The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.

The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds:

Pressure Ulcers
Diabetic/Neuropathic Ulcers
Venous Insufficiency Ulcers
Traumatic Wounds
Post-Operative and Dehisced Surgical Wounds
Skin Flap and Grafts

Device Description

The UNI NPWT Foam Dressing Kit without pump is manufactured using a reticulated flexible polyether based polyurethane hydrophobic foam material. The UNI NPWT Foam Dressing Kit includes the (1) foam dressing, (2) occlusive drape and (3) silicon suction dome with (4) negative pressure tubing.

UNI NPWT Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device called the "UNI NPWT Foam Dressing Kit." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a standalone clinical trial for novel device approval.

It's important to note that for a 510(k) submission, the "acceptance criteria" are often related to demonstrating equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than meeting pre-defined clinical performance metrics for a completely new device.

Based on the provided text, here's the information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance
Material Equivalence: Flexible polyether and polyester polyurethane foam dressing material, hydrophobic.	The UNI NPWT Foam Dressing Kit is manufactured using a reticulated flexible polyether based polyurethane hydrophobic foam material. The discussion states both devices use "flexible polyether and polyester polyurethane foam dressing material" and are "hydrophobic."
Sterility: Provided sterile.	The discussion states both devices "are provided sterile." Non-clinical tests include "ANSI/AAMI/ISO 11137-2 Sterilization of health care products."
Size Variability: Offered in various sizes.	The UNI NPWT Foam Dressing Kit is available in three sizes: small, medium, and large. The discussion states both devices "offer various size dressings."
Intended Use: For negative pressure wound therapy.	The UNI NPWT Foam Dressing Kit is intended for use in conjunction with NPWT pumps for the application of negative pressure wound therapy. The discussion states both devices are "used for negative pressure wound therapy" and have the "same indications for use."
Mechanical Performance Equivalence: Similar tensile strength, stress (elongation), ultimate elongation, tear resistance, and fluid removal rate compared to the predicate device.	A "mechanical comparative test was conducted between the UNI NPWT Foam Dressing Kit and that of the predicate. The results of these tests demonstrated that the UNI NPWT Foam Dressing Kit is substantially equivalent in terms of tensile strength, stress (elongation), ultimate elongation, tear resistance and fluid removal rate." Non-clinical tests include "ASTM D3574-11 Standard Test Methods for Flexible Cellular Materials - Slab, Bonded, and Molded Urethane Foams."
Biocompatibility: Non-toxic, non-irritating, non-sensitizing, and non-pyrogenic.	Non-clinical tests conducted include: ISO 10993-5 Cytotoxicity, ISO 10993-10 Irritation and Sensitization, ISO 10993-11 Tests for Systemic Toxicity, USP 35, NF 30 <85> Bacterial Endotoxins Test (LAL), and USP <151> Pyrogen Test.
Sterile Barrier Integrity: Packaging maintains sterility.	Non-clinical tests include: ASTM F88-09 Seal Strength Test and ASTM F1929-98 Dye Penetration Test.
Risk Management: Adherence to medical device risk management standards.	Non-clinical tests include: ISO 14971 Medical Devices Application of Risk Management to Medical Devices.

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

Test Set Size: Not applicable in the context of a 510(k) non-clinical submission. The document explicitly states: "No clinical study was conducted." The "test set" here refers to samples of the device and predicate device used for mechanical and biocompatibility testing, not patient data.
Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are based on recognized international (ISO) and national (ASTM, USP) standards. The study is not a clinical study, so terms like "retrospective" or "prospective" clinical data don't apply. It's a non-clinical, laboratory-based study.

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

Not applicable. As no clinical study was conducted, there was no "ground truth" derived from expert consensus for clinical outcomes. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles behind the test methods (e.g., how to measure tensile strength, how to assess cytotoxicity).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study involving human assessment or interpretation for which adjudication would be needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a negative pressure wound therapy foam dressing kit, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

Not applicable. This device is a dressing kit, not an algorithm or software.

7. The Type of Ground Truth Used

Non-Clinical Ground Truth: For the mechanical and biocompatibility tests, the "ground truth" is defined by the validated and standardized test methods themselves (e.g., ISO 10993, ASTM F88, USP pyrogen test). The results are compared against these established standards or directly against the predicate device's performance under identical testing conditions. There is no pathology, outcomes data, or expert consensus on clinical findings mentioned to establish a "ground truth."

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. As no training set exists, no ground truth was established for it.

Summary of the Study:

The study described is a non-clinical comparative study designed to demonstrate substantial equivalence of the UNI NPWT Foam Dressing Kit to a legally marketed predicate device (Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing) per 21 CFR 807.92(a)(6) and 807.92(b)(1). The key findings are:

Technological Characteristics Comparison: The device shares the same indications for use, uses similar materials (flexible polyether and polyester polyurethane foam), is hydrophobic, sterile, and offered in various sizes as the predicate.
Non-Clinical Testing: A series of standardized biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, bacterial endotoxins, pyrogen) and physical/mechanical tests (sterilization, seal strength, dye penetration, foam properties) were conducted.
Mechanical Comparative Test: A specific mechanical comparative test against the predicate demonstrated substantial equivalence in terms of tensile strength, stress (elongation), ultimate elongation, tear resistance, and fluid removal rate.
No Clinical Study: Importantly, no clinical studies were performed to establish safety or effectiveness directly from patient data. The assertion of safety and effectiveness relies on the demonstrated substantial equivalence to a device already deemed safe and effective.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure in profile, with three faces overlapping to suggest a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

December 31, 2014

Blue Ocean Medical Product, LLC % E.J. Smith Smith Associates 1468 Harwell Avenue Crofton. Maryland 21114

Re: K133333

Trade/Device Name: UNI NPWT Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: December 2, 2014 Received: December 3, 2014

Dear Smith:

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.

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

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K133333

Device Name UNI NPWT Foam Dressing Kit

Indications for Use (Describe)

The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.

The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds:

· Pressure Ulcers
· Diabetic/Neuropathic Ulcers
· Venous Insufficiency Ulcers
· Traumatic Wounds
· Post-Operative and Dehisced Surgical Wounds
· Skin Flap and Grafts

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{3}------------------------------------------------

510(k) Summary 807.92(c)

SPONSORCompany Name:	Blue Ocean Medical Product, Inc.		807.92(a)(1)
Company Address	135 Calkins Rd., Suite 600Rochester, NY 14623
Telephone:	585.203.7652
Fax:	866.929.4761
Contact Person:	Dana Ledgerwood
Summary Preparation Date:	December 31, 2014
DEVICE NAME			807.92(a)(2)
Trade Name:	UNI NPWT Foam Dressing Kit (Small, Medium, Large)
Common/Usual Name:	Foam Dressing Kit
Classification Name:	Powered Suction Pump
Regulation Number:	21 CFR 878.4780
Product Code:	OMP
Device Class:	Class II
Panel:	General & Plastic Surgery
PREDICATE DEVICE			807.92(a)(3)
Legally Marketed Equivalent DeviceCompany	Genadyne Biotechnologies, Inc.	ProductA4-XLR8 Foam Dressing	510(k) #K092992

DEVICE DESCRIPTION

807.92(a)(4)

UNI NPWT Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large.

{4}------------------------------------------------

DEVICE INDICATIONS FOR USE

The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds:

Pressure Ulcers
Diabetic/Neuropathic Ulcers
Venous Insufficiency Ulcers
Traumatic Wounds
Post-Operative and Dehisced Surgical Wounds
Skin Flap and Grafts

DISCUSSION OF TECHNOLOGICAL CHARACTERISTICS

The UNI NPWT Foam Dressing Kit and the predicate device (Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing Kit) have the same indications for use, both use flexible polyether and polyester polyurethane foam dressing material, are hydrophobic, are provided sterile, offer various size dressings, and are used for negative pressure wound therapy.

NON-CLINICAL PERFORMANCE DATA

807.92(B)(1)

807.92(a)(6)

The following non-clinical tests and risk management were conducted:

ISO 10993-5 Cytotoxicity
ISO 10993-10 Irritation and Sensitization ●
ISO 10993-11 Tests for Systemic Toxicity ●
ANSI/AAMI/ISO 11137-2 Sterilization of health care products
USP 35, NF 30 <85> Bacterial Endotoxins Test (LAL)
USP <151> Pyrogen Test
ASTM F88-09 Seal Strength Test
ASTM F1929-98 Dye Penetration Test
ASTM D3574-11 Standard Test Methods for Flexible Cellular Materials - Slab, Bonded, and Molded Urethane Foams
ISO 14971 Medical Devices Application of Risk Management to Medical Devices ●

A mechanical comparative test was conducted between the UNI NPWT Foam Dressing Kit and that of the predicate. The results of these tests demonstrated that the UNI NPWT Foam

807.92(a)(5)

{5}------------------------------------------------

Dressing Kit is substantially equivalent in terms of tensile strength, stress (elongation), ultimate elongation, tear resistance and fluid removal rate.

CLINICAL PERFORMANCE DATA

807.92(b)(2)

No clinical study was conducted.

Conclusion

807.92(b)(3)

The Blue Ocean UNI NPWT Foam Dressing is similar to the predicate device in indications for use, materials, and operating principle as a negative pressure wound therapy foam dressing. The Blue Ocean UNI NPWT Foam Dressing is substantially equivalent to the predicate device and introduced no new issues of safety and effectiveness.

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.