(120 days)
No
The description focuses on microprocessor control for fluid pumping and monitoring based on scales, with no mention of AI or ML terms, image processing, or data training/testing.
Yes
The device is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, which is a medical procedure. It also monitors fluid volume, which aids in patient safety during the procedure.
Yes
Explanation: The device is intended to "monitor the volume differential between the irrigation fluid flowing into and out of the uterus" and to "observe the quantity of fluids left in the patient," and "indicates any fluid deficit." While also used for operative hysteroscopy, the monitoring functions provide information that can inform diagnosis (e.g., of fluid overload or perforation).
No
The device description clearly outlines physical hardware components including an irrigation pump unit, fluid monitoring unit, touch-screen display, and tube sets. It also mentions electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, the Hysteroscopy Pump HM6 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide liquid distension of the uterus and monitor fluid volume during hysteroscopy. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device is a pump and fluid monitoring system used during a surgical procedure. It does not analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. The device is focused on managing fluid within the uterus during a procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hysteroscopy Pump HM6 does not fit this definition.
N/A
Intended Use / Indications for Use
The Hysteroscopy Pump HM6 is intended to provide liquid distension of the uterus during 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 Hysteroscopy Pump HM6 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a man-machine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.
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
surgeon
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
The design modifications, which affect both the mechanical, hardware and software were verified and validated throughout the results from the internal design control process, including risk analysis.
Validation and verification testing of the system specification were performed as bench tests.
Software validation was performed in accordance with the FDA Guidance document "General Principles of Software Validation". The Software of the Hysteroscopy Pump HM6 is considered "Major Level of Concern".
Electrical Safety and EMC testing was performed in accordance with IEC 60601-1 by an accredited test institute.
Key Metrics
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.
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K123732
pg. 1 of 4
WORLD OF M Hysteroscopy Pump HIV Special 510(k) Premarket Notification
APR 0 4 2013
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
Submitter:
W.O.M. WORLD OF MEDICINE AG Salzufer 8 10587 Berlin Germany
Phone: +49 30 399 81 594 +49 30 399 81 593 Fax:
Contact Person:
Susanne Raab Regulatory Consultant 1480 Cambridge Street Cambridge, MA 02139
Phone: (617) 547-0628 (617) 520-2401 Fax: e-mail: sbraab@comcast.net
Date Prepared:
December 4, 2012
Tube Sets
II
Trade Name:
Hysteroscopy Pump HM6 Hysteroscopic Insufflator, Fluid Monitoring System and
Common Name:
Classification Name:
Hystersoscopic Insufflator and Accessories under 21 C.F.R. 884.1700
Regulatory Class:
HIG Product Code:
1
K123732
Pg. 2 of 4
Predicate Devices:
Device Description:
The Hysteroscopy Pump HM6 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a manmachine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.
Intended Use:
The Hysteroscopy Pump HM6 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
Summary of Similarities and Differences in Technological Characteristics:
The proposed device Hysteroscopy Pump HM6 is a modified version of the Aquilex Fluid Control System H112, K112642, (the "Aquilex System"). The Hysteroscopy Pump HM6 and the Aquilex System use the same basic operating principles and incorporate the same basic design including materials. Specifically, the Hysteroscopy Pump HM6 and the Aquilex System incorporate the following main components: (i) an irrigation pump unit, (ii) a fluid monitoring unit, and (iii) an inflow and an outflow tube set.
The irrigation pump units of both the proposed device Hysteroscopy Pump HM6 and Aquilex System are all electro-mechanical and microprocessor controlled devices that function according to the peristaltic principle. Both the Hysteroscopy Pump HM6 and the Aquilex System utilize a pressure sensor to monitor the intrauterine pressure. To achieve the desired pressure within the cavity, the pressure sensor of both the Hysteroscopy Pump HM6 and the Aquilex System are connected to a processor that controls the speed of the roller wheel and thus the volume of fluid that is delivered into the cavity. The maximum selectable pressure of the Hysteroscopy Pump HM6 is identical to that of the Aquilex System (150 mmHg). Furthermore, both the Hysteroscopy Pump HM6 and the predicate devices are
2
K123732
pg. 3 of 4
designed with the same or similar setting keys, display elements and safety features (e.g. active pressure reduction, overpressure warnings and fluid deficit warnings). The fluid monitoring unit of both the proposed device Hysteroscopy Pump HM6 and Aquilex System are micro-processor controlled devices, which monitor the amount of delivered irrigation solution and compare it with the volume of the secretions returned to the container. The fluid monitoring unit consists of the following main components: (1) scale, (2) a support plate, (3), a bag holder, (4) a container holder, and (5) a roller base. Finally, the inflow tube set and outflow tube set of the proposed device Hysteroscopy Pump HM6 is identical in design, material, packaging and sterilization to the inflow and outflow tube set of the Aquilex System except for a minor change to the length of the tubing that is attached to the Yconnector of the inflow tube set and the equipment of the outflow tube set with an additional clamp. Also, the outflow tube set of the Hysteroscopy Pump HM6 is not designed with suction connectors.
The modification to the predicate device Aquilex System consists of a change in software and design. The main differences are related to the inclusion of a manmachine interface (MMI) including a 7" touch-screen and to the incorporation of a separate scale for determination of the inflow volume. Also, unlike the Aquilex System, the Hysteroscopy Pump HM6 is not equipped with vacuum pumps and therefore, not capable of applying suction. Other minor differences include the location of the roller wheel at the front of the device, a reduction of the maximum flow rate, the ability to choose a flow rate, the ability to use the irrigation pump unit without fluid monitoring unit and the optional performance of the instrument detection feature.
Substantial Equivalence:
The Hysteroscopy Pump HM6 is substantially equivalent to the Aquilex System (K112642) and to the Hysteroscopy Pump HM4 (K022449). The proposed device has the same intended use as the predicate devices. In addition, both the proposed device and the predicate devices incorporate the same fundamental scientific technology. Specifically, both the predicate device and the predicate devices use the same basic operating principles and incorporate the same basic design.
The differences between the Hysteroscopy Pump HM6 and the predicate device Aquilex System are minor and do not raise new questions of safety and effectiveness.
Specifically, the implementation of an interactive man-machine interface (MMI) including a 7" touch screen display into the proposed device as well as the modification that are related the above changes (e.g. incorporation of a faster processor, larger casing of the irrigation pump unit, optional display of the set flow rate and graphical display fluid deficit in % of the set pressure limit) improve the ease of use of the proposed device and do not raise new questions of safety and effectiveness. In addition, the incorporations of a separate scale to determine the
3
inflow volume for calculation of the fluid deficit including any related modifications inflow volume for carculation of the fictiveness. Not only improves the use of a separate scale the accuracy of the fluid deficit measurement from volume a separate state hic accuracy of and to the predicate device Aquilex System but measurement = 10 % to = 0 % compared to my fluid bag detection feature as a new safety feature that informs the user if the fluid in the fluid bag is