(190 days)
Not Found
No
The 510(k) summary describes a simple fluid collection bag with no mention of AI or ML technology. The modifications are related to volume capacity and comfort features.
No
The device is a drainage bag intended for collection of fluid, not for treatment or therapy.
No
The device is a drainage bag intended for collection of fluid, not for diagnostic purposes.
No
The device description clearly identifies the device as a "4L drainage bag," which is a physical medical device for fluid collection, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "collection of fluid which is on its way away from the body." This describes a device used in vivo (within the body or collecting substances leaving the body), not in vitro (testing substances outside the body).
- Device Description: The description focuses on a drainage bag for collecting fluid, consistent with the intended use.
- Lack of IVD Characteristics: There is no mention of analyzing or testing the collected fluid, which is a key characteristic of an IVD. The purpose is simply collection.
Therefore, the Maersk Medical 4L drainage bag is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The 4L drainage bag will not come into contact with neither skin or drugs and therefore no biocompatibility test has been carried out.
The device. label will state the following:
A: "Peritoned Dialysis Drainage bag"
B: "Collection bag fer urine"
Product codes (comma separated list FDA assigned to the subject device)
78 KNX, 78 FKX
Device Description
The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications.
The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The performance data showed that the product has lives up to high quality performance demands that fully shows that the 4L drainage bag is substantially equivalent to the unmodified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
maersk
Image /page/0/Picture/1 description: The image shows the text "K973364 p.1/2". The text appears to be handwritten in black ink on a white background. The text is arranged in two lines, with the first line containing the alphanumeric string "K973364" and the second line containing "p.1/2".
MAR 17 1998
510(k) Summary
1. Trade/propriety name:
Urias and Pharma Plast brand names will be used but products may also be marketed without brand names especially in case of OEM products or in some cases with private labels.
4L Drainage bag 2. Common/usual name:
-
Classification name: Gasenterology and urology
-
Establishment Registration number: 8021523
-
Manufacturing/sterilization facility address:
Maersk Medical A/S Drainage Bags Haarlev Mark 2 DK - 4652 Haarlev, Denmark.
6. Substantial equivalence:
The products included in this notification is equivalent to the components described in K843480.
- Device Description.
The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications.
The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.
8. Intended use.
The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The 4L drainage bag will not come into contact with neither skin or drugs and therefore no biocompatibility
1
Image /page/1/Picture/0 description: The image shows the Maersk logo. The logo consists of a white, eight-pointed star inside of a black square. Below the square is the word "MAERSK" in a bold, sans-serif font.
test has been carried out.
9. Technological Characteristics.
K973364
p. 2/2
The technological characteristics of the device has not been affected by these modifications.
10. Performance Data.
The performance data showed that the product has lives up to high quality performance demands that fully shows that the 4L drainage bag is substantially equivalent to the unmodified device.
11. Conclusion
Based on the equivalency in all the mentioned areas including functional and quality testing, Maersk Medical has determined that the 4L drainage bag are substantially equivalent to the devices currently marketed in the United States.
2
Image /page/2/Picture/0 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a stylized graphic. The graphic consists of three curved lines that resemble the silhouette of a bird in flight. The logo is black and white and appears to be a seal or emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joergen M. Nielsen Product Manager Maersk Medical A/S Harlev Mark 2 4652 Harlev, DENMARK Re: K973364 Arias and Pharma Plast Drainage Bag MAR 17 1998 Dated: February 13, 1998 Received: February 17, 1998 Regulatory Class: II 21 CFR 876.5250/Procode: 78 KNX 21 CFR 876.5630/Procode: 78 FKX
Dear Mr. Nielson:
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 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 (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 (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 (OS) for Medical Devices: General regulation (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 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), 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/cdrb/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1 - 1 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2
Page 1 of 1
510(k) Number (if known): K973361
Device Name: 4h Drainaz Bag
Indications For Usc:
The device. label will state the following:
A: "Peritoned Dialysis Drainage bag"
B: "Collection bag fer urine"
Raersk Medical A/S
Jorgen Hamm 18/12-
(PLUASE 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 1-2-96)
Robert R. Retting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K973364