(39 days)
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.
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.
The provided text is a 510(k) Premarket Notification for the Aesculap Neuro Patties, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.
Therefore, the input does not contain the information needed to fill out all the requested sections of your query. This device is a cottonoid pattie, which is a low-risk device where performance is typically assessed by material properties and comparison to existing similar devices, not through a clinical trial with performance metrics like sensitivity, specificity, etc.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit "acceptance criteria" here is substantial equivalence to the predicate devices.
- Reported Device Performance: No quantitative performance metrics (like sensitivity, specificity, F1-score, etc.) are reported. The document describes the device's physical characteristics and intended use.
| Acceptance Criteria (Implicit) | Reported Device Performance (Description) |
|---|---|
| Substantial equivalence to predicate devices (Codman Surgical Pattie K880402, Pacific Surgical Patties K993019) in terms of safety and efficacy for intended use. | Aesculap Neuro Patties are rectangular fluid absorption pads made of natural woven cotton fiber (tight weave - neurosorb 4/6, open gauze - neurosorb 75). Sizes vary from 4mm to 70mm width and 6mm to 150mm length. Available with suture string and optional x-ray detectable markers. Packaged 10 per card, single-use, not for resterilization. Intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a medical device for surgical use, not an AI/software device that undergoes testing on a "test set" of data in the typical sense. There is no mention of a test set, data provenance, or a study that uses such a set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth in the context of AI/ML evaluation is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or related adjudication process is mentioned.
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:
- No. This is a physical medical device (cottonoid patties), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. There is no "ground truth" as a reference standard for performance evaluation in the context of this type of device submission. The assessment is based on material properties, manufacturing controls, and comparison to legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth for it is mentioned.
In summary: The provided 510(k) document is for a Class II physical medical device (Aesculap Neuro Patties) and focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or studies in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, test sets, ground truth establishment, MRMC studies) because such evaluations are not typically required or relevant for this type of device.
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510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Matthew M. Hull, Sr. Requlatory Affairs Associate800-258-1946 (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:
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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.
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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
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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)
§ 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).