(7 days)
cannulation of the ductal system and sphincterotomy.
The proposed OMNI™ Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating wire guides from .018" to .035" in diameter while allowing simultaneous injection of contrast media through separate lumens. The subject sphincterotome also incorporates DomeTip™ technology and a breakthrough catheter feature.
The provided text is a 510(k) summary for the Wilson-Cook OMNI™ Sphincterotome. It states that the device is substantially equivalent to existing predicate devices based on performance characteristics and biocompatibility. However, it does not contain the detailed information requested regarding specific acceptance criteria, a study proving those criteria were met, sample sizes, ground truth establishment, or clinical performance metrics such as those typically found in a multi-reader multi-case study.
The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device, rather than providing a detailed performance study report.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states, "We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility." It does not list specific acceptance criteria or their corresponding performance results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No information about experts or ground truth for a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information about adjudication methods is present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The device is a medical instrument (sphincterotome), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not applicable to this type of device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This question is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No information about ground truth is present.
8. The sample size for the training set
- Cannot be provided. No information about a training set is present.
9. How the ground truth for the training set was established
- Cannot be provided. No information about a training set or its ground truth establishment is present.
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Ko 5205/
AUG 5 - 2005
ATTACHMENT F: 510(k) Summary
SPONSOR: Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105 Marge Walls-Walker CONTACT/SUBMITTER: Regulatory Affairs Manager [800] 245-4707 Ex.6290 DATE OF SUBMISSION: July 28, 2005 DEVICE: OMNI™ Sphincterotome OMNI™ Sphincterotome Trade Name: Common Name: Sphincterotome Unit, Electrosurgical, Endoscopic w/w/o Classification: Accessories, Class II 21 CFR § 876.4300 Wilson-Cook Triple Tome Select Plus PREDICATE DEVICES: Sphincterotome (K033203) Wilson-Cook's OMNI™Sphincterotome is INTENDED USE: intended for cannulation of the ductal system and sphincterotomy. The proposed OMNI™ Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating wire guides from .018" to .035" DEVICE DESCRIPTION: in diameter while allowing simultaneous injection of contrast media through separate lumens. We believe the proposed device to be COMPARISON OF CHARACTERISITICS: substantially equivalent to currently marketed triple-lumen transendoscopic sphincterotomes with respect to Intended Use and Method of Operation. The subject sphincterotome also incorporates DomeTip™ technology and a breakthrough catheter feature.
PERFORMANCE DATA:
We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility.
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Image /page/1/Picture/2 description: The image shows a partial view of a logo or emblem. The visible portion includes a stylized bird-like figure with flowing lines, possibly representing wings or movement. Surrounding the figure is text arranged in a circular pattern, though only fragments of the words are legible. The overall design appears to be from a government or organizational entity, given the formal and symbolic nature of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
Ms. Marge Walls-Walker Regulatory Affairs Manager Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K052051
Trade/Device Name: Wilson-Cook OMNI™ Sphincterotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 28, 2005 Received: July 29, 2005
Dear Ms. Walls-Walker:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms loter will and in your your finding of substantial equivalence of your device to a legally promatics motively on " 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), please ir you don't if you of Compliance at one of the following numbers, based or the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allot process nother general information on your responsibilities under the Act from the 001:37): " Col may overnin varies, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kus 2051
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Wilson-Cook OMNI™ Sphicterotome
Indications for Use:
Used for cannulation of the ductal system and sphincterotomy.
.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Leggrom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
Prescription Use Only_ (Per 21 CFR § 801.109
OR
Over-the-Counter_
§ 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).