SATURN 3 LASER SYSTEM

K060764 · Research Instruments , Ltd. · MRX · Mar 12, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K060764
• Device Name: SATURN 3 LASER SYSTEM
• Applicant: Research Instruments , Ltd.
• Product Code: MRX · Obstetrics/Gynecology
• Decision Date: Mar 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Saturn 3 Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age, Prior failed IVF, Cryopreserved embryos, Abnormal zona pellucida morphology.

Device Story

Saturn 3 Laser System is an assisted reproduction device used to ablate a tangential hole in or thin the zona pellucida of an embryo. The system uses an infrared laser to perform assisted hatching or related procedures. It includes a pilot laser for alignment, a custom objective for focusing, and integrated imaging capabilities for recording and measurement. Operated by embryologists in a clinical laboratory setting, the device allows the user to target the embryo, control laser power and pulse duration, and visualize the procedure via video/still image recording. The output assists in embryo preparation for IVF, potentially improving pregnancy outcomes for patients with poor prognosis. The system provides report generation and measurement tools to support clinical decision-making during the procedure.

Clinical Evidence

Clinical evidence consists of a literature review (Chatzimeletiou et al., Reproductive BioMedicine Online 2005) evaluating the safety of non-contact infrared laser zona drilling on human biopsied embryos. The study assessed blastomere viability, cytoskeletal analysis, and molecular cytogenetics, concluding the laser method is safe for use on human embryos.

Technological Characteristics

Infrared laser system for zona pellucida ablation. Features include pilot laser for alignment, custom objective lens, and computer-generated targeting. Provides video/still image recording, measurement tools, and report generation. Operates via user-defined pulse times and power settings. Connectivity includes video output for imaging.

Indications for Use

Indicated for IVF patients with poor pregnancy prognosis, including advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida morphology.

Regulatory Classification

Identification

The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.

Predicate Devices

• Hamilton Thorne Zilos-tk (K050768)

Submission Summary (Full Text)

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KU60764

Premarket Notification [510]

MAR 1 2 2007

## 5. 510(k) Summary

# RESEARCH INSTRUMENTS LIMITED

Image /page/0/Picture/5 description: The image shows a logo with the letters 'RI' in a bold, serif typeface. A curved line underlines the letters, adding a sense of motion or emphasis to the design. The logo is simple, yet impactful, with the bold letters and curved line creating a visually appealing and memorable image.

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Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, U.K. Tel: [phone] [International [phone]] Fax: [phone] [International [phone]] e-mail: [e-mail] website: www.research-instruments.com

Date prepared [21CFR807.92(a)(1)]

March 20, 2006

Submitter's information [21CFR807.92(a)(1)]

Company Name: Research Instruments LTD. Registration number: 9617095 Address: Bickland Water Industrial Park Falmouth Cornwall. United Kingdom Tr 11 4ta Telephone: [phone] Fax: [phone] Contact person: David Lansdowne Contact title: Technical Director Contact email: [e-mail]

Trade Name, Common Name, Classification [21CFR807.92(a)(2)]

Trade Name: Saturn 3 Laser System Common Name: Assisted Reproduction Laser System Device Class: Class J Regulation Number: 21CFR884.6200 Product Code: MRX

Identification of Predicate Device [21CFR807.92(a)(3)]

Substantial Equivalence to Hamilton Thorne Zilos-tk (K050768)

Description of the Device [21CFR807.92(a)(4)]

The Saturn 3 Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small

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tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

Intended Use [21CFR807.92(a)(5)]

The Saturn 3 Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age, Prior failed IVF, Cryopreserved embryos, Abnormal zona pellucida morphology.

Technological Characteristics [21CFR807.92(a)(6)]

Features Compared and found equivalent Laser Wavelength Laser Power Pulse time range Laser classification Number of preset pulse times Presets user definable Pilot laser for alignment checking Pilot laser power. Pilot laser classification Custom objective to focus infrared parfocal to visible Objective magnification Obiective Numerical Aperture Computer generated target Hole size indicator Still image recording Video image recording Measurement tools Report generation

Non-clinical Testing [21CFR807.92(b)(1)]

Measurement of laser power and pulse lengths demonstrates that the Saturn 3 delivers pulse energies comparable to the predicate. With the alignment procedure correctly performed the coalignment of the target and the ablated hole is within 1 µm. This is also comparable to the predicate.

Clinical Testing [21CFR807.92(b)(2)]

A recent study has shown that the Saturn 3 Laser System is safe for use on human embryos.

Reproductive BioMedicine Online 2005 Vol. 11, No. 6. 697-710

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"Comparison of the effects of zona drilling by non-contact infrared laser or acid Tyrode's on the development of human biopsied embryos as revealed by blastomere viability, cytoskeletal analysis and molecular cytogenetics" K Chatzimeletiou et al

### Conclusions [21CFR807.92(b)(3)]

The Research Instruments Saturn 3 Laser System is substantially equivalent to the Hamilton Thorne Zilos-tk based on the following:

(a) The pulse energies delivered by the two systems are comparable, and create similarly sized holes in the embryo zona pellucida.

(b) Clinical trials show that both systems are safe for use on human embryos, when operated in the prescribed manner.

(c) Both systems are operated in a similar way by the user.

The Research Instruments Saturn 3 Laser System has the same intended use as the predicate, and has performance and method of operation substantially equivalent to the predicate.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Research Instruments Ltd. c/o Ms. Grace Holland Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

MAR 1 2 2007

K060764 Re:

> Trade/Device Name: Saturn 3 Laser System Regulation Number: 21 CFR §884.6200 Regulation Name: Assisted reproduction laser system Regulatory Class: II Product Code: MRX Dated: January 9, 2007 Received: January 11, 2007

#### Dear Ms. Holland:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Promoting and Promoting Public Health

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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# 4. Indications for Use Statement Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

The Saturn 3 Laser System is to be used to drill a small tangential hole in, or to thin, the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as:

Advanced maternal age Prior failed IVF Cryopreserved embryos Abnormal zona pellucida morphology

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number

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REGULATORY SPECIALISTS, INC.

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