(27 days)
Not Found
No
The summary describes a mechanical cannula for injecting contrast media and does not mention any AI/ML components or functions.
No
The device is used to inject contrast media for diagnostic imaging, not to treat a disease or condition. While "cannulate" is used, the purpose is for imaging.
No
The device is used to inject contrast media for imaging, but the device itself does not perform diagnosis. The diagnosis is made based on the fluoroscopy or x-ray images.
No
The device description clearly describes a physical, single-lumen cannula, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Alien™ RX Micro Cannula is a device used within the body to inject contrast media into the biliary and pancreatic ductal systems for imaging purposes (fluoroscopy or x-ray). It is a surgical/interventional device, not a device that analyzes samples in vitro.
The description clearly indicates its use in a procedure performed directly on the patient, not on a sample outside the body.
N/A
Intended Use / Indications for Use
The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.
Product codes (comma separated list FDA assigned to the subject device)
ODD
Device Description
The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Microvasive Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .025" guidewire while passing through a .035" lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy or x-ray
Anatomical Site
biliary and pancreatic ductal systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device is substantially equivalent to currently marketed ERCP cannulating devices in terms of performance characteristics tested and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 27 2015
Boston Scientific Corporation Microvasive Endoscopy Ms. Lisa M. Quaglia Regulatory Affairs Manager One Boston Scientific Place Natick, MA 01760-1537
Re: K010993
Trade/Device Name: Alien™ RX Micro Cannula, Model 4530 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODD Dated (Date on orig SE Itr): April 2, 2001 Received (Date on orig SE ltr): April 3, 2001
Dear Ms. Quaglia,
This letter corrects our substantially equivalent letter of April 30, 2001.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Special 5l0(k) Premarket Notification Alien™ RX Micro Cannula March 30, 2001
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760
Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known) | K010993 |
|---|---|
| Device Name | Alien™ RX Micro Cannula |
| Indications for Use | The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram. |
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----------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use OR Prescription Use i (Per 21 CFR 801.109) In (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deviçes 510(k) Number
34
Proprietary and Confidential Information of Boston Scientific Corporation
3
APR 3 0 2001
Special Sl0(k) Premarket Notification Alien™ RX Micro Cannula
April 2, 2001
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760
Section 9 510(K) SUMMARY
| Provided in accordance with 21 CFR 807.92 | |
|---|---|
| SPONSOR: | Boston Scientific Corporation (BSC) Microvasive Endoscopy Division One Boston Scientific Place Natick, MA 01760 |
| CONTACT/SUBMITTER: | Lisa Quaglia Regulatory Affairs Manager Tel: 508-650-8267 |
| DATE OF SUBMISSION: | April 2, 2001 |
| DEVICE: | Alien™ RX Micro Cannula |
| Trade Name: | Alien™ Micro Cannula |
| Common Name: | Cannula |
| Classification: | Endoscope and Accessories Classified Under 21 CFR Part 876, Section 1500. Classified as a Class II Device. |
| PREDICATE DEVICE: | Contour™ ERCP Cannula (K833417, ERCP Cannula) |
| DEVICE DESCRIPTION: | The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Microvasive Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .025" guidewire while passing through a .035" lumen. |
| INTENDED USE: | The Alien™ RX Micro Cannula is intended for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram. |
| COMPARISON OF CHARACTERISTICS: | The proposed device is substantially equivalent to currently marketed devices used for cannulation and injection of contrast media into the biliary and pancreatic ductal systems. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to currently marketed ERCP cannulating devices in terms of performance characteristics tested and biocompatibility. |