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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the Hysteroscopy Pump HM4. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, ground truth, or expert review.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria (e.g., pressure range, fluid loss accuracy) or a table of reported device performance values. It broadly states the device "will comply" with certain international and national standards.

Acceptance Criteria	Reported Device Performance
Not specified directly in the document. Performance is inferred through compliance with general safety and electromagnetic compatibility standards.	"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."

2. Sample size used for the test set and the data provenance:

Not specified. The document refers to compliance with standards, implying internal testing, but no details on sample size or data provenance (country, retrospective/prospective) are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This type of detail is usually found in clinical performance studies, which are not described in this 510(k) summary. The submission focuses on technical specifications and substantial equivalence, not clinical effectiveness studies requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a hysteroscopy pump, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device does not feature an algorithm for standalone performance assessment in the context of diagnostic or interpretive tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this type of device would likely relate to the accuracy of its physical functions (e.g., pump pressure, fluid volume monitoring) against calibrated standards, rather than clinical outcomes or interpretations. These details are not provided.

8. The sample size for the training set:

Not applicable. This device is a hardware pump, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set for this device.

Summary

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K022449

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
----------------------	---

1. 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:

VI. Device Description:

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

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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

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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.

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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

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STATEMENT OF INDICATIONS FOR USE

APPLICANT:

W.O.M. WORLD OF MEDICINE AG

K022449

510(K) NUMBER (if known):

DEVICE NAME:

Hysteroscopy Pump HM4

INDICATIONS FOR USE:

(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 _

Regulation Number and Section

§ 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.