(182 days)
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No
The 510(k) summary describes a simple drainage bag and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used for drainage collection, which is a therapeutic purpose to manage bodily fluids and promote healing.
No
A drainage bag is used for the collection of fluids (e.g., in nephrostomy or biliary drainage), which is a therapeutic or supportive function rather than a diagnostic one. It does not measure or interpret physiological data to identify a disease or condition.
No
The device description clearly states "Drainage Bag," which is a physical hardware component used for fluid collection. There is no mention of software as the primary or sole component.
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 collection of drainage from procedures like nephrostomy, biliary, and abscess drainage. This is a physical collection of bodily fluids for disposal or potentially further analysis, but the device itself is not performing a diagnostic test in vitro (outside the body).
- Device Description: It's described as a "Drainage Bag," which is a container for collecting fluids.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples, detecting analytes, or providing diagnostic information. IVDs typically involve reagents, test strips, analyzers, or other components used to perform tests on biological samples.
Therefore, this device is a medical device used for fluid collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.
Product codes
78 EXF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
used by a urologist or a gastroenterologist in a healthcare setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1:2 1999
Mr. Steve Woody Submission Correspondent Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005
Re: K990428 Drainage Bag Dated: June 25, 1999 Received: June 28, 1999 Requiatory Class: II 21 CFR §876.5010/Procode: 78 EXF
Dear Mr. Woody:
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 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 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 requlatory 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 regulations.
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), piease 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
1
| Remington Medical, Inc. | |
|---|---|
| Appendix B | |
| Indication for Use Statement | |
| 510(k) Number (if known): | Pending 510(k) Request |
| Device Name: | Drainage Bag |
| Indications for Use: | |
| Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection. |
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K990428/5002 |
|---|---|
| --------------- | -------------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |