(30 days)
Indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.
The DualFlex™ RX ERCP Cannula is a rapid exchange wire-guided catheter used to cannulate and for delivery of contrast media in the biliary duct.
The provided text describes a 510(k) summary for the Boston Scientific DualFlex™ RX ERCP Cannula, focusing on its substantial equivalence to a predicate device. This document is a premarket notification for a medical device and, as such, does not typically contain "acceptance criteria" and "device performance" in the sense of a clinical or AI-based study with quantifiable metrics like accuracy, sensitivity, or specificity. Instead, the "performance data" referred to here relates to engineering and functional testing to demonstrate that the new device meets its design specifications and is as safe and effective as the predicate device.
Therefore, many of the requested items (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable or cannot be extracted from this type of regulatory submission. The device described is a physical medical instrument (a cannula), not a diagnostic algorithm or AI system.
Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner (e.g., specific thresholds for flow rates, burst pressures, or imaging quality). Instead, the performance is demonstrated through "design control activities" and "physical comparison and functional testing" to support substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same operating principle as predicate device | Yes, stated as "same operating principal" |
| Same intended use as predicate device | Yes, stated as "same intended use" |
| No new issues of safety or effectiveness compared to predicate | Yes, stated as "results of design control activities do not raise any new issues of safety or effectiveness" |
| Functional equivalence supported by physical comparison and functional testing | Yes, stated as "results of physical comparison and functional testing support a determination of substantial equivalence" |
| Compliance with FDA's "Guidance for the Content of Premarket Notifications" | Yes, stated that the guidance was followed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical device subject to engineering and functional testing, not a study involving patient data in the typical sense of a test set for an AI algorithm. The performance data refers to device testing, not data from human subjects.
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 applicable. "Ground truth" in this context would refer to engineering specifications or validated test methods, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used for resolving disagreements among human readers or experts in diagnostic studies, which is not relevant for this physical device's regulatory review.
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. MRMC studies are for evaluating diagnostic performance, often with AI, and this device is a physical medical instrument, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (cannula), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic performance. For a physical device, "ground truth" implicitly refers to established engineering standards, material specifications, and validated functional performance tests (e.g., flow rate measurements, burst pressure tests, material compatibility), which are part of design control activities. The document states that "design control activities" and "physical comparison and functional testing" were used, but does not specify the exact nature of these tests or their 'ground truth' validation methods.
8. The sample size for the training set
Not applicable. There is no "training set" for this type of physical medical device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth" establishment in this context.
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510 (k) SUMMARY
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | Paige K. SweeneySenior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name: | DualFlex™ RX ERCP Cannula |
| Common Name: | Injection Cannula |
| Classification: | Class II, per 21 CFR Part 876, Section 1500 |
| PREDICATE DEVICE: | Boston Scientific Tandem™ RX ERCP Cannula(K970054). |
| DESCRIPTION: | The DualFlex™ RX ERCP Cannula is a rapid exchangewire-guided catheter used to cannulate and for deliveryof contrast media in the biliary duct. |
| INTENDED USE: | The DualFlex™ RX ERCP is indicated for use tocannulate and inject contrast media to obtain acholangiogram of the biliary duct system. The contrastmedia is injected through the cannula and fluoroscopy orx-ray is performed to obtain the cholangiogram. |
| COMPARISON OFCHARACTERISTICS: | The modified device is substantially equivalent to thepredicate device, as they have the same operatingprincipal and intended use. In addition, the results ofdesign control activities do not raise any new issues ofsafety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of PremarketNotifications", and the results of physical comparisonand functional testing support a determination ofsubstantial equivalence for the modified device whencompared to the predicate device(s). The modifieddevice is substantially equivalent to the currently |
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Image /page/1/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. The logo is encircled by text, which is difficult to read due to the image quality. The overall design is simple and symbolic, likely representing a company or organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Ms. Paige Sweeney Senior Regulatory Affairs Specialist Boston Scientific Corporation Microvasive Endoscopy One Boston Scientific Place NATICK MA 01760-1537
Re: K041827
Trade/Device Name: Dualflex™ RX ERCP Cannula Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCJ Dated: July 6, 2004 Received: July 7, 2004
Dear Ms. Sweeney:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becament in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard nent date of the Medical Device Amendments, or to conniner to may 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicience, manner the act include requirements for annual registration, listing of general controls provisions of 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 your device is classified (500 above). 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 mat I Dri has made a docemmancis in administered by other Federal agencies. You must of any I ederal studess and regulations, including, but not limited to: registration and listing Compry with an the Hot 5 requiremEl Part 801); good manufacturing practice requirements as set (21 CFR Part 607), laooming (21 CFR Part 820); and if applicable, the electronic ford in the quanty 25 Events (sections 531-542 of the Act); 21 CFR 1000-1050.
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l'age 2
This letter will allow you to begin marketing your device as described in your Section 510(k)
the successful and and of the first of also which anywalance of your device 10 This letter will allow you to begin marketing your convealerse of your device to a legally premarket notification - The F17A midming of sessuation of 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 his regularion of 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 and the regulation entitled, "Misloranding
Office of Compliance at (301) 594-4639. Association may obtesin. Other general Othice of Compliance at (301) 554-4057. Facts, promosed from the Division of Sma by reference to premarket nonmeation (210) it is a very obtained from the Division of Strall
information on your responsibilities under the Act may be since sumber (800) 638, information on your responsibilities and critic and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its todal demagain http:// Manufacturers, International and Coulsamer Absocative and Could Chicker and main.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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INDICATIONS FOR USE STATEMENT
| 510(k) Number | K041827 |
|---|---|
| Device Name | DualFlex™ RX ERCP Cannula |
| Indications For Use | Indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use । ਅ (Per 21 CFR 801.109) OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K041821
§ 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.