(21 days)
The VersaJet™ Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.
The VersaJet Hydrosurgery System uses pressurized streams of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. The device provides cutting, irrigation and evacuation in the same tool. The stream of fluid simultaneously washes the tissue surface and removes foreign material from the wound or surgical site. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The fluid acts to ablate the surface of the tissue and propel excised tissue and debris out of the surgical site. The debris and fluid are directed immediately within the instrument into a flexible tube, which carries the effluent to the drain or a collection canister. The system employs two basic system components: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text.
The text describes a 510(k) Summary for the VersaJet™ Hydrosurgery System. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not necessarily for proving the device meets specific acceptance criteria through a dedicated study with pre-defined performance metrics.
Here's why the requested information isn't directly available in the provided text:
- Acceptance Criteria/Performance Metrics: The document does not define specific quantitative or qualitative acceptance criteria (e.g., a certain percentage reduction in bacterial load, a specific time to debridement, or a defined tissue sparing percentage) for the device's performance. It describes the device's function and intended use.
- Study Design for Performance Proof: The document focuses primarily on comparing the subject device to a predicate device (K011612) and expanding its indications for use to include burn wounds. The "Clinical Literature Review" section refers to two existing external clinical studies/descriptions from Rennekampff et al. and Klein et al. These are cited to support the expanded indication for burn wounds, but they are not presented as a pre-planned, dedicated study designed by Smith & Nephew to prove the device meets specific, pre-defined acceptance criteria for its overall performance.
- Missing Details for Study Analysis: Consequently, details like sample size for test sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used for performance assessment, or training set specifics are not addressed because the review section is a summary of external literature, not a report of an internal validation study against a pre-defined performance threshold.
In summary, the provided document is a regulatory submission for substantial equivalence and an expanded indication, which often relies on a comparison to a predicate device and existing literature, rather than a detailed report of a new study designed to meet specific, pre-defined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study design based on the information given.
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APR 1 2 2006
510(k) Summary
In accordance with the requirements of 21 CFR 807.92, Smith & Nephew is hereby submitting a 510(k) Summary for the VersaJet™ Hydrosurgery System.
510(k) # K060782
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- Submitter:
Smith & Nephew, Inc. Wound Management 11775 Starkey Road Largo, FL 33773
- Submitter:
Company Contact:
Terry C. McMahon Regulatory Affairs Manager-Devices 727-399-3785 Telephone 727-399-3468 Fax
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- Device Name:
Trade name: VersaJet™ Hydrosurgery System
- Device Name:
Common name: Pulse lavage with sharp debridement
Classification Name: Jet Lavage, 21 CFR 880.5475
Product Classification: II
Code: FQH
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- Identification of Legally Marketed Device:
Hydrocision Debridement System (VersaJet) Smith & Nephew, Inc. Largo, Florida 510(k) # K011612
- Identification of Legally Marketed Device:
- Device Description:
The VersaJet Hydrosurgery System uses pressurized streams of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. The device provides cutting, irrigation and evacuation in the same tool.
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K0607822/2
The stream of fluid simultaneously washes the tissue surface and removes foreign material from the wound or surgical site. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The fluid acts to ablate the surface of the tissue and propel excised tissue and debris out of the surgical site. The debris and fluid are directed immediately within the instrument into a flexible tube, which carries the effluent to the drain or a collection canister.
The system employs two basic system components: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.
- Intended Use:
The VersaJet Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.
- Comparison of Technological Characteristics
There have been no changes to the design of the predicate VersaJet Hydrosurgery System cleared in 510(k) number K011612 and the device in this premarket notification. This submission supports an expansion of the indications for use of the device to include debridement of burn wounds.
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- Clinical Literature Review
Rennekampff et al evaluated seventeen patients with burn wound areas of between 0.5% and 5% total body surface (TBSA) involving the face, arm, hand, leg and foot. VersaJet™ was able to sufficiently debride superficial partial thickness and middermal partial thickness wounds for subsequent placement of Biobrane® (Bertek Pharmaceuticals Inc, NC, USA), with successful autografting of deeper partial thickness wounds following excision. In a sub-group of seven of the patients, bacterial analysis of the wound bed was also performed pre- and post-debridement. Of the four wounds exhibiting pre-debridement bacterial load, two showed no growth post-debridement and one showed a reduction in bacterial load from >10° colonyforming units down to only one colony. Of the three wounds with no pre-debridement growth, one showed bacterial growth post-debridement. No post-operative infections or complications were reported. The authors concluded that VersaJet™ may lower the bacterial load in burn wounds and is effective in its ability to debride irregular and complex contours and sparing vital tissue.
- Clinical Literature Review
Klein et al described their experience of 21 burn patients debrided from January 2003 onwards. This series was later extended and a total of 44 patients (age range 3 months - 83 years) were reported by Klein et al 13. In this cohort, VersaJet™ was used routinely in the excision of eschar from the eyelids, fingers and web spaces as well as being utilized for a variety of other areas such as the scalp, ears, lip and periareola. VersaJet™ was used as an adjunct to Watson and Gouilian knjves or electrocautery, depending on the depth of the remainder of the burn wound. While the learning curve, inefficient excision of farge surfaces and costs associated with the device were noted, no patients required repeat grafting as the result of inadequate excision with VersaJet, and no patients had graft loss as the result of excessive tissue excision. The authors concluded that VersaJet™ is a useful adjunct in burn wound excision.
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Image /page/2/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the logo. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Smith & Nephew, Inc. c/o Mr. Terry C. McMahon Regulatory Affairs Manager - Devices 11775 Starkey Road Largo, Florida 33773
Re: K060782
Trade/Device Name: VersaJet™ Hydrosurgery System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQH Dated: March 21, 2006 Received: March 22, 2006
Dear Mr. McMahon:
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 application (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 such 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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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forth in the quality systems (OS) 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 begin 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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Q. Mall
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): K060782
Device Name: VersaJet™ Hydrosurgery System
Indications for Use:
The VersaJet Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.
Prescription Use × (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)
Q.mll
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K0607日2 510(k) Number.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.