Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Device Description

The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight.

The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences.

These devices are intended for one-time use and will be marked sterile.

These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.

AI/ML Overview

The Sunlight Medical, Inc. Biopsy Pipettes (Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes) underwent a 510(k) submission (K092554) to demonstrate substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria in the traditional sense. The equivalence was established based on similarities in indications for use, materials, physical construction, manufacturing processes, and quality controls.

Here's an analysis based on the provided document:

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

The submission does not specify "acceptance criteria" for clinical performance as would be seen in a diagnostic accuracy study. Instead, the "acceptance specifications" refer to quality control tests performed on the manufactured devices. The primary "performance" reported is related to the equivalence to the predicate device and the results of these quality control tests.

Acceptance Criteria (Quality Control)	Reported Device Performance
Mouse Embryo Toxicity Test: ≥80% of 2-cell mouse embryos to blastocysts	Meets the acceptance specification (implied, as it's part of Quality Assurance Program)
Endotoxin Test: ≤ 0.5 EU/device	Meets the acceptance specification (implied, as it's part of Quality Assurance Program)
Material: Borosilicate glass	Borosilicate glass (same as predicate)
Tip features (Beveling, Angulations, Fire Polished, Bended)	Similar to predicate, with variations in inner diameter for Blastomere and potential spike for Polar Body
Inner Diameter (Blastomere Biopsy Pipettes)	18-42 um (Predicate: 28-42 um) - noted as a bigger variation
Inner Diameter (Polar Body Biopsy Pipettes)	13-15 um (Same as predicate)
Sterility	One-time use, marked sterile

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

There is no test set of clinical images or cases described for evaluating device performance in a clinical setting. The "test set" for the quality control criteria would be a sample of manufactured pipettes, but the number of devices tested is not specified. The provenance of the data for these quality control tests (Mouse Embryo Toxicity and Endotoxin) is from the manufacturer's internal "Quality Assurance Program".

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)

This is not applicable as there was no test set requiring expert ground truth for clinical performance evaluation.

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

This is not applicable as there was no test set requiring adjudication for clinical performance evaluation.

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

This is not applicable. The device is a surgical tool (pipette) and not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. The device is a physical tool, not an algorithm.

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

The "ground truth" for the quality control tests is based on established biological and chemical assays:

Mouse Embryo Toxicity: The ability of 2-cell mouse embryos to develop to the blastocyst stage in the presence of the device's leachables. This is an accepted biological indicator for cytotoxicity in reproductive medical devices.
Endotoxin Test: Quantification of bacterial endotoxins, which is a standard safety measure for medical devices that may come into contact with biological systems.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of device performance in a clinical scenario or AI training, as this is a physical medical device. The "training" for the device would pertain to the manufacturing process and quality system setup, for which sample sizes are not specified in the document.

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

This is not applicable as there is no training set of clinical data. The "ground truth" for manufacturing consistency and quality is established through standard operating procedures, material specifications, and quality control methodologies (like the mouse embryo and endotoxin tests).

Summary

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Premarket Notification - Sunlight Medical, Inc - Biopsy Pipettes

510(k) SUMMARY

510(k) Number (if known): K092554

Submitter's Name: Sunlight Medical, Inc.

APR 3 0 2010

10f3

Address: 12443 San Jose Blvd, Suite 602, Jacksonville, FL 32223

Telephone #: (904) 866-7978

FAX #: (904) 886 2900

Contact person: Dunsong Yang

Date summary prepared: August 12, 2009, revised January 5, 2010

Device name:

Common / usual name: Preimplantation Genetic Diagnosis Pipettes (Biopsy Pipettes)

Proprietary names:	Blastomere Biopsy PipettesPolar Body Biopsy Pipettes
Classification name:	Class II Assisted reproduction microtools85MQH
CER Reference:	884.6130

Predicate Devices:

The Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes to be manufactured by Sunlight Medical, Inc. are substantially equivalent to the Blastomere Biopsy Micropipets and Polar Body Micropipets (510K number: K012811) manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way, Charlottesville, VA 22901-7928. Specially, the Biopsy Pipettes are similar to other pipettes manufactured by Sunlight Medical and approved under K072600. The Biopsy Pipettes vary only by size and shape of the tip as determined by their usage as do the pipettes already approved. The material, manufacture process, testing and controls are the same.

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Comparing to Humagen Blastomere Biopsy Micropipets, our Blastomere Biopsy Pipettes have a bigger variations in inner diameter (Sunlight 18-42 um vs Humagen 28-42 um). Other specifications, i.e., beveling and angulations, are the same.

Comparing to Humagen Polar Body Biopsy Micropipets, our Polar Body Biopsy Pipettes may have a spike draw on the tip. The inner diameter, beveling and angulations are the same.

Description of Device:

These devices are intended for one-time use and will be marked sterile.

Indications for Use:

These devices are to be used by professionals trained in assisted reproduction technologies (ART). Federal law restricts these devices to sale by or on the order of a physician.

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Substantial Equivalence:

These devices will be manufactured according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510K substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

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

APR 3 0 2010

Dunsong Yang, M.D. President/CEO Sunlight Medical, Inc. 12443 San Jose Blvd. Suite 602 JACKSONVILLE FL 32223

Re: K092554

Trade/Device Name: Blastomere Biopsy Pipette and Polar Body Biopsy Pipette Regulation Number: 21 CFR §884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: MOH Dated: April 12, 2010 Received: April 13, 2010

Dear Dr. Yang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related

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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/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

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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Indications For Use

510(k) Number (if known): K092554

Device name: Blastomere Biopsy Pipettes

Indications for Use:

The Blastomere Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

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

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)

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

Page 1 of _2

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Premarket Notification - Sunlight Medical, Inc - Biopsy Pipettes

Indications For Use

510(k) Number (if known): K092554

Device name: Polar Body Biopsy Pipettes

Indications for Use:

The Polar Body Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Theod L. Stole

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

Page_2_of_2

Regulation Number and Section

§ 884.6130 Assisted reproduction microtools.

(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.