(118 days)
Not Found
Not Found
No
The summary describes a mechanical device for delivering a capsule endoscope and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML-powered devices.
No
The device is used to deliver another device (the M2A® Capsule Endoscope) for diagnostic evaluation, not for treating a condition itself.
No
Explanation: The device is used to deliver another device (M2A® Capsule Endoscope) which is used for diagnostic evaluation, but the delivery device itself does not perform diagnostics. Its function is purely delivery.
No
The device description explicitly states it is a "disposable Capsule Delivery Device" and a "single sheathed device," indicating a physical hardware component for delivering a capsule endoscope.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of a capsule endoscope to the duodenum. This is a procedural device used to facilitate an in-vivo diagnostic procedure (the capsule endoscopy itself).
- Device Description: The description is of a physical delivery device, not a reagent, instrument, or system used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool for delivering another device that performs the diagnostic imaging inside the body.
N/A
Intended Use / Indications for Use
The disposable Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
Product codes
78 NEZ, 78 KOG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
duodenum, pylorus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2004
Ms. Gretchen Y. Cohen Executive Vice President United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060
Re: K040494
Trade/Device Name: Capsule Delivery Device Regulation Number: 21 CFR 876.1300 & 876.1500 Regulation Name: Ingestible telemetric gastrointestinal capsule imaging system & Endoscope and accessories
Regulatory Class: II Product Code: 78 NEZ and 78 KOG Dated: May 24, 2004 Received: May 25, 2004
Dear Ms. Cohen:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your becaller of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally to regally the Medical Device Americal Production of D commence provision to May 20, 1970, the clordance with the provisions of the Federal Food, Drug, devices that have occh reculired in accordance approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, maries and e Act include requirements for annual registration, listing of gencral controls provisions or vractice, 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 If your device is classince (soc aboro) ins. Existing major regulations affecting your device can may be subject to such additional controller 21, Parts 800 to 898. In addition, FDA may be found in the Oouver ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I DA s issumed of that your device complies with other requirements of the Act that FDA has made a decommandian has Journalistered by other Federal agencies. You must comply of CEP Part of any Federal statutes and regulations asnumbly and limited to: registration and listing (21 CFR Part with an the Act s requirements, meading, ourfacturing practice requirements as set forth in the 807), labornig (21 OF N Part 820); and if applicable, the electronic product quality systems (QD) regulars (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin harketing your even of your device of your device to a legally premarket notification. The PDA miding of dacomment of 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 If you desire specific advice for your de if the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4610 |
| 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 Adultionally, for questions of the promotions. Also, please note the regulation entitled, "Misbranding Other of Compliansoul (2017 - 21 CFR Part 807.97) you may obtain. Other general by relefence to premarked nombanon (er the Act may be obtained from the Division of Small miornlandin on your responsionities and 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. Boyden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
Indications for Use
510(k) Number (if known): K040494
Device Name: Capsule Delivery Device
Indications for Use:
The disposable Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
Prescription Use (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)
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Page 1 of 1