(353 days)
Integuseal Microbial Sealant is intended for use after typical preoperative 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.
INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based product provided in a ready-to-use applicator. The Sealant is intended to be applied on the skin over commonly used surgical skin preparation products with standard surgical draping prior to a surgical incision. Upon polymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteria and thereby reducing the risk of skin flora contamination throughout a surgical procedure.
The provided text describes the INTEGUSEAL Microbial Sealant, a device intended to reduce the risk of skin flora contamination during surgical procedures. The submission details a summary of the device, its intended use, and substantial equivalence to a predicate device, as well as the testing conducted.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state numerical or specific performance acceptance criteria in a table format. However, it indicates the device was tested to demonstrate "substantial equivalence" to the predicate device, ACTI-Gard Antimicrobial Film, based on its ability to reduce the risk of skin flora contamination.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reduce risk of skin flora contamination throughout a surgical procedure when used after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. | Achieved through "in vitro microbial and other barrier testing as well as in vivo surgical incision microbial contamination testing," demonstrating substantial equivalence to the predicate device (ACTI-Gard Antimicrobial Film) for this intended purpose. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in vivo surgical incision microbial contamination testing" as part of the substantial equivalence testing. However, it does not specify the sample size used for this test set nor the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily laboratory-based (in vitro) and clinical performance-based (in vivo microbial contamination) rather than subjective expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method. It describes testing and comparison to a predicate device, not a process involving multiple human evaluators making judgments that would require adjudication.
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
The device is a "Microbial Sealant," a physical product, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance would not be applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical product, not an algorithm. Therefore, a standalone (algorithm only) performance study would not be applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "in vivo surgical incision microbial contamination testing" would likely involve microbiological culture results quantifying the presence and levels of skin flora contamination, possibly compared to a control or the predicate device. This is a direct measurement of the biological outcome the device is designed to affect.
8. The sample size for the training set
The device is a physical product and does not involve machine learning or AI. Therefore, there is no training set in the context of AI/ML models.
9. How the ground truth for the training set was established
As there is no training set for this device, this question is not applicable.
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PREMARKET NOTIFICATION (510(K)) SUMMARY
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SEP 2 9 2006
| Submitted by: | Kimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076 USATel: 770-587-8000 |
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| Contact Person: | Tierney Norsted Ph.D., M.P.H.Exec Vice President, Principal AdvisorRegulatory & Clinical Research Institute, Inc.5353 Wayzata Blvd., Suite 505Minneapolis, Minnesota 55416952-746-8021tnorsted@rcri-inc.com |
| Date of Summary: | September 14, 2006 |
| Device Trade Name: | INTEGUSEAL Microbial Sealant |
| Common or Usual Name: | Surgical Drape Accessory |
| Classification Name: | 878.4370 Surgical Drape Accessory |
| Predicate Device(s): | Medical Development Concepts ACTI-Gard Antimicrobial Film (K000442) |
| Device Description: | INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-basedproduct provided in a ready-to-use applicator. The Sealant is intended tobe applied on the skin over commonly used surgical skin preparationproducts with standard surgical draping prior to a surgical incision. Uponpolymerization, INTEGUSEAL bonds to the skin, immobilizing the bacteriaand thereby reducing the risk of skin flora contamination throughout asurgical procedure. |
| Indication for Use: | INTEGUSEAL Microbial Sealant is intended for use after typicalpreoperative skin preparations, with standard surgical draping, and priorto a surgical incision. The product is used to reduce the risk of skin floracontamination throughout a surgical procedure. |
| Substantial Equivalence: | INTEGUSEAL is substantially equivalent to Medical ConceptsDevelopment ACTI-Gard Antimicrobial Film. Both products are placed onthe skin following the application of standard surgical skin preparationproducts and prior to surgical incision and are intended to reduce the riskof skin flora contamination throughout a surgical procedure. |
| Substantial EquivalenceTesting Summary: | Testing demonstrating the substantial equivalence of INTEGUSEAL toACTI-Gard included in vitro microbial and other barrier testing as well asin vivo surgical incision microbial contamination testing. |
| Other Testing Summary: | Significant testing was performed to demonstrate that INTEGUSEAL iscompatible with various surgical circumstances, including: |
| • | Is compatible with standard skin preparation products and with incise drapes |
| • | Is compatible with various surgical materials, tools and techniques, including electro-surgical and defibrillation procedures |
| • | Is compatible with various incisional closure techniques and products, including wound closure adhesion strips |
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*Registered Trademark of Kimberly-Clark Worldwide, Inc. or its affiliates. ©2005 KCWW. All rights reserved. 190061-00.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting community and connection. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2006
Medlogic Global, Limited C/O Dr. Tierney Norsted Executive Vice-President Regulatory & Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334
Re: K052870
Trade/Device Name: Integuseal Microbial Sealant Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: NZP Dated: August 3, 2006 Received: August 4, 2006
Dear Dr. Norsted:
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 cither 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.
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Page 2 – Dr. Norsted
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.
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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely yours,
Clus
Chiu Lin, Ph.D. 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
K052870 510(k) Number:
Integuseal Microbial Sealant Device Name:
Integuseal Microbial Sealant is intended for use after Indications For Use: typical preoperative 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ × (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)
Shila F. Murphy, MD 9/24/06
Jn-Off) on of Anesthesiology, General Hospital, ാന Control, Dental Devices
Page 1 of 1
Number: K 052870
§ 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.