ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4

K050768 · Hamilton Thorne Biosciences · MRX · Apr 28, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050768
• Device Name: ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
• Applicant: Hamilton Thorne Biosciences
• Product Code: MRX · Obstetrics/Gynecology
• Decision Date: Apr 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Hamilton Thorne ZILOS-tk 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 Story

The ZILOS-tk is a 1480nm diode laser system used for laser-assisted hatching (LAH) of embryos during in vitro fertilization. The device operates by delivering precise laser energy to the zona pellucida of an embryo to create a small hole or thinning, facilitating the hatching process. It is intended for use by trained embryologists in a clinical laboratory setting. The system integrates with an optical microscope, allowing the operator to visualize the embryo and target the zona pellucida accurately. By assisting the hatching process, the device aims to improve implantation rates in patients with poor prognosis. The output is a physical modification of the embryo's outer layer, performed under direct visual guidance by the clinician.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

1480nm diode laser system; optical microscope integration; laser-assisted hatching mechanism; standalone system for laboratory use.

Indications for Use

Indicated for IVF patients with poor prognosis for pregnancy, including advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida morphology.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Hamilton Thorne Zona Infrared Laser Optical System (K040045)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2005

Mr. Diarmaid H. Douglas-Hamilton Senior Vice President, Research & Development Hamilton Thorne Biosciences, Inc. 100 Cummings Center, Suite 465E BEVERLY MA 01915-6143

Re: K050768 Trade/Device Name: Zona Infrared Laser Optical System [ZILOS-tk™] 1480nm Diode Laser for Laser Assisted Hatching [LAH] Regulation Number: 21 CFR 884.6200 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MRX Dated: March 24, 2005 Received: March 29, 2005

Dear Mr. Douglas-Hamilton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 710(ts) promanted interest in the indications for use fated in above and have determined the devices marketed in interstate commerce prior to the enclosure) to legally marketed products as a sendments, or to devices that have been May 26, 1978, the ellacincine and of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act) that reclassified in accordance with the provisions of application (PMA). You may, therefore, market the comprisions of the do not require approval on a premaince approvisions of the Act. The general controls provisions of the Act. device, subject to the general controls provisions 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 (Prematket if your device is classified (see above) into valso regulations affecting your offecting your and time your Approval), it may be subject to sach adultions, Title 21, Parts 800 to 898. In addition, FDA device can be nound in the code of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised had I DA s Issuallo of a sace as a sace as a securements of the Act or any
FDA has made a determination that your device complies with other requirements wi FDA has made a delemination that your dovice other Federal agencies. You must comply with all the Federal statues and regulations administer of stration and listing (21 CFR Patt 807); abeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801), good manufacturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the may and conference for the tisk against of your device to a legal This letter will allow you to begin haketing your artice of your device of your device to a legally premarket notification. The FDA Inding of Subscannal of 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), piecase If you desire specific advice for your device on our labeling organisal (
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 Also, please note the regulation entitled, "Misoruanante of our responsibilities under the Act from the (80 807.97). You may obtain other general miornation on your copy.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) DIVISION of Binal) 443-6597 or at its Internet address 056-2041 or (></ref> </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ > </ > </ > </ > </ > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >

Sincerely yours,

Nancy C. Hogdon

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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## ATTACHMENT I

| Indications for Use | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number: | K040045 K050768 |
| Device Name: | The Hamilton Thorne Zona Infrared Laser Optical System<br>[ZILOS-tkTM] 1480 nm Diode Laser for Laser Assisted<br>Hatching [LAH]. |
| Indications for Use: | The Hamilton Thorne ZILOS-tk is to be used to drill a<br>small tangential hole in or to thin the zona pellucida of the<br>embryo in selected <i>in vitro</i> fertilization (IVF) patients with<br>otherwise poor prognosis for successful pregnancy<br>outcome, such as:<br>Advanced maternal age<br>Prior failed IVF<br>Cryopreserved embryos<br>Abnormal zona pellucida morphology |

please do not write below this line – continue on another page if needed

## Concurrence of CDRH. Office of Device Evaluation

Nancy C. Boynton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 05 510(k) Number _

t Prescription Use

OR

Over-The-Counter Use __