(118 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI or ML capabilities. The primary change is a mechanical interface improvement.
Yes.
The device is specifically intended for wound and soft tissue debridement and cleansing of surgical sites, which are therapeutic applications.
No
The device is described as a surgical tool for debridement and cleansing, which involves removing tissue and foreign matter. It does not perform diagnostic functions like analyzing, detecting, or predicting.
No
The device description clearly outlines physical components: a reusable power console and a single-use handpiece and tubing assembly. The performance studies also focus on the physical interaction and function of these hardware components.
Based on the provided information, the VersaJet II Hydrosurgery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states wound debridement, soft tissue debridement, and cleansing of the surgical site. These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a system that uses a pressurized fluid stream to cut, ablate, and remove tissue and foreign matter. This is a surgical tool for physical intervention, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VersaJet II Hydrosurgery System is a surgical tool used for debridement and cleansing during procedures.
N/A
Intended Use / Indications for Use
The VersaJet II 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.
Product codes
FQH
Device Description
The VersaJet II Hydrosurgery System uses a pressurized stream 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 saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.
The system employs two basic system components: the reusable power console and the single-use, sterile handpiece and tubing assembly.
The primary change to the system is the design of the interface of the handpiece into the console. The new design is a simple, intuitive "key lock mechanism" design that improves the ease of connection of the handpiece to the console.
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
Design verification testing has been completed to document that all performance specifications have been met.
The testing included: No increase in weight when compared to current console, Ability to load pump cartridge up or down (0° or 180°) without affecting performance and/or damaging pump or console, Low noise level, Easy insertion and removal in a single attempt with positive feedback to user that the handpiece is engaged in the console, Force to load and unload disposable mechanism should be no greater than current VERSAJET loading, Effective Cutting levels (1 to 10) - console operation must provide equivalent pressures to the new handpiece cutting window equal to existing handpiece models and console, The VersaJet II handpiece will operate using the footswitch when correctly connected to the console. Transmission design provides reciprocating axial force to cartridge, LED indicators on front panel are visible under normal OR conditions, Footswitch provides the control signal to the console to activate the handpiece when depressed and deactivate when released, The footswitch will provide the capabilities to control the (up/down) power level setting functions using designated push buttons on the footswitch, Handpiece capable of completing 30 minutes average debridement procedure, Handpiece is effective at all cutting power levels.
Based on the results of design verification testing, it is concluded that the new VersaJet II system meets all defined performance specifications and is substantially equivalent to the currently marketed VersaJet Hydrosurgery System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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510(k) Summary VersaJet II Hydrosurgery System
AUG - 1 2011
-
- Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
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- Contact: Laura D. Reynolds Director, Regulatory Affairs 727-329-7702
-
- Date Prepared: April 4, 2011
- Device Name: VersaJet™ II Hydrosurgery System র্বা Common Name: Pulse lavage with sharp debridement Classification Name: Jet Lavage, 21 CFR 880.5475 Product Classification/Code: Class II / FQH
5. Predicate Device Information:
VersaJet Hydrosurgery System 510(k) # K060782 Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
6. · Device Description:
200
The VersaJet II Hydrosurgery System uses a pressurized stream 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 saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.
The system employs two basic system components: the reusable power console and the single-use, sterile handpiece and tubing assembly.
The primary change to the system is the design of the interface of the handpiece into the console. The new design is a simple, intuitive "key lock mechanism" design that improves the ease of connection of the handpiece to the console.
7. Intended Use:
The VersaJet II 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.
1
Summary of Non-Clinical Testing: 8.
There have been no changes to the patient contacting components of the disposable handpiece. Biocompatibility has previously been completed in accordance with ISO 10993 and is on file at Smith & Nephew:
| Evaluation Tests Conducted | Result |
|---|---|
| Cytotoxicity | Passed |
| Sensitization | Passed |
| Irritation | Passed |
Design verification testing has been completed to document that all performance specifications have been met. The following table summarizes the testing that has been successfully completed.
| Design Input Description | Result |
|---|---|
| No increase in weight when compared to current | |
| console. | Passed |
| Ability to load pump cartridge up or down (0° or 180°) | |
| without affecting performance and/or damaging pump | |
| or console. | Passed |
| Low noise level | Passed |
| Easy insertion and removal in a single attempt with | |
| positive feedback to user that the handpiece is | |
| engaged in the console. | Passed |
| Force to load and unload disposable mechanism | |
| should be no greater than current VERSAJET loading. | Passed |
| Effective Cutting levels (1 to 10) - console operation | |
| must provide equivalent pressures to the new | |
| handpiece cutting window equal to existing handpiece | |
| models and console. | Passed |
| The VersaJet II handpiece will operate using the | |
| footswitch when correctly connected to the console. | |
| Transmission design provides reciprocating axial force | |
| to cartridge. | Passed |
| LED indicators on front panel are visible under normal | |
| OR conditions. | Passed |
| Footswitch provides the control signal to the console to | |
| activate the handpiece when depressed and deactivate | |
| when released. | Passed |
| The footswitch will provide the capabilities to control the | |
| (up/down) power level setting functions using | |
| designated push buttons on the footswitch. | Passed |
| Handpiece capable of completing 30 minutes average | |
| debridement procedure. | Passed |
| Handpiece is effective at all cutting power levels. | Passed |
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U110958
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g. Conclusions Drawn:
Based on the results of design verification testing, it is concluded that the new VersaJet II system meets all defined performance specifications and is substantially equivalent to the currently marketed VersaJet Hydrosurgery System. The VersaJet II Hydrosurgery System is safe and effective for the intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Laura Reynolds Director Regulatory Affairs 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716
AUG - 1 2011
Re: K110958
Trade/Device Name: VersaJet II Hydrosurgery System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQH Dated: July 15, 2011 Received: July 19, 2011
Dear Ms. Reynolds:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 limited to: registration and listing (21
4
Page 2 - Ms. Laura Reynolds
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Muh A. Millkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K110958
Device Name: VersaJet II Hydrosurgery System
Indications for Use:
The VersaJet II 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 X (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)
Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K110958