H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

K013972 · Ackard Laboratories · LKF · Dec 17, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013972
• Device Name: H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
• Applicant: Ackard Laboratories
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Dec 17, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The H/S Elliptosphere Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

Device Story

The H/S Elliptosphere Catheter Set is a sterile, single-use device designed for the delivery of diagnostic contrast media into the female reproductive tract. It is used by clinicians to perform hysterosalpingography (x-ray examination) or hysterosonography (ultrasound examination) of the uterus and fallopian tubes. The device functions as a cannula/manipulator for contrast agent injection. By enabling the visualization of the uterine cavity and fallopian tubes, the catheter assists healthcare providers in diagnosing reproductive tract conditions. The device is intended for prescription use only.

Clinical Evidence

Bench testing only.

Technological Characteristics

The device is a catheter set for uterine manipulation and contrast injection. It utilizes the same materials, design, and sterilization processes as the predicate device. No specific ASTM standards or software components are described.

Indications for Use

Indicated for use in the female reproductive tract for the delivery of diagnostic contrast media agents to facilitate examination of the uterus and fallopian tubes via hysterosalpingography or hysterosonography.

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 with Polyurethane Balloon (K961752)

Submission Summary (Full Text)

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# 510(k) Summary

| Device<br>Description | Trade Name: | H/S Elliptosphere Catheter Set | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--|
| | Common Name: | Hysterosalpingography or Hysterosonography<br>Catheter | |
| | Classification Name: | Cannula, manipulator/injector, Uterine, Product<br>Code LKF | |
| Predicate<br>Device | Modified Hysterosalpingography Set with Polyurethane Balloon<br>K961752, 8/19/96 | | |
| Date | November 26, 2001 | | |
| Contact | Richard Hettenbach<br>Vice President, Regulatory Affairs and Quality Assurance<br>Ackrad Laboratories, Inc.<br>70 Jackson Drive<br>Cranford, NJ 07016<br>Tel: [phone]<br>Fax: [phone] | | |
| Device<br>Description | The H/S Elliptosphere Catheter Set can be used for conducting either<br>Hysterosalpingography (examination of the uterus and fallopian tubes<br>using x-rays) or Hysterosonography (examination of the uterus and<br>fallopian tubes using ultrasound sonography). All components are<br>provided sterile for single use only. | | |
| Technological<br>Characteristics | The H/S Elliptosphere Catheter Set has the same technological<br>characteristics as the predicate device. The intended use, operating<br>principle are identical. The H/S Elliptosphere Catheter Set incorporates the<br>same product design and is packaged and sterilized using the same<br>materials and processes. | | |

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| Performance Data | Pre-clinical testing has been conducted to verify that the product meets the performance requirements described. It was determined that the H/S Elliptosphere Catheter Set performs safely and effectively. |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The H/S Elliptosphere Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set with Polyurethane Balloon. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 1 7 2001

Mr. Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories 70 Jackson Drive P.O. Box 1085 CRANFORD NJ 07016

Re: K013972

Trade/Device Name: H/S Elliptosphere Catheter Set Model 61-4005 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: November 26, 2001 Received: December 3, 2001

Dear Mr. Hettenbach:

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 for assuration 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 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri incing of succement of the specification for your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific acvies at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.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 Additionally, for questions on and process. Also, please note the regulation entitled, "Misbranding Office of Comphanee at [phone] (21 CFR Part 807.97). Other general information on by relected to premail.com the Act may be obtained from the Division of Small Manufacturers, your itsponsibilities and Consumer Assistance at its toll-free number [phone] or [phone] internet and Goress 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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## Attachment 2

## Indications for Use Statement

| 510(k) Number | K 013972 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | H/S Elliptosphere Catheter Set |
| Indications for Use | The H/S Elliptosphere Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes. |

#### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

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

| Prescription Use<br>(Per 21 CFR 801.109) | | OR | Over-The Counter Use |
|------------------------------------------|--|----|----------------------|
|------------------------------------------|--|----|----------------------|

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K013972 |
|---------------|---------|
|---------------|---------|

510(k) Number ________________________________________________________________________________________________________________________________________________________________