(105 days)
Hydrofera TM ophthalmic sponges are intended as external wicking device for use in local management of fluids during cataract surgery.
Ophthalmic Sponge
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an ophthalmic sponge and outlines regulatory information, but it does not detail any acceptance criteria, study methodologies, performance metrics, or ground truth establishment for a device.
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Food and Drug Administration 9200 Corporate Boulevard MAR - 2 1998 Rockville MD 20850
Ms. Heather S. Bond Director Polymer Technology Hydrofera LLC 322 Main Street Willimantic CT 06226
Re: K974313 Trade Name: Hydrofera Surgical Spear Regulatory Class: II Product Code: 86 HOZ Dated: December 19, 1997 Received: January 2, 1998
Dear Ms. Bond:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Heather Bond
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Raerl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K974313
Device Name: Ophthalmic Sponge
Indications For Use:
Hydrofera
TM
ophthalmic sponges are intended as
external wicking device for use in local management
of fluids during cataract surgery.
(PLEASE DO NOT WRIDE BELOW THIS LINE-COMPLINE ON AMOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
mue Chuer S
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974313
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Us
(Optional Format 1-2.96)
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.