(249 days)
Integuseal Microbial Sealant
Not Found
No
The summary describes a chemical sealant and its performance in reducing microbial contamination, with no mention of AI or ML technologies.
No
The device is described as a microbial sealant used to reduce the risk of skin flora contamination during surgery; it is a prophylactic device, not a therapeutic one.
No
The device is a microbial sealant used to reduce contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a "film forming, cyanoacrylate based microbial sealant provided in a ready to use applicator," which are physical components, not software.
Based on the provided information, the Flora Seal™ Microbial Sealant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to be applied to the skin prior to a surgical incision to reduce the risk of skin flora contamination during a surgical procedure. This is a direct application to the patient's body for a therapeutic/preventative purpose related to the surgical process.
- Device Description: It's a film-forming sealant applied topically.
- Mechanism of Action: It works by creating a physical barrier on the skin to immobilize bacteria.
- Testing: The clinical testing involves applying the product to the skin of volunteer subjects and evaluating its effect on the in situ bacterial flora.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Flora Seal™ does not involve the analysis of such specimens.
Therefore, Flora Seal™ is a medical device intended for topical application to the skin, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (specifically the right inguinal region for clinical testing)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The clinical test included volunteer subjects who participated in a washout period of 14 days prior to the evaluation for stabilization of skin bacterial flora. The test site was the right inguinal region where FloraSeal and Povidone - Iodine were applied and evaluated for indigenous bacterial immobilization at 15 minutes, 4 and 24 hours.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
The clinical test included volunteer subjects. The treatments reduced microbial colonization by 99.9% within 15 minutes of application and maintained this reduction for 24 hours.
Bench Tests:
Bench test were preformed with Integuseal as control and showed FloraSeal to provide results that were equal to or better than Integuseal. These test included effect on wound closure strength, film integrity over time, flexibility properties (FloraSeal significantly better), MVTR, setting time, surface coverage, hydrostatic pressure and water impact penetration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microbial colonization reduction: 99.9% within 15 minutes of application, maintained for 24 hours.
Predicate Device(s)
Integuseal Microbial Sealant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510 (K) SUMMARY
.
JUL 20 2009
| Submitted by: | Adhezion Biomedical LLC
One Meridian Blvd
Suite 1802
Wyomissing, PA 19610
Phone: 484-334-2929 | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard G. Jones
Sr. Vice President
Phone: 610-431-2398
Email: 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 Accessory
Product 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 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. | | |
| Indications for Use | FLORASEAL™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 skin flora
contamination throughout a surgical procedure. | FLORASEAL™ | 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 skin flora
contamination throughout a surgical procedure. |
| FLORASEAL™ | 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 skin flora
contamination throughout a surgical procedure. | | |
| Substantial Equivalence: | FloraSeal is substantially equivalent to InteguSeal. This is based on comparable dispensing application
design, same indication for use, bench, in vitro bacterial immobilization studies as well as clinical study, plus
animal 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 the
evaluation for stabilization of skin bacterial flora. The test site was the right inguinal region where FloraSeal
and Povidone - lodine were applied and evaluated for indigenous bacterial immobilization at 15 minutes, 4
and 24 hours. The treatments reduced microbial colonization by 99.9% within 15 minutes of application and
maintained this reduction for 24 hours. | | |
| Other Testing: | Bench test were preformed with Integuseal as control and showed FloraSeal to provide results that were
equal to or better than Integuseal. These test included effect on wound closure strength, film integrity over
time, flexibility properties (FloraSeal significantly better), MVTR, setting time, surface coverage, hydrostatic
pressure and water impact penetration. | | |
1
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. .
2
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.
3
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
4
Indications for Use
510(k) Number (if known): K083354
KU8554
Device Name: Flora Seal Microbial Sealant
Indications For Use:
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.
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
Page 1 of
510(k) Number. K083354