(214 days)
The Versatile 1 EZCare™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.
This 510(k) summary describes a device that is a Versatile 1 EZCare™ Wound Vacuum System, a portable suction pump intended to promote wound healing. The submission focuses on demonstrating substantial equivalence to a predicate device (Versatile 1™ Wound Vacuum System, K042134 and K052456) rather than clinical performance against specific acceptance criteria for a new clinical claim. Therefore, the provided document does not contain the requested detailed information about acceptance criteria and a study proving the device meets those criteria in a clinical context.
Here's what can be extracted based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define quantitative acceptance criteria for clinical performance that would typically be seen in a study proving a device meets a specific efficacy threshold. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Not explicitly stated in the document for clinical efficacy) | Reported Device Performance (as per the document for substantial equivalence) |
|---|---|
| (Implied criteria are related to safety and effectiveness comparable to predicate device) | "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use." |
| (Specific technical and performance parameters would be in a design specification or test report, but are not in this summary) | "BlueSky Medical evaluated the indications for use, materials, technology, product specifications, and energy requirements of the system." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a "test set" in the context of clinical performance data. The "performance testing" referred to is likely engineering and bench testing to demonstrate the device functions as intended and is comparable to the predicate. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, the document does not mention an MRMC study or any study comparing human readers with and without AI assistance. This device is a wound vacuum system, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device (a wound vacuum system), not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable, as no clinical study with ground truth establishment is described. The "ground truth" for this type of submission is typically based on the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set:
Not applicable. The document does not describe a training set for an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of what the document does communicate regarding evidence for the device:
The document is a 510(k) Summary for a Class II medical device (Powered Suction Pump). The primary method of demonstrating approval is through substantial equivalence to a legally marketed predicate device (Versatile 1™ Wound Vacuum System).
- Evidence for Equivalence: BlueSky Medical states they "evaluated the indications for use, materials, technology, product specifications, and energy requirements of the system."
- Performance Testing: "Performance testing has been completed to demonstrate the safe and effective use of the Versatile 1 EZCare™ Wound Vacuum System for the intended use." This likely refers to bench testing, engineering verification, and validation to ensure the device meets its design specifications and operates safely and effectively, consistent with the predicate device.
- Conclusion: "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use."
The provided information is typical for a 510(k) submission where the device is not novel in its mechanism or intended use, but rather a modification or new version of an existing cleared device. It relies on a comparison to a predicate device rather than de novo clinical trial data establishing new efficacy claims against specific, quantitative acceptance criteria.
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K06 1919
Page 1/1
510(k) Summary
General Information
Submitters Name/Address:
FEB
5 2007
Establishment Registration Number:
Contact Person:
Phone Number:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
BlueSky Medical Group, Inc. 5924 Balfour Ct., Suite 102 Carlsbad, CA 92008
2032666
Jasper Benke
(760) 603-8130
June 30, 2006
Versatile 1 EZCare™ Wound Vacuum System
Suction Pump and Accessories
Powered Suction Pump (21 CFR 878.4780, Product Code BTA)
Predicate Device Information
Versatile 1™ Wound Vacuum System cleared originally in K042134 (November 15, 2004) and amended in K052456 (November 4, 2005).
Product Description
The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.
Intended Use
The Versatile 1 EZCare™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
Substantial Equivalence
In establishing substantial equivalence to the predicate device, BlueSky Medical evaluated the indications for use, materials, technology, product specifications, and energy requirements of the system. Performance testing has been completed to demonstrate the safe and effective use of the Versatile 1 EZCare™ Wound Vacuum System for the intended use.
Summary of Safety and Effectiveness
Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR -7 2009
Smith & Nephew, Inc. % Ms. Laura Kreici 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716
Re: K061919
Trade/Device Name: Versatile 1 EZCare™ Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: January 18, 2007 Received: January 19, 2007
Dear Ms. Krejci:
This letter corrects our substantially equivalent letter of February 5, 2007.
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 vour 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
KO6 1919 510(k) Number:
Device Name:
Versatile 1 EZCare™ Wound Vacuum System
Indications for Use:
The Versatile 1 EZCare™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subport C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 2061919 |
| Page 1 of | 1 |
§ 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.