K Number

Device Name

VERSATILE 1 WOUND VACUUM SYSTEM

Manufacturer

BLUE SKY MEDICAL GROUP INCORPORATED

Date Cleared

2004-11-01

(84 days)

Product Code

OMP

Regulation Number

878.4780

Intended 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.

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: 1. Silicone or Wound drain 2. Connecting tubing 3. Impregnated gauze 4. Gauze fill Material 5. Polyurethane Cover dressing

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

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

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a mechanical suction device with manual controls and no mention of AI or ML capabilities.

Therapeutic

Yes

The device is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, which is a therapeutic effect.

Diagnostic

This device is a suction device used for therapeutic purposes such as promoting wound healing and removing surgical fluids, tissues, and infectious materials. It does not perform any diagnostic functions.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical, portable suction device with a vacuum pump, control system, battery, and various hardware accessories and disposables. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, the Versatile 1 Wound Vacuum System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
Device Function: The Versatile 1 Wound Vacuum System is a suction device used to remove fluids, tissue, and other materials directly from a patient's body (wounds, airway, respiratory system). It is a therapeutic and surgical/procedural device, not a diagnostic one.
Intended Use: The intended use clearly states its purpose is for suction and removal of materials from the patient, and to promote wound healing. These are not diagnostic activities.
Device Description: The description focuses on the mechanical aspects of the suction pump and its accessories for direct patient application.

Therefore, the Versatile 1 Wound Vacuum System falls under the category of a medical device used for treatment and procedural support, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OMP

Device Description

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:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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)

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

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