(82 days)
No
The description details a microprocessor-controlled pump and a monitoring unit that uses pressure sensors, volume differential measurement, and software control for pressure regulation and alarms. There is no mention of AI, ML, image processing, or any learning algorithms. The system appears to operate based on pre-programmed logic and sensor feedback.
No
The device is used to distend the uterus and monitor fluid loss during hysteroscopic procedures, which are diagnostic and operative, but the device itself does not claim to treat any disease or condition.
Yes.
The "Intended Use / Indications for Use" states that the system is "intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy". This indicates it is used for diagnostic purposes.
No
The device description explicitly details multiple hardware components including a microprocessor controlled pump, roller wheel, pump head, pressure sensors, display unit, bag holder, weighting unit, and load controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide liquid distension of the uterus and monitor fluid volume differential during a surgical procedure (hysteroscopy). This is a therapeutic and monitoring function performed in vivo (within the body), not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a pump and a monitoring unit that work together to manage fluid flow and volume during a procedure. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or other methods for analyzing biological samples to detect diseases, conditions, or markers. This device does not perform any such analysis.
The device is a surgical fluid management system used to facilitate a diagnostic and operative procedure, but it is not itself a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The IUR Fluid Management System is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
Product codes
HIG
Device Description
The IUR Fluid Management System consists of a microprocessor controlled pump intended to distend the uterus and a monitoring unit designed to monitor the irrigation fluid losses during hysteroscopic procedures.
The pump unit functions according to the peristaltic principle. It consists of a power supply, main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active pressure reduction ensures the conformity of the preset nominal pressure value with the actual measured pressure. The pump unit is designed with several alarms to inform the operator in case of an overpressure. The fluid monitoring unit operates with a volume differential measurement to determine the fluid losses remained in the patient. It consists of the following components: display unit, bag holder, bag deflector, carrier plate for the pump unit, scale pole, unit stands pole, weighting unit, container holder, roller base and load controller. The deficit threshold alarm level can be selected by the operator in the range of 0-2000 ml.
The IUR Fluid Management System is only functional if the monitoring unit is connected to the pump unit and a specific resectoscope is attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
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 device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
AUG 1 3 2003
K031616
page 1 of 2
510(K) SUMMARY IUR Fluid Management System
I. Applicant:
W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany
II. Device Names:
-
Classification Name: 1.
Proprietary Name: -
Common or Usual Name: 2.
Hysteroscopic Insufflator and Accessories Hysteroscopic Insufflator, Fluid Monitoring System and Tubing Sets IUR Fluid Management System
III. Classification:
Class II. This device is described in 21 C.F.R. § 884.1700. The product code for the device is HIG.
IV. Predicate Devices:
- Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Flo-Stat Fluid Monitoring System (K954775) manufactured by Gynecare ● Innovation Center.
V. Intended Use:
The IUR Fluid Management System is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
Device Description: VI.
The IUR Fluid Management System consists of a microprocessor controlled pump intended to distend the uterus and a monitoring unit designed to monitor the irrigation fluid losses during hysteroscopic procedures.
The pump unit functions according to the peristaltic principle. It consists of a power supply, main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to
1
K031616
Page 2 of 2
510(K) SUMMARY Page -2- / -2-
perform redundant pressure measurement. A software controlled active pressure reduction ensures the conformity of the preset nominal pressure value with the actual measured pressure. The pump unit is designed with several alarms to inform the operator in case of an overpressure. The fluid monitoring unit operates with a volume differential measurement to determine the fluid losses remained in the patient. It consists of the following components: display unit, bag holder, bag deflector, carrier plate for the pump unit, scale pole, unit stands pole, weighting unit, container holder, roller base and load controller. The deficit threshold alarm level can be selected by the operator in the range of 0-2000 ml.
The IUR Fluid Management System is only functional if the monitoring unit is connected to the pump unit and a specific resectoscope is attached.
VII. Substantial Equivalence:
The IUR Fluid Management System described in this notification is similar in design and technological characteristics to the Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD OF MEDICINE AG and to the Flo-Stat Fluid Monitoring System (K954775) manufactured by Gynecare Innovation Center.
In addition, both the IUR Fluid Management System and the predicate devices are intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and/or to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
The differences between the IUR Fluid Management System and the predicate devices are minor and raise no new questions of safety and effectiveness.
Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the IUR Fluid Management System is substantially equivalent to the predicate devices currently on the market.
VIII. Performance Data:
The device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
Signed:
S. Roals
Susanne Raab Official Correspondent
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal features a stylized eagle with three lines emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
AUG 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W.O.M. World of Medicine % Ms. Susanne Raab Official Correspondent 320 North Columbus Street ALEXANDRIA VA 22314 Re: K031616
Trade/Device Name: IUR Fluid Management System Hysteroscopy Pump HM4 Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopy insufflator Regulatory Class: II Product Code: 85 HIG Dated: May 7, 2003 Received: July 14, 2003
Dear Ms. Raab:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA), 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 (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 that FDA has made 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 comply with all the Act's requirements, 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 (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
Page 2
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): 4031616
Device Name: IUR Fluid Management System
Indications for Use:
The IUR Fluid Management System is a device intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use _ (Per 21 C.F.R. 801.109)
OR
Over-The-Counter
Nancy Brogdon
Division Sign-Off
(Division Sign-Off (Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
(Optional Format 3-10-98)
10-1