(224 days)
The device is intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding.
Not Found
This looks like a 510(k) clearance letter from the FDA for a medical device called "Medline Neuro Sponge". This document is an approval letter, not a scientific study report or clinical trial summary.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies.
Here's why and what kind of information is present:
- 510(k) Clearance: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on demonstrating equivalence to an existing device, rather than proving novel performance against specific acceptance criteria through a new study.
- Content of this Document:
- It confirms that the FDA has reviewed the 510(k) premarket notification (K140369) for the "Medline Neuro Sponge".
- It states that the device is "substantially equivalent" to legally marketed predicate devices.
- It outlines the regulatory classification (Class II, Product Code: HBA) and regulation number (21 CFR 882.4700 - Neurosurgical Paddle).
- It lists the general controls provisions of the Act that apply to the device.
- It includes the "Indications for Use" for the device, which state it is "intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding."
To answer your prompt, you would need a different type of document, such as:
- A clinical study report.
- A summary of safety and effectiveness data (such as an SSED for a PMA device, though this is a 510(k)).
- A scientific publication describing the device's performance.
Since none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, training set details) is present in this FDA clearance letter, I cannot populate your table or answer your specific questions based on this input.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The profiles are simple and abstract, and the overall design is clean and professional.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medline Industries, Inc. Mr. Matt Clausen One Medline Place Mundelein, IL 60060-4486
Re: K140369
Trade/Device Name: Medline Neuro Sponge Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical Paddie Regulatory Class: Class II Product Code: HBA Dated: August 8, 2014 Received: August 25, 2014
Dear Mr. Clausen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
September 26, 2014
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena-S
Carlos L. Peña, Ph.D. M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140369
Device Name Medline Neuro Sponge
Indications for Use (Describe)
The device is intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).