The subject device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.

Device Description

The Elutia ™ Coated Closed Surgical Wound Drain is a radiopaque, single-use silicone wound drain with extension tubing for use with available drain reservoirs that include an anti-reflux valve. The drain is channeled for its entire length. It is available in round or flat configurations and in multiple sizes. A low profile connector joins the drain to clear silicone extension tubing. The drain is packaged sterile in a double pouch and is non-pyrogenic. The hydrogel coating containing silver sulfadiazine has been shown to reduce bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7 day period as tested under USP <51> conditions against the following microorganisms: S. aureus, P. aeruginosa, E. coli, and C. albicans. The clinical significance of this finding is unknown. The subject device is composed of materials that have been successfully used in medical devices including the predicate devices. The subject device is composed of medical grade silicone (indwelling catheter, connector, and external tubing). The device is coated with silver sulfadiazine. USP grade silver sulfadiazine is used. The active drug substance is chemically synthesized and does not contain any animal or cell cultures derived from products or additives such as albumin or serum. The materials used in the subject device have been subjected to and passed biocompatibility testing. Additionally, the materials have been successfully used in other medical devices including the predicate devices. The subject devices are sterile single-use devices. Sterilization was performed.

AI/ML Overview

Here's a breakdown of the requested information based on the provided 510(k) summary for the Elutia™ Coated Closed Surgical Wound Drain:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Bacterial Contamination Reduction	Reduced bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7-day period. (Tested under USP <51> conditions against S. aureus, P. aeruginosa, E. coli, and C. albicans).
Biocompatibility	Passed (per ISO 10993). Materials previously used successfully in medical devices, including predicate devices.
Pyrogenicity	Passed (per USP <29>).
Physiochemical Testing	Passed (per ISO 10993 and USP <29>).
Bubble Emission Leak Packaging Tests	Passed (per ASTM 2096-04, ISO 11607).
Package Burst Testing	Passed (per ASTM F1140-00, ISO 11607).
Accelerated Aging Studies	Passed.

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

The 510(k) summary does not explicitly state the sample size for the bacterial contamination reduction test or other performance tests (biocompatibility, packaging, etc.).

Test Set Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would typically be generated by the manufacturer during product development and testing, likely in a laboratory setting. No country of origin for the data is specified, nor is it described as retrospective or prospective clinical data. The primary test mentioned (USP <51>) is a standard in vitro microbiological method.

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

N/A. This type of information (expert consensus for ground truth) is not typically applicable or reported for a device like a surgical drain, especially for the in vitro performance tests described. The "ground truth" for the bacterial reduction test is the measurable reduction in bacterial count against controls in a laboratory setting.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. This is not relevant to the in vitro and laboratory-based performance testing described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The 510(k) summary does not mention any MRMC comparative effectiveness study. The submission focuses on substantial equivalence to predicate devices based on technological characteristics and performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a physical medical device (surgical drain), not a software algorithm or AI-based diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For the key performance claim:

Bacterial Reduction: The ground truth was established through laboratory-based microbiological assays (USP <51>) comparing the coated drain's performance against control samples or expected bacterial growth.
For other tests:
Biocompatibility, Pyrogenicity, Physiochemical: Ground truth was based on standardized test methods and associated acceptance criteria (e.g., ISO 10993, USP <29>).
Packaging Tests: Ground truth was based on standardized engineering and packaging test methods and associated acceptance criteria (e.g., ASTM 2096-04, ISO 11607, ASTM F1140-00).

8. The Sample Size for the Training Set

N/A. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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K063245 4/2

Image /page/0/Picture/1 description: The image shows the logo for Bacterin International, Inc. The logo features a stylized "B" with a series of dots and lines emanating from it, suggesting a scientific or technological theme. The text "BACTERIN" is written in bold, uppercase letters, followed by "INTERNATIONAL, INC." in a smaller font size.

510(k) Summary

Date Prepared [21 CFR 807.92(a)(1)]

November 26, 2007

Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by a Joseph Azary (Regulatory/Quality Consultant) on behalf of Bacterin International Inc.

Joseph Azary can be contacted by telephone at (203) 944-9320 or fax at (203) 944-9317. Mailing address; 543 Long Hill Avenue, Shelton, CT 06484.

Bacterin International, Inc. is located at 600 Cruiser Lane, Belgrade, MT 59714. Bacterin International, Inc. is registered with FDA under Establishment Registration #3005168462.

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade name: Elutia™ Coated Closed Surgical Wound Drain

Common/Classification Name: Drainage Catheter, Coated Drainage Catheter

Classification: Classification of this device falls under the responsibility of the Division of General and Plastic Surgery. Class II, Product Code: OEI, 21 CFR 878.4780.

Predicate Device [21 CFR 807.92(a)(3)]

The following predicate devices have been identified:

Wound Drain Comparison

. Johnson & Johnson/Ethicon J-VAC Surgical Wound Drain - K953655

The subject device is similar to the J&J J-VAC Surgical Wound Drain with regard to length, diameter, radiopacity, dot indicator, adaptor, cross section, intended use, sterility, packaging, and flow rate.

The main difference is that the Elutia™ Surgical Wound Drain has a hydrogel coating containing silver sulfadiazine.

Silver Coating

. Arrow Blue Central Venous Catheter (Silver Coated) - K900263
Bard Dialysis Catheter with BioBloc Coating K053589 .
Sil-Med Flat Suction Drain/Kit with Spi-Argent II K961295 .

The subject device is coated with silver sulfadiazine. The predicate devices are coated with silver sulfadiazine or ionic silver. The subject device is a wound drain with different dimensions and shapes compared to the Arrow and Bard catheter devices.

NOV 28 2007

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Description of the Device [21 CFR 807.92(a)(4)]

The Elutia ™ Coated Closed Surgical Wound Drain is a radiopaque, single-use silicone wound drain with extension tubing for use with available drain reservoirs that include an anti-reflux valve.

The drain is channeled for its entire length. It is available in round or flat configurations and in multiple sizes. A low profile connector joins the drain to clear silicone extension tubing. The drain is packaged sterile in a double pouch and is non-pyrogenic.

The hydrogel coating containing silver sulfadiazine has been shown to reduce bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7 day period as tested under USP <51> conditions against the following microorganisms: S. aureus, P. aeruginosa, E. coli, and C. albicans. The clinical significance of this finding is unknown.

The subject device is composed of materials that have been successfully used in medical devices including the predicate devices. The subject device is composed of medical grade silicone (indwelling catheter, connector, and external tubing). The device is coated with silver sulfadiazine.

USP grade silver sulfadiazine is used.

The active drug substance is chemically synthesized and does not contain any animal or cell cultures derived from products or additives such as albumin or serum.

The materials used in the subject device have been subjected to and passed biocompatibility testing. Additionally, the materials have been successfully used in other medical devices including the predicate devices.

The subject devices are sterile single-use devices. Sterilization was performed.

Intended Use [21 CFR 807.92(a)(5)]

The subiect device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various specialties including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic/cardiovascular, and plastic surgery.

Technological Characteristics [21 CFR 807.92(a)(6)]

The subject device is substantially equivalent to the predicate device.

Performance Data [21 CFR 807.92(b)(1)]

The subject device has becn subjected to and passed a variety of biocompatibility, pyrogen, and physiochemical testing pcr ISO 10993 and USP <29>.

The device and packaging have also been subjected to and passed other testing including Bubble Emission Leak Packaging Tests (per ASTM 2096-04, ISO 11607), Package Burst Testing (per ASTM F1140-00, ISO 11607), and Accelerated Aging Studies.

Conclusion [21 CFR 807.92(b)(3)]

The differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three curved lines that resemble a person's profile. The text is arranged in a circular pattern around the symbol.

NOV 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Bacterin International, Inc. % Azary Technologies, LLC Mr. Joseph M. Azary 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K063245

Trade/Device Name: Elutia™ Coated Closed Surgical Wound Drain Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OEI Dated: October 23, 2007 Received: October 26, 2007

Dear Mr. Azary:

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 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. Joseph M. Azary

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kobzuws 111

Indication for Use

510(k) Number: K063245

Device Name: Elutia™ Coated Closed Surgical Wound Drain

Indication for Use:

The subject device is intended for the evacuation of biological fluids from wounds or body cavities.

Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device &valuation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)

Plo
(Division Sign-Off)

(Division Sign-C Division of General, Restorative, and Neurological Device

510(k) Number /<063248

NOTE DECARLO/LOOE
AGO FIRM TORI SA-PIRA OVER
REVIEW 11/12/84

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.