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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Saturn 3 Laser System." This device is intended for assisted reproduction procedures. The submission focuses on demonstrating substantial equivalence to a predicate device, the Hamilton Thorne Zilos-tk (K050768). As such, the concept of "acceptance criteria" for performance and a study proving those criteria are met, in the sense of a new clinical trial establishing efficacy, is not explicitly presented for the Saturn 3 Laser System itself. Instead, the submission relies on demonstrating equivalence in key technical characteristics and referencing existing clinical evidence for similar technology.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The submission does not specify numerical "acceptance criteria" for the Saturn 3 Laser System's performance in the traditional sense. Instead, it asserts its equivalence to the predicate device in specific technical aspects and overall safety.

Acceptance Criteria	Reported Device Performance (Saturn 3 Laser System)
Equivalence to Predicate Device (Hamilton Thorne Zilos-tk (K050768))	Substantially equivalent based on multiple factors.
Pulse energies delivered	Comparable to the predicate device.
Hole size creation in embryo zona pellucida	Creates similarly sized holes to the predicate device.
Safety for use on human embryos	Clinical trials show the system is safe for use on human embryos when operated in the prescribed manner.
Method of operation	Operated in a similar way by the user compared to the predicate device.
Co-alignment of target and ablated hole (Non-clinical)	Within 1 µm (comparable to the predicate).
Laser Wavelength	Equivalent
Laser Power	Equivalent
Pulse time range	Equivalent
Laser classification	Equivalent
Number of preset pulse times	Equivalent
Presets user definable	Equivalent
Pilot laser for alignment checking	Equivalent
Pilot laser power	Equivalent
Pilot laser classification	Equivalent
Custom objective to focus infrared parfocal to visible	Equivalent
Objective magnification	Equivalent
Objective Numerical Aperture	Equivalent
Computer generated target	Equivalent
Hole size indicator	Equivalent
Still image recording	Equivalent
Video image recording	Equivalent
Measurement tools	Equivalent
Report generation	Equivalent

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission references a clinical study for the general safety of laser drilling but doesn't detail a specific "test set" for the Saturn 3 Laser System in terms of sample size or provenance. The non-clinical testing refers to measurements, not a patient-based test set.

Clinical Testing Sample Size: Not specified for a study specifically testing the Saturn 3 Laser System. The reference is to a published paper showing the safety of laser use on human embryos, implying it's not a de novo study for this specific device in this submission.
Data Provenance (Clinical): "Reproductive BioMedicine Online 2005 Vol. 11, No. 6. 697-710" refers to a published scientific article, suggesting a peer-reviewed study. The text doesn't specify if it was retrospective or prospective or the country of origin of the data from that specific paper.
Non-clinical Testing Sample Size: Not applicable in terms of patients; measurements of laser power, pulse length, and co-alignment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The clinical evidence cited is a published study on the effects of zona drilling, not a diagnostic device requiring expert consensus for ground truth on a test set. Non-clinical data involves objective measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no described test set requiring expert adjudication for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Saturn 3 Laser System is an active laser device for assisted reproduction, not a diagnostic device involving "human readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device with human operation, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the safety assertion: The clinical study referenced implies outcomes data related to "development of human biopsied embryos as revealed by blastomere viability, cytoskeletal analysis and molecular cytogenetics" in comparing different zona drilling methods. This serves as the "truth" for the safety claim.
For the technical characteristics: Objective physical measurements (e.g., laser power, pulse length, co-alignment accuracy) and feature comparison against the predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary

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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.

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

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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)]

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.

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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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

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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 (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

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4. Indications for Use Statement Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

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.

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Regulation Number and Section

§ 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.