FEMVUE CORNUAL BALLOON CATHETER

K100662 · Femasys, Inc. · LKF · Apr 7, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100662
• Device Name: FEMVUE CORNUAL BALLOON CATHETER
• Applicant: Femasys, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Apr 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended 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 Story

FemVue Cornual Balloon Catheter (FCBC) is a latex-free balloon catheter housed within a transcervical delivery sheath. Used by clinicians during HSG or SIS procedures to deliver contrast media or saline into the uterus and fallopian tubes. The device facilitates selective evaluation of tubal patency and uterine cavity assessment for pathologies like polyps, fibroids, or adhesions. By enabling controlled delivery of media, the device assists in visualizing the reproductive tract, aiding clinical diagnosis and decision-making regarding fertility or uterine health.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity per ISO 10993), tensile testing of joint bonds, component functionality, and inflation balloon integrity testing.

Technological Characteristics

Latex-free balloon catheter with transcervical delivery sheath. Biocompatibility per ISO 10993. Mechanical inflation mechanism. Non-powered, manual device.

Indications for Use

Indicated for patients undergoing hysterosalpingography (HSG) or saline infusion hysterosonography (SIS) to evaluate the uterus or fallopian tubes for suspected polyps, fibroids, adhesions, endometrial thickening, or to assess tubal patency.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FemVue™ Catheter System (K083690)

Submission Summary (Full Text)

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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<br>Vice President, Regulatory Affairs<br>Femasys Inc.<br>5000 Research Court<br>Suite 100<br>Suwanee, GA 30024<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] | |
| 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<br>hysterosalpingography (HSG) and saline infusion<br>hysterosonography (SIS) for the evaluation of the<br>fallopian tube(s) selectively and/or the uterus. The<br>following are some clinical indications: suspected<br>polyps, fibroids, adhesions, or endometrial thickening,<br>and/or the selective evaluation of fallopian tube patency. | |
| Device Description: | The FemVue Cornual Balloon Catheter ("FCBC") is a<br>latex-free Balloon Catheter within a transcervical<br>Delivery Sheath. | |
| Predicate Device: | FemVue™ Catheter System, K083690 | |

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K100662

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 .

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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

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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 [phone] or [phone] 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

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## 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