INTRAUTERINE VENOGRAM NEEDLE SET

K041062 · Cook Urological, Inc. · LKF · Oct 1, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041062
• Device Name: INTRAUTERINE VENOGRAM NEEDLE SET
• Applicant: Cook Urological, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion.

Device Story

The Intrauterine Venogram Needle Set is a manual surgical instrument used by clinicians for diagnostic imaging procedures. It consists of a single-lumen access catheter (nylon) with a blunt tip, turn connector cap, and lock assembly, paired with a stainless steel injection needle with a polycarbonate hub. The device is used in a clinical setting to facilitate the injection of contrast media for hysterography and intrauterine venography. By providing access to the uterine cavity, the device enables the visualization of pelvic structures, assisting physicians in the assessment of chronic pelvic pain and congestion. The device is supplied sterile in lengths ranging from 15 cm to 30 cm.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Nylon (catheter sheath), stainless steel (injection needle), polycarbonate (hub). Form factor: Single-lumen access catheter with blunt tip, turn connector cap, and lock assembly; 15-30 cm lengths. Energy source: None (manual). Sterilization: Standard medical device sterilization procedures.

Indications for Use

Indicated for patients undergoing hysterography and intrauterine venography for the assessment of chronic pelvic pain or congestion.

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

• Ott Intrauterine Catheter Set (K891290)
• Echotip Disposable Percutaneous Needle (Exempt)

Submission Summary (Full Text)

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## 510(k) SUMMARY

## Submitted By:

K041062

SI

Cindy Rumple Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 [phone] April 15, 2004

## Device

| Trade Name: | Intrauterine Venogram Needle Set |
|-------------------------------|----------------------------------------------------------------------|
| Proposed Classification Name: | Cannula Manipulator/Injector, Uterine<br>Blood, Lancet-Venous System |

#### Intended Use:

The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion

## Predicate Devices:

The Intrauterine Venogram Needle Set is similar with respect to indications for use and technology to exist predicate devices in commercial distribution. Specifically, the Intrauterine Venogram Needle Set is similar to the Ott Intrauterine Catheter Set (K891290) manufactured by Cook OB/GYN, and the Echotip Disposable Percutaneous Needle (Exempt) manufactured by Cook OB/GYN.

## Device Description:

The Intrauterine Venogram Needle Set contains two components: a catheter sheath and a needle. The single-lumen access catheter has a butb tip, turn connector cap and lock assembly manufactured from nylon. The injection needle is manufactured from stainless steel with a polycarbonate hub. The Information in Venogram Needle set is supplied sterile in lengths from 15 cm to 30 cm and is packaged in a sealed peel-open container.

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## Substantial Equivalence:

The Intrauterine Venogram Needle Set will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials, and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines extending from its head, representing the department's mission to promote health and well-being.

#### Public Health Service

# OCT 1 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cindy Rumple Regulatory Affairs Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460

Re: K041062 Trade/Device Name: Intrauterine Venogram Needle Set Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: August 23, 2004 Received: August 24, 2004

,Dear Ms. Rumple:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w thave and have determined the device is substantially equivalent (for the indications for use stated in above and have detenmentarket predicate devices marketed in interstate commerce prior to the enclosate) to regarly mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the charactivity 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 do not require approval or a premisions of the Act. The general controls provisions of the Act device, subject to the general 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 n your do rise to subject to such additional controls. Existing major regulations affecting your Apple rally, It ifed of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advisod that i breation 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 r carrar states and regularing but not limited to registration and listing (21 CFR Part 807); labeling / 1 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter withing on. The FDA finding of substantial equivalence of your device to a legally premaince notificate 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/dsma/dsmamain.html

Sincerely yours,

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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# PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K041062 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Intrauterine Venogram Needle Set |
| Indications for Use: | The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion. |

Prescription Use_ × (Part 21 CFR 801 Subpart D)

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OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number_