(410 days)
Not Found
No
The description focuses on the mechanical and fluid dynamics of the device for debridement, with no mention of AI or ML capabilities.
Yes
The device is intended for wound debridement and cleansing of surgical sites, which are therapeutic applications.
No
The device is described as a system for cutting, ablating, and removing tissue and foreign matter from wounds (debridement), not for diagnosing conditions or diseases.
No
The device description explicitly states it consists of a reusable console, foot pedal, and single-use hand pieces, which are hardware components. The system operates via pressurized saline, indicating a physical mechanism, not solely software.
Based on the provided information, the VERSAJET III Hydrosurgery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for cutting, ablating, and removing foreign matter and tissue from wounds and surgical sites via pressurized saline. This is a surgical/procedural application performed directly on the patient's body.
- Device Description: The description details a system that physically interacts with tissue and debris for removal. It describes a console, foot pedal, and handpieces that deliver pressurized saline to the wound.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. The VERSAJET III does not perform any analysis or testing of biological samples in a laboratory setting.
- Anatomical Site: The anatomical sites mentioned (wounds, soft tissue, surgical sites) are locations on the patient's body where a procedure is being performed, not where samples are being collected for analysis.
The VERSAJET III is a surgical device used for debridement and cleansing during medical procedures.
N/A
Intended Use / Indications for Use
The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement:
- wound debridement (acute and chronic wounds, burns),
- soft tissue debridement and cleansing of surgical sites.
Product codes
FQH
Device Description
The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.
The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline 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 foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.
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
physician's judgment
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)
The following tests were completed to prove safety and effectiveness of the subject device, as well as demonstrate substantial equivalence in performance to the predicate device:
- Pressure, Flow Rate and Hand Piece Reliability -
- -Hand Piece Aerosolization & Bacterial Transmission
- -Console Cut-Off Pressure
- -Console Reliability
- -Operating Environment
- -Human Factors Summative Testing
Guidance and Standards Used
- Electrical safety per IEC 60601-1 -
- EMC per IEC 60601-1-2 -
- Human factors per IEC 62366, IEC 60601-1-6 and applicable guidelines listed in FDA Guidance -Document: Applying Human Factors and Usability Engineering to Medical Devices (FDA 2011-D0469)
- -Bench top performance testing including challenge conditions
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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May 16, 2023
Smith & Nephew Medical Limited Zoe Smith Regulatory Affairs Specialist 101 Hessle Road Hull, HU3 2BN United Kingdom
Re: K220964
Trade/Device Name: VERSAJET Hydrosurgery System (III) Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: Class II Product Code: FQH Dated: March 2, 2023 Received: March 2, 2023
Dear Zoe Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
- for Julie A. Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220964
Device Name VERSAJET III Hydrosurgery System
Indications for Use (Describe)
The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement: - wound debridement (acute and chronic wounds, burns),
- soft tissue debridement and cleansing of surgical sites.
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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Traditional 510(k) Premarket Notification - K220964
510(k) Summary (K220964)
| 21 CFR 807.92 (a)(1): Submitter's Information | |
|---|---|
| 510(k) Owner | |
| Name | Smith & Nephew Medical Ltd |
| Address | 101 Hessle Road, Hull, HU3 2BN, United Kingdom |
| Establishment | |
| Registration Number | 8043484 |
| Contact Name | Zoe Smith |
| Telephone Number | +447583672659 |
| Date Prepared | 15th May 2023 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name | |
| (Trade/Proprietary | |
| Name) | VERSAJET III Hydrosurgery System |
| Common Name | Hydrosurgery System |
| Review Panel | General and Plastic Surgery |
| Regulation | |
| Number | 21 CFR 880.5475 |
| Regulatory Class | Class II |
| Product Code | FQH |
| 21 CFR 807.92 | |
| (a)(3): Legally | |
| marketed device to | |
| which equivalence | |
| is claimed | 510(k) Number: K143115 |
| Device Name: VERSAJET II Hydrosurgery System |
21 CFR 807.92 (a)(4): Device Description
The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.
The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline 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 foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.
21 CFR 807.92 (a)(5): Intended Use / Indications for Use
The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement:
-
wound debridement (acute and chronic wounds, burns),
-
soft tissue debridement and cleansing of surgical sites.
4
Traditional 510/k) Premarket Notification - K220
21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices
The technological principle for debridement and cleansing of the surgical site for the VERSAJET III Hydrosurgery System is identical to the predicate device, the VERSAJET II Hydrosurgery System. Both the subject and predicate devices use 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 subject and predicate devices are based on the following same technological elements:
- Consists of two primary components: an electrically (mains) powered console that is reusable equipment, and single-use, sterile disposable handpieces with tubing and pump cartridge.
- -Uses a pressurized stream of sterile fluid to cut, ablate and remove tissue
- -The pressure settings can be adjusted from 1-10 at factory pre-set increments.
The indications for use are similar for the subject and predicate device, although the phrase "pulse lavage irrigation" is removed and the mechanism of action is clarified by the addition of "The VERSAJET III Hydrosurgery System cuts, ablates and removes tissue and foreign matter from wounds via pressurized saline".
There are no technological differences between the subject and predicate devices that raise new questions o safety or efficacy. Only minor modifications have been made to the device to improve reliability and enhance quality.
21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
The following tests were completed to prove safety and effectiveness of the subject device, as well as demonstrate substantial equivalence in performance to the predicate device:
- Pressure, Flow Rate and Hand Piece Reliability -
- -Hand Piece Aerosolization & Bacterial Transmission
- -Console Cut-Off Pressure
- -Console Reliability
- -Operating Environment
- -Human Factors Summative Testing
Guidance and Standards Used
- Electrical safety per IEC 60601-1 -
- EMC per IEC 60601-1-2 -
- Human factors per IEC 62366, IEC 60601-1-6 and applicable guidelines listed in FDA Guidance -Document: Applying Human Factors and Usability Engineering to Medical Devices (FDA 2011-D0469)
- -Bench top performance testing including challenge conditions
21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
No clinical data were provided to support the demonstration of substantial equivalence.
21 CFR 807.92 (b)(3): Conclusions drawn
In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, principle of operation, materials, technology, product specifications and energy requirements of the device. Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the VERSAJET III Hydrosurgery System is substantially equivalent to the predicate device for the intended use.