(29 days)
No
The summary describes a mechanical device for surgical procedures and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for use in "transendoscopic sphincterotomy," which is a therapeutic procedure to cut or widen a sphincter. It also mentions it can be used to "inject contrast medium," which can be diagnostic, but its primary indicated use is a therapeutic intervention.
No
The device is indicated for therapeutic procedures (transendoscopic sphincterotomy, cannulation, and contrast medium injection), not for diagnosing conditions.
No
The device description clearly states it is a "triple lumen sphincterotome," which is a physical medical device used in endoscopic procedures, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (transendoscopic sphincterotomy, cannulation, and contrast injection) performed directly on a patient's anatomy (Papilla of Vater and Sphincter of Oddi).
- Device Description: The device is a surgical instrument designed for manipulation within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Autotome™ RX is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.
Product codes
78 KNS
Device Description
The proposed Autotome™ RX is a triple lumen sphincterotome with controlled orientation and rotation features. It is compatible with the Boston Scientific Microvasive® Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .035" guidewire while allowing simultaneous injection through an adjacent lumen.
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
The proposed device is substantially equivalent to currently marketed Rapid Exchange™ Cannulating Sphincterotome in terms of performance characteristics tested and biocompatibility.
Key Metrics
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
OCT 1 9 2001
KD13153
Section 9 510(K) SUMMARY
| 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: | September 19, 2001 |
| DEVICE: | Autotome™ RX |
| Trade Name:
Common Name:
Classification: | Autotome™ RX
Sphincterotome
Endoscope and Accessories
Classified Under 21 CFR Part 876, §4300.
Classified as a Class II Device. |
| PREDICATE DEVICE: | Rapid Exchange™ Cannulating Sphincterotome
(K970053, Ultratome RX) |
| DEVICE DESCRIPTION: | The proposed Autotome™ RX is a triple lumen
sphincterotome with controlled orientation and rotation
features. It is compatible with the Boston Scientific
Microvasive® Endoscopy's Rapid Exchange™ platform,
and is capable of accommodating a .035" guidewire
while allowing simultaneous injection through an
adjacent lumen. |
| INTENDED USE: | The Autotome™ RX is indicated for use in
transendoscopic sphincterotomy of the Papilla of Vater
and/or the Sphincter of Oddi. This device can also be
used to cannulate and inject contrast medium. |
| COMPARISON OF
CHARACTERISTICS: | The proposed device is substantially equivalent to
currently marketed devices used for transendoscopic
sphincterotomy of the Papilla of Vater and/or the
Sphincter of Oddi, and for injection of contrast media
into the biliary and pancreatic ductal systems. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to
currently marketed Rapid Exchange™ Cannulating
Sphincterotome in terms of performance characteristics
tested and biocompatibility. |
1
Image /page/1/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2001
Ms. Lisa M. Quaglia Regulatory Affairs Manager Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K013153 Trade/Device Name: Ultratome™ RX Model # 4515, 4516 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: September 19, 2001
Received: September 20, 2001
Dear Ms. Quaglia:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enorment date of 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, do nees 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 r ou may, arores, many of the Act include requirements for annual registration, listing of Econoral ocurrities profice, 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 does not mean r read o a nove 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 or any r subtal butter equirements, 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 (scctions 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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/cdrh/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
Indications for Use Statement
510(k) Number (if known)
Page 1 of 1
Device Name
Autotome™ RX
Indications for Use
The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use _
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013153