H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

K961752 · Ackrad Laboratories · LKF · Aug 8, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961752
• Device Name: H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
• Applicant: Ackrad Laboratories
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Aug 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Modified Hysterosalpingography Set is to be used for the injection of contrast material in the examination of the uterus and fallopian tubes.

Device Story

Device consists of double-lumen balloon catheter, semi-rigid placement sheath, and inflation syringe. Catheter (5F or 7F) features radiopaque flexible plastic tube with distal side or end port and polyurethane balloon. Sheath provides semi-rigid guidance; syringe controls balloon inflation volume. Used by clinicians during hysterosalpingography to facilitate contrast media delivery for uterine and fallopian tube imaging. Balloon inflation secures catheter position; contrast injection enables visualization. Benefits include stable catheter placement and effective contrast administration for diagnostic imaging.

Clinical Evidence

Bench testing only. Performance data includes inflation diameter comparisons, over-inflation testing (3x prescribed volume), and fatigue testing (50 inflation-deflation cycles). Biocompatibility supported by historical use of polyurethane catheter material since 1984 in >500,000 procedures.

Technological Characteristics

Double-lumen catheter (5F/7F) with radiopaque flexible plastic tube (30cm); polyurethane elastomer balloon; semi-rigid placement sheath (20cm); 3cc or 6cc inflation syringe. Balloon mounted 5-8mm from distal end. Non-pigmented, transparent balloon material.

Indications for Use

Indicated for patients undergoing hysterosalpingography examinations requiring contrast media injection into the uterus and fallopian tubes.

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

• Modified Hysterosalpingography Set (K953034)

Submission Summary (Full Text)

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K961752
8 Aug 96

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: May 2, 1996

2. Device name
Modified Hysterosalpingography Set

3. Predicate Device
Modified Hysterosalpingography Set - K953034

4. Description of the device (See Exhibit 2)
The Modified Hysterosalpingography Set consists of three parts: a double-lumen, balloon bearing catheter; a semi-rigid placement sheath, and a syringe to inflate the balloon.

The double-lumen catheter will be available in two diameters, 5F and 7F, and is composed of a radiopaque flexible plastic tube 30cm. long. The distal end will have either a side port or end port. The balloon which is composed of a synthetic elastomer of a natural, clear polyurethane material is mounted 5 to 8 mm proximal to the distal end. The proximal end of the catheter is composed of a fitting leading to a bifurcation; one extension is for balloon inflation, the other for contrast injection.

The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and an outside diameter sufficient to provide semi-rigid flexibility. The length is 20cm. The distal end is flanged to provide a smooth non-traumatic surface to the tissues.

The syringe is either a 3cc or 6cc size for the 5F or 7F catheter, respectively. The 3cc syringe has a vent at the 1.5cc graduation providing that volume for inflation of the 5F balloon. The recommended volume for the 7F balloon is 4.0cc.

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5. Intended use
The Modified Hysterosalpingography Set is to be used for the injection of contrast material in the examination of the uterus and fallopian tubes.

6. Technological characteristics
The materials and construction of the modified hysterosalpingography set with the polyurethane balloon are identical to the approved predicate device with the exception of the inflatable balloon. The characteristics of the proposed polyurethane balloon are at least the equivalent of the Kraton balloons of the predicate device, in terms of safety and effectiveness. (see part B, PERFORMANCE DATA)

B. PERFORMANCE DATA

1. Non-clinical tests
a. Inflation comparisons showed that the inflated diameter of the polyurethane balloon is not significantly different from the balloons of the predicate device.
b. Over-inflation of the polyurethane balloons showed that the balloons will withstand a volume of three times the prescribed volume on the label with no ill effects.
c. The proposed balloon passed a fatigue test of 50 inflation-deflation cycles, representing a five-fold margin of safety over the expected practice in actual use.

2. Biocompatibility
a. The balloon material is the same as that of the catheter except that the balloon material contains no radiopaque component or pigment, and is completely transparent. The balloon is mounted on the catheter in a manner identical to the predicate device. The polyurethane material used for the catheter tubing has been in use since 1984 in more than 500,000 procedures with no report of any adverse effect on body tissues.

C. CONCLUSION OF SAFETY AND EFFECTIVENESS
The above description, intended use, and technological characteristics of the Modified Hysterosalpingography Set demonstrate that it is substantially equivalent in safety and effectiveness to the predicate device of the same description, K953034.

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