(58 days)
K940176/A
Not Found
No
The device description focuses on the physical components of a catheter and sheath for saline injection during ultrasound, with no mention of AI or ML capabilities.
Yes
The device is used to inject saline for the examination of the uterus, which is a procedure aimed at diagnosing or treating a condition, fitting the definition of a therapeutic device.
No
This device is used for injecting saline into the uterus during an ultrasound examination, which is a procedure that aids in diagnostic imaging. However, the device itself is not performing a diagnostic function (i.e., it is not analyzing data or identifying conditions); rather, it is an accessory used during a diagnostic procedure.
No
The device description clearly outlines physical components (catheter, sheath) and does not mention any software as the primary or sole component.
Based on the provided information, 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.
- Device Function: The description clearly states the device is used for the "Injection of saline in the examination of the uterus using ultrasound techniques." This is a procedure performed in vivo (within the living body) to enhance visualization during an imaging study. It does not involve testing samples taken from the body.
- Lack of Diagnostic Testing: The device facilitates an imaging procedure; it does not perform any diagnostic test on a biological sample.
Therefore, the Tampa Hysterosonography set is a medical device used for an imaging procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Injection of saline in the examination of the uterus using ultrasound techniques.
Product codes
Not Found
Device Description
The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath.
The catheter will be available in a 5-French diameter with a length of 33 cm. The distal end will have either a side port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip.
The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 cm. long, and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound techniques
Anatomical Site
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)
Non-clinical tests Not applicable
Clinical results Procedures for hysterosonography using the predicate IUI Set demonstrate the safety and effectiveness of that product for hysterosonography. (See exhibits 5A and 5B)
Biocompatibility Equivalent to the predicate IUI Set , as material and location of use are identical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K940176/A, Goldstein Sonohysterography Catheter
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.
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Image /page/0/Picture/0 description: The image shows a black and white abstract figure. The figure is composed of a series of connected rectangular shapes. The figure is mostly black, with some white space in the center.
ACKRAD LABORATORIES · 70 Jackson drive · cranford, n.j. 07016 · (908) 2
APR - 9 1997
510(k) Summary
REQUIRED INFORMATION A.
-
- Submitted by Ackrad Laboratories, Inc., 70 Jackson Drive, Cranford, NJ 07016, Telephone No. (908) 276-6390, Fax No. (908) 276-1895, Contact person: Bernard Ackerman, Ph.D. Date: February 3, 1997
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- Device name Tampa Hysterosonography Set
Predicate Devices 3. Ackrad Intrauterine Insemination Set, K940176/A a.
- "Goldstein" Sonohysterography Catheter. b.
-
- Description of the device (see exhibit 2)
The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath.
The catheter will be available in a 5-French diameter with The distal end will have either a side a length of 33 cm. port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip.
The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 cm. long, and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.
-
- Indication for use
Injection of saline in the examination of the uterus using ultrasound techniques.
- Indication for use
1
-
- Technical Characteristics
p2qz
- Technical Characteristics
The materials and construction of the Tampa Hysterosonography Set are identical to those of the approved predicate device, K940176/A with the exception of the lengths of the catheter and placement sheath.
- PERFORMANCE DATA B.
-
- Non-clinical tests Not applicable
-
- Clinical results Procedures for hysterosonography using the predicate IUI Set demonstrate the safety and effectiveness of that product for hysterosonography. (See exhibits 5A and 5B)
-
- Biocompatibility Equivalent to the predicate IUI Set , as material and location of use are identical.
-
- CONCLUSION OF SAFETY AND EFFECTIVENESS C.
The above description, indications for use, technological characteristics, and clinical results demonstrate that the Tampa Hysterosonography Set is substantially equivalent in safety and effectiveness to the predicate devices, the Ackrad IUI Catheter Set, K940176/A and the Goldstein Sonohysterograhy Catheter.
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