ECHOSAMPLER

• K Number: K041237
• Device Name: ECHOSAMPLER
• Manufacturer: GYNETICS MEDICAL PRODUCTS NV
• Date Cleared: 2004-09-08 ( 120 days)
• Product Code: HFF
• Regulation Number: 884.1060
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The EchoSampler™ is a single-use, sterile, disposable curette for:

• Detection of abnormalities of the uterus and endometrium using real-time sonography during injection of sterile saline into the uterine cavity
• Obtaining histological biopsy of the glandular epithelium and superficial uterine endometrial wall or sample extraction of uterine menstrual content for any of the following:
• a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable,
• b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms
• c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia
• d) Identification of specific uterine pathogens by bacterial culturing of uterine samples
• e) Inadequate imaging of the endometrium by endovaginal sonography
• f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris,
• q) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts
• h) Congenital abnormalities and/or anatomic variants of the uterine cavity
• i) Infertility and habitual abortion

Device Description

The EchoSampler™ is a single-use, sterile, disposable curette.

AI/ML Overview

This is an FDA Premarket Notification (510(k)) K041237 for the EchoSampler, an endometrial aspirator. This document is a regulatory clearance letter, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA has determined it is as safe and effective as a similar device already on the market. This determination is typically based on comparing the new device's design, materials, and technological characteristics to those of the predicate device, rather than requiring new clinical studies with established acceptance criteria and performance metrics described in detail in the 510(k) summary provided to the FDA.

Therefore, I cannot provide the requested information from the provided text.

Specifically, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Results from a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gynétics Medical Products N.V. . % Ms. Grace Holland Regualtory Consultant 3722 Ave. Sausalito IRVINE CA 92606

Re: K041237

SEP - 8 2004

Trade/Device Name: EchoSampler Regulation Number: 21 CFR 884.1060 Regulation Name: Endometrial aspirator Regulatory Class: II Product Code: 85 HFF Dated: August 23, 2004 Received: August 25, 2004

Dear Ms. Holland:

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 such additional controls. Existing major regulations affecting your device can he 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with the FDA finding of substantial equivalence of your device to a legally promance noticate 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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Indications for Use Statement

510(k) Number (if known): ____K041237

Device Name:

Indications For Use:

The EchoSampler™ is a single-use, sterile, disposable curette for:

• Detection of abnormalities of the uterus and endometrium using real-time . sonography during injection of sterile saline into the uterine cavity
• Obtaining histological biopsy of the glandular epithelium and superficial . Obtaining historical arterine endometrial wall or sample extraction of uterine menstrual content

for any of the following:

• a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable,
• b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms
• c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia
• d) Identification of specific uterine pathogens by bacterial culturing of uterine samples
• e) Inadequate imaging of the endometrium by endovaginal sonography
• f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris,
• q) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts
• h) Congenital abnormalities and/or anatomic variants of the uterine cavity
• i) Infertility and habitual abortion

Prescription Use _ V __ 無秘/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Logsdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices RD41237 510(k) Number __

Page 1 of

Regulation Number and Section

§ 884.1060 Endometrial aspirator.

(a)
Identification. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(2) Labeling:
(i) Indication: Only to evaluate the endometrium, and
(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
(3) The sampling component is covered within vagina.