EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER

K992307 · Fertility Technology Resources, Inc. · MQF · Sep 13, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K992307
• Device Name: EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
• Applicant: Fertility Technology Resources, Inc.
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Sep 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF procedures to introduce embryo(s) into the female body.

Device Story

Embryo Glide™ is an assisted reproduction catheter used during IVF procedures to transfer embryos into the female uterus. The device consists of a 5 Fr polyurethane catheter (18 cm or 23 cm lengths) with color-coded hubs, a 7 Fr sheath for smooth uterine passage, and an optional accessory stylet for sheath placement. The device is supplied sterile in a peel-able pouch. It is intended for use by clinicians in a clinical setting. The catheter facilitates the mechanical delivery of embryos, potentially improving the success of IVF procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity, vaginal mucosal sensitization, and dermal sensitization. Mouse Embryo Assays were conducted to ensure safety for embryo contact.

Technological Characteristics

Materials: Polyurethane (catheter), polypropylene (sheath). Dimensions: 5 Fr catheter (18 cm/23 cm), 7 Fr sheath. Principle: Mechanical catheter-based delivery. Sterilization: Sterile, peel-able pouch. No software or electronic components.

Indications for Use

Indicated for use in IVF procedures to introduce embryos into the female uterus.

Regulatory Classification

Identification

Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Submission Summary (Full Text)

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# 510(k) Summary

K992307

Submitted on behalf of:

| | Company Name: | Lifetek Medical, Inc. |
|-----------------|-------------------------------------------------------------|--------------------------------------------|
| | Address: | 732 Morningstar Drive<br>Portage, WI 53901 |
| | Telephone: | 608-742-1188 |
| by: | Elaine Duncan, M.S.M.E., RAC | |
| | President, Paladin Medical, Inc. | |
| | PO Box 560 | |
| | Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | July 8, 1999 | |
| TRADE NAME: | Embryo Glide™ Embryo Transfer Catheter and accessory stylet | |
| COMMON NAME: | Assisted Reproduction Catheters | |

### SUBSTANTIALLY EQUIVALENT TO:

The Embryo Clide™ Embryo Transfer Catheter and accessory stylet is Class II and substantially equivalent, due to conformance with descriptions from CFR 884.6110 Assisted Reproduction Catheters (Procode 85 MOF) as described in the Final Rule in the Federal Register, Vol. 63. No. 175, Thursday, September 10, 1998, page 48436.

#### DESCRIPTION of the DEVICE:

The Embryo Glide™ Embryo Transfer Catheter and accessory stylet (ETC) is used during In-Vitro Fertilization (IVF) procedures to introduce embryo(s) into the female body. The embryo passes through the clear, 5 Fr polyurethane catheter, which is open on the end. The 5 Fr catheter is available in 18 cm and 23 cm lengths. Catheters have color-coded hubs to indicate different lengths. Each ETC comes with a 7 Fr sheath which provides a smooth passage into the uterus. An optional stylet (accessory) is available to aid in the initial placement of the 7 Fr sheath. Both the Embryo Transfer Catheter and stylet accessory (optional) are protected within a polypropylene sheath in a sterile, peel-able pouch.

#### INDICATIONS FOR USE:

The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF procedures to introduce embryo(s) into the female body.

## SUMMARY of TESTING:

The Embryo Glide™ Embryo Transfer Catheter and accessory stylet has undergone biocompatibility testing according to the recommended methods within ISO 10993, which includes cytotoxicity testing, vaginal mucosal and dermal sensitization. In addition, Mouse Embryo Assays were conducted for the catheter and stylet accessory.

510(k) Submission: Embryo Glide™ Embryo Transfer Catheter & accessory stylet; Lifetek Medical, Inc.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.

SEP 1 4 1999

Lifetek Medical, Inc. c/o Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical®, Inc. and Requiatory Consultant to Lifetek Medical. Inc. P.O. Box 560 Stillwater, MN 55082-0560

Re: K992307

Embryo Glide™ Embryo Transfer Catheter and Accessorv Stylet Dated: July 8, 1999 Received: July 9, 1999 Requiatory Class: II 21 CFR \$884.6110/Procode: 85 MQF

Dear Ms. Duncan:

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 Requlation (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 labeling requlation (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.

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

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| 510(k) Number (if known) | K992307 |
|--------------------------|----------------------------------------------------------|
| Device Name: | EMBRYO GLIDE EMBRYO TRANSFER CATHETER + ACCESSORY STYLET |

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# Indications for Use:

The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

# (Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992307

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510(k) Submission: Embryo Glide™ Embryo Transfer Catheter & accessory stylet; Lifetek Medical, Inc.