(148 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical/fluidic, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is used to access the uterine cavity for injecting contrast fluid for visualization, which is a diagnostic purpose, not a therapeutic one. The "Indications for Use" list clinical conditions that the visualization helps diagnose or evaluate, rather than treat.
Yes
The device aids in visualizing the uterine cavity and fallopian tubes for conditions like infertility, menorrhagia, and suspected endometrial polyps, which are used to diagnose these conditions.
No
The device description explicitly states "Softseal Catheter (a uterine manipulator/injector)", which is a physical medical device used for injecting fluid. This is not a software-only device.
Based on the provided information, the Softseal 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.
- Softseal Catheter's Function: The Softseal Catheter is a device used to inject contrast fluid into the uterus for visualization. It is a tool used during a medical procedure (likely a hysterosalpingogram or similar imaging study) to facilitate the imaging process. It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it's for accessing the uterine cavity for injection and retention of contrast fluid to enable visualization. This is a procedural device, not a diagnostic test performed on a sample.
Therefore, the Softseal Catheter falls under the category of a medical device used in a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for the injection and retention of contrast fluid (or gas) into the uterus to enable the visualization of the uterine cavity and fallopian tubes. This device is not for intrafallopian procedure. The performing clinical indications are some of the applications
-
- Infertility
-
- Menorrhagia
-
- Dysmenorrhca Due to Uterine Synechia
-
- Suspected Endometrial Polyp
-
- Submucous Fibroid
-
- Postpartum Uterine Synechia (Asherman Syndrome)
-
- Congenital Uterine Abnormality
Product codes
85 LKF
Device Description
Softseal HSG Catheter (a uterine manipulator/injector)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine cavity, fallopian tubes
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2004
Al Muzzammel, MD Official Correspondent Modern Medical Equipment Mfg., Ltd. E & M Engineering 1705 Dabney Road RICHMOND VA 23230
Re: K040238
Trade/Device Name: Softseal HSG Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: June 2, 2004 Received: June 4, 2004
Dear Dr. Muzzammel:
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 for are carsion 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 such 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 that a Printeral 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product qadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my you to ough finding of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spoolite at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Addisonaliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphanes at (2017-2211) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1. Indications for Use
510(k) Number (if known): K040238
Device Name: Softseal HSG Catheter
Indications For Use:
Indications I VI OSC.
Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for Softseal Catheter (a atention of contrast fluid (or gas) into the uterus to enable the the injection and retemator of contrast not for intrafallopian procedure. The perforing clinical indications are some of the applications
-
- Infertility
-
- Menorrhagia
-
- Dysmenorrhca Due to Uterine Synechia
-
- Suspected Endometrial Polyp
-
- Submucous Fibroid
-
- Submutorus I lorean Uterine Synechia (Asherman Syndrome)
-
- Congenital Uterine Abnormality
Prescription Use
AND/OR Over-The Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 .
Daniel G. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number.