SALINE/ CONTRAST MEDIA INFUSION CATHETER

K063611 · Utah Medical Products, Inc. · LKF · May 23, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K063611
• Device Name: SALINE/ CONTRAST MEDIA INFUSION CATHETER
• Applicant: Utah Medical Products, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes.

Device Story

TVUS/HSG-Cath is a catheter for intracervical delivery of saline or contrast media into the female reproductive tract. Used by clinicians during transvaginal ultrasonography (TVUS) or hysterosalpingography (HSG) procedures. Device facilitates visualization of uterine cavity and fallopian tubes; aids diagnosis of uterine pathology, infertility, and pregnancy loss. Operates via manual infusion; provides pathway for diagnostic media. Benefits patient by enabling enhanced imaging for clinical decision-making regarding uterine health.

Clinical Evidence

No clinical data provided; device relies on substantial equivalence to a legally marketed predicate device.

Technological Characteristics

Manual infusion catheter for intracervical use. Materials and design are consistent with standard gynecological infusion catheters. Device is non-powered and standalone.

Indications for Use

Indicated for patients undergoing TVUS (SIS) with saline infusion for persistent abnormal/dysfunctional uterine bleeding, suspected myometrial/intraluminal abnormalities (fibroids/polyps), thickened/irregular endometrium, recurrent pregnancy loss, or pre-/post-operative assessment of uterine pathology. Also indicated for HSG with contrast media for unexplained infertility or recurrent pregnancy loss.

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

• H/S Elliptosphere Catheter (K013972)

Submission Summary (Full Text)

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K063611

Image /page/0/Picture/1 description: The image shows the logo for Utah Medical Products Inc. The logo features the company name in bold, uppercase letters above a large, stylized symbol. The symbol resembles a combination of the letters 'U' and 'M', forming a circular shape with a gap in the middle.

MAY 2 3 2007

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# SECTION 9: 510(k) SUMMARY

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| 510(k) Owner: | Utah Medical Products, Inc. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 7043 South 300 West<br>Midvale, UT 84047 USA |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |
| Contact: | Kevin L. Cornwell, CEO |
| Date: | 9 April 2007 |
| Trade Name: | TVUS/HSG-Cath™ Saline/ Contrast Media Infusion Catheter |
| Common Name: | Hysterosonography or Hysterosalpingography Catheter |
| Classification: | Obstetric-gynecologic specialized manual instrument,<br>21 CFR 884.1700 (a)(4) |
| Predicate Device: | H/S Elliptosphere Catheter, (K013972)<br>ACKRAD Laboratories, Inc., a CooperSurgical company. |
| Intended Use: | TVUS/HSG-Cath™ is intended for intracervical injection of saline<br>into the uterus for enhanced transvaginal ultrasonography (TVUS)<br>also known as saline infusion sonography (SIS). TVUS/HSG-Cath<br>may also be used for the delivery of contrast media into the female<br>reproductive tract for diagnostic examination of the uterus and<br>fallopian tubes. |
| Indications for Use: | TVUS (SIS) with saline infusion:<br>persistent abnormal or dysfunctional uterine bleeding suspected myometrial or intraluminal abnormalities (e.g., fibroids or polyps) thickened or irregular endometrium recurrent pregnancy loss pre- and post-operative assessment of uterine pathology HSG with contrast media: unexplained infertility recurrent pregnancy loss |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Kevin Cornwell Chairman & CEO Utah Medical Products, Inc. (UTMD) 7043 South 300 West MIDVALE UT 84047

MAY 2 3 2007

Re: K063611

Trade/Device Name: TVUS/HSG-Cath"; Saline/Contrast Media Infusion Catheter Regulation Number: None Regulation Name: Unclassified Regulatory Class: II Product Code: 85 LKF Dated: April 13, 2007 Received: April 16, 2007

Dear Mr. Cornwell:

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 commerce prior 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 (Premarket Approval), 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.

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Protecting and Promoting Public Health

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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 or any Federal 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours,

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 3: INTENDED USE / INDICATIONS for USE

## 510(k) Number: K063611

Device Name: TVUS/HSG-Cath™; Saline/ Contrast Media Infusion Catheter

Intended Use:

TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes.

(The intended use is the same as the intended use of the predicate devices listed in Section 8, Substantial Equivalence.)

### Indications for Use:

TVUS (SIS) with saline infusion:

- persistent abnormal or dysfunctional uterine bleeding .
- suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps)
- . thickened or irregular endometrium
- recurrent pregnancy loss t
- pre- and post-operative assessment of uterine pathology . HSG with contrast media:
- unexplained infertility .
- recurrent pregnancy loss

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Nancy Brogdon

Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number

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