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 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.

AI/ML Overview

The provided document K062406 describes a 510(k) premarket notification for "Aesculap Neuro Patties" (Neurosorb Premium). This device is a neurosurgical paddie, and the submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies against specific acceptance criteria.

Therefore, many of the requested categories (e.g., acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable or not explicitly detailed in this type of submission.

Here's an analysis based on the provided text, acknowledging the limitations for a 510(k) submission for a cottonoid paddie:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance
Material Composition	Manufactured from viscose fibers.
Shapes and Sizes	Offered in similar shapes and sizes as the predicate device.
Indications for Use	Intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures. This is identical to the predicate device K031008.
Sterility	Provided sterile or non-sterile (for kit packager).
Single Use Only	Designed for single use only.
Non-Resterilizable	Should not be resterilized.
Suture String	All patties have a suture string attached for ease in count verification.
X-ray Detectable Markers	Available with x-ray detectable markers if desired.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable or not specified. This submission is for establishing substantial equivalence for a Class II medical device (Neurosurgical paddie) based on comparison to a predicate device, rather than a clinical performance study with a test set.
Data Provenance: Not applicable. Performance data from a clinical test set is not explicitly provided or referenced as the basis for this 510(k) clearance. The provenance of the predicate device (Aesculap Neuro Patties K031008) is that it was legally marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth establishment is described in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (neurosurgical paddie), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance improvement are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of 510(k) submission, the "ground truth" is primarily based on the equivalence to the legally marketed predicate device and compliance with general controls and recognized safety/performance attributes for such devices (e.g., material biocompatibility, sterility, absorption capacity, which would have been established during the development and clearance of the predicate).
- The "study" that proves the device meets (implicit) acceptance criteria is the comparison to the predicate device. The claim is that 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."

8. The sample size for the training set

Not applicable. No training set is described for this device.

9. How the ground truth for the training set was established

Not applicable. No training set or associated ground truth establishment is described.

Summary of the "Study" for this K062406 Submission:

The provided document describes a substantial equivalence claim rather than a "study" in the typical sense of a clinical trial or performance evaluation. The "study" that proves the device meets the (implied) acceptance criteria is the comparison to the predicate device, Aesculap Neuro Patties (K031008).

The basis for this substantial equivalence is stated as:

The material (viscose) is the same as the predicate.
The shapes and sizes will be similar to the predicate.
The indications for use are identical to the predicate: "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."

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the fundamental technological characteristics and indications for use with a previously cleared device, implying similar safety and effectiveness. No new clinical performance or efficacy studies are detailed in this 510(k) summary because the device is a simple, well-understood product type with a clear predicate.

Summary

{0}------------------------------------------------

K062406

Page 1/

ulap Neuro Patties
(Neurosorb Premium)

SEP 1 5 2006

в. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY:	Aesculap ®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Lisa M. Boyle, Regulatory Specialist800-258-1946 (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

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

Regulation Number and Section

§ 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).