(100 days)
The Wilson-Cook Double Lumen Biliary Cytology Brush is intended to collect cells in the biliary system.
The proposed Cytology Brush is a modification to existing cytology brushes currently marketed by Wilson-Cook. The Double Lumen Cytology Brush is supplied sterile and intended for single use only.
This 510(k) summary for the Wilson-Cook Double Lumen Biliary Cytology Brush does not include acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (Wilson-Cook Cytology Brushes, K896318).
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria or performance data are provided. The document states: "We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This implies that the performance characteristics were compared to the predicate, but the specific metrics and targets (acceptance criteria) for this comparison are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided. The document does not describe 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)
- No information provided. Since no specific test set is detailed, there is no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information provided.
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. This device is a physical cytology brush, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical cytology brush.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- No information provided.
8. The sample size for the training set
- No information provided.
9. How the ground truth for the training set was established
- No information provided.
Summary of what is present:
The document focuses on establishing substantial equivalence based on the following:
- Identical materials of basic composition: The new brush uses the same materials as the predicate.
- Same operating principal: Both devices function in the same way to collect cells.
- Same technological characteristics: The underlying technology is considered equivalent.
- Intended Use: Both devices are for collecting cells in the biliary system.
- Biocompatibility: This is mentioned as a characteristic where the devices are considered equivalent, implying that biocompatibility testing was either conducted for the new device or referenced from the predicate.
In essence, this 510(k) submission is a "modification to existing cytology brushes" where the manufacturer believes the changes are minor enough that the new device shares the same fundamental characteristics and performance as the previously cleared predicate, thus not requiring new, extensive performance data with specific acceptance criteria beyond demonstrating this equivalence. The FDA concurred with this assessment.
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MAY 2 0 2004
:
ATTACHMENT B-1: 510(k) Summary
KO40324
PAGE 1 OF 1
| SPONSOR: | Wilson-Cook Medical4900 Bethania Station RoadWinston-Salem, NC 27105 |
|---|---|
| CONTACT/SUBMITTER: | Marge Walls-WalkerRequlatory Affairs Specialist[336] 744-0157 Ex.290 |
| DATE OF SUBMISSION: | February 6, 2004 |
| DEVICE: | Double Lumen Biliary Cytology Brush |
| Trade Name:Common Name:Classification: | Double Lumen Biliary Cytology BrushCytology BrushBrush, Cytology for Endoscope, Class II21 CFR § 876.1500 78 FDX |
| PREDICATE DEVICES: | Wilson-Cook Cytology Brushes (K896318) |
| INTENDED USE: | Wilson-Cook's Double Lumen Biliary CytologyBrush is intended to collect cells in the biliarysystem. |
| DEVICE DESCRIPTION: | The proposed Cytology Brush is a modificationto existing cytology brushes currently marketedby Wilson-Cook. The Double Lumen CytologyBrush is supplied sterile and intended for singleuse only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to besubstantially equivalent to currently marketedWilson-Cook cytology brushes as cleared byK896318. Both devices share identical materialsof basic composition, the same operatingprincipal and the same technologicalcharacteristics. |
| PERFORMANCE DATA: | We believe the proposed device to besubstantially equivalent to the named predicatein terms of Intended Use, performancecharacteristics tested and biocompatibility. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040324
Trade/Device Name: Wilson-Cook Double Lumen Biliary Cytology Brush Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDX Dated: April 2, 2004 Received: April 5, 2004
Dear Ms. Walls-Walker:
We have reviewed your Scction 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 for assumerous 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, I'DA 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 r 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 l'ederal 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) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA intuitig of basification 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 If you desire specific advice for your device on our last to good 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 Additionally, for questions on the promotion the regulation entitled, "Misbranding Othce of Compliance at (501) 554-4057. Taxa, produkt (1) you may obtain. Other general by reference to premarked notification (21 cm ray be obtained from the Division of Small
information on your responsibilities under the Act may be of the surpher (800) 633, 2 information on your responsionalities und reserved its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremospain bron Manufacturers, International and Collidation - Letters http://www.fda.gov/cdch/dsmall.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdch/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
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510(k) Number (if known): _K
Device Name: Wilson-Cook Double Lumen Biliary Cytology Brush
Indications for Use:
The Wilson-Cook Double Lumen Biliary Cytology Brush is intended for the collection of cells in The Wilson Oook Double 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 R. Lymm
Over-the-Counter______________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.