(29 days)
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.
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.
The provided document is a 510(k) summary for the Autotome™ RX device, which is a sphincterotome. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for novel AI/machine learning devices.
Therefore, much of the requested information cannot be extracted from this specific document, as it describes a traditional medical device submission based on predicate device comparison.
Here's an attempt to answer the questions based on the available information and highlighting what is not present:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Rapid Exchange™ Cannulating Sphincterotome (K970053, Ultratome RX) in terms of performance characteristics and biocompatibility. | The submission states, "The proposed device is substantially equivalent to currently marketed Rapid Exchange™ Cannulating Sphincterotome in terms of performance characteristics tested and biocompatibility." This indicates that the device's performance characteristics (though not specified in detail) were compared to the predicate and found to be similar enough to warrant substantial equivalence. Specific quantitative performance metrics or acceptance criteria beyond "substantially equivalent" are not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The submission focuses on device comparison rather than a clinical study requiring a specific test set.
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)
This information is not applicable/provided. Ground truth establishment by experts for a test set is typically relevant for studies validating diagnostic or AI devices, which is not the nature of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/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
This information is not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithmic/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The evaluation is based on "performance characteristics tested and biocompatibility" compared to a predicate device, not on diagnostic accuracy against a ground truth.
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided.
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OCT 1 9 2001
KD13153
Section 9 510(K) SUMMARY
| SPONSOR: | Boston Scientific Corporation (BSC)Microvasive Endoscopy DivisionOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT/SUBMITTER: | Lisa QuagliaRegulatory Affairs ManagerTel: 508-650-8267 |
| DATE OF SUBMISSION: | September 19, 2001 |
| DEVICE: | Autotome™ RX |
| Trade Name:Common Name:Classification: | Autotome™ RXSphincterotomeEndoscope and AccessoriesClassified 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 lumensphincterotome with controlled orientation and rotationfeatures. It is compatible with the Boston ScientificMicrovasive® Endoscopy's Rapid Exchange™ platform,and is capable of accommodating a .035" guidewirewhile allowing simultaneous injection through anadjacent lumen. |
| INTENDED USE: | The Autotome™ RX is indicated for use intransendoscopic sphincterotomy of the Papilla of Vaterand/or the Sphincter of Oddi. This device can also beused to cannulate and inject contrast medium. |
| COMPARISON OFCHARACTERISTICS: | The proposed device is substantially equivalent tocurrently marketed devices used for transendoscopicsphincterotomy of the Papilla of Vater and/or theSphincter of Oddi, and for injection of contrast mediainto the biliary and pancreatic ductal systems. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent tocurrently marketed Rapid Exchange™ CannulatingSphincterotome in terms of performance characteristicstested and biocompatibility. |
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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.
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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
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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
§ 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).