(356 days)
Not Found
No
The summary describes a laser system for assisted hatching in IVF, focusing on imaging, targeting, and laser control. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used to perform a procedure on an embryo to improve the chances of a successful pregnancy, which aligns with the definition of a therapeutic intervention.
No
Explanation: The device is used for therapeutic procedures (drilling or thinning the zona pellucida), not for diagnosing a condition or disease.
No
The device description explicitly states it is a "Laser System" and describes hardware components like a laser beam, power control, and pulse duration control, which are not software-only elements.
Based on the provided information, the Saturn 3 Laser System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Saturn 3 Laser System is used to directly interact with and modify an embryo, which is a living entity, not a specimen being examined for diagnostic purposes.
- The intended use is a procedure (assisted hatching/thinning the zona pellucida) to improve the chances of pregnancy. It's not a test to diagnose a condition or provide information about a patient's health status based on analyzing a sample.
- The device description focuses on the physical action of the laser on the embryo. It doesn't describe any analytical or diagnostic function.
Therefore, the Saturn 3 Laser System falls under the category of a medical device used for a therapeutic or procedural purpose in the context of assisted reproduction, not an IVD.
N/A
Intended Use / 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.
Product codes
MRX
Device Description
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 tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Embryo zona pellucida
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical Testing: 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: A recent study has shown that the Saturn 3 Laser System is safe for use on human embryos. "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, Reproductive BioMedicine Online 2005 Vol. 11, No. 6. 697-710
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, U.K. Tel: 01326 372753 [International +44 1326 372 753] Fax: 01326 378783 [International +44 1326 378 783] e-mail: technical@research-instruments.com 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: +44 (0) 1326 372 753 Fax: +44 (0) 1326 378 783 Contact person: David Lansdowne Contact title: Technical Director Contact email: david@research-instruments.com
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
1
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
2
"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.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are below the word "Centennial". The text around the circle is difficult to read.
Promoting and Promoting Public Health
4
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 (800) 638-2041 or (301) 443-6597 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
5
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
Page 1 of
REGULATORY SPECIALISTS, INC.
Page 10