(109 days)
Not Found
No
The description focuses on precise laser control, image storage, database, and analysis functions, but does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for microsurgery on a cellular level to assist in in vitro fertilization (IVF) procedures, directly impacting patient health by improving the chances of a successful pregnancy for selected patients with poor prognosis.
No
The device is described as a laser system for microsurgery, specifically for ablating a hole in the zona pellucida during IVF, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "laser system" and a "microscope based micromanipulation tool," indicating the presence of hardware components beyond just software.
Based on the provided information, the OCTAX Laser Shot™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The OCTAX Laser Shot™ is a laser system used for a physical manipulation (ablating a hole in the zona pellucida) of an embryo, which is a biological entity, but the purpose is not to diagnose, monitor, or screen the embryo itself in a diagnostic sense.
- The intended use is a therapeutic intervention (assisted hatching) to improve the chances of pregnancy. While this process is part of an IVF procedure, the device's function is a physical manipulation, not a diagnostic test performed on a specimen.
- The device description focuses on its function as a micromanipulation tool. It uses a laser to perform a physical action on the embryo.
- There is no mention of analyzing biological samples or providing diagnostic information.
The OCTAX Laser Shot™ is a medical device used in the context of assisted reproductive technology (ART), but its function aligns with a therapeutic or procedural device rather than a diagnostic one.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
MRX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not applicable
Indicated Patient Age Range
Not Found
Intended User / Care Setting
IVF patients, In Vitro Fertilization laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.6200 Assisted reproduction laser system.
(a)
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.(b)
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.
0
510(k) Pre-Market Notification Summary Report
| Submitted By: | Minitube of America, Inc.
411 B Venture Ct. PO Box 930187
Verona WI. 53593 | DEC 15 2006 | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|
| Contact Person: | Frederick Rikkers
Rikkers Law
419 Venture Court, P.O. Box 930555
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
MRX - CFR # 884.6200 | | | | |
| Special Controls Document: | "Class II Special Controls Guidance Document: Assisted
Reproduction Laser System" issued on December 28th, 2004 | | | | |
| Predicate Device: | Hamilton Thorne Zona Infrared Laser Optical System (Zilos),
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 | ||
| scientific history | Both devices implement the same | |
| technological principle and are based on the | ||
| same scientific background as published in | ||
| the literature. | In addition to sharing the common history, the | |
| OCTAX Laser Shot™ system is more close to | ||
| the scientific background of the technology due | ||
| to the fact that its development was lead by Dr. | ||
| Klaus Rink, who was also a member of the team | ||
| of researchers who established this scientific | ||
| background. | ||
| Indications for use | The indications for use regarding zona | |
| pellucida drilling are identical for both | ||
| devices. | The indication for zona thinning of the predicate | |
| device has not been included in the indications | ||
| for use of the OCTAX Laser Shot™ system to | ||
| lower the requirements for documentation of the | ||
| device and of relevant clinical studies in this | ||
| extent. Additionally, as a result of a more | ||
| conservative approach to potential hazards of | ||
| laser assisted hatching, an additional requirement | ||
| of the availability of more than one embryo for | ||
| transfer was added. | ||
| Target Population | Identical | |
| Laser type | Identical (infrared diode laser) | |
| Wavelength | Identical (1.48 μm) | |
| Laser interaction | ||
| with target | Identical interaction process | |
| Objective | Objective with high infrared transmission | The OCTAX Laser Shot™ system includes an |
| objective with a 40x magnification, while the | ||
| objective of the predicate device has a 50x | ||
| magnification. | ||
| Laser path | Functionally identical - from the laser diode | |
| passing by a semi-transparent mirror into | ||
| (and focused by) the objective onto the | While the predicate device integrates objective, | |
| semitransparent mirror and laser diode into a | ||
| 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 | |
| journal articles published in the literature) | ||
| Clinical studies | Similar (reference of relevant journal articles | |
| published in the literature) | ||
| Electrical Safety | Compliance with relevant electrical safety | |
| standards, IEC 60101-1, IEC 61010-1 and | ||
| EMC compliance according to IEC 61326 | ||
| Radiation Safety | Compliance with relevant eye safety | |
| regulations according to IEC EN 60825-1 | According to IEC EN 60825-1, the OCTAX | |
| Laser Shot™ system is a class 1M device. The | ||
| Hamilton Thorne Zilos system is a class 1 device. | ||
| As stated in Exhibit A, both class I and class 1M | ||
| imply sufficient safety for the use of the device. |
Substantial Equivalence Performance
2
.
.
3
3
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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Image /page/4/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
Image /page/4/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health" in a decorative font. The logo is circular and contains the letters FDA in a stylized design. The text is centered below the logo.
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Page 2 -
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 (800) 638-2041 or (240) 276-3150
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
6
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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