(345 days)
Not Found
No
The description focuses on mechanical action (pressurized saline streams and vacuum) for debridement and cleansing, with no mention of AI/ML terms or functions.
Yes
The device is described as being used for "wound debridement, soft tissue debridement, and cleansing of the surgical site," which constitutes therapeutic treatment of a condition.
No
This device is for debridement and cleansing of wounds, which are therapeutic actions, not diagnostic ones. It is used in situations where a physician's judgment already indicates its need.
No
The device description clearly outlines physical components: a reusable power console unit and a sterile, disposable pump cartridge, handpiece, and tubing assembly. This indicates a hardware-based system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The HydroCision Debridement System is a surgical tool used to physically clean and remove tissue from wounds. It operates externally on the wound site and does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "wound debridement, soft tissue debridement, and cleansing of the surgical site." This is a therapeutic and cleansing function, not a diagnostic one.
- Device Description: The description details a system that uses pressurized saline streams and vacuum to clean wounds. This is a mechanical process, not an in vitro test.
Therefore, the HydroCision Debridement System falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.
Product codes
FQH
Device Description
The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds. The streams of saline simultaneously wash the tissue surface and vacuum away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound, soft tissue, surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, surgical or medical clinical site
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
Bench testing was conducted to determine device functionality. In addition, a porcine study compared the HydroCision device to the Zimmer Puls-A-Vac II pulsatile lavage device in combination with sharp debridement. The results of this evaluation found both techniques were equally effective in clearing bacterial and particulate contamination from the wounds as examined by quantitative bacteriology and radiographic analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to determine device functionality. In addition, a porcine study compared the HydroCision device to the Zimmer Puls-A-Vac II pulsatile lavage device in combination with sharp debridement. The results of this evaluation found both techniques were equally effective in clearing bacterial and particulate contamination from the wounds as examined by quantitative bacteriology and radiographic analysis.
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.
0
MAR 3 1 2000
HYDROCISION, INC. 100 Burtt Rd, Suite G01 Andover, MA 01810
510K Summary HydroCision, Inc. Debridement System
Sponsor Name 1. HydroCision, Inc 100 Burtt Road, Suite GO1 Andover, MA 01810 Telephone: 978 474-9300 Contact Individual: Debbie Iampietro
2. Device Name
Proprietary Name: HydroCision Debridement System Common/Usual Name: pulse lavage with sharp debridement Classification Name: unclassified
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- Identification of Legally Marketed Device
The HydroCision, Inc Debridement System is substantially equivalent in intended use to the Stryker Corporation Interpulse Pulse Lavage System (K972069) in combination with sharp debridement. The intended use is also the same as the Zimmer Pulsavac Wound Debridement System in combination with sharp debridement.
- Identification of Legally Marketed Device
It is also substantially equivalent in design, materials and construction to its own ArthroJet System cleared under K982266.
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- Device Description
The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds. The streams of saline simultaneously wash the tissue surface and vacuum away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose:
- Device Description
-
the reusable power console unit t
-
t the sterile, disposable pump cartridge, handpiece and tubing assembly
1
Intended Use
The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.
6 Comparison of Technological Characteristics
The HydroCision. Inc Debridement System is substantially equivalent in intended use to the Stryker Corporation Interpulse Pulse Lavage System (K972069) in combination with sharp debridement. This device is intended for wound debridement, soft tissue debridement, and cleansing of the surgical or medical clinical site. The device helps to remove blood, tissue debris and foreign matter from the operative or wound site. The intended use is also the same as the Zimmer Pulsavac Wound Debridement System in combination with sharp debridement. It is also substantially equivalent in design, materials and construction to its own ArthroJet System cleared under K982266.
The devices have similar flow rates and power requirements. The components of each system are similar in that they each contain: a reusable power console unit, a sterile. disposable pump cartridge, a handpiece assembly, and a tubing set
6. Performance Testing
Bench testing was conducted to determine device functionality. In addition, a porcine study compared the HydroCision device to the Zimmer Puls-A-Vac II pulsatile lavage device in combination with sharp debridement. The results of this evaluation found both techniques were equally effective in clearing bacterial and particulate contamination from the wounds as examined by quantitative bacteriology and radiographic analysis.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.
MAR 3 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debbie Iampietro Regulatory Affairs Hydrocision, Inc. 100 Burtt Road, Suite G01 Andover, Massachusetts 01810
Re: K991383 Trade Name: HydroCision Inc. Debridement System Regulatory Class: II Product Code: FQH Dated: January 7, 2000 Received: January 10, 2000
Dear Ms. Iampietro:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Debbie Iampietro
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stypt Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment b
510(k) Number K991383
HydroCision Inc. Debridement System Device Name:
Indications For Use:
The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph Edwards
(Division Sigh-Off) Division of General Restorative Devices K991383 510(k) Number _
Prescription Use
OR
Over-The-Counter Use