(47 days)
No
The description focuses on the mechanical and physical characteristics of a medical device for endoscopic procedures and does not mention any AI or ML components.
No
The description indicates the device is used for surgical procedures (cannulation and sphincterotomy), classifying it as a surgical instrument rather than a therapeutic device that delivers treatment or therapy itself.
No
The device is described as a papillotome for transendoscopic cannulation and sphincterotomy, which are interventional procedures, not diagnostic ones.
No
The device description clearly describes a physical catheter with specific dimensions, materials (radiopaque tip), and features (triple lumen, cutting wire), indicating it is a hardware medical device.
Based on the provided information, the Axcess Papillotome is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (transendoscopic cannulation and sphincterotomy) performed in vivo on a patient's anatomy (Papilla of Vater and Sphincter of Oddi).
- Device Description: The description details a physical catheter designed for insertion into the body and manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro to diagnose a condition. IVDs are typically reagents, instruments, or systems intended for use in the examination of specimens derived from the human body.
The Axcess Papillotome is a surgical instrument used for therapeutic intervention, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
Product codes
KNS
Device Description
The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Papilla of Vater and/or the Sphincter of Oddi
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 Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
ONMED
MAY 20 2008
Axcess Papillotome 510K Summary of Safety and Effectiveness January 14, 2008
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- Sponsor Name Sponsor/Manufacturer ConMed Endoscopic Technologies 129 Concord Rd Billerica, MA 01821 Telephone: 978 964 4251 Contact Individual: Beth Zis
rina CDPH DMC
- Sponsor Name Sponsor/Manufacturer ConMed Endoscopic Technologies 129 Concord Rd Billerica, MA 01821 Telephone: 978 964 4251 Contact Individual: Beth Zis
MAY - 5 2008
000 2002
2. Device Name
Proprietary Name: ConMed Axcess Papillotome Common/Usual Name: Papillotome
3. Identification of Predicate or Legally Marketed Device The Axcess Papillotome is substantially equivalent to the following devices:
- Bard Apollo Papillotome cleared under K982557 .
- Boston Scientific Corporation Autotome cleared under K013153 .
4. Device Description
The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.
-
- Intended Use The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
- Comparison of Technological Characteristics 6. The Axcess Papillotome and the predicates have similar design characteristics. They both have construction which consists of a handle, triple lumen shaft, a
1
2800446
ConMed Endoscopic Technologies Axcess Papillotome Premarket Notification
cutting wire, and a precurved radiopaque tip. The device lengths and wire diameters are comparable. The materials of construction are different but the materials used are widely used in medical devices and tested to be biocompatible. The Axcess Papillotome is multidirectional whereas the Apollo Papillotome is not, however the BSC Autotome is a multidirectional Papillotome.
-
- Performance Testing
The Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications.
- Performance Testing
-
- Statement of Equivalency
The Axcess Papillotome is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Axcess Papillotome has the same intended use and technological characteristics as the predicate device, the Axcess Papillotome does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.
- Statement of Equivalency
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 20 2008
ConMed Endoscopic Technologies, Inc. % Mr. Daniel W. Lehtonen Intertek Testing Services NA, Inc. 2307 E. Aurora Road., Unit B7 TWINSBURG OH 44087
Re: K080946
Trade/Device Name: ConMed Axcess Papillotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: May 2, 2008 Received: May 5, 2008
Dear Mr. Lehtonen:
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.
Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. In the center of the seal are the letters "FDA" in a stylized font. Below the letters, the word "Centennial" is written in cursive. The seal is surrounded by a border with stars and other decorative elements.
Protecting and Promoting Public Health
3
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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
4
ConMed Endoscopic Technologies Axcess Papillotome Premarket Notification
Indications for Use
510(k) Number (if known): K
Device Name: Axcess Papillotome
Indications For Use:
The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nogu M. Khan
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K080946
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