(86 days)
The FemVue™ Saline-Air Device instills a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
The FemVue™ Saline-Air Device is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter to instill saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity.
The FemVue™ Saline-Air Device, as described in the K110288 510(k) submission, is a physical medical device, specifically a contrast media syringe, rather than an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.
However, based on the provided text, the acceptance criteria and the study performed can be described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary of Testing) |
|---|---|
| Fluid and air instillation function of syringe | Demonstrated |
| Catheter attachment | Demonstrated |
| Single-hand actuation | Demonstrated |
| Delivers continuous and consistent stream of an alternating pattern of saline and air | Demonstrated |
2. Sample size used for the test set and the data provenance
Not applicable for a physical device where the "test set" would typically refer to a dataset for an AI/ML algorithm. The testing described is non-clinical performance testing of the physical hardware itself. The document does not specify a numerical sample size for the devices tested, nor does it refer to data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical performance study of a physical device. Ground truth, in the context of expert review, is not relevant here. The "ground truth" for these tests is the physical and mechanical functionality of the device against predefined performance targets.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used when subjective assessments by multiple experts need to be reconciled for establishing ground truth in clinical or image-based studies. This submission describes non-clinical performance testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and thus no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would have been the pre-defined engineering specifications and performance targets for the device's mechanical and fluidic functionalities. For example, "continuous and consistent stream of an alternating pattern of saline and air" would have specific measurable parameters that the device was designed to meet.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical device, and there is no training set as understood in AI/ML development.
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K110288
510(k) Summary for the FemVue™ Saline-Air Device APR 2 8 2011
| Date of Summary: | March 25, 2011 |
|---|---|
| 510(k) Submitter andPrimary Contact: | Lisa PeacockVice President, Regulatory AffairsFemasys Inc.5000 Research CourtSuite 100Suwanee, GA 30024Tel: 770-500-3910Fax: 770-500-3980LPEACOCK@FEMASYS.COM |
| Device CommonName: | Contrast media syringe (as an accessory to anintrauterine catheter) |
| FDA DeviceClassification Name: | Cannula, Manipulator/Injector, Uterine |
| Product Code: | LKF |
| ClassificationRequlation: | Unclassified |
| Device Class: | Unclassified, Pre-Amendment 510(k) Submission |
| Panel: | Obstetrics/Gynecology |
| Indication for Use: | The FemVue Saline-Air Device instills a consistentalternating pattern of saline and air as a continuousstream of contrast media into the uterus andfallopian tubes to be used in conjunction with anintrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG). |
| Device Description: | The FemVue™ Saline-Air Device is a dual-barrelcontrast media syringe that can be connected to anintrauterine catheter to instill saline-air contrastmedia during sono-hysterosalpingogram (SonoHSG) procedures. Sono HSG consists of anultrasound evaluation of the fallopian tubes with orwithout assessment of the uterine cavity. |
| Predicate Device: | Ackrad H/S Elliptosphere Procedure Tray K020954 |
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The FemVue was tested by the following non-clinical Summary of Testing: methods to demonstrate that the device is substantially equivalent to the predicate device in functionality, safety, and effectiveness:
- Fluid and air instillation function of syringe
- Catheter attachment
- Single-hand actuation
- Delivers continuous and consistent stream of an alternating pattern of saline and air
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
APR 2 8 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Peacock VP, Regulatory Affairs Femasys, Inc. 5000 Research Court, Suite 100 SUWANEE GA 30024
Re: K110288
Trade/Device Name: FemVue™ Saline-Air Device Regulation Number: None Regulatory Class: Unclassified Product Code: LKF Dated: March 25, 2011 Received: March 28, 2011
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 CFR 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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert Lemun MD
erbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K110288
Device Name: FemVue™ Saline-Air Device
Indications for Use:
The FemVue™ Saline-Air Device instills a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
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)
_
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110288
§ 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.