H/S CATHETER SET

K032835 · Catheter Research, Inc. · LKF · Dec 11, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032835
• Device Name: H/S CATHETER SET
• Applicant: Catheter Research, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Dec 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.

Device Story

HS and SHG Catheters are medical devices used for uterine and fallopian tube examinations. HS Catheters feature a plastic tube with a distal inflatable cuff for cervical sealing, a stiffening sheath, and a proximal stopcock for cuff inflation; a center lumen allows fluid injection via a luer connector. SHG Catheters consist of a plastic tube with a blunt tip, side holes, and a sponge stop to reduce fluid back-leakage; intended for saline delivery. Devices are operated by physicians in clinical settings. Output is the delivery of contrast media or saline to facilitate imaging or examination. Benefit includes enabling diagnostic visualization of the female reproductive tract.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Plastic tube catheters; HS model includes inflatable cuff and stiffening sheath; SHG model includes blunt tip and sponge stop; luer connector for fluid injection; 5F and 7F sizes available.

Indications for Use

Indicated for use in female patients requiring examination of the uterus and fallopian tubes via delivery of diagnostic contrast media or saline.

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

• Uterine Injector (Catheter Research, Inc.) (K020292)
• H/S Catheters (Ackrad Laboratories) (K020951)
• Uterine Injector (Thomas Medical, Inc.) (K022503)

Submission Summary (Full Text)

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DEC 1 1 2003

## 510(k) Summary

Applicant/Sponsor: Catheter Research, Inc. (CRI) 6131 West 80th Street Indianapolis, IN 46278

John A. Steen, Ph.D. Contact Person: [phone] x17

Proprietary Name: H/S Catheter Set

Classification Name: Cannula, manipulator/injector, uterine

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| Uterine Injector (Catheter Research, Inc.) | K020292 |
|--------------------------------------------|-------------------|
| H/S Catheters (Ackrad Laboratories) | K020951 & K020951 |
| Uterine Injector (Thomas Medical, Inc.) | K022503 |

Device Description: The HS Catheter devices consist of a plastic tube, the distal end of which has an inflatable cuff. A sheath is over the tube to provide a stiffener and guide. When the cuff is inflated inside the uterus, the device seals the cervix. A stopcock is provided at the proximal end of the device to allow inflation of the cuff with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. The HS catheters will be available in 5F and 7F sizes.

The SHG Catheter devices consist of a plastic tube with a blunt tip and one or more side holes at the distal tip. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. A sponge stop is provided to press on the external os of the cervix to reduce the back leakage of injected fluids. This devices is intended for use with saline solution, only. I n addition to the individual catheters, convenience kits will be offered that provide the physician with items helpful to the completion of the procedure.

Intended Use: The intended use of the H/S Catheter Kit is for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes

Summary of Technologies: The H/S Catherter Set has the same technological characteristics as the predicate devices. The intended use and operating principles are identical. The H/S Catheter Set incorporates similar product design, materials packaging and sterilization as the predicate products.

Non-Clinical/Clinical Testing: None provided

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2003

John A. Steen, Ph.D. President and CEO Catheter Research, Inc. 6131 West 80th Street INDIANAPOLIS IN 46278 Re: K032835

Trade/Device Name: HS and SHG Catheters Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: September 10, 2003 Received:September 12, 2003

Dear Dr. Steen:

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 (PMA), 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.

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 (QS) regulation (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) 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 the letter:

| 8xxx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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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## Indications for Use

510(k) Number (if known): K032835

Device Name: HS and SHG Catheters

Indications For Use: The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Prescription Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032835

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