(58 days)
Not Found
No
The summary describes a portable suction pump with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" states that the device "may promote wound healing" and the "Device Description" also mentions "promotion of wound healing," which are therapeutic claims.
No
Explanation: The device is described as a "suction device" and a "portable suction pump for general purpose drainage or for the promotion of wound healing," and for "aspiration and removal of surgical fluids, tissue...gases, bodily fluids or infectious materials." This indicates it is a therapeutic or surgical device, not one used for diagnosis.
No
The device description explicitly states it is a "portable suction pump," which is a hardware device.
Based on the provided information, the Versatile 1 Wound Vacuum System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a suction device for promoting wound healing, aspirating surgical fluids, tissue, gases, bodily fluids, or infectious materials from a patient's airway or respiratory system. This involves direct interaction with the patient's body or substances removed from the body for therapeutic or procedural purposes.
- Device Description: The device is described as a portable suction pump for general purpose drainage or wound healing. This aligns with the intended use and does not involve the examination of specimens in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens (like blood, urine, tissue samples) to diagnose a disease, condition, or state of health.
IVDs are specifically designed to perform tests on specimens taken from the human body to provide information for diagnostic purposes. The Versatile 1 Wound Vacuum System's function is therapeutic and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
The Versatile 1TM 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.
Product codes
BTA, OMP
Device Description
The product is a portable suction pump for general purpose drainage or for the promotion of wound healing when used with various accessory wound sealing kits.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV - 4 2005
510(k) Summary
General Information
Submitters Name/Address:
BlueSky Medical Group, Inc. 5924 Balfour Ct., Suite D Carlsbad, CA 92008
| Establishment Registration Number: | 2032666 |
|---|---|
| Contact Person: | Jasper Benke |
| Phone Number: | (760) 603-8130 |
| Date Prepared: | August 30, 2005 |
Device Description
| Trade Name: | Versatile 1™ Wound Vacuum System |
|---|---|
| Generic/Common Name: | Suction Pump and Accessories |
| Classification Name: | Powered Suction Pump (21 CFR 878.4780, Product Code BTA) |
Predicate Device Information
Versatile 1TM Wound Vacuum System. K042134; cleared on November 15, 2004
Product Description
The product is a portable suction pump for general purpose drainage or for the promotion of wound healing when used with various accessory wound sealing kits.
Intended Use
The Versatile 1TM 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.
Substantial Equivalence
This Special 510(k) proposes a modification in materials and labeling for the Versatile 1 TM Wound Vacuum System, which were previously cleared under K042134 on November 15, 2004. The indications for use, technology, principle of operation, packaging, and sterilization parameters of the device remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified Versatile 1TM Wound Vacuum System, as described in this submission, is substantially equivalent to the predicate, unmodified device. The proposed modifications in materials and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol, with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
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: K052456
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: October 19, 2005 Received: October 21, 2005
Dear Ms. Krejci:
This letter corrects our substantially equivalent letter of November 4, 2005.
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. 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
K052456 510(k) Number:
Versatile 1 ™ Wound Vacuum System Device Name:
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marlene Buell
Restorative. and Neurological Devices
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510(k) Number K052456