EMBRYON ULTRASOUND NEEDLE GUIDE

K032015 · Rocket Medical Plc · MQE · Aug 8, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032015
• Device Name: EMBRYON ULTRASOUND NEEDLE GUIDE
• Applicant: Rocket Medical Plc
• Product Code: MQE · Obstetrics/Gynecology
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6100
• Device Class: Class 2

Intended Use

Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers. For use in ultrasound guided oocyte harvesting and tissue biopsy.

Device Story

Embryon® Ultrasound Needle Guide is a single-use accessory designed to attach needles to specified ultrasound transducers. It facilitates needle guidance during ultrasound-guided oocyte harvesting and tissue biopsy procedures. The device is intended for use by clinicians in a clinical setting. By providing a stable attachment, it assists the physician in accurately directing the needle toward the target site under ultrasound visualization, potentially reducing procedure time and improving accuracy compared to manual guidance. The device is a single-use version of established re-usable needle guides, intended to mitigate cross-infection risks.

Clinical Evidence

No clinical data provided. The safety and effectiveness are supported by the history of use of re-usable ultrasound needle guides (over 20 years) and the use of similar single-use versions in the UK for the past 3 years without reported incidents.

Technological Characteristics

Single-use ultrasound needle guide for attachment to ultrasound transducers. Mechanical accessory design. No electronic components, software, or energy source. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing ultrasound-guided oocyte harvesting or tissue biopsy 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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# Rocket Medical plc - 510(k) Notification Embryon® Ultrasound Needle Guide AUG - 8 2003

KD32015

### Summary of Safety and Effectiveness

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

Re-usable ultrasound needle guides have been in use for over 20 years. The device is safe and effective for the application for which it is intended. More recently concerns about cross infection and patient pain have produced some single use versions being in use for the past 3 years, without any known incident in the UK.

Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

#### CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

20/6/03
Date

Date

T. Cordentia

Signed by Tracy Charlton Regulatory Affairs Manager Rocket Medical plc Wear Industrial Estate, Washington Tyne & Wear, England. NE38 9BZ

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Ms. Tracy Charlton Regulatory Affairs Manager Rocket Medical PLC Wear Industrial Estate District 6, Washington Tyne & Wear, NE38 9BZ UNITED KINGDOM

Re: K032015

Trade/Device Name: Embryon® Ultrasound Needle Guide Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted reproduction needles Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed imaging system Regulatory Class: II Product Code: 85 MQE and 90 IYO Dated: June 20, 2003 Received: July 21, 2003

Dear Ms. Charlton:

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 (PMA), it may be subject to 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.

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.

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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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# Rocket Medical plc - 510(k) Notification Embryon® Ultrasound Needle Guide

### Indications for Use

Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers.

For use in ultrasound guided oocyte harvesting and tissue biopsy.

T. Chauta

Signed T.Charlton Regulatory Affairs Manager

Rocket Medical Plc 20th June 2003

**Prescription Use**
(Per 21 CFR 801.109)

David A. Symm

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device 510(k) Number