The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.

Device Description

The BlueSky Versatile 1 WVS is a portable suction device that can be powered by an internal battery pack, wall current or 12 Volt input via optional cigarette lighter adaptor. The pump can be used for removal of surgical fluids, tissue, gases, bodily fluids or infected materials during surgery or from a patients airway or respiratory support system. The pump can also be used to create localized topical negative pressure when used with the Chariker-Jeter® accessory kits to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.

The BlueSky versatile 1 Wound Vacuum System (V1 WVS) consists of a medium sized housing that contains a vacuum pump and control system with a location for a fluid canister system. Accessories include are a vehicle power adaptor and a Mobil Stand. A variety of disposables are available from a number of medical device manufacturers depending on the pump application. For the expanded indication of use for wound healing the Chariker -Jeter® accessory kits would be available from BlueSky Medical. This kit consists of individually reviewed medical components that have added instructions for use.

The Versatile 1 Wound Vacuum system is an ideal pump for military use and triage use. By combining a unit that can be used for wound resolution as well as tracheal use or for use in the operating theatre a minimum of products can be used for maximum versatility. The BlueSky V1 WVS is 15 inches by 11.2 inches by 6.7 inches and weighs 11.2 pounds. The battery will last for 30-45 minutes when not plugged in. the Pump can additionally be powered by a 12 volt source such as a cigarette lighter adaptor.

Switching the power switch to either continuous or intermittent suction turns on the pump. Pressing inwards on the suction control knob and then turning the knob in the desired direction adjust the level of suction. The knob will lock when it is not pressed to avoid accidental changes. The operator will view the suction gauge and when proper suction is reached the knob can be released.

Canisters
The pump includes a 250ml reusable polysulfone canister that can be autoclaved. The canister includes a mechanical overflow float to prevent backups into the pump itself. The canister can be autoclaved in a standard hospital autoclave for 134 degrees Celsius for 10 minutes. The pump also includes a 800ml liter disposable canister that has a mechanical overflow float. This canister is non-sterile and is designed by be discarded when full or partially full.

Single Use Disposables
Marketed as part of the VI Wound Vacuum System is a disposable kit. This kit is named after the pioneers in the field Katherine Jeter and Dr. Mark Chariker who popularized this technique of wound drainage, which caused wounds to heal more rapidly. "From the days of drainage through ostomy pouches to the current use of suction systems there has evolved a closed suction system incorporating moist wound management principals with the benefits of an inert silicone drain to maximize wound healing" "

The Chariker-Jeter wound vacuum system accessory kit. These kits consist of products from existing manufacturers that have met the regulatory requirements of the FDA. They include an additional set of instructions for use. The Kits include:

Silicone or Wound drain
Connecting tubing
Impregnated gauze
Gauze fill Material
Polyurethane Cover dressing

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided documents. Please note that this document is a 510(k) summary for a medical device (a wound vacuum system) and primarily establishes substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and results as one might expect for a novel high-risk device or AI model.

The document focuses on demonstrating that the "Versatile 1 Wound Vacuum System" is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" here are generally related to the device's functional specifications being comparable to the predicate devices and its ability to meet its stated indications for use. There isn't a "study that proves the device meets acceptance criteria" in the sense of a clinical trial with specific performance metrics and statistical analysis in this document, but rather a description of the device's design and intended use aligning with existing, approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance
Functional Equivalence to Predicate Devices: - Powered suction pump functionality - Ability to create localized topical negative pressure	Versatile 1 Wound Vacuum System (V1 WVS) Description: - Portable suction device - Powered by internal battery, wall current, or 12V adaptor - Used for removal of surgical fluids, tissue, gases, bodily fluids, or infected materials. - Can also be used to create localized topical negative pressure when used with Chariker-Jeter® accessory kits to promote wound healing and drainage of fluids/infected materials. - Pump includes a control system, suction gauge, and mechanisms to adjust suction level which locks to avoid accidental changes.
Dimensions & Weight Comparable to Predicate Devices	V1 WVS Dimensions & Weight: - 15 inches by 11.2 inches by 6.7 inches - Weighs 11.2 pounds
Battery Life & Power Options	V1 WVS Battery Life & Power Options: - Battery lasts 30-45 minutes when not plugged in. - Can be powered by a 12-volt source (e.g., cigarette lighter adaptor).
Canister System & Sterilization	V1 WVS Canister System: - Includes a 250ml reusable polysulfone canister that can be autoclaved (134 degrees Celsius for 10 minutes). - Includes an 800ml disposable canister that is non-sterile and designed to be discarded. - Both canisters have mechanical overflow floats to prevent backups into the pump.
Compatibility with Accessories/Disposables	V1 WVS Accessories: - Vehicle power adaptor and Mobil Stand. - For wound healing, uses Chariker-Jeter® accessory kits, consisting of: Silicone or Wound drain, Connecting tubing, Impregnated gauze, Gauze fill Material, Polyurethane Cover dressing. These kits are composed of existing, regulatory-compliant medical components.
Intended Indications for Use	V1 WVS Indications for Use: - For patients who would benefit from a suction device, particularly as the device may promote wound healing. - For aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.
Contraindications and Precautions	V1 WVS Contraindications for Wound Healing Application: - Presence of Necrotic tissue - Untreated Osteomyelitis - Malignancy (except terminal patients for quality of life issues) - Untreated malnutrition - Use on exposed arteries, veins, or organs V1 WVS Precautions: - Patients on anticoagulations or difficult hemostasis - Non-Compliant patients - Health care provider must evaluate patient to ensure appropriate use.

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

This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a new clinical study with a "test set" in the typical sense of a de novo approval or a performance study for an AI/CAD system.

Sample Size for Test Set: Not applicable in the context of this 510(k) summary as no specific test set data is presented for a new device performance study. The equivalence is based on comparing the design and function of the new device to existing predicate devices.
Data Provenance: Not applicable for a traditional test set. The 'data' effectively consists of the specifications and performance characteristics of the predicate devices (V.A.C.® Plus and Medela Vario) and the design description of the Versatile 1 Wound Vacuum System.

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

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/CAD system requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No "test set" in the context of human interpretation requiring adjudication is mentioned.

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 a submission for a physical medical device, not an AI or CAD system.

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

Not applicable. This is a submission for a physical medical device, not an AI or CAD system.

7. The Type of Ground Truth Used

The "ground truth" for the Versatile 1 Wound Vacuum System's approval is the established safety and effectiveness of its predicate devices:

V.A.C.® Plus (510(k) No. 945062)
Medela Vario (510(k) No. 983552)

The new device is deemed acceptable because its technological characteristics, intended use, and performance are substantially equivalent to these already legally marketed and safe/effective devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data points would be used to develop an algorithm.

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

Not applicable. As above, this document describes a physical medical device, not an AI/ML system, so there is no training set or ground truth derived in that manner. The "ground truth" for the predicate devices would have been established through their original regulatory reviews and market experience.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2009

Smith & Nephew, Inc. % Ms. Laura Krejci 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

Re: K042134

Trade/Device Name: Versatile 1 Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 4, 2004 Received: August 9, 2004

Dear Ms. Krejci:

This letter corrects our substantially equivalent letter of November 15, 2004.

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 (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.

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

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Page 2 - Ms. Laura Krejci

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 continue 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). 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/dsma/dsmamain.html.

Sincerely yours,

Mark N. Mallery, Ph.D.

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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Indications for Use

510(k) Number (if known): K042134 Device Name: Versatile 1 Wound Vacuum System

Indications for Use:

Nilse Ogden

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number K042134

Prescription Use XX (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for BlueSky Medical. The words "BlueSky" are in a bold, sans-serif font, with the word "Medical" in a smaller font below. The logo has a curved line above and below the text, creating a sense of motion or dynamism. The overall design is simple and professional.

510(k) Summary

I. Device name: Versatile 1 Wound Vacuum System (Assisted Drainage Device) (VI WVS)
II. Classification Name: Powered suction Pump (per 21 CFR 878.4780)
III. Substantial Equivalence V.A.C.® Plus 510(k) No. 945062

Medela Vario 510(k) 983552

IV. Device Description
The BlueSky Versatile 1 WVS is a portable suction device that can be powered by an internal battery pack, wall current or 12 Volt input via optional cigarette lighter adaptor. The pump can be used for removal of surgical fluids, tissue, gases, bodily fluids or infected materials during surgery or from a patients airway or respiratory support system. The pump can also be used to create localized topical negative pressure when used with the Chariker-Jeter® accessory kits to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.

Canisters

The pump includes a 250ml reusable polysulfone canister that can be autoclaved. The canister includes a mechanical overflow float to prevent backups into the pump itself. The canister can be autoclaved in a standard hospital autoclave for 134 degrees Celsius for 10 minutes. The pump also includes a 800ml liter disposable canister that has a mechanical overflow float. This canister is non-sterile and is designed by be discarded when full or partially full.

6965 El Camino Real • Suite 105-602 • La Costa, CA 92009 • (760) 727-1477 • FAX (760)727-0236 Http://www.blueskymedical.com ● Email:Info@blueskymedical.com

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Image /page/4/Picture/0 description: The image shows the logo for BlueSky Medical. The words "BlueSky" are in large, bold, black font, with the word "Medical" underneath in a smaller font. There is a black curved line above the word "BlueSky" and a curved line below the word "Medical."

Single Use Disposables

Marketed as part of the VI Wound Vacuum System is a disposable kit. This kit is named after the pioneers in the field Katherine Jeter and Dr. Mark Chariker who popularized this technique of wound drainage, which caused wounds to heal more rapidly. "From the days of drainage through ostomy pouches to the current use of suction systems there has evolved a closed suction system incorporating moist wound management principals with the benefits of an inert silicone drain to maximize wound healing" "

1. Silicone or Wound drain
1. Connecting tubing
1. Impregnated gauze
1. Gauze fill Material
1. Polyurethane Cover dressing

Indications for Use

The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.

Contraindications for Wound Healing Application

The V1 WVS is contraindicated for the following reasons for Wound treatment

Presence of Necrotic tissue

Untreated Osteomyeltitis

Malignancy (except terminal patients for quality of life issues)

Untreated malnutrition
Use on exposed arteries, veins, or organs

Precautions:

Patients on anticogagulations or difficult hemostatis Non-Compliant patients

General Precautions for all indications for use: Health care provider must evaluate patient to insure that use of V1 WVS is an appropriate use for the patient.

1 Effective Management of Incisional and Cutaneous Fistulae With Closed Suction Wound drainage Mark E. Chariker MD, Katherine F. Jeter, Ed.D. Et et. al. Contemporary Surgery Vol 34 Junc 1989 199 59-63

6965 El Camino Real • Suite 105-602 • La Costa, CA 92009 • (760) 727-1477 • FAX (760)727-0236 Http://www.blueskymedical.com · Email:Info@blueskymedical.com

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.