(179 days)
AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery
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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the AlphaMed™ Surgical Spear, and it primarily focuses on regulatory approval and substantial equivalence to a predicate device.
The document does not contain details about:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance studies.
- Types of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory communication, not a scientific study report.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AlphaMed, Inc. c/o Mr. James M. Gubachy Vice President 3912 Mountain Avenue El Paso, TX 79930
OCT 2 8 2009
Re: K091240
Trade Name: AlphaMed™ Surgical Spear Regulation Number: 21 CFR 886.4790 Regulation Name: Ophthalmic Sponge Regulation Class: Class II Product Code: HOZ Dated: October 5, 2009 Received: October 7, 2009
Dear Mr. Gubachy:
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 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 (reporting of medical device-related 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.
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Page 2 - Mr. James M. Gubachy
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Eydelman, M.D.
Malvina B. Eydelman, I Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091240
Device Name: AlphaMed™ Surgical Spear, Model 70-5000
Indications For Use:
AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paul Vanderhyde
Division Sign-Off
Division of Ophthalmic, Neurologica Nose and Throat Devices
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510(k) Number K091240
§ 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.