(258 days)
Not Found
No
The description details a microprocessor-controlled pump and monitoring system with pressure sensors, alarms, and volume differential measurement. While it uses software control and a microprocessor, there is no mention of AI or ML algorithms for tasks like image analysis, predictive modeling, or adaptive control beyond basic feedback loops.
Yes.
The device is used to provide liquid distension of the uterus during hysteroscopy, which is a medical procedure, making it a therapeutic device.
No
The device is described as 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." While it is used in "diagnostic hysteroscopy," its primary function is distension and fluid management, not directly diagnosing medical conditions itself. It's a tool used during a diagnostic procedure, rather than a diagnostic device in its own right.
No
The device description explicitly details numerous hardware components, including a microprocessor-controlled pump, monitoring unit, power supply, roller wheel, pump head, pressure sensors, display unit, bag holder, weighting unit, and load controller. While software is mentioned for control and pressure reduction, the device is clearly a physical system with integrated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the patient (in vitro).
- Device Description: The description details a pump and monitoring system for managing fluid during a surgical/diagnostic procedure. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical (pumping fluid) and measurement-based (monitoring fluid volume).
Therefore, the Hysteroscopy Pump HM4 is a medical device used in a clinical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hysteroscopy Pump HM4 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 (comma separated list FDA assigned to the subject device)
HIG
Device Description
The Hysteroscopy Pump HM4 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.
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 will comply with the International Standard IEC 601-1 (Electrical Safety) and IEC 601-1-2 (Electromagnetic Compatibility). In addition, the device will meet the requirements of the Underwriter Laboratories standard UL 2601-1 and will bear the CE mark in accordance with the Medical Device Directive 93/42/EEC.
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
§ 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
510(K) SUMMARY Hysteroscopy Pump HM4
APR 1 0 2003
I. Submitter:
W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany
II. Device Names:
| Classification Name: | H |
|---|---|
| ---------------------- | --- |
-
- Common or Usual Name:
- Proprietary Name:
fysteroscopic Insufflator and Accessories Hysteroscopic Insufflator, Fluid Monitoring System and Tubing Sets Hysteroscopy Pump HM4
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:
- . HYS-Surgimat (K934866) manufactured by W.O.M. WORLD OF MEDICINE AG
- Karl Storz Model 203020 20 Equimat (K961091) distributed by Karl Storz Endoscopy-America, Inc.
- . Karl Storz Hamou Endomat (K936231) distributed by Karl Storz Endoscopy-America, Inc.
V. Intended Use:
The Hysteroscopy Pump HM4 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.
VI. Device Description:
The Hysteroscopy Pump HM4 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
510(K) SUMMARY Page -2-1-2-
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.
VII. Substantial Equivalence:
The Hysteroscopy Pump HM4 described in this notification is similar in design and technological characteristics to the HYS-Surgimat (K934866) manufactured by W.O.M. WORLD OF MEDICINE AG, the Karl Storz Model 203020 20 Equimat (K961091) and the Karl Storz Hamou Endomat (K936231) both devices distributed by Karl Storz Endoscopy-America, Inc.
In addition, both the Hysteroscopy Pump HM4 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 Hysteroscopy Pump HM4 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 Hysteroscopy Pump HM4 is substantially equivalent to the predicate devices currently on the market.
VIII. Performance Data:
The device will comply with the International Standard IEC 601-1 (Electrical Safety) and IEC 601-1-2 (Electromagnetic Compatibility). In addition, the device will meet the requirements of the Underwriter Laboratories standard UL 2601-1 and will bear the CE mark in accordance with the Medical Device Directive 93/42/EEC.
Signed:
S. Roeb
Susanne Raab Official Correspondent
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
W.O.M. World of Medicine AG % Ms. Susanne Raab Official Correspondent 320 North Columbus Street ALEXANDRIA VA 22314
Re: K022449
Trade/Device Name: Hysteroscopy Pump HM4 Regulation Number: 21 CFR 884.1700 Regulation Name: Hysteroscopic insufflator Regulatory Class: II Product Code: 85 HIG Dated: February 20, 2003 Received: February 24, 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
Page 2
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
4
STATEMENT OF INDICATIONS FOR USE
APPLICANT:
W.O.M. WORLD OF MEDICINE AG
510(K) NUMBER (if known):
DEVICE NAME:
Hysteroscopy Pump HM4
INDICATIONS FOR USE:
The Hysteroscopy Pump HM4 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
Prescription Use
David A. Seaman
(Division Sign-Off) Division of Reproductiv and Radiological Devic 510(k) Number _