(65 days)
Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.
The Wilson-Cook Bipolar Probe is comprised of a mono or dual plug, flush port, catheter shaft and probe. The dual or single plug is located at the proximal end of the catheter shaft and is used for connection to the appropriate bipolar generator. The flush port is also located at the proximal end of the catheter and is used as necessary for irrigation. The distal tip of the device is the probe component used for hemostasis.
The Wilson-Cook Bipolar Probe is a medical device intended for endoscopic hemostasis throughout the gastrointestinal tract, used in conjunction with bipolar electrosurgical generators. The provided document is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or performance assessments that would typically involve statistical measures like AUC, sensitivity, or specificity.
Here's an analysis of the provided information concerning acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantitative acceptance criteria for the device's clinical performance (e.g., success rate of hemostasis, safety outcomes in patients). Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.
The "acceptance criteria" mentioned in the document refer to internal design verification testing, not clinical performance.
| Acceptance Criteria Category | Specific Criteria/Tests (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with patient-contacting material standards. | Established through history of use of materials in the Biosearch Bipolar Probe. |
| Design Verification | Visual inspection criteria. | Met predetermined acceptance criteria. |
| Dimensional conformity criteria. | Met predetermined acceptance criteria. | |
| Functional testing criteria. | Met predetermined acceptance criteria. | |
| Substantial Equivalence | Similar intended use. | Yes, demonstrated to the predicate device (Biosearch Dobbhoff Bipolar Hemostatic Probe K912129). |
| Similar design. | Yes. | |
| Similar materials of construction. | Yes. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of device performance in a clinical setting. The "test set" here refers to internal design verification, for which the sample size is not specified but would typically be a fixed number of manufactured units.
- Data Provenance: The data provenance is from internal "Design Verification" conducted by Wilson-Cook Medical Inc. This is internal company testing, not clinical data from patients or a specific geographical region. It is retrospective in the sense that it evaluates manufactured devices against design specifications.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable for establishing ground truth related to clinical performance, as no clinical study data is presented. The "ground truth" for design verification would be the design specifications and manufacturing standards set by the company's engineers and quality control personnel. Their specific qualifications are not detailed.
4. Adjudication Method
- Adjudication Method: Not applicable, as there is no clinical data requiring expert adjudication for performance outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. This type of study typically involves assessing the performance of human readers (e.g., physicians) with and without the assistance of an AI algorithm, which is not relevant for this, an electrosurgical device.
6. Standalone Performance Study
- Standalone Performance Study: No, a standalone algorithm-only performance study was not performed. The device is a physical electrosurgical probe, not a software algorithm. The "performance" in this context refers to its ability to meet design specifications, which was confirmed through internal design verification testing.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "tests" described, the ground truth is the design specifications, manufacturing standards, and biocompatibility requirements for the materials. There is no clinical or pathological "ground truth" established in this submission as it's not a diagnostic device or a study involving patient outcomes.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The device is a physical medical instrument, not an AI or machine learning model that requires a "training set."
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
In summary: The 510(k) submission for the Wilson-Cook Bipolar Probe primarily demonstrates substantial equivalence to a predicate device, relying on design verification and biocompatibility established by material history of use. It does not contain information about clinical acceptance criteria, clinical study power analyses, sample sizes for patient data, expert ground truth establishment, or any form of AI performance metrics (e.g., AUC, sensitivity, specificity). The "acceptance criteria" mentioned refer to internal engineering and quality control specifications.
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3/25/99
PREMARKET NOTIFICATION FOR THE WILSON-COOK BIPOLAR RE: PROBE
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS I.
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Bipolar Probe is comprised of a mono or dual plug, flush port, catheter shaft and probe. The dual or single plug is located at the proximal end of the catheter shaft and is used for connection to the appropriate bipolar generator. The flush port is also located at the proximal end of the catheter and is used as necessary for irrigation. The distal tip of the device is the probe component used for hemostasis.
| Trade Name: | Wilson-Cook Bipolar Probe |
|---|---|
| Common/Usual Name: | Bipolar Probe |
| Classification Name/Code: | Unit, Electrosurgical, Endoscopic (with or without accessories)/78 KNS |
| Classification: | FDA has classified similar devices as Class II, as per 21 CFR § 876.4300. This device falls within the purview of the Gastroenterology and Urology Device Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for this device do not exist. |
| Intended Use: | Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract. |
Predicate Device:
| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROLNUMBER |
|---|---|---|
| Dobbhoff BipolarHemostatic Probe | Biosearch MedicalProducts, Inc. | K912129 |
Substantial Equivalence:
The Wilson-Cook Bipolar Probe is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.
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PREMARKET NOTIFICATION FOR THE WILSON-COOK BIPOLAR RE: PROBE
| DEVICECHARACTERISTIC | Wilson-Cook BipolarProbe[Subject of 510(K)] | Biosearch Hydromergrafted BipolarHemostatic Probe(K912129) |
|---|---|---|
| Intended Use | Used in conjunction withsingle or dual plug bipolarelectrosurgical generatorsto endoscopically providehemostasis throughout thegastrointestinal tract. | The probe is designed tofunction as a conventionalelectro-coagulation devicewhen supplied with currentfrom a standard bipolarelectro-surgical generator.The device is intended tobe passed through anendoscope's workingchannel to providehemostasis throughout theGI tract. |
| Sterility | Sterile Disposable | Non-Sterile Disposable |
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Testing: Biocompatibility has been established for the patient contacting materials through a history of use in the Biosearch Bipolar Probe. This product line has been subjected to Design Verification. During Design Verification, visual, dimensional and functional testing to ensure the performance, design integrity for this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
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Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
MAR 2 5 1999
Ms. Paula Joyce QA/RA Manager Wilson-Cook® Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K990145
Wilson-Cook® Bipolar Probe Dated: January 15, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 876.4300/Procode: 78 KNS
Dear Ms. Joyce:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Dan Petit
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 13_ of __ 13
510(k) Number (if known): _K99 Ol 45
Wilson-Cook Bipolar Probe Device Name:
Indications for Use:
Used in conjunction with a single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.
t
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-2-96)
Elarid le. Heyman
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).