(30 days)
Not Found
No
The summary describes a physical catheter device for delivering contrast media and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device is intended for the delivery of contrast media for diagnostic evaluation (HSG and SIS) of the fallopian tubes and uterus, not for treating a condition.
Yes
Explanation: The device is used to deliver contrast media for HSG and SIS, which are imaging techniques employed for the "evaluation of the fallopian tube(s) selectively and/or the uterus." This evaluation is performed to identify clinical indications such as "suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency." The act of evaluating these conditions falls under the definition of diagnosis.
No
The device description explicitly states it is a "latex-free Balloon Catheter within a transcervical Delivery Sheath," indicating it is a physical medical device, not software only.
Based on the provided information, the FemVue™ Cornual Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- FemVue™ Function: The FemVue™ Cornual Balloon Catheter is a device used within the body to facilitate imaging procedures (HSG and SIS) for evaluating anatomical structures (fallopian tubes and uterus). It delivers contrast media or saline, but it does not analyze samples taken from the body.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The FemVue™ Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Product codes
LKF
Device Description
The FemVue Cornual Balloon Catheter ("FCBC") is a latex-free Balloon Catheter within a transcervical Delivery Sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fallopian tube(s), uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The FCBC was tested by the following non-clinical methods to demonstrate that the device is substantially equivalent to the predicate device in functionality, safety, and effectiveness:
- The cytotoxicity, irritation, sensitization and acute . systemic toxicity biocompatibility methods of ISO 10993
- F Tensile testing of joint bonds
- . Component functionality
- Inflation balloon integrity testing .
Key Metrics
Not Found
Predicate Device(s)
FemVue™ Catheter System, K083690
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Page 1 of 2
K 100662
510(k) Summary for the FemVue™ Cornual Balloon Catheter
| Date of Summary: | April 7, 2010 | APR - 7 2010 |
|---|---|---|
| 510(k) Submitter and Primary Contact: | Lisa Peacock | |
| Vice President, Regulatory 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: | Hysterosalpingography or Hysterosonography Catheter | |
| FDA Device Classification Name: | Uterine Manipulator/Injector Cannula | |
| Product Code: | LKF | |
| Classification Regulation: | Unassigned | |
| Device Class: | Unclassified, Pre-Amendment 510(k) Submission | |
| Panel: | Obstetrics/Gynecology | |
| Indication for Use: | Intended for the delivery of contrast media during | |
| hysterosalpingography (HSG) and saline infusion | ||
| hysterosonography (SIS) for the evaluation of the | ||
| fallopian tube(s) selectively and/or the uterus. The | ||
| following are some clinical indications: suspected | ||
| polyps, fibroids, adhesions, or endometrial thickening, | ||
| and/or the selective evaluation of fallopian tube patency. | ||
| Device Description: | The FemVue Cornual Balloon Catheter ("FCBC") is a | |
| latex-free Balloon Catheter within a transcervical | ||
| Delivery Sheath. | ||
| Predicate Device: | FemVue™ Catheter System, K083690 |
1
510(k) Summary for the FemVue™ Cornual Balloon Catheter, Page 2 of 2
Summary of Testing:
The FCBC was tested by the following non-clinical methods to demonstrate that the device is substantially equivalent to the predicate device in functionality, safety, and effectiveness:
- The cytotoxicity, irritation, sensitization and acute . systemic toxicity biocompatibility methods of ISO 10993
- F Tensile testing of joint bonds
- . Component functionality
- Inflation balloon integrity testing .
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an eagle or bird-like figure with three stylized lines forming its wings and body. The emblem is black, and the text is arranged to follow the circular shape of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Peacock Vice President Regulatory Affairs Femasys Inc. 5000 Research Court, Suite 100 SUWANEE GA 30024
APR - 7 2010
Re: K100662
Trade Name: FemVue™ Cornual Balloon Catheter Regulation Number: N/A Regulation Name: Uterine Manipulator/Injector Cannula Regulatory Class: Unclassified Product Code: LKF Dated: March 5, 2010 Received: March 8, 2010
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFF Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
3
Page 2 -
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/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/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
4
Indications for Use
100 667
510(k) Number (if known):
Device Name: FemVue™ Cornual Balloon Catheter
Indications for Use:
The FemVue™ Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Prescription Use X (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)
Danny Hurst
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
000010