(87 days)
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Not Found
No
The 510(k) summary describes a mechanical suction curette for tissue sampling and makes no mention of AI, ML, or any computational analysis of data.
No
This device is primarily used for diagnostic purposes (obtaining tissue samples for biopsy & precancer screening) and menstrual extraction, which is not considered a therapeutic treatment in itself for a disease or condition.
Yes
The device obtains tissue samples for the purpose of biopsy and precancer screening, which are diagnostic activities.
No
The device description clearly identifies it as a physical endometrial suction curette, which is a hardware device used for tissue removal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove samples of material from the uterus for biopsy, precancer screening, or menstrual extraction. This is a procedure to obtain the sample, not to analyze it.
- Device Description: The device is described as a suction curette, a tool for physical removal of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to perform tests on biological samples in vitro (outside the body). IVDs typically involve reagents, analyzers, or other components used to detect or measure substances in a sample.
This device is a surgical or procedural tool used to collect a sample, which might then be sent to a laboratory for in vitro diagnostic testing. The curette itself is not performing the diagnostic test.
N/A
Intended Use / 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.
Product codes
85 HHK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Uterus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1175 Endometrial suction curette and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
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.
1
Page 2
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 | (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 Additionally, for questions on the promotion and acrease on your of the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note the repu Office of Compliance at (301) 394-4039. 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 (301) 443-6597
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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Page 1 of 1
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