(170 days)
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Not Found
No
The 510(k) summary describes a simple, disposable mechanical curette for tissue sampling and makes no mention of AI, ML, image processing, or any computational analysis.
No
The device is used for obtaining tissue samples for histological analysis, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is used to obtain tissue samples for histological analysis, which is a method of diagnosis.
No
The device description clearly states it is a "sterile, disposable curette," which is a physical medical instrument, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used in vitro (in glass, or outside the body) to diagnose diseases or other conditions.
- The FemECC™ Endocervical Curette is a tool used to obtain the specimen. It is a surgical instrument used in vivo (in the body) to collect tissue. The tissue collected by this device would then be sent to a laboratory for in vitro analysis (which might involve IVD tests), but the curette itself is not an IVD.
The description clearly states its purpose is "obtaining tissue samples from the endocervical canal for histological analysis." This is a sample collection device, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
Product codes
PCF
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
endocervical canal
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.)
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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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§ 884.1050 Endocervical aspirator.
(a)
Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2013
FemSpec. LLC c/o Carl Youngmann, Ph.D., RAC Director, Regulatory and Quality Affairs The Presidio, HQ, Building 220. Suite 120 P.O. Box 29450 SAN FRANCISCO CA 94129-0450
Re: K060320
Trade/Device Name: FemSpec, LLC, FemECC™ Endocervical Curette Regulation Number: 21 CFR 884.1050 Regulation Name: Endocervical aspirator Regulatory Class: II Product Code: PCF Dated: June 23, 2006 Received: June 26, 2006
Dear Dr. Youngmann:
This letter corrects our substantially equivalent letter of July 28, 2006.
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 (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
1
Page 2 - Carl Youngmann, Ph.D., RAC
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 (reporting of medical device-related 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/CDRH0ffices/ucm115809.html 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section IV-Indications for Use Statement
510(k) Number: K060320
Device Name: FemSpec, LLC, FemECC™ Endocervical Curette
Indications for Use:
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
V. barry C. Ferguson
(Division Sign-Off)
Division of Reproductive, Ab and Radiological Devices 510(k) Number
Prescription Use _ × (Per 21 CFR §801 subpart D) OR
Over-The-Counter Use_ (Per 21 CFR §801 subpart C)