INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER

K970492 · Ackrad Laboratories · LKF · Apr 9, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970492
• Device Name: INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
• Applicant: Ackrad Laboratories
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Apr 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

Injection of saline in the examination of the uterus using ultrasound techniques.

Device Story

Tampa Hysterosonography Set consists of a 5-French single-lumen catheter (33 cm length, side or end port, luer-lock hub) and a 16 cm semi-rigid introducing sheath. Used by clinicians during hysterosonography procedures to inject saline into the uterus to facilitate ultrasound imaging. Sheath provides non-traumatic access; catheter allows saline delivery. Device aids visualization of uterine cavity for diagnostic purposes.

Clinical Evidence

No new clinical data provided. Safety and effectiveness are supported by clinical results from the predicate IUI Set used in hysterosonography procedures.

Technological Characteristics

Materials and construction identical to K940176/A. Components: 5-French single-lumen catheter (33 cm) and semi-rigid introducing sheath (16 cm). Catheter features female luer-lock hub and non-toxic ink banding. Sheath is flanged and rounded at the distal end.

Indications for Use

Indicated for patients undergoing ultrasound examination of the uterus requiring saline injection.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ackrad Intrauterine Insemination Set (K940176/A)
• Goldstein Sonohysterography Catheter

Submission Summary (Full Text)

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K970492
P192
ACKRAD LABORATORIES · 70 JACKSON DRIVE · CRANFORD, N.J. 07016 · [phone] · FAX [phone]

APR - 9 1997
510(k) Summary

A. REQUIRED INFORMATION

1. Submitted by
Ackrad Laboratories, Inc., 70 Jackson Drive, Cranford, NJ 07016, Telephone No. [phone], Fax No. [phone],
Contact person: Bernard Ackerman, Ph.D.
Date: February 3, 1997

2. Device name
Tampa Hysterosonography Set

3. Predicate Devices
a. Ackrad Intrauterine Insemination Set, K940176/A
b. "Goldstein" Sonohysterography Catheter.

4. 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 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.

5. Indication for use

Injection of saline in the examination of the uterus using ultrasound techniques.

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K970492
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6. 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.

B. PERFORMANCE DATA

1. Non-clinical tests
Not applicable

2. 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)

3. Biocompatibility
Equivalent to the predicate IUI Set, as material and location of use are identical.

C. CONCLUSION OF SAFETY AND EFFECTIVENESS

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 Sonohysterography Catheter.

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