(111 days)
Not Found
No
The summary describes a mechanical device for tissue sampling and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is indicated for obtaining tissue samples for histological analysis, which is a diagnostic purpose, not a therapeutic one.
No
Explanation: The device is used to obtain tissue samples for histological analysis, which is a method of diagnosis, but the device itself is a collection tool, not a diagnostic tool that provides a diagnosis.
No
The device description clearly states it is a "sterile, disposable device that collects an endocervical tissue sample," indicating it is a physical medical device, not software. The performance studies also describe bench testing and clinical studies involving the physical manipulation and collection capabilities of the device.
Based on the provided information, the Femasys FemCerv is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to obtain a tissue sample. The histological analysis is performed after the sample is collected, likely in a laboratory setting using other IVD devices and procedures. The FemCerv itself is a tool for sample collection, not for performing the diagnostic test on the sample.
- Device Description: It is described as a device that collects a tissue sample.
- Lack of Diagnostic Function: The description does not mention any function of the device that analyzes the sample or provides a diagnostic result. The "histological analysis" is a separate process.
In essence, the FemCerv is a sample collection device, which is a crucial step in the diagnostic process, but it is not the diagnostic device itself. The IVD would be the laboratory equipment and reagents used to perform the histological analysis on the tissue sample collected by the FemCerv.
N/A
Intended Use / Indications for Use
The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include:
- further evaluation of an abnormal Pap smear;
- cervical lesions extending into the endocervical canal;
- undiagnosed uterine bleeding.
Product codes (comma separated list FDA assigned to the subject device)
PCF
Device Description
The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocervical canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Bench testing was conducted to evaluate device functionality and integrity over cycle testing of opening and closing the device's sample collection chamber. In addition, the bench testing included simulated use testing in a model of the endocervical canal evaluating insertion capability, sheath opening functionality, rotational functionality, sheath closure, and sample release into a specimen container. A sample set of 29 devices was tested and passed all criteria.
- Shelf life integrity up to 1 year accelerated aging was evaluated using the same test methodology and acceptance criteria in the point above. A sample set of 29 devices was tested and passed all criteria.
- Biocompatibility of components according to ISO 10993 standards: cytotoxicity, irritation, and sensitization was conducted and passed all criteria.
- A clinical study was conducted involving endocervical sampling on subjects prior to scheduled hysterectomy to demonstrate insertion, device opening and closing, and adequate sampling capability based upon a pathologist's evaluation. An 85.7% sample adequacy rate was based on sampling with 7 devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
An 85.7% sample adequacy rate was based on sampling with 7 devices.
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.
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.
Not Found
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).
Not Found
§ 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
510(k) Summary for the FemCerv™ Endocervical Sampler
(Models REF FCV-009, FCV-011, and FCV-013)
| Date: | December 18, 2012 DEC 2 0 2012 |
|---|---|
| 510(k) Submitter and Primary Contact: | Lisa Peacock |
| Vice President, Regulatory and Clinical Affairs | |
| Femasys Inc. | |
| 5000 Research Court | |
| Suite 100 | |
| Suwanee, GA 30024 | |
| Tel: 770-500-3910 | |
| Fax: 770-500-3980 | |
| LPEACOCK@FEMASYS.COM | |
| Device Common Name: | endocervical sampler |
| FDA Device Classification Name: | endocervical aspirator |
| Product Code: | PCF |
| Classification Regulation: | 21 CFR 884.1050 |
| Device Class: | 2 |
| Panel: | Obstetrics/Gynecology |
| Indication for Use: | The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: |
| further evaluation of an abnormal Pap smear;cervical lesions extending into the endocervical canal;undiagnosed uterine bleeding. | |
| Device Description: | The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation. |
| Predicate Device: | K060320 FemECC™ Endocervical Curette |
| The FemCerv is substantially equivalent to the predicate in intended use, sample collection method using a single-pass |
1
Summary of Testing:
rotational scraping mode within the endocervical canal, sample transfer method, and in its sterile, disposable, non-metal design.
Final, finished, sterilized FemCerv devices were tested by the following methods for verification of functionality, safety, and effectiveness.
- · Bench testing was conducted to evaluate device functionality and integrity over cycle testing of opening and closing the device's sample collection chamber. In addition, the bench testing included simulated use testing in a model of the endocervical canal evaluating insertion capability, sheath opening functionality, rotational functionality, sheath closure, and sample release into a specimen container. A sample set of 29 devices was tested and passed all criteria.
- · Shelf life integrity up to 1 year accelerated aging was evaluated using the same test methodology and acceptance criteria in the point above. A sample set of 29 devices was tested and passed all criteria.
- · Biocompatibility of components according to ISO 10993 standards: cytotoxicity, irritation, and sensitization was conducted and passed all criteria.
- · A clinical study was conducted involving endocervical sampling on subjects prior to scheduled hysterectomy to demonstrate insertion, device opening and closing, and adequate sampling capability based upon a pathologist's evaluation. An 85.7% sample adequacy rate was based on sampling with 7 devices.
Conclusions of Substantial Equivalence Demonstrations:
- · FemCerv is substantially equivalent to its proposed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2012
Femasys, Inc. % Ms. Lisa Peacock Vice President, Regulatory and Clinical Affairs 5000 Research Court, Suite 100 SUWANEE GA 30024
Re: K122658
Trade/Device Name: FemCerv™ Endocervical Sampler Regulation Number: 21 CFR§ 884.1050 Regulation Name: Endocervical aspirator Regulatory Class: II Product Code: PCF Dated: December 11, 2012 Received: December 12, 2012
Dear Ms. Peacock:
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.
3
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/CDRHQffices/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herbert R. Lerner
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
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Femasys Inc.
Page 1 of 1
Indications for Use
510(k) Number (if known): K122658
Device Name: FemCerv™ Endocervical Sampler (Models REF FCV-009, FCV-011, and FCV-013)
Indications for Use:
The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include:
- further evaluation of an abnormal Pap smear; ●
- cervical lesions extending into the endocervical canal; 미
- undiagnosed uterine bleeding. 8
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert R. Lerner
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122658 510(k) Number