(193 days)
The FemVue™ Catheter System is 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.
The FemVue Catheter System ("FCS") is comprised of two components: a Sheath and a latex free balloon Catheter. The Sheath is used to deliver the Catheter into the uterus.
The provided text for the FemVue™ Catheter System (K083690) is a 510(k) summary and FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.
The summary focuses on demonstrating substantial equivalence to predicate devices through:
- Equivalent device type, indication for use, principle of operation, and device description.
- Similar principles of operation for device placement, device description, and safety features.
- Substantially equivalent indication for use, placement location, and principle of operation for evaluation of the fallopian tubes.
The only "testing" mentioned is biocompatibility testing (cytotoxicity, irritation, and sensitization) in compliance with ISO 10993. This type of testing ensures the material safety of the device when in contact with tissues, but it does not evaluate the device's functional performance in terms of diagnostic accuracy or effectiveness for its intended use (e.g., evaluating fallopian tube patency or uterine abnormalities).
Therefore, based solely on the provided text, I cannot complete the requested tables and sections related to performance acceptance criteria and a study demonstrating that the device meets those criteria. Such information is typically found in the clinical study section of a 510(k) submission, which is not included here.
The document indicates that the device was cleared based on substantial equivalence to existing devices, implying that its performance is presumed to be similar to its predicates, rather than requiring a de novo performance study with specific acceptance criteria.
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510(k) Summary for the FemVue™ Catheter System
| Date of Summary: | December 10, 2008 (Supplement 001: May 7, 2009) |
|---|---|
| 510(k) Submitter and Primary Contact: | Marc FinchVice President, Regulatory and Clinical AffairsFemasys Inc.5000 Research CourtSuite 100Suwanee, GA 30024Tel: 770-500-3910Fax: 770-500-3980mfinch@femasys.com |
JUN 23 2009
| 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 Catheter System ("FCS") is comprised of two components: a Sheath and a latex free balloon Catheter. The Sheath is used to deliver the Catheter into the uterus. |
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Substantial Equivalence:
Primary substantial equivalence focuses on equivalent device type, indication for use, principle of operation, and device description of the FCS compared to the Ackrad H/S Catheter Set and the AngioTech/MD Tech PBN Fallopian Tube Catheter System. The FCS also shares substantially equivalent key features with the Ackrad IUI Set for Intrauterine Insemination, including similar principles of operation for device placement, device description, safety features, and laboratory bench verification. Finally, the FCS has a substantially equivalent indication for use, placement location, and principle of operation for evaluation of the fallopian tubes, as compared to the Stargate Falloposcopy Catheter and Trifurcated Irrigation Tubing.
Summary of Testing:
The FCS was tested in compliance with the cytotoxicity, irritation, and sensitization biocompatibility methods of ISO 10993.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 2009
Mr. Marc Finch Vice President of Regulatory and Clinical Affairs Femasys, Inc. 5000 Research Court, Suite 100 SUWANEE GA 30024
Re: K083690
Trade Name: FemVue™ Catheter System Regulatory Class: Unclassified Product Code; LKF Dated: June 5, 2009 Received: June 9, 2009
Dear Mr. Finch:
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.
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
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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/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/cdrl/indr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Iarine M. Morris
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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Femasys Inc. 510(k) for the FemVue™ Catheter System
Page 1 of 1
Indications for Use
510(k) Number (if known): K083690
Device Name: FemVue™ Catheter System
Indications for Use:
The FemVue™ Catheter System is intended for the delivery of contrast media during hysterosalpingostin (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical increations: suspected polyps, fibroids, The
endomotrial thickening and/or/lications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency,
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)
Helu Pluss
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
00010
§ 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.