MEDWORKS VISUALIZATION INSEMINATION CATHETER

K982630 · Medworks Corp. · MFD · Jan 14, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982630
• Device Name: MEDWORKS VISUALIZATION INSEMINATION CATHETER
• Applicant: Medworks Corp.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Jan 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2

Intended Use

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Device Story

Malleable catheter with distal side ports and lumen; accommodates fiberoptic device for visualization of uterine interior. Used by physicians during intrauterine insemination to confirm placement of insemination fluid in uterine cavity. Device provides visual confirmation of catheter tip location, potentially improving accuracy of fluid delivery compared to blind placement.

Clinical Evidence

No clinical data included; substantial equivalence based on bench-level design and performance characteristics.

Technological Characteristics

Malleable catheter with distal side ports and central lumen for fiberoptic device insertion. Design allows for visual guidance during intrauterine insemination. Materials and performance specifications are equivalent to predicate insemination catheters and endoscopic visualization devices.

Indications for Use

Indicated for intrauterine artificial insemination procedures using washed spermatozoa or semen in patients undergoing fertility treatment.

Regulatory Classification

Identification

A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

Predicate Devices

• Roseff's Double Lumen Standard Intrauterine Insemination Catheter (K884696)
• Standard Intrauterine Insemination Catheter (K884696)
• Mini-Embryon Intra Uterine Insemination Catheter (K972823)
• Jansen-Anderson Insemination Set (K914150)
• Centurion Vaginal Speculum (K897100)
• Galileo Disposable Endoscope (K981928)
• Imagyn MicroSpan Insemination System (970750)
• MicroSpan Hysteroscope Sheath (K961506)
• MicroSpan Hysteroscope (K961688)

Submission Summary (Full Text)

{0}------------------------------------------------

MedWorks Corp. 510(k) Premarket Notification

# 510(k) Summary

4782630

| Trade Name: | MedWorks Visualization Insemination Catheter |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | MedWorks Corp.<br>2400 Crittenden Drive<br>Louisville, KY 40217<br>Registration #1530618 |
| Device Generic Name: | Intrauterine Insemination Catheter |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | Roseff's Double Lumen Standard Intrauterine Insemination Catheter<br>(K884696)<br>Fertility Technologies, Inc. |
| | Standard Intrauterine Insemination Catheter (K884696)<br>CCD International |
| | Mini-Embryon Intra Uterine Insemination Catheter (K972823)<br>A&A Medical, Inc. |
| | Jansen-Anderson Insemination Set (K914150)<br>Cook Ob/Gyn |
| | Centurion Vaginal Speculum (K897100)<br>Tri-State Hospital Supply |
| | Galileo Disposable Endoscope (K981928)<br>Galileo Electro-Optics Corp. |
| | Imagyn MicroSpan Insemination System (970750), MicroSpan Hysteroscope<br>Sheath (K961506) and MicroSpan Hysteroscope (K961688)<br>Imagyn Medical, Inc. |

# Product Description:

Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.

#### Indications for Use:

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

## Safety and Performance:

Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Visualization Catheter are equivalent to those of the predicate devices.

{1}------------------------------------------------

MedWorks Corp. 510(k) Premarket Notification

## Conclusion:

Based on the indications for use, technological characteristics, and comparison to currently marketed devices, the MedWorks Visualization Insemination Catheter has been shown to be safe and effective for its intended use.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

Pamela L. Papineau President Delphi Medical Device Consulting for MedWorks Corp. 50 Brewster Street Pawtucket, RI 02860

Re: K982630 MedWorks Insemination Catheter Dated: November 8, 1998 Received: November 12, 1998 Regulatory Class: II 21 CFR 884.5250/Procode: 85 MFD

Dear Ms. Papineau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

J. J. J.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MedWorks Visualization Insemination Catheter

Indications for Use:

For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X OR Over-the -Counter Use **__**

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K982630/S