CURELLE, PREFERRED CURELLE, CUTEQ 2.5

K020628 · Bioteque America, Inc. · HHK · May 24, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020628
• Device Name: CURELLE, PREFERRED CURELLE, CUTEQ 2.5
• Applicant: Bioteque America, Inc.
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: May 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

Intended Use

An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.

Device Story

The device is a manual endometrial suction curette used by clinicians to obtain tissue samples from the uterine mucosal lining. It functions via mechanical scraping or vacuum suction to collect material. The device is used in a clinical setting for diagnostic biopsy, precancer screening, or menstrual extraction. The collected tissue sample is subsequently analyzed by a pathologist to inform clinical decision-making regarding uterine health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual endometrial suction curette; plastic construction; dimensions/form factor designed for uterine access; non-powered; sterile, single-use device.

Indications for Use

Indicated for patients requiring uterine tissue sampling for biopsy, precancer screening, or menstrual extraction.

Regulatory Classification

Identification

An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

Submission Summary (Full Text)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 4 2002

Mr. Denis Dorsey Bioteque America, Inc. 340 E. Maple Avenue

Re: K020628

Trade/Device Name: Curelle, Preferred Curelle and Cuteq 2.5 Endometrial Suction Curettes Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and Accessories Regulatory Class: II Product Code: 85 HHK Dated: February 25, 2002

Received: February 26, 2002

## Dear Mr. Dorsey:

Suite 204C

LANGHORNE PA 19047

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > rotty premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure for tegally manated to of the Medical Device Ameralments, or to commerce prior to May 28, 1970, the enactified in accordance with the Frovisions of the Federation (1914) devices that have been reclassince in accordance vil.of a premarket approval application (PMA). and Cosment Act (Act) that to hot require approvine of the general controls provisions of the Act. The You may, therefore, market the device, becycer overements for annual registration, listing of general controls provisions of the fiel necessarials and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classifica (see above) and existing major regulations affecting your device can be it may be subject to additional controllar Libring 1 . Parts 800 to 898. In addition, FDA may round in the Code of I caerax resgacerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe auvised that FDA 3 issualled of a budevice complies with other requirements of the Act that FDA has made a decommentsin and regulations administered by other Federal agencies. You must of ally Federal Statutes and regulations and limited to: registration and listing Comply with an the Act 3 requirements, months, od manufacturing practice requirements as set (21 CFR Fall 807), labornig (21 OFF Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 1000, 1950 for in the quality systems (QS) reguestions 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 510(k) prematice This letter will allow you to begin mattential equivalence of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivalence of 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 a If you desire specific advice for your device on our laboling regulation (regulation in
contact the Office of Compliance at one of the following numbers, based on the regulat number at the top of this 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 Additionally, for questions on the promotion and acrease on your of the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note the repu Office of Compliance at [phone]. Also, part 807. Other general information on by reference to premarket notification" (21 CFS Far 807.77). Vision of Small Manufacturers,
your responsibilities under the Act may be obtained from the Division of Small Man your responsibilities under the Act may on bollaries non the BRO) 638-2041 or [phone]
International and Consumer Assistance at its toll-free main brol International and Consumer Assistance as to costs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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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K020628 Number (if known):_ 510(k) Device Name: Indications For Use:

An endometrial suction curette, such as
Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are
devices used to remove samples of materials
from the uterus and from the mucosal lining
of thee uterus by scraping or vacuum suction
These devices obtain tissue samples for purpos
of biopsy & precancer screening or they can be
used for menstrual extraction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use (Per 21 CFR 801.109)

David A. Bergman

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Device 510(k) Number