(175 days)
The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Medline Surgical Sponge Scanning System. It does not contain information about acceptance criteria, study design, or device performance metrics.
Therefore, I cannot answer your request based on the provided input. The document mainly states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medline Industries, Inc. % Ms. Lara N. Simmons Corporate Director, Regulatory Affairs One Medline Place
Mundelein, Illinois 60060-4486
NOV - 2 2006
Re: K061316
Trade/Device Name: Medline Surgical Sponge Scanning System Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH Dated: August 30, 2006 Received: August 31, 2006
Dear Ms. Simmons:
We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced aboye and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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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Page 2 -- Ms. Lara N. Simmons
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N. Melkerson
Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use
Page Page 2 of
510(k) Number (if known): K061316
Device Name: Medline Surgical Sponge Scanning System
Indications for Use:
The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Pelo Htz
(Division Sign-Off) Division of General, Restorative, and Neurological Devices Page __ of
510(k) Number K06136
§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.