(156 days)
Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.
Three Lumen Papillotome/Sphincterotome
Here's an analysis of the provided text regarding acceptance criteria and a device study:
Important Note: The provided documents (FDA 510(k) K992402 letter and "Indications For Use" attachment) are for a Three Lumen Papillotome/Sphincterotome, which is a medical device, not an AI/software device. The questions you've asked (e.g., about AI assistance, standalone algorithm performance, training sets, expert consensus for ground truth) are highly specific to AI/software products.
Therefore, the information you're requesting, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9 about detailed study design and acceptance criteria for an AI device, cannot be extracted from these documents. These documents confirm the device's substantial equivalence to a predicate device, which is a regulatory pathway for hardware medical devices, not a detailed performance study for an AI algorithm.
Based only on the provided documents, I can answer the following, while clarifying that AI-specific details are absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission was the demonstration of substantial equivalence to legally marketed predicate devices. The documents do not detail specific performance metrics (like sensitivity, specificity, accuracy) or associated thresholds typically seen for AI devices.
- Reported Device Performance: The documents do not report specific performance metrics for the device itself (e.g., success rates, complication rates from a clinical study). The FDA statement focuses on the determination of substantial equivalence (i.e., that it's as safe and effective as existing devices), not on a quantitative performance report.
| Criterion (Implicit for 510(k)) | Reported Device Performance (Implicit for 510(k)) |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent. |
The following points (2-9) are not applicable or cannot be answered from the provided documents as they pertain to AI device studies, which is not what this 510(k) describes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This information is not present in the 510(k) documents as it's not an AI device study requiring a "test set" in that context. The 510(k) likely relied on bench testing, biocompatibility data, and comparison to predicate device characteristics.
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: This relates to AI/diagnostic imaging ground truth establishment, which is not relevant to this mechanical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This is for AI/diagnostic studies for resolving discrepancies in ground truth.
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: This is specific to AI-assisted reading studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: There is no algorithm for this mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Ground truth as described is not relevant to a 510(k) submission for a mechanical device. The "truth" in this context is its safe and effective deployment based on its design and comparison to existing products.
8. The sample size for the training set
- Not Applicable: This refers to AI model training, which is not involved here.
9. How the ground truth for the training set was established
- Not Applicable: This refers to AI model training, which is not involved here.
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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three heads, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HES 22 1936
Mr. John A. Chaves President & CEO Telemed Systems, Inc. 19 Brigham Street. Unit 1 Marlborough, MA 01752 Re: K992402 Three Lumen Papillotome/Sphincterotome Models 5102, 5104, 5106, 5108 and 5110 Dated: November 1. 1999 Received: November 1, 1999 Requlatory Class: II 21 CFR 876.4300/Procodes: 78 KNS and FDI
Dear Mr. Chaves:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 vour 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTAchment IT
Page 1
510(k) Number (If known)_K992402
Device Name: Three Lumen Papillotome/Sphincterotome
Indications For Use:Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.
(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 (Optional Format 1-2-9) |
|---|---|
| -------------------------------------------------- | ----------------------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K992402 |
|---|---|
| --------------- | --------- |
§ 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).