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 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.

AI/ML Overview

This 510(k) submission (K052456) is a Special 510(k) for a modification to an already cleared device, the Versatile 1™ Wound Vacuum System (predicate K042134).

Therefore, the submission does not present a new clinical study to prove the device meets acceptance criteria. Instead, it relies on the principle of substantial equivalence to its predicate device. This means the manufacturer is asserting that the modifications made do not significantly affect the safety or efficacy of the device, and thus, the device still meets the criteria previously established for the predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the Special 510(k) submission for K052456. Since it's a modification, the acceptance criteria would have been established and met during the clearance of the original predicate device (K042134). The current submission states that "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." This implicitly means the modified device is expected to perform at the same level as the predicate in meeting its original acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable. No new clinical or performance studies using a test set are presented in this Special 510(k). The modifications were related to "materials and labeling."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth establishment was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a wound vacuum system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a wound vacuum system, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for K052456. The original predicate device's clearance would have relied on appropriate testing (e.g., bench testing, biocompatibility, electrical safety) to demonstrate its performance relative to its intended use.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary:

This 510(k) is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device. The core of such a submission is to demonstrate that the modifications do not significantly affect the safety or effectiveness of the device. Therefore, it does not typically involve new extensive clinical studies or the establishment of new acceptance criteria. The claim is that the device, with the modifications, still meets the safety and effectiveness profile established during the clearance of its predicate device (K042134). The specific acceptance criteria and the studies that originally proved the predicate device met them would be found in the documentation for K042134.

Summary

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K052456

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:

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

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.