WALLACE ARTIFICIAL INSEMINATION CATHETER

K061679 · Irvine Scientific Sales Co., Inc. · LKF · Oct 13, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061679
• Device Name: WALLACE ARTIFICIAL INSEMINATION CATHETER
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.

Device Story

Single-use, sterile, disposable catheter; 18cm length; consists of flexible-end inner catheter (16 gauge) and detachable outer sheath with luer lock. Inner catheter protrudes 5cm from sheath; outer sheath features 1cm graduations for insertion depth assessment. Used in clinical settings by healthcare providers for two procedures: 1) artificial insemination, delivering washed spermatozoa into uterine cavity; 2) Saline Infusion Sonography (SIS), delivering saline solution into uterine cavity to facilitate ultrasound imaging of abnormalities. Device provides physical conduit for fluid/sperm delivery; enables visualization of uterine anatomy during ultrasound procedures; assists clinicians in diagnostic and reproductive interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and comparison to predicate and reference devices. Field testing and end-user evaluation were cited as demonstrating suitability for intended use.

Technological Characteristics

16-gauge flexible inner catheter; detachable outer sheath with luer lock; 18cm total length; 1cm distal graduations. Materials are sterile, single-use, disposable. Functions as a fluid delivery conduit for saline or spermatozoa. No energy source or software components.

Indications for Use

Indicated for patients undergoing artificial insemination (introduction of washed spermatozoa into uterine cavity) or Saline Infusion Sonography (SIS) for detection of uterine cavity abnormalities.

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

• Wallace Artificial Insemination Catheter (K964848)

Reference Devices

• Hysterosalpingorgraphy Set (K842231)
• H/S Catheter Set (K020951)
• Intrauterine Insemination and Sonohysterography (K970492)
• Bard Hysterosalpingography Catheters (K890869)
• HSG Catheter Set (K041094)
• Softseal HSG Catheter (K040238)

Submission Summary (Full Text)

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Irvine Scientific

K061679
June 7, 2006
Page 1 of 3

### 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

| Submitted by: | Irvine Scientific Sales Co., Inc.<br>2511 Daimler Street<br>Santa Ana, CA 92705-5588 | | | | OCT 13 2006 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--|--|-------------|
| | Telephone: [phone]<br>Facsimile: [phone]<br>Contact: Wendell Lee, Pharm.D.<br>Vice President<br>Regulatory Affairs/Quality Systems | | | | |
| | Date Submitted: June 7, 2006 | | | | |
| Device Identification: | | | | | |
| Trade Name: | | Wallace SIS/AI Catheter | | | |
| Trade or Proprietary Name: | | Wallace Artificial Insemination Catheter | | | |
| Device Classification Name: | | Assisted Reproductive Catheter (21 CFR § 884.6110, Class II, Product Code 85 MQF) | | | |
| | | Cannula, Manipulator/Injector, Uterine,<br>(Unclassified, Class II, Product Code 85 LKF) | | | |

## Description:

The Wallace Artificial Insemination Catheter (K964848) is a single-use, sterile, disposable device that was originally submitted and cleared with the intended use for insertion of catheters and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/AI Catheter for the purpose of this submission is intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection of abnormalities within uterine cavities. The catheter is also intended to be used in artificial insemination (AI) procedures.

Wallace SIS/AI Catheter

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June 7, 2006

The Catheter has two opposing smooth side eyes and a rounded smooth closed distal tip. It has an overall length of 18cm and consists of a flexible-end inner catheter and a detachable outer sheath attached to the inner catheter by a luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath luer is attached to the hub of the catheter, the inner catheter protrudes from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end, the graduations are used to assess the depth of the insertion.

An inner tube with an outer sheath that covers 2/3 segments of the inner sheath with marks of the distance from the distal part of the catheter and a cover rigid protective tube. Please refer to photographs of the catheter presented in Appendix E of this submission.

#### Intended Use:

The SIS/AI Catheter for the purpose of this submission is intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection of abnormalities within uterine cavities. The catheter is also intended to be used in artificial insemination (AI) procedures.

### Technological Characteristics:

Catheters are routinely used in Saline Infusion Sonography in diagnostic Obstetrics and Gynecological procedures. The catheter is used to deliver a saline solution into the patient for the intended purposes. The catheter was originally cleared for market with the intended use of introduction of washed spermatozoa into the uterine cavity. The proposed intended use of the Wallace Artificial Insemination and SIS Catheter is equivalent to the identified predicate devices. The comparison to the predicate device is as follows:

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June 7, 2006

K.06/679
Page 3 of 3

| Applicant | Product Name | K # | Address | |
|------------------------------------------|-------------------------------------------------------------------|---------|-------------------------------------------------------|--|
| ACKRAD<br>Laboratories | Hysterosalpingorgraphy Set | K842231 | 70 Jackson Dr.<br>Cranford, NJ 07016 | |
| ACKRAD<br>Laboratories | H/S Catheter Set<br>Hysterosalpingography or<br>hysterosonography | K020951 | 70 Jackson Dr.<br>Cranford, NJ 07016 | |
| ACKRAD<br>Laboratories | Intrauterine Insemination<br>and Sonohysterography | K970492 | 70 Jackson Dr.<br>Cranford, NJ 07016 | |
| C.R. Bard, INC. | Bard Hysterosalpingography<br>Catheters | K890869 | 5 Federal St. P.O. Box<br>5069 Billerica, MA<br>01822 | |
| Bioteque<br>America, Inc. | HSG Catheter Set<br>Infusion of contrast dye or<br>sterile saline | K041094 | 340 East Maple Ave.,<br>#204-C<br>Langhorne PA 19047 | |
| Modern Medical<br>Equipment MFG.<br>LTD. | Softseal HSG Catheter<br>Sonohysterography | K040238 | 1705 Dabney Rd.<br>Richmond, VA 23230 | |
| Marlow Surgical<br>Technologies,<br>Inc. | Wallace Artificial<br>Insemination Catheter | K964848 | 1810 Joseph Lloyd<br>Parkway<br>Willoughby, OH 44094 | |

## Conclusion:

The results from the field testing and evaluation of this product by the end-user demonstrate that the Wallace Artificial Insemination and SIS Catheter are suitable for their intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT 1 3 2006

Wendell Lee, Pharm.D. Vice President Regulatory Affairs/Quality Systems Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K061679

Trade/Device Name: Wallace SIS/AI Catheter Regulation Number: 21 CFR §884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF and LKF Dated: September 5, 2006 Received: September 6, 2006

Dear Dr. Lee:

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.

Image /page/3/Picture/10 description: The image is a circular logo with the text "FDA Centennial" in the center. Above the text is "1906-2006". The letters "FDA" are in a bold, stylized font. The logo is surrounded by a circular border with text, but the text is too blurry to read. There are three stars below the word "Centennial".

noting Public J

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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 (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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours.

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 STATEMENT (page 1 of 1)

510(K) Number: KO60 1679

Device Name: Wallace SIS/Al Catheter

Indications for Use:

The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/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)

Daniel A. Seymour

(Division Sign-Off) Division of Reproductive and Radiological Devic 510(k) Number

Wallace SIS/AI Catheter