Flora Seal™ Microbial Sealant is intended for use after topical operative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of the skin flora contamination throughout a surgical procedure.

Device Description

Flora Seal Microbial Sealant is a film forming, cyanoacrylate based microbial sealant provided in a ready to use applicator. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.

AI/ML Overview

The provided text describes the FloraSeal Microbial Sealant and its substantial equivalence to the predicate device, InteguSeal. Since this is a 510(k) summary for a medical device (microbial sealant) rather than an AI/ML powered device, many of the requested categories in the prompt relate specifically to AI/ML studies and are not applicable here.

Here's an analysis based on the provided text:

FloraSeal Microbial Sealant

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Reduce microbial colonization by a significant percentage and duration.	Reduced microbial colonization by 99.9% within 15 minutes of application and maintained this reduction for 24 hours.
Performance equal or better than predicate device (Integuseal) in bench tests.	FloraSeal provided results that were equal to or better than Integuseal in tests for wound closure strength, film integrity over time, flexibility properties (FloraSeal significantly better), MVTR, setting time, surface coverage, hydrostatic pressure, and water impact penetration.

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

Sample Size: The clinical test involved "volunteer subjects." The exact number of subjects is not specified.
Data Provenance: The study was a clinical test on human subjects. The country of origin is not specified, but given the FDA 510(k) submission, it is likely that the data was generated in the US or under US regulatory standards. It was a prospective study, as subjects participated in a washout period prior to evaluation for stabilization of skin bacterial flora.

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

Not Applicable. This device is a microbial sealant, and its performance (microbial reduction) would be assessed through microbiological laboratory analysis and clinical observation, not by human experts establishing ground truth for image interpretation or similar AI/ML tasks.

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

Not Applicable. As above, this concept is not relevant for the evaluation of a microbial sealant.

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 not an AI/ML device.

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

Not Applicable. This is not an AI/ML device. The device (sealant) performs its function directly.

7. The type of ground truth used:

For microbial reduction: Microbiological assays/measurements (e.g., bacterial counts from skin samples) to quantify the reduction in microbial colonization.
For bench tests: Engineering and material science measurements for various properties like wound closure strength, film integrity, flexibility, MVTR, setting time, surface coverage, hydrostatic pressure, and water impact penetration.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant.

Summary

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K083354

510 (K) SUMMARY

JUL 20 2009

Submitted by:	Adhezion Biomedical LLCOne Meridian BlvdSuite 1802Wyomissing, PA 19610Phone: 484-334-2929
Contact Person:	Richard G. JonesSr. Vice PresidentPhone: 610-431-2398Email: rjones@adhezion.com
Date of Summary:	July 14, 2009
Device Trade Name:	FloraSeal Microbial Sealant
Common or Used Name:	Microbial Sealant
Classification Name:	Surgical Drape and Drape AccessoryProduct Code: NZP
Predicate Device:	Integuseal Microbial Sealant
Device Description:	Flora Seal Microbial Sealant is a film forming, cyanoacrylate based microbial sealant provided in a ready touse applicator. Each applicator consists of a thermoformed blister tray with a heat sealed lid with anattached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.
Indications for Use	FLORASEAL™Microbial Sealant is Intended for use after topical operative skinpreparations, with standard surgical draping, and prior to a surgicalincision. The product is used to reduce the risk of skin floracontamination throughout a surgical procedure.	FLORASEAL™	Microbial Sealant is Intended for use after topical operative skinpreparations, with standard surgical draping, and prior to a surgicalincision. The product is used to reduce the risk of skin floracontamination throughout a surgical procedure.
FLORASEAL™	Microbial Sealant is Intended for use after topical operative skinpreparations, with standard surgical draping, and prior to a surgicalincision. The product is used to reduce the risk of skin floracontamination throughout a surgical procedure.
Substantial Equivalence:	FloraSeal is substantially equivalent to InteguSeal. This is based on comparable dispensing applicationdesign, same indication for use, bench, in vitro bacterial immobilization studies as well as clinical study, plusanimal and clinical studies for both efficiency and safety including biocompatibility.The clinical test included volunteer subjects who participated in a washout period of 14 days prior to theevaluation for stabilization of skin bacterial flora. The test site was the right inguinal region where FloraSealand Povidone - lodine were applied and evaluated for indigenous bacterial immobilization at 15 minutes, 4and 24 hours. The treatments reduced microbial colonization by 99.9% within 15 minutes of application andmaintained this reduction for 24 hours.
Other Testing:	Bench test were preformed with Integuseal as control and showed FloraSeal to provide results that wereequal to or better than Integuseal. These test included effect on wound closure strength, film integrity overtime, flexibility properties (FloraSeal significantly better), MVTR, setting time, surface coverage, hydrostaticpressure and water impact penetration.

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The following criteria have been met for the releasable 510(k) Summary

. The summary includes only the information that is also covered in the body of the 510(k)
The summary does not contain any puffery or unsubstantiated labeling claims. .
. The summary does not contain any raw data, i.e., contains only summary data.
The summary does not contain any trade secret or confidential commercial information. .
The summary does not contain any patient identification information. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three talons, representing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard G. Jones Senior Vice President Regulatory Affairs, Ouality Assurance and Clinical Affairs Adhezion Biomedical LLC One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610

JUL 2 0 2009

Re: K083354

Trade/Device Name: FloraSeal Microbial Sealant Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: NZP Dated: June 18, 2009 Received: June 18, 2009

Dear Mr. Jones:

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 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. Jones

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Weston for.
Susan Runner, D.D.S., M.A.

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K083354

KU8554

Device Name: Flora Seal Microbial Sealant

Indications For Use:

Prescription Use X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Shala H. Margolis, MD

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Pouises Division of Antoch, Dental Devices

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510(k) Number. K083354

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.