(29 days)
Not Found
No
The device description and intended use are for simple fluid absorption pads, and there is no mention of AI or ML in the provided text.
No.
The device is described as a fluid absorption pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding. It does not provide any therapeutic effect such as treating or diagnosing a disease, or restoring, correcting, or modifying a physiological function. Its primary function is mechanical absorption and protection.
No
The device, Aesculap's Neuro Patties, is intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding. These are therapeutic or supportive functions, not diagnostic ones. Diagnostic devices are used to identify a condition or disease, which is not the stated purpose of this device.
No
The device description clearly states it is a physical product (fluid absorption pads) made from cotton or viscose fibers, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures." This describes a device used during a surgical procedure on a patient's body, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details a physical pad used for absorption and protection during surgery. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue samples, or any other biological specimens. There is no mention of diagnostic purposes or providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.
Product codes (comma separated list FDA assigned to the subject device)
84 HBA
Device Description
Aesculap's Neuro Patties are rectanqular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions and sizes. The neuro patties are manufactured from either a cotton or viscose fibers. All patties have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are provided sterile or non-sterile (for kit packager), single use only, and should not be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Page 1/
ulap Neuro Patties
(Neurosorb Premium)
SEP 1 5 2006
в. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle, Regulatory Specialist
800-258-1946 (phone)
610-791-6882 (fax)
lisa.boyle@aesculap.com (email) |
| TRADE NAME: | Aesculap Neuro Patties |
| COMMON NAME: | Cottonoid Paddie |
| CLASSIFICATION NAME: | Neurosurgical Paddie |
| REGULATION NUMBER: | 882.4700 |
| PRODUCT CODE: | 84 HBA |
SUBSTANTIAL EQUIVALENCE
Aesculap, Inc. believes that the Neurosorb Premium Patties are substantially equivalent to:
- . Aesculap Neuro Patties (K031008)
DEVICE DESCRIPTION
Aesculap's Neuro Patties are rectanqular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions and sizes. The neuro patties are manufactured from either a cotton or viscose fibers. All patties have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are provided sterile or non-sterile (for kit packager), single use only, and should not be resterilized.
INDICATIONS FOR USE
Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.
TECHNOLOGICAL CHARACTERISTICS (compared to predicate(s)}
The Neurosorb Premium Pattie will be offered in similar in shapes and sized as the predicate devices. The Neurosorb Premium Paddie is manufactured from viscose, which is the same material as the existing predicate device.
PERFORMANCE STANDARDS
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2006
Aesculap, Inc. % Ms. Lisa M. Boyle Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K062406
Trade/Device Name: Neuro Patties Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical paddie Regulatory Class: Class II Product Code: HBA Dated: August 17, 2006 Received: August 18, 2006
Dear Ms. Boyle:
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.
2
Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your e FDA finding of substantial equivalence of your device to a legally premation for notification of 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 n you desire of Compliance at (240) 276-0115. Also, please note the regulation entitled, Contider the Office of Complete 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
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number (if known):
Kda2406
Device Name: Neuro Patties
Indication for Use:
Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.
Prescription Use X (per 21 CFR 801.109)
and/or Over-the-Counter Use (21 CFR 897 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CO # ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k)
002