(301 days)
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Not Found
No
The summary describes a physical medical device (endometrial suction curette) used for tissue sampling and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as being used to remove tissue samples for biopsy or menstrual extraction, which are diagnostic or procedural uses, not therapeutic interventions.
Yes
The device obtains tissue samples for purposes of biopsy and precancer screening, which are diagnostic procedures.
No
The device description clearly states it is a physical endometrial suction curette used for scraping or vacuum suction, which are hardware functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the device is used to remove samples of material from the uterus. It is a tool for obtaining the sample, not for analyzing it.
- Intended Use: The intended use is to obtain tissue samples for biopsy or screening, or for menstrual extraction. While the analysis of the obtained tissue might be an IVD process, the device itself is a surgical or procedural tool.
Therefore, the endometrial suction curette described is a medical device used for sample collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
Product codes
HHK
Device Description
"The Curette" (3.0 mm outer diameters) and "Preferred Curette" (2.5mm and 3.0 mm outer diameters)
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
Not Found
Intended User / Care Setting
Not Found
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Yen-Ming Pan President Panpac Medical Corporation 6F-2. No. 202. Sec. 3 Ta-Tong Road, Shi-Chih City Taipei Hsien, 22103 TAIWAN, R.O.C
UUL 2 3 2010
Re: K092982
Trade Name: The Curette and Preferred Curette Regulation Number: 21 CFR § 884.1175 Regulation Name: Endometrial Suction Curette Regulatory Class: II Product Code: HHK Dated: July 12, 2010 Received: July 15, 2010
Dear Mr. Yen-Ming Pan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related .
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Panpac Medical Corporation 510(k) Notification
.
The Curette & Preferred Curette
510(k) Number (if known):K092982
Device Name: "The Curette" (3.0 mm outer diameters) and "Preferred Curette" (2.5mm and 3.0 mm outer diameters)
Indications for Use:
:
An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PACE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
.
Prescription Use X (Pet 21 CFR 801. 109)
Over-The-Counter Use
ਤੋ
Helin Penn
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 29 ટીન 510(k) Number