(39 days)
Not Found
No
The device description focuses on the physical properties and materials of the surgical patties, with no mention of AI or ML capabilities.
No.
The device is described as a fluid absorption pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding, rather than to treat or cure a disease or condition.
No
Explanation: The device is a surgical fluid absorption pad intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding. Its function is to assist in surgical procedures, not to diagnose medical conditions.
No
The device description clearly states the device is a physical, material-based product (rectangular fluid absorption pads made of natural woven cotton fiber) and does not mention any software components.
Based on the provided information, Aesculap's Neuro Patties are not an In Vitro Diagnostic (IVD) device.
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 in vivo (within the body) during surgery for physical functions (protection, absorption, hemostasis).
- Device Description: The description details a physical pad made of cotton fiber for absorbing fluids and controlling bleeding. This aligns with a surgical accessory used directly on tissue.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Neuro Patties does not involve any such testing or analysis of specimens.
Therefore, the Neuro Patties are a surgical device used during procedures, not an IVD.
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
84 HBA
Device Description
Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions, with widths from 4mm to 70mm and lengths from 6mm to 150mm. The material used for the patties is natural woven cotton fiber, this material is available in either a tight weave (neurosorb 4 or 6) or a more open gauze-like weave (neurosorb 75). The neurosorb 4 material consists of 4 layers while neurosorb 6 is constructed with 6 layers, the layers provide different levels of absorbency for surgeon preference. All pattles 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 for 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
nervous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Codman Surgical Pattie (K880402), Pacific Surgical Patties (K993019)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull, Sr. Requlatory Affairs Associate
800-258-1946 (phone)
610-791-6882 (fax)
matt.hull@aesculap.com (email) |
| TRADE NAME: | Aesculap Neuro Patties |
| COMMON NAME: | Cottonoid Paddie |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | 84 HBA |
| REGULATION: | 882.4700 |
| REVIEW PANEL: | Neurology |
INTENDED 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.
DEVICE DESCRIPTION
Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions, with widths from 4mm to 70mm and lengths from 6mm to 150mm. The material used for the patties is natural woven cotton fiber, this material is available in either a tight weave (neurosorb 4 or 6) or a more open gauze-like weave (neurosorb 75). The neurosorb 4 material consists of 4 layers while neurosorb 6 is constructed with 6 layers, the layers provide different levels of absorbency for surgeon preference. All pattles 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 for single use only and should not be resterilized.
PURPOSE FOR SUBMISSION
The purpose for this submission is to gain marketing clearance for the Aesculap Neuro Patties.
PERFORMANCE STANDARDS
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
The Aesculap Neuro Patties described in this premarket notification are substantially equivalent to these predicate devices:
is
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal 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, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
Aesculap, Inc. c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K031008
Trade/Device Name: Neuro Patties Regulation Number: 21 CFR 882.4700 Regulation Name: Cottonoid Patties Regulatory Class: II Product Code: HBA Dated: April 22, 2003 Received: April 24, 2003
Dear Mr. Preiss:
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. Iisting 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 - Mr. Stefan Preiss
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 (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification
Aesculap Neuro Patties Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
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.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO31008
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or Over-the-Counter Use
(per 21 CFR 801.109)
(Optional Format 3-10-98)