The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The Delicot product line is made from lyocell, a manmade fiber derived from cellulose, better known under the brand name of Tencel - a type of rayon; it is supplied in various lengths and widths and has been marketed since 1990. The Delicot product line is one of three rayon-based sponges. The Delicot sponges are manufactured using Dupont Style 8623 consisting of 100% lyocell. Dupont has discontinued the manufacture of Style 8623. Dupont Style 8471 consisting of 58% polyester and 42% lyocell is our proposed replacement.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Delicot Neurosurgical Sponge) seeking substantial equivalence to a predicate device. It does not describe a study proving the device meets specific acceptance criteria in the way a diagnostic AI device or a device with measurable performance metrics would. Instead, the submission focuses on demonstrating equivalence through material and process changes.

Therefore, many of the requested categories are not applicable to this type of submission.

Here's an analysis based on the provided text:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria:

The core "acceptance criteria" in this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device. The study to prove this involves comparing the modified device (using a new material) to the predicate device across various aspects.

The specific "acceptance criteria" are implied by the points of comparison for substantial equivalence:

Same indications for use and intended use.
Same principle of operation.
Same basic design.
Equivalent materials.
Same shelf life.
Packaged and sterilized using the same materials and processes.

The study conducted to prove this focused on Biocompatibility Testing and Comparability Testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (from submission)
Biocompatibility: Lack of toxicity	"The results of the study demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge." (Cytotoxicity testing completed per ISO-10993 and GLP regulations)
Comparability (Existing vs. Modified Sponge):	"American Surgical Company conducted comparability testing on the existing Delicot sponge and the Delicot sponge with the replacement material." (Specific performance metrics or results of this comparability testing are not detailed in the provided summary, beyond the conclusion of substantial equivalence). The overarching conclusion is that the modified device "is substantially equivalent to the predicate device."
Indications for Use: Same as predicate	"have the same indications for use and intended use"
Principle of Operation: Same as predicate	"use the same principle of operation"
Basic Design: Same as predicate	"incorporate the same basic design"
Materials: Equivalent to predicate	"incorporate equivalent materials" (change from 100% lyocell to 58% polyester and 42% lyocell, supported by biocompatibility and comparability testing)
Shelf Life: Same as predicate	"have the same shelf life"
Packaging & Sterilization: Same as predicate	"are packaged and sterilized using the same materials and processes"

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: The document does not specify the sample size for the biocompatibility testing or the comparability testing.
Data Provenance: Not explicitly stated, but typically, such testing is conducted in a laboratory setting, either internally or at a contract research organization. The biocompatibility testing was conducted "in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58." This implies a systematic, controlled study. It is prospective for the device under review.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. This is not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists reading images). Biocompatibility and comparability testing relies on objective laboratory assays and measurements.

4. Adjudication Method for the Test Set:

Not applicable. There is no human interpretation or adjudication described for these materials and biocompatibility tests.

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 is a submission for a physical medical device (surgical sponge), not an AI/diagnostic software device.

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:

Biocompatibility: The "ground truth" is defined by established international standards (ISO-10993) and regulatory guidelines (FDA's Blue Book Guidance G95-1) for evaluating biological response and toxicity. The test results (e.g., cell viability in cytotoxicity assays) are compared against these predetermined thresholds for what constitutes a safe response.
Comparability: The "ground truth" for evaluating the "equivalence" of the new material for mechanical or functional properties (which are not detailed in this summary but would be part of a comparability study) would be the performance characteristics of the predicate device. The new device's performance would need to fall within an acceptable range of the predicate's performance.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not a machine learning or AI device.

Summary

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12/822

510(k) Summary SEP 1 0 2012 510(K) Owner: American Surgical Company, LLC (formerly American Surgical Sponges, LLC and American Silk Sutures Inc.) 82 Sanderson Avenue Lynn, MA 01902 781-592-7200 Owner/Operator Number: 10030544 Submitter: Cheryl Marotta American Surgical Company 82 Sanderson Avenue Lynn, MA 01902 Telephone: 781-592-7200 Email: cheryl.marotta@americansurgical.com Contact: Erik Piasio Managing Director Tel: 781-592-7200 Fax: 781-595-5460 Email: erik.piasio@americansurgical.com Manufacturer: American Surgical Company, LLC 82 Sanderson Avenue, Suite 212 Lynn, MA 01902 781-592-7200 Registration Number: 1221144 Date Prepared: 8 June 2012 Delicot Surgical Sponge Trade name: Common name: Neurosurgical Paddie or Sponge Classification name: 21 CFR § 882.4700 Product Code(s): HBA (neurosurgical paddie) Classification: Class II Current Legally Marketed Device: Ray-Cot, Uniqcot and Delicot Neurosurgical Sponges K902921

American Surgical Company Special 1 510(k)

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X121822

Policot Neurosurgical Sponge K862494

Summarv Description of the Device:

Intended Use:

The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Indications for Use:

The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Substantial Equivalence:

The modified Delicot Neurosurgical Sponges are equivalent to the previously cleared 510(k) (K902921 Sept. 18, 1990 and K862494 July 30, 1986) as these devices:

have the same indications for use and intended use, ●
use the same principle of operation. .
. incorporate the same basic design,
. incorporate equivalent materials,
. have the same shelf life, and
. are packaged and sterilized using the same materials and processes.

In summary, the modification to the Delicot Neurosurgical Sponges described in this submission is substantially equivalent to the predicate device.

Biocompatibility Testing:

American Surgical Company Special 2 510(k)

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Biocompatibility testing included Cytotoxicity and was completed in accordance with FDA's Blue Book Guidance G95-1 ("Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' "). The results of the study demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge. The study was conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58.

Performance Standards:

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, American Surgical Company conducted comparability testing on the existing Delicot sponge and the Delicot sponge with the replacement material.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

American Surgical Company, LLC c/o Mr. Erik Piasio 82 Sanderson Avenue Lynn, MA 01902

SEP 10 2012

Re: K121822

Trade/Device Name: Delicot Surgical Sponge Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical Paddie Regulatory Class: Class II Product Code: HBA Dated: August 13, 2012 Received: August 16, 2012

Dear Mr. Piasio:

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.

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Page 2 - Mr. Erik Piasio

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.0 Indications for Use

510(k) Number (if known): K121822

Device Name:

Delicot Neurosurgical Sponge

Indications for Use: The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Prescription Use V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
American Surgical Company	1-1	V171822

. American Surgical Company Special 510(k)

510(k) Number.

KIZ|822

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).