<GEN>SINGLE LUMEN NEEDLE

K991262 · <Genx> Intl., Inc. · MQE · Sep 9, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991262
• Device Name: <GEN>SINGLE LUMEN NEEDLE
• Applicant: <Genx> Intl., Inc.
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Indications for Use

Used to obtain oocytes from the body

Device Story

The <genX> Single Lumen Needle is a medical device used to retrieve oocytes from the body during assisted reproductive procedures. It is operated by a physician in a clinical setting. The device functions as a mechanical tool for oocyte aspiration. It is provided sterile via gamma irradiation or steam sterilization. The output is the collected oocyte sample, which is then used by the clinical team for further reproductive laboratory processing. The device facilitates the oocyte retrieval process, a critical step in assisted reproduction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single lumen needle for oocyte retrieval. Sterilization via gamma irradiation or steam sterilization. Class II device (21 CFR 884.6100).

Indications for Use

Indicated for use in patients undergoing assisted reproductive procedures to obtain oocytes from the body.

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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170 Fort Path Road, Madison, CT 06443 203-245-4994 FAX [phone]

510K Summarv

KG91262

1. Device Name: Propriety Name: <genX> Single Lumen Needle

Classification: Reproductive Media

- 2. Submission Date: Submission Date: March 26, 1999
- 3. Submitted by:

<genX> international, Inc. 170 Fort Path Road Madison, CT 06443

Establishment Registration No .: 9003605

Tel: [phone] Fax: [phone] E-mail:[e-mail]

Contact Individual: Michael D. Cecchi President

- 4. Classification: Class II Assisted Reproductive Needles Product: <genX> Single lumen Needle Procode: 85 MQE CFR#: 884.6100
- ട്. Performance Standards:

No Performance Standards have been developed by Food and Drug Administration under Section 514 of the Act for this device. However, certain Special Controls have been identified in order to provide reasonable assurance of the safety and effectiveness of the device used in assisted reproduction procedures.

- ଚ. Proposed labels, Labeling and Advertising: The product labeling is included in this application in the appropriate section.

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- 7. Substantially Equivalence Comparison This product is substantially equivalent to several product currently sold in the market See Section 2.0 for this data.
- Device Description, Intended Use 8.

The <genX> Single Lumen Needle is intended to obtain oocytes from the body.

- All needles manufactured, will be Gamma Irradiated and or steam sterilized by 9. and in accordance to the guidelines in place. See Section 11.0

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP g 1999

Mr. Michael D. Cecchi President <genX> International, Inc. 170 Fort Path Road, Unit 14 Madison, CT 06443

Re: K991262 <genX> Single Lumen Needle Dated: June 5, 1999 Received: June 18, 1999 Requlatory Class: II 21 CFR §884.6100/Procode: 85 MQE

Dear Mr. Cecchi:

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 fer 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 III (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 Compilance 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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<genX> international, inc.

Re: K991262 Sperm Washing Media

Response to #2

510(K) Premarket Notification

INDICATION FOR USE

510 (k) Number ( if known ) K991262

Device Names: <genX> single Lumen Needle

Indication for Use:

"Used to obtain oocytes from the body"

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| Concurrence of CDRH, Office of Device Evaluation ( ODE ) |
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| (Division Sign-Off) |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices |

| 510(k) Number | K9912162 |
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| Prescription Use | <div style="display:inline-block;width:20px;">X</div> | or | Over-the Counter Use |
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