(187 days)
Not Found
No
The summary describes a mechanical pressure-limiting syringe and associated components. There is no mention of AI, ML, image processing, or any data-driven decision-making process. The performance studies focus on mechanical and biocompatibility testing.
Yes.
The device is used to instill contrast media into the uterus and fallopian tubes for hysterosalpingogram (HSG) procedures, which is a medical procedure for diagnosing and treating conditions.
No
The device is described as a "Pressure Management Device" that limits pressure during contrast media instillation for HSG procedures. It does not perform diagnostic functions itself but is used in conjunction with an HSG, which is a diagnostic procedure. The device's function is to limit applied pressure, a safety/management function, not a diagnostic one.
No
The device description explicitly states it is a "pressure-limiting contrast media syringe" and is provided with a "fluid collector, stopcock, and intrauterine catheter," indicating it is a hardware device with physical components.
No, this device 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.
- FemChec Function: The FemChec device is used to instill contrast media into the uterus and fallopian tubes during a hysterosalpingogram (HSG) procedure. This is a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Purpose: The purpose of the FemChec is to manage pressure during the instillation of contrast media, not to analyze a biological sample for diagnostic information.
While the HSG procedure itself is a diagnostic imaging technique, the FemChec device is a tool used during that procedure to facilitate the imaging, not an in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.
The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus and fallopian tubes
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)
The FemChec was tested by the following non-clinical methods to demonstrate that the device is substantially equivalent to the predicate devices in functionality, safety, and effectiveness:
- · fluid instilling function of syringe
- · attachment functionality
- · single-hand actuation
- · pressure testing
§ 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.
0
OCT 1 2 2011
510(k) Summary for the FemChec™ Pressure Management Device
Date of Summary: May 31, 2011
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
contrast media syringe
LKF
unassigned
unclassified
Obstetrics/Gynecology
Name:
FDA Device
cannula, manipulator/injector, uterine Classification Name:
Product Code:
Classification Regulation:
Device Class:
Panel:
Indication for Use:
Device Description:
The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHq.
The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.
The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.
1
KII0993
510(k) Summary for the FemChec™ Pressure Management Device
Predicate Devices:
K020954 H/S Elliptosphere Procedure Tray K792134 Bonchek Vein Distention System. 200 mm Ha K082725 VasoShield Pressure Controlling Syringe
The FemChec is similar to the H/S Elliptosphere Procedure Tray in that FemChec is a manually operated piston syringe for contrast media instillation, as an accessory to an intrauterine catheter for HSG procedures. Likewise, the predicate tray contains accessories to intrauterine catheters for HSG procedures, including a manually operated piston syringe for contrast media instillation.
The FemChec is similar to the Bonchek Vein Distention System, 200 mm Hq, in that both devices: 1) are svringes for instilling fluids, 2) contain pressure management components, and 3) limit applied pressures to a similar value. The devices differ in the mechanisms of operation and materials of the pressure management component and in their labeled anatomical locations of use, as Bonchek is labeled for use in cardiovascular applications. Although, the clinical use of the Bonchek to limit applied intrauterine pressure during HSG tubal occlusion confirmation tests was reported in the PMA Summary of Safety and Effectiveness Data for the Adiana Permanent Contraception System.
The FemChec is similar to the VasoShield Pressure Controlling Syringe in that both devices: 1) are syringes for instilling fluids, 2) contain pressure management components with similar mechanisms of operation and with similar materials, and 3) limit applied pressures to a similar value. The devices differ in the anatomical locations of use, as VasoShield is indicated for use in cardiovascular applications. ·
Summary of Testing:
The FemChec was tested by the following non-clinical methods to demonstrate that the device is substantially equivalent to the predicate devices in functionality, safety, and effectiveness:
- · fluid instilling function of syringe
- · attachment functionality
- · single-hand actuation
- · pressure testing