OCTAX LASER SHOT SYSTEM

K062524 · Minitube of America, Inc. · MRX · Dec 15, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K062524
• Device Name: OCTAX LASER SHOT SYSTEM
• Applicant: Minitube of America, Inc.
• Product Code: MRX · Obstetrics/Gynecology
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.6200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cyropreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

Device Story

Microscope-based micromanipulation tool for IVF laboratories; uses 1.48 μm infrared diode laser to ablate small hole in zona pellucida (assisted hatching). System integrates laser, miniature digital video camera, and PC software. Operator (embryologist) views live video feed on PC monitor; uses software-based crosshair overlay to target laser pulse. Laser energy delivered through microscope objective. Device enables precise microsurgery on cellular level; intended to improve pregnancy outcomes in poor-prognosis patients. System operates as Class 1M laser device.

Clinical Evidence

No clinical data generated for this submission; substantial equivalence supported by reference to fundamental research and clinical journal articles published in literature regarding the technology's safety, accuracy, and efficacy over 10+ years of use.

Technological Characteristics

1.48 μm infrared diode laser; Gaussian beam profile; 40x objective; PC-based control; Class 1M laser (IEC EN 60825-1); electrical safety per IEC 60101-1, IEC 61010-1; EMC per IEC 61326. Materials are standard microscopy components; non-contact device.

Indications for Use

Indicated for assisted hatching in IVF patients with poor prognosis (advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida). Contraindicated if only one embryo is available for transfer.

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 Zona Infrared Laser Optical System (Zilos) (K040045)

Reference Devices

• Fertilase (predecessor device)

Submission Summary (Full Text)

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# 510(k) Pre-Market Notification Summary Report

| Submitted By: | Minitube of America, Inc.<br>411 B Venture Ct. PO Box 930187<br>Verona WI. 53593 | DEC 15 2006 | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|
| Contact Person: | Frederick Rikkers<br>Rikkers Law<br>419 Venture Court, P.O. Box 930555<br>Verona, WI 53593 | | | | |
| Date Prepared: | July 18, 2006 | | | | |
| Trade Name: | OCTAX Laser Shot™ System | | | | |
| Common Name: | OCTAX Laser | | | | |
| Device Classification Name: | Assisted Reproduction Laser Systems<br>MRX - CFR # 884.6200 | | | | |
| Special Controls Document: | "Class II Special Controls Guidance Document: Assisted<br>Reproduction Laser System" issued on December 28th, 2004 | | | | |
| Predicate Device: | Hamilton Thorne Zona Infrared Laser Optical System (Zilos),<br>510(k) number: K040045. | | | | |

#### Description of Device:

The OCTAX Laser Shot™ laser device is a microscope based micromanipulation tool for use in ART in In Vitro Fertilization laboratories. The device uses a 1.48 um infrared diode laser and has been supplemented with a miniature digital video camera and computer software allowing precise laser control, image storage and database and analysis functions.

The OCTAX Laser Shot™, introduced to the market in October 2000, is the 2nd generation infrared diode laser developed at OCTAX Microscience GmbH by a team lead by Dr. Klaus Rink, based on extensive experience with the first commercial 1.48 um infrared diode laser (Fertilase), introduced to the market 1996, director research and development at that time: Dr. Klaus Rink (Physicist).

#### Statement of Indicated Use

The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cyropreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

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## Technological Characteristics

The OCTAX Laser Shot™ system is to be compared with the following predicate device: Hamilton Thorne Zona Infrared Laser Optical System (Zilos), 510(k) number: K040045, based upon the criteria provided by the FDA. The technological and performance characteristics of the OCTAX Laser Shot™ system are substantially equivalent to this predicate device and are detailed in the Substantial Equivalence Performance section of the 510(k) submission document. The substantial equivalence applies both on a technological level, as well as preclinical/clinical data and operating characteristics.

### Testing Performed for Safety, Accuracy and Software Validation

The OCTAX Laser Shot™ system, and its predecessor, the Fertilase system have been used throughout the world for over 10 years. Its efficacy, safety and accuracy has been tested and retested over the years and noted in many publications. Also, the software used in the OCTAX Laser Shot™ system has been validated on numerous occasions.

| | Similarities | Differences |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological and<br>scientific history | Both devices implement the same<br>technological principle and are based on the<br>same scientific background as published in<br>the literature. | In addition to sharing the common history, the<br>OCTAX Laser Shot™ system is more close to<br>the scientific background of the technology due<br>to the fact that its development was lead by Dr.<br>Klaus Rink, who was also a member of the team<br>of researchers who established this scientific<br>background. |
| Indications for use | The indications for use regarding zona<br>pellucida drilling are identical for both<br>devices. | The indication for zona thinning of the predicate<br>device has not been included in the indications<br>for use of the OCTAX Laser Shot™ system to<br>lower the requirements for documentation of the<br>device and of relevant clinical studies in this<br>extent. Additionally, as a result of a more<br>conservative approach to potential hazards of<br>laser assisted hatching, an additional requirement<br>of the availability of more than one embryo for<br>transfer was added. |
| Target Population | Identical | |
| Laser type | Identical (infrared diode laser) | |
| Wavelength | Identical (1.48 μm) | |
| Laser interaction<br>with target | Identical interaction process | |
| Objective | Objective with high infrared transmission | The OCTAX Laser Shot™ system includes an<br>objective with a 40x magnification, while the<br>objective of the predicate device has a 50x<br>magnification. |
| Laser path | Functionally identical - from the laser diode<br>passing by a semi-transparent mirror into<br>(and focused by) the objective onto the | While the predicate device integrates objective,<br>semitransparent mirror and laser diode into a<br>single enclosure, the OCTAX Laser Shot™ |
| | specimen | |
| Beam information | Identical (radially symmetric, with Gaussian beam profile) | |
| Power levels | Same order of magnitude | While predicate device operates with a power in focus in air of up to 300 mW, the OCTAX Laser Shot™ has a power in focus in air of 90-130 mW (which is more close to the power levels used in the fundamental safety studies published in the literature). |
| Laser pulse duration | Resulting in same order of magnitude energy per laser pulse | While the predicate device relies on shorter pulses (0.1-2ms) at higher power levels, the OCTAX Laser Shot™ uses slightly longer pulses (0.1-10ms) while the total energy per laser pulse remains lower compared to the predicate device, while achieving similar ablation performance (size of ablations) |
| Laser pulse repetition | Identical (single pulses without repetition) | |
| Laser targeting | Identical (through crosshair overlay superimposed to a live video display of the microscope image implemented by software on a PC). | |
| Materials | Both use standard materials common to microscopy equipment. The materials in use are of no concern as the devices do not come into direct (physical) contact with the target. | |
| Performance | Both devices have substantially similar performance due to the substantial similarity of the laser beam characteristics. | |
| Sterility | Both devices present no concern regarding sterility as they do not come into direct (physical) contact with the target | |
| Biocompatibility | Not applicable, see Sterility. | |
| Mechanical Safety | The mechanical safety aspects are similar for both devices. | The difference in design relating to the specific place where the laser is introduced into the microscope beam path is addressed with respect to its safety implications in Exhibit A. |
| Chemical Safety | Not applicable | |
| Anatomical Sites | Not applicable | |
| Human Factors | As the design and the use of the device is substantially similar, the same human factors apply. | |
| Energy Used and/or Delivered | The amount of laser energy delivered in a treatment procedure is similar. | The OCTAX Laser Shot™ system can achieve similar ablation performance (size of ablations) with a lower laser beam power in focus and a lower total delivered energy. |
| Compatibility with Environment and Other Devices | Relevant compatibility aspects consist of compatibility with electrical standards and compatibility with listed microscopes. Both devices satisfy the similar/identical requirements. | |
| Where Used | Both devices are used in IVF routine and are mounted on compatible inverted | |
| | microscopes. | |
| Preclinical studies | Identical (reference of fundamental research<br>journal articles published in the literature) | |
| Clinical studies | Similar (reference of relevant journal articles<br>published in the literature) | |
| Electrical Safety | Compliance with relevant electrical safety<br>standards, IEC 60101-1, IEC 61010-1 and<br>EMC compliance according to IEC 61326 | |
| Radiation Safety | Compliance with relevant eye safety<br>regulations according to IEC EN 60825-1 | According to IEC EN 60825-1, the OCTAX<br>Laser Shot™ system is a class 1M device. The<br>Hamilton Thorne Zilos system is a class 1 device.<br>As stated in Exhibit A, both class I and class 1M<br>imply sufficient safety for the use of the device. |

### Substantial Equivalence Performance

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# Conclusion

The non-clinical and clinical data for the OCTAX Laser Shot™ system, as reported in the Substantial Equivalence Performance section above, shows that the device is as safe, as effective, and performs as well or better than the predicate device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Minitube of America, Inc. % Mr. Frederick T. Rikkers Attorney at Law 419 Venture Court P.O. Box 930555 VERONA WI 53593

DEC 1 5 2006

Re: K062524

Trade/Device Name: OCTAX Laser Shot System Regulation Number: 21 CFR 884.6200 Regulation Name: Assisted reproduction laser system Regulatory Class: II Product Code: MRX Dated: November 2, 2006 Received: November 3, 2006

Dear Mr. Rikkers:

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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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.

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.xxx | (Gastroenterology/Renal/Urology | | 240-276-0115 |
|----------------|---------------------------------|--|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | | 240-276-0120 |
| Other | | | 240-276-0100 |

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 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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# Indications for Use

#### K062524 510(k) Number (if known):

Device Name: OCTAX Laser Shot™

**Indications For Use:**

Indications For Use: The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David B. Lyman

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

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