Code | KOB | |
| [Catheter, Suprapubic (And Accessories)] | Identical | |
| Classification | II | Identical |
| 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. | Used for introducing a drainage catheter | |
| suprapubically into the bladder. | ||
| Set | Syringe, scalpel, 18 gauge needle, peel-away | Peel-away sheath, dilator, wire guide, trocar |
| Components | sheath, dilator, and guidewire, Foley Catheter | needle |
Table 2.0-2 Comparison Table
| Predicate Device | Subject Device | |
|---|---|---|
| Suprapubic Catheter and Introducer Set | ||
| (K132890) | Cook SP Tube Introducer Set | |
| Manufacturer | MediPlus Ltd. | Cook, Inc. |
| Regulation | 876.5090 | Identical |
| Product Code | KOB | |
| [Catheter, Suprapubic (And Accessories)] | Identical | |
| Classification | II | Identical |
| 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. | Used for introducing a drainage catheter | |
| suprapubically into the bladder. | ||
| Set | ||
| Components | Syringe, scalpel, 18 gauge needle, peel-away | |
| sheath, dilator, and guidewire, Foley Catheter | Peel-away sheath, dilators, wire guide, trocar | |
| needle |
Device Description:
The O'Brien Suprapubic Peel-Away Access Set includes a peel-away sheath, dilator, trocar needle and wire guide. The peel-away sheath is available in even-numbered French sizes ranging from 16.0 to 20.0 and measures 22 centimeters in length. Dual knobs allow the sheath, manufactured from thick wall radiopaque polytetrafluoroethylene material, to be peeled back and removed.
The Cook SP Tube Introducer Set is comprised of a 20 Fr sheath which is 15 cm in length, an introducer that fits within this sheath, two dilators, a wire guide and needle.
Intended Use:
The O'Brien Suprapubic Peel-Away Access Set and Cook SP Tube Introducer Set are intended for introducing a drainage catheter suprapubically into the bladder.
4
5
Cook Incorporated - Traditional 510(k) O'Brien Suprapubic Peel-Away Access Set Cook SP Tube Introducer Set July 31, 2018
Comparison to Predicate:
The subject and predicate device, Suprapubic Catheter Introducer Set, are substantially equivalent in that these devices are similar in indications for use and method of placement. Additionally, the subject devices have a similar design and technological characteristics as the predicate devices. The differences between the subject devices and the predicate devices include, the absence of a drainage catheter in the set, materials, and dimensions. Characteristics of the subject devices that differ from the predicate devices are supported by testing and do not raise any new questions of safety and effectiveness.
Performance Data:
The subject devices, O'Brien Suprapubic Peel-Away Access Set and the Cook SP Tube Introducer Set, were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
- Radiopacity Testing ●
- Peel-Away Shaft Tensile Test ●
- Dilator Shaft Tensile Test ●
- Peel Force ●
- Rollback Testing ●
- Dilator Hub-to-Shaft Tensile Test ●
- Compatibility Testing
- Biocompatibility Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, ● and Acute Systemic Toxicity
- Sterilization
- Package integrity and stability
- Shelf-life
All predetermined acceptance criteria were met.
Conclusion:
The data included in this submission indicate that the subject devices do not raise new questions of safety or effectiveness compared to the predicate device, the Suprapubic Catheter and Introducer Set (K132890), which supports a determination of substantial equivalence.