(258 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics for tissue debridement, with no mention of AI or ML technologies.
Yes
The device is intended for wound debridement, 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 cutting, ablating, and removing tissue and foreign matter. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a power console, handpiece, tubing assembly, and footswitch, indicating it is a hardware-based system with potential software control, not a software-only device.
Based on the provided information, the Versalet II Hydrosurgery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for wound debridement, soft tissue debridement, and cleansing of the surgical site. This involves direct interaction with the patient's body for therapeutic purposes (removing tissue and debris).
- Device Description: The device uses a pressurized fluid stream to cut, ablate, and remove tissue and foreign matter. This is a surgical tool used on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Versalet II does not perform this function. It is used on the patient, not on a sample from the patient.
Therefore, the Versalet II Hydrosurgery System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Versalet 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 (comma separated list FDA assigned to the subject device)
FQH
Device Description
The VERSAJET™ II Hydrosurgery System consists of two basic system components: the reusable power console and the single-use, sterile (Ethylene Oxide) handpiece and tubing assembly. A footswitch is also available for operating the system.
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 high velocity stream of saline simultaneously washes the tissue surface and vacuums away foreign material from the wound. The fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of 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 pressure can be adjusted using either the footswitch or a sealed membrane switch on the front panel of the power console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on user preference and the needs of a particular application.
Associated accessories include:
- VERSAJET EXACT Handpieces, single-use, sterile, in three configurations .
- . VERSAJET PLUS Handpieces, single-use, sterile, in three configurations
- Footswitch
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)
Non-Clinical Tests (Bench)
Testing has been conducted to verify the modifications to the VERSAJET™ II Hydrosurgery System meet design specifications and demonstrate substantial equivalence to the predicate device.
The list below summarizes the bench testing undertaken and successfully completed for the VERSAJET™ II Hydrosurgery System device:
- Environmental testing of the device including the extremes of the operating range and under general operating room conditions.
- Reliability testing demonstrating that the modified components improved the reliability of ● the device.
- . Monitoring of aerosols generated through the use of the device outside of the operating room in conditions such as out-patient surgery.
- . Performance testing demonstrating that the effective cutting pressure range per console power setting, system priming, console cut off pressure function, and handset insertion, removal, engagement and disengagement forces are substantially equivalent to the predicate.
Biocompatibility on the VersaJet Handpieces has been successfully completed in accordance with applicable parts of ISO 10993 as follows:
- Cytotoxicity
- Skin Irritation
- Sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a staggered formation, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith and Nephew Incorporated Ms. Laura Reynolds Director Regulatory Affairs 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33716
Re: K143115
Trade/Device Name: The VersaJet II Hydrosurgery System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: Class II Product Code: FQH Dated: June 11, 2015 Received: June 12, 2015
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.
July 15, 2015
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 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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143115
Device Name The VersaJet II Hydrosurgery System
Indications for Use (Describe)
The Versalet 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the text "K143115" in black font at the top. Below that is the Smith & Nephew logo, with the words "We are" in gray and "smith&nephew" in orange. The logo is a stylized flower with orange petals.
Wound Management Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 F 727 392-1261 F 727 392-6914 or 727 392-0797 Customer Care Center: 1 800 876-1261 www.smith-nephew.com
510(k) Summary
| General Information | |
|---|---|
| Submitters Name/Address: | Smith & Nephew, Inc. |
| 970 Lake Carillon Drive | |
| Suite 110 | |
| St. Petersburg, FL 33716 | |
| Establishment Registration Number: | 3006760724 |
| Contact Person: | Laura Reynolds |
| Director Regulatory Affairs | |
| Phone Number: | (727) 329-7702 |
| Date Prepared: | July 8, 2015 |
| Device Description | |
| Trade Name: | VERSAJET™ II Hydrosurgery System |
| Generic/Common Name: | Jet Lavage |
| Classification Name: | Jet Lavage, 21 CFR 880.5475 |
| Product Code: FQH |
Predicate Device Information
| Current Device | Predicate Device | 510k# | Clearance Date |
|---|---|---|---|
| VERSAJET™ II Hydrosurgery | |||
| System | VERSAJET™ II Hydrosurgery | ||
| System | K110958 | 08/01/2011 |
Device Description
The VERSAJET™ II Hydrosurgery System consists of two basic system components: the reusable power console and the single-use, sterile (Ethylene Oxide) handpiece and tubing assembly. A footswitch is also available for operating the system.
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 high velocity stream of saline simultaneously washes the tissue surface and vacuums away foreign material from the wound. The fluid acts to tangentially ablate the surface of the tissue and
4
propel excised tissue and debris out of 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 pressure can be adjusted using either the footswitch or a sealed membrane switch on the front panel of the power console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on user preference and the needs of a particular application.
Associated accessories include:
- VERSAJET EXACT Handpieces, single-use, sterile, in three configurations .
- . VERSAJET PLUS Handpieces, single-use, sterile, in three configurations
- Footswitch
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.
| New Device: | Predicate Device: | |
|---|---|---|
| 510(k)# K110958 | ||
| Trade Name: | VERSAJET™ II | |
| Hydrosurgery System | VERSAJET™ II | |
| Hydrosurgery System | ||
| Indications for Use: | Identical | Identical |
| Environment of use | Identical | Identical |
| VersaJet II Handpiece | Substantially Equivalent | Substantially Equivalent |
| Console case | Identical | Identical |
| Power Supply | Substantially Equivalent | Substantially Equivalent |
| Motor | Identical | Identical |
| Transmission | Substantially Equivalent | Substantially Equivalent |
| User Interface PCB | Substantially Equivalent | Substantially Equivalent |
| User Interface Housing | Substantially Equivalent | Substantially Equivalent |
| User Interface Chamber | Substantially Equivalent | Substantially Equivalent |
| Method of Sterilization: | Identical | Identical |
| Biocompatibility | Identical | Identical |
| Software | Identical | Identical |
Summary Comparison between New and Predicate Devices
5
Table of Modifications
| Modification | Reason For Change | Verification Testing
Performed |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Saline Bag Spike resin | Obsolete material | Comprehensive verification
was completed which
demonstrated acceptable
device performance;
retested biocompatibility |
| Retainer Fitting-changed
from a metal injection
molded part to a
machined part; no
specification changes | Improve manufacturability of the
part | Comprehensive verification
was completed which
demonstrated acceptable
device performance |
| Body Pump with Chamfer
- increase length of dowel
pin component | Length of the dowel pin was
increased to assure full
engagement between the pump
body and retaining fitting;
improve manufacturability | Comprehensive verification
was completed which
demonstrated acceptable
device performance |
| High Pressure Hose -
nylon material resin
change | Obsolete material | Comprehensive verification
was completed which
demonstrated acceptable
device performance;
retested biocompatibility |
| Change to power supply
Printed Circuit Board
(PCB) layout | Address electrical issues of not
turning on | Comprehensive verification
and reliability was
completed which
demonstrated acceptable
device performance |
| Changes to the oil seals,
gasket and compression
spring in the transmission | Increase reliability and address
oil leakage | Comprehensive verification
and reliability was
completed which
demonstrated acceptable
device performance |
| Replacing passivation
process with electro-
polishing of the user
interface components | Increase their corrosion
resistance | Comprehensive verification
and reliability was
completed which
demonstrated acceptable
device performance |
| Replace a bronze bushing
in the user interface
chamber, with a Rulon™
bushing | Eliminate galvanic corrosion | Comprehensive verification
and reliability was
completed which
demonstrated acceptable
device performance |
| Minor modifications to
comply with IEC 60601-1
3rd Edition safety
standards | Compliance with safety standard | Device complies with the
IEC 60601-1 3rd Edition
series of electrical safety
standards |
6
Non-Clinical Tests (Bench)
Testing has been conducted to verify the modifications to the VERSAJET™ II Hydrosurgery System meet design specifications and demonstrate substantial equivalence to the predicate device.
The list below summarizes the bench testing undertaken and successfully completed for the VERSAJET™ II Hydrosurgery System device:
- Environmental testing of the device including the extremes of the operating range and under general operating room conditions.
- Reliability testing demonstrating that the modified components improved the reliability of ● the device.
- . Monitoring of aerosols generated through the use of the device outside of the operating room in conditions such as out-patient surgery.
- . Performance testing demonstrating that the effective cutting pressure range per console power setting, system priming, console cut off pressure function, and handset insertion, removal, engagement and disengagement forces are substantially equivalent to the predicate.
Biocompatibility on the VersaJet Handpieces has been successfully completed in accordance with applicable parts of ISO 10993 as follows:
- Cytotoxicity
- Skin Irritation
- Sensitization
Device complies with the following standards:
- . ISO13485:2003, Medical Devices - Quality Management Systems
- ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices ●
- ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, . labelling, and information to be supplied Part 1: General requirements.(General)
- . ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied-Part 2: Symbol development, selection and validation. (General)
- BS EN 980:2008 Graphical Symbols for use in the labeling of Medical Devices
- BS EN 1041:2008 +A1:2013 Information Supplied by the Manufacturer with Medical Devices
- IEC 60601-1-2:2007(3rd edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, Interpretation Sheet
- . IEC 60601-1:2005 (3rd edition). Medical Electrical Equipment - Part 1: General Requirements for Safety
- ISO 11135: 2014 Medical Devices - Validation and routine control of ethylene oxide sterilization
- ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: ● Requirements for materials, sterile barrier systems and packaging systems
- . ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing with a risk management process
7
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10:Tests for irritation and skin sensitization
Conclusions
In establishing substantial equivalence to the currently marketed predicate devices, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing, biocompatibility testing and electrical safety testing has been successfully completed to demonstrate that the VERSAJET™ II Hydrosurgery System is substantially equivalent to the predicate device for the intended use.