(22 days)
The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.
The proposed USW Needleknife Papillotome is a triple-lumen catheter, with one lumen dedicated to the cutting wire, wire guide access and contrast injection respectively. The wire guide lumen is compatible with a .035" wire quide. The 24 GA stainless steel cutting wire allows for the transfer of electric current enhance cannulation efforts when traditional cannulation efforts have been exhausted. The handle contains an electrocautery connection pin, which is compatible with a variety of active cords currently sold separately.
The provided text is a 510(k) summary for the Wilson-Cook USW Needleknife Papillotome. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and the comprehensive study details (such as sample size for test sets, ground truth establishment, expert qualifications, or MRMC studies).
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "Non-Clinical Testing was performed on characteristics of the USW Needleknife Papillotome deemed necessary to verify safety and performance." However, no specific acceptance criteria or quantitative performance results are provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text. The document only mentions "Non-Clinical Testing."
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)
Not available in the provided text. This device is a medical instrument, not an AI or imaging diagnostic tool, so the concept of "ground truth" and expert review to establish it in the usual sense for diagnostic algorithms doesn't directly apply here. The "performance data" refers to non-clinical testing of the device's physical/functional characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/available. This is typically relevant for studies involving human interpretation or subjective assessment, which is not described for this device's non-clinical testing.
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
Not applicable/available. This device is a surgical instrument, not an AI diagnostic tool, so an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question pertains to AI algorithms, which this device is not. The "Non-Clinical Testing" would assess the device's standalone physical and functional performance, but not in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not available/applicable in the traditional sense. For a medical device like a papillotome, "ground truth" for performance would likely revolve around objective engineering metrics related to its cutting ability, electrical conductivity, guidewire compatibility, mechanical integrity, and biocompatibility, as determined by a testing protocol. The summary does not provide these details.
8. The sample size for the training set
The device is a medical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "Non-Clinical Testing" refers to laboratory or bench testing. No sample size for this testing is provided.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of medical device.
In summary, the provided document is a regulatory submission summary for a medical device and focuses on establishing substantial equivalence to a predicate device. It does not include the detailed scientific study breakdown typically provided for a diagnostic or AI-driven medical device, which would contain specific acceptance criteria, sample sizes, and ground truth methodologies.
{0}------------------------------------------------
MAY - 7 2004
ATTACHMENT F: 510(k) Summary
| SPONSOR:CONTACT/SUBMITTER: | Wilson-Cook Medical4900 Bethania Station RoadWinston-Salem, NC 27105Marge Walls-WalkerRequlatory Affairs Specialist[336] -744-0157 Ex.290 |
|---|---|
| DATE OF SUBMISSION:DEVICE: | April 14, 2004USW Needleknife Papillotome |
| Trade Name:Common Name:Classification: | Wilson-Cook USW Needleknife PapillotomeNeedleknife, PrecutUnit, Electrosurgical Endoscopic w,w/oAccessories. 21 CFR § 876.4300, 78 KNS |
| PREDICATE DEVICES: | Wilson-Cook Needleknife Papillotome (K972674) |
| INTENDED USE: | Wilson-Cook's USW Needleknife Papillotome isintended for accessing the common bile ductwhen standard cannulation methods have beenexhausted. This device is supplied sterile andintended for single use. |
| DEVICE DESCRIPTION: | The proposed USW Needleknife Papillotome isa triple-lumen catheter, with one lumendedicated to the cutting wire, wire guide accessand contrast injection respectively. The wireguide lumen is compatible with a .035" wirequide. The 24 GA stainless steel cutting wireallows for the transfer of electric currentenhance cannulation efforts when traditionalcannulation efforts have been exhausted. Thehandle contains an electrocautery connectionpin, which is compatible with a variety of activecords currently sold separately. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to besubstantially equivalent to the named predicatein terms of Intended Use, Indications for Use,performance characteristics tested, materials ofconstruction, operation and biocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed oncharacteristics of the USW NeedleknifePapillotome deemed necessary to verify safetyand performance. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040981
Trade/Device Name: USW Needleknife Papillotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: April 14, 2004 Received: April 20, 2004
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 (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.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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.
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) r as lotter unfication. 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/cdrfv/dsma/dsmamain.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
{3}------------------------------------------------
510(k) Number (if known): K0409 8 (
Device Name: Wilson-Cook USW Needleknife Papillotome
Indications for Use:
The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Per 21 CFR § 801.109
OR
David A. Aymer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
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).