OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138

K992308 · Lifetek Medical, Inc. · MQE · Sep 13, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K992308
• Device Name: OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
• Applicant: Lifetek Medical, Inc.
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Sep 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for use and intended to be used for obtaining female gametes/oocytes from the body.

Device Story

The Oocyte Retrieval Needle Set is a single-lumen needle used in In-Vitro Fertilization (IVF) procedures to retrieve female gametes/oocytes. The device includes PTFE connecting tubes and a silicone stopper. It is operated by physicians experienced in IVF procedures. The needle facilitates the physical collection of oocytes from the body, which are then used for further reproductive laboratory processing. The device is designed for short-term tissue contact.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity and sensitization. The device passed the mouse embryo assay (MEA) and bacterial endotoxin assay (limit 9.6 EU/device).

Technological Characteristics

Single-lumen needle; includes PTFE connecting tubes and silicone stopper. Materials are biocompatible per ISO 10993. No electronic components, software, or energy sources.

Indications for Use

Indicated for obtaining female gametes/oocytes from the body for assisted reproduction procedures.

Regulatory Classification

Identification

Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

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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COMMON NAME:

# 510(k) Summary

K992308

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: | Oocyte Retrieval Needle Set | |

#### SUBSTANTIALLY EQUIVALENT TO:

The Oocyte Retrieval Needle Set is Class II and substantially equivalent, due to conformance with descriptions from CFR 884.6100 Assisted Reproduction Catheters (Procode 85 MQE) as described in the Final Rule in the Federal Register, Vol. 63. No. 175, Thursday, September 10, 1998, page 48436.

Assisted Reproduction Needle

#### DESCRIPTION of the DEVICE:

The Oocyte Retrieval Needle Set is used in In-Vitro Fertilization (IVF) procedures to obtain female gametes/oocytes from the body. It is a single-lumen needle of the proper length and diameter. Some physicians experienced in this procedure prefer a 17 ga x 35 cm needle which complies to the government specification GG-N-196. For convenience the needle is provided with PTFE connecting tubes and a silicone stopper.

### INDICATIONS FOR USE:

The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for use and intended to be used for obtaining female gametes/oocytes from the body.

#### SUMMARY of TESTING:

Based upon conventional biocompatibility testing (per blue book memorandum #G95-1 entitled: Use of International Standard ISO 10993: "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing," the materials of which the Oocyte Needle Set is fabricated are biocompatible with their intended use. Tests included those recommended for an "external communicating device" for tissue contact which have limited (short-term): 1) cytotoxicity, 2) sensitization. In addition, FDA has required the mouse embryo assay (MEA) for any device coming into contact with gametes and/or embryos. The Oocyte Needle Set passed the bacterial endotoxin assay at a limit sensitivity of 9.6 EU/device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

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

Re: K992308 Oocyte Retrieval Needle Set Dated: July 8, 1999 Received: July 9, 1999 Requiatory Class: II 21 CFR §884.6110/Procode: 85 MQE

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 vour 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 requlations 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 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 requlation 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) | K992308 |
|--------------------------|-----------------------|
| Device Name: | Doayte Retrieval Set. |

## Indications for Use:

:

The Lifetek Medical Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for r he Broton modiour over obtaining female gametes/oocytes from the body.

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over -The-Counter Use _________ |
|------------------|---|----|---------------------------------|
|------------------|---|----|---------------------------------|

(Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K992308 |
|---------------|---------|
|---------------|---------|

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