SATURN ACTIVE LASER SYSTEM

• K Number: K083208
• Device Name: SATURN ACTIVE LASER SYSTEM
• Manufacturer: RESEARCH INSTRUMENTS LTD.
• Date Cleared: 2009-08-25 ( 298 days)
• Product Code: MRX
• Regulation Number: 884.6200
• Type: Abbreviated
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: K060764
• Predicate For: K141434

Intended Use

Saturn Active is a 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 Active Laser System is a device that images, targets, and controls the power and pulse duration of a laser beam to ablate a small tangential hole in, or thin, the Zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Saturn Active Laser System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data to define and meet specific acceptance criteria in the way a novel device might.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

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

The document does not explicitly state "acceptance criteria" for the Saturn Active Laser System in a quantitative, measurable sense against specific performance metrics that a clinical trial would typically establish for a new device. Instead, it aims to demonstrate that its performance is "comparable to the predicate."

Acceptance Criteria (Implied)	Reported Device Performance
Laser power delivery comparable to predicate	"delivers pulse energies comparable to the predicate."
Co-alignment of target and ablated hole within a specific tolerance	"co-alignment... is within 1um, this is also comparable to the predicate."
Creates same sized holes in embryo zona pellucida	"create the same sized holes in the embryo zona pellucida."
Operates in a similar way to the predicate	"operated in a similar way by the user."
Substantial equivalence to predicate device	Concluded to be substantially equivalent based on shared components, similar pulse energies, hole sizes, and operation.

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

The document explicitly states: "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 co-alignment of the target and the ablated hole is within 1um, this is also comparable to the predicate."

• Sample size for the test set: Not specified for the non-clinical testing. It refers to "measurement of laser power and pulse lengths" and "alignment procedure" which implies laboratory testing, but no specific number of measurements or trials is given.
• Data provenance: Not explicitly stated but implies laboratory testing conducted by the manufacturer, Research Instruments Ltd., based in the United Kingdom.
• Retrospective or prospective: Not applicable as this is non-clinical testing of device characteristics rather than clinical data.

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 non-clinical testing described involves direct physical measurements of laser parameters (power, pulse length, co-alignment) rather than human interpretation or expert-established ground truth.

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

Not applicable, as there is no human interpretation or adjudication described for the non-clinical tests.

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. This device is a laser system for assisted reproduction, not an AI-powered diagnostic imaging tool that would typically involve human readers or MRMC studies.

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

The device itself is a standalone laser system. The "non-clinical testing" can be considered performance evaluation of the device in a standalone capacity (i.e., the laser system's output characteristics). The document focuses on demonstrating that the device's performance characteristics (laser energy, alignment accuracy, hole size) are comparable to its predicate.

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

For the non-clinical testing: The "ground truth" is intrinsically defined by the physical measurements themselves against established benchmarks of the predicate device's performance. For example, a power meter reading for laser energy, or a microscopic measurement for alignment and hole size.

8. The sample size for the training set

Not applicable. This is a medical device approval based on substantial equivalence to an existing predicate, not an AI/ML device that requires a training set.

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

Not applicable. No training set is mentioned in the context of this device.

Summary of Device and Approval Context:

The "Saturn Active Laser System" is being submitted for 510(k) clearance based on substantial equivalence to an existing device, the "Research Instruments Ltd. Saturn 3 Laser System." The primary claims for equivalence are based on:

• Shared components (control unit, laser sources, fiber optics, lenses, mirrors, objective).
• Similar intended use.
• Comparable technological characteristics (laser wavelength, power, pulse time, classification, objective magnification, etc.).
• The only significant difference is the addition of a motorized beam steering module in the Saturn Active.

The study that demonstrates the device meets the (implied) acceptance criteria is non-clinical testing. This testing confirmed:

• Measurement of laser power and pulse lengths shows the Saturn Active "delivers pulse energies comparable to the predicate."
• Co-alignment of the target and ablated hole is "within 1um," which is also "comparable to the predicate."
• Through these equivalent characteristics, the system is expected to "create the same sized holes in the embryo zona pellucida."
• The additional components and software were also "validated by non-clinical testing."

No clinical trials were performed with this specific device as it leverages the established safety and efficacy of its predicate through the substantial equivalence pathway.

Summary

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Image /page/0/Picture/1 description: The image shows a logo with the letters 'RI' in a stylized font. The letters are large and bold, with a slightly distressed texture. A curved line runs beneath the letters, adding a sense of movement or flow to the design. The overall impression is classic and elegant.

Bickland Industrial Park, Falmouth, Cornwall, ' Tel: [phone] [International [phone] Fax: [phone] [International [phone] e-mail: [e-mail] Website: http://www.research-instruments.com/

5. 510(k) Summary

struments.com
h-instruments.com/
XC083208.

AUG 2 5 2009

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

October 22nd, 2008

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

Company Name: Research Instruments Ltd. Registration Number: 9617095 Address: Bickland Water Industrial Park Falmouth, Cornwall TR11 4TA United Kingdom Telephone: [phone] [phone] Fax: Contact person: David Lansdowne Contact Title: Technical Director Contact email: [e-mail]

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

Trade Name: Saturn Active Laser System Common Name: Assisted Reproduction Laser System Device Class: 11 Regulation Number: 21CFR884.6200 Product code: MRX

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

Substantial Equivalence to Research Instruments Ltd. Saturn 3 Laser System Predicate 510(k) No. K060764

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

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

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

The Saturn Active 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.

Company Registered in England, Number: 341 9143 Registered Address: Bickland Industrial Park. Falmouth, Cornwall TR11 4TA VAT Number: 750 4247 49

Page_1_of_1

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Image /page/1/Picture/1 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 the bold font and curved line give it a distinctive and memorable appearance. The letters and line are solid black against a white background.

Bickland Industrial Park, Falmouth, Cornwall, TR11 4 Tel: [phone] [International [phone]] Fax: [phone] [International [phone]] e-mail: [e-mail] Website: http://www.research-instruments.com/

Technological Characteristics [21CFR807.92(a)(5]

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 Objective Numerical Aperture Computer generated target Hole size indicator Still image recording Video image recording Measurement tools Report generation

Features Compared and not found equivalent

Motor module to position laser

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 co-alignment of the target and the ablated hole is within 1um, this is also comparable to the predicate.

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

To our knowledge no clinical trials have been performed with Saturn Active.

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

The Research Instruments Saturn Active Laser System is substantially equivalent to the Research-Instruments Saturn 3 Laser System based on the following:

The two systems share the majority of components. The control unit, laser sources, fibre optics, collimation lens, dichroic mirror and objective are the same. The only significant difference between the two systems is the addition of a motorised beam steering module in Saturn Active.

Company Registered in England, Number: 341 9143 Registered Address: Bickland Industrial Park, Falmouth, Cornwall TR11 4TA VAT Number: 750 4247 49

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows a logo with the letters 'RJ' in a stylized, bold font. A curved line underlines the letters, adding a decorative element to the design. The logo is presented in black against a white background, creating a high contrast and making the letters stand out.

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

The pulse energies delivered by the two systems are the same, and create the same sized holes in the embryo zona pellucida.

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

The additional components and software have been validated by non-clinical testing.

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

Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three curved lines representing the wings and a stylized base. The image is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. David Lansdowne Technical Director Research Instruments Limited Bickland Industrial Park Falmouth, Cornwall TR114TA UNITED KINGDOM

AUG 2 5 2009

Re: K083208

Trade/Device Name: Saturn Active Laser System Regulation Number: 21 CFR §884.6200 Regulation Name: Assisted reproduction laser system Regulatory Class: II Product Code: MRX Dated: August 10, 2009 Received: August 12, 2009

Dear Mr. Lansdowne:

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 (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Samur M. Mouk

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/1 description: The image shows a logo with the letters "RJ" in a stylized, bold font. A curved line underlines the letters, adding a sense of elegance or emphasis to the design. The overall impression is one of a classic or established brand identity.

Bickland Industrial Park, Falmouth, Cornwall, TR11 4T/ Tel: [phone] {International [phone]] Fax: [phone] {International [phone]] e-mail: [e-mail] Website: http://www.research-instruments.com/

4 Indications for Use

083208 510(k) Number (if known):

Device Name: Saturn Active Laser System

Indications for Use:

Saturn Active is a 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 YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use NO (Part 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aon Khan

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

Page 1 of 1

Registered Address: Bickland Industrial Park, Falmouth, Comwall TR11 4TA VAT Number: 750 4247 49

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.