(84 days)
The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "MicroSTAAR™ Indigo Injector Foam Tip System." This letter grants market clearance based on a finding of "substantial equivalence" to legally marketed predicate devices, not on the results of a clinical study demonstrating the device meets specific acceptance criteria in the manner that an AI/ML device would be evaluated.
Therefore, the information requested in your prompt (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this document.
This document is for a Class I medical device (intraocular lens guide) and focuses on regulatory clearance rather than a detailed performance study as would be required for a novel AI/ML diagnostic or prognostic device. The 510(k) process for this type of device typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
In summary, this document does not contain the information necessary to answer your request regarding acceptance criteria and a study proving a device meets those criteria, as it pertains to AI/ML device evaluation.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
STAAR Surgical Co. C/o Ms. Diana Smith Director of Regulatory Affairs 1911 Walker Avenue, Monrovia, CA 91016
Re: K073586
Trade Name: MicroSTAAR™ Indigo Injector Foam Tip System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: February 14, 2008 Received: February 19, 2008
Dear Ms. Smith:
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 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.
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 (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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Malvina B. Edwards, and
Malvina B. Evdelman. M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Ms. Smith
Indications for Use
510(k) Number (if known): K0703586
Device Name: MicroSTAAR™ Indigo Injector Foam Tip System
Indications For Use:
The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AZ
Division Sign-Off
(Division Sign Only,
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number K0130
Page 1 of 1
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.