(34 days)
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
The Hamilton Thorne Zona Infrared Laser Optical System [ZILOS-tkTM] 1480 nm Diode Laser for Laser Assisted Hatching [LAH].
This appears to be a 510(k) clearance letter from the FDA for a medical device called the "Zona Infrared Laser Optical System [ZILOS-tk™] 1480nm Diode Laser for Laser Assisted Hatching [LAH]".
The document does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary submitted by the manufacturer, not in the clearance letter itself.
The clearance letter primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to "indications for use" but does not detail performance criteria or study results that would demonstrate how those indications are met.
Therefore, I cannot provide the requested table and study details based on the provided text.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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 (> </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ </ > </ > </ > </ > </ > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >
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
{2}------------------------------------------------
ATTACHMENT I
| Indications for Use | |
|---|---|
| 510(K) Number: | K040045 K050768 |
| Device Name: | The Hamilton Thorne Zona Infrared Laser Optical System[ZILOS-tkTM] 1480 nm Diode Laser for Laser AssistedHatching [LAH]. |
| Indications for Use: | The Hamilton Thorne ZILOS-tk is to be used to drill asmall tangential hole in or to thin the zona pellucida of theembryo in selected in vitro fertilization (IVF) patients withotherwise poor prognosis for successful pregnancyoutcome, such as:Advanced maternal agePrior failed IVFCryopreserved embryosAbnormal 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 __
§ 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.