(51 days)
Not Found
Not Found
No
The summary describes a physical catheter device used for fluid infusion and blocking, with no mention of software, data processing, or AI/ML terms.
No
The device is used for diagnostic purposes (evaluating causes of conditions, assessing uterine pathology) rather than directly treating or preventing a disease. It facilitates the infusion of fluid for imaging or assessment.
Yes
The device is indicated to "evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility" and "assess uterine pathology," which are diagnostic purposes.
No
The device is described as a catheter set used to infuse fluid into the uterine cavity, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed on the patient's body (infusing fluid into the uterine cavity) to visualize and assess the uterus. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: While not found, the description of the procedure clearly indicates a physical device used within the body.
- Anatomical Site: The anatomical sites listed (Uterine cavity, external cervical OS, uterus) are all within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside the body, which is a hallmark of IVD devices.
This device is a medical device used for a diagnostic imaging procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy. HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.
Product codes
85 LKF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity, external cervical OS, uterus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized wing or feather shapes extending from the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mr. Robert Mosenkis President CITECH Medical Device Testing and Consulting 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K041094 Trade/Device Name: HSG Catheter Set Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: June 1, 2004
Received: June 2, 2004
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enolosare) to tegary to tegars and the Medical Device American For to commerce provision to may 20, 1970, the morance with the provisions of the Federal Food, Drug, devices that have oven require approval of a premarket approval application (PMA). and Cosmetic rice (710c) that 80 nover subject to the general controls provisions of the Act. The I ou may, therefore, market 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 If your device is classinod ($60 a0070) and . Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to save additional benn bions, Title 21, Parts 800 to 898. In addition, FDA may or found in the Obecements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri a lastants over device complies with other requirements of the Act that 1 DA has made a decormination administered by other Federal agencies. You must comply or any I coural statures and regalanteding, but not limited to: registration and listing (21 CFR Part with an the 71er 3 requirements, as sood manufacturing practice requirements as set forth in the 807), laocimig (21 CFR Part 820), and if applicable, the electronic product quality Systems (Sections (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 his letter will anow you to begin hands. By
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The Privation 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 specific advise 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Comphanoour (2017 97) 997 1999 (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation 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
11-1-25-2004 21:48
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F (1) + lorne Page | CORH Home Page | Search | CORH A: Z \ndex | Cordact CORN
Indications for Use
510(k) Number (if known):
Device Name: HSG CATHETER SET
Indications for Use:
Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy.
HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.
Prescription Use (Part 21 CFR 801 Subpart D)
ALD/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel R. Lynn
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
Page of
http://www.fda.gov/cdrh/ode/indicate.html
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