HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM by HYDROCISION, INC.

The intended use of the HydroCision General Surgery FluidJet System is for the tangential cutting, resection and removal of soft tissue or fluid from the body. HydroCision General Surgery FluidJet System is not intended for use in suction lipoplasty procedures.

Device Description

The HydroCision General Surgery FluidJet System uses a pressurized stream of sterile saline to lavage and clean wounds. 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 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.

AI/ML Overview

This 510(k) premarket notification for the HydroCision General Surgery FluidJet System does not contain the level of detail required to answer your questions about acceptance criteria and study design for Artificial Intelligence (AI) / Machine Learning (ML) enabled devices.

Here's why and what information is missing:

The document describes a medical device called the "HydroCision General Surgery FluidJet System" which is a surgical instrument using a pressurized stream of sterile saline. This is a mechanical device, not an AI/ML powered device. The "performance testing" mentioned refers to traditional engineering and biological tests, not AI model evaluation.

Therefore, for this specific document, I cannot provide the requested information about acceptance criteria and study details for an AI-powered device.

To answer your questions for an AI/ML device, the input document would need to include information such as:

Quantitative performance metrics: Specific thresholds for sensitivity, specificity, AUC, F1-score, accuracy, etc.
A "study" section detailing the evaluation of an AI algorithm. This would typically involve:
- Descriptions of training and test datasets.
- Ground truth establishment methods.
- Expert involvement in ground truth and/or reading studies.
- Details of any comparative effectiveness studies (e.g., MRMC).
- Reporting of standalone performance.

Without an AI component in the described device, the concept of "acceptance criteria" as you've framed it (referring to AI performance) and an AI-specific study is not applicable to this document.

Summary

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MAY - 9 2003

HydroCision 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Fax: 978-474- 5037

510K Summary of Safety and Effectiveness HydroCision, Inc. General Surgery FluidJet System April 26, 2003 K021813

Sponsor Name HydroCision, Inc 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Contact Individual: Debbie Iampietro
Device Name

Proprietary Name: HydroCision General Surgery FluidJet System Common/Usual Name: Surgical Instrument

Classification Name: Surgical Instrument, AC Powered motors and accessories, Class II - General Surgery Devices 21 CRF 878. 4820 Procode 87HWE

Identification of Legally Marketed Device 3.
The HydroCision General Surgery FluidJet System is substantially equivalent to the following devices:
HydroCision Debridement System, K011612 O
o . Xomed XPS Power Sculpt, K992855
Andreas Pein, GMBH, Helix HydroJet, K012464 O
ValleyLab, Force 2 Electrosurgical Generator K844403 O

HydroCision, Inc. 100 Burtt Road G01, Andover, MA 01810 Telephone (978) 474-9300 · Fax (978) 474-5037 www.hydrocision.com

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Image /page/1/Picture/0 description: The image shows the logo for HydroCision. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "The Leader in Hydrosurgery" in a smaller font. The logo also includes a registered trademark symbol and a trademark symbol.

Device Description 4.
The HydroCision General Surgery FluidJet System uses a pressurized stream of sterile saline to lavage and clean wounds. 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 system employs two basic system components to achieve this purpose:
. the reusable power console unit
the sterile, disposable pump cartridge, handpiece and tubing ● assembly
1. Intended Use

6 Comparison of Technological Characteristics
The HydroCision, Inc General Surgery FluidJet System is identical in function and technology and design to the currently marketed HydroCision, Inc Debridement System (K011612). The components of the General Surgery FluidJet System and the Debridement systems are identical in that they each contain: a reusable power console unit, a sterile, disposable pump cartridge, a handpiece assembly, and a tubing set.

The components and mechanism of action of the HydroCision General Surgery FluidJet System and the Xomed device are different in that the Xomed unit operates on suction while the General Surgery FluidJet System operates on water energy.

The Helix HydroJet also operates on water energy but with slightly different handpieces.

1. Performance Testing
  Bench testing, biocompatibility and animal testing were conducted to determine device functionality and conformance to design input requirements.

HydroCision, Inc. 100 Burtt Road G01, Andover, MA 01810 Telephone (978) 474-9300 · Fax (978) 474-5037 www.hydrocision.com

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

Ms. Debbie Iampietro HydroCision, Inc. 100 Burtt Road, Suite G01 Andover, Massachusetts 01810

Re: K021813

Trade/Device Name: HydroCision General Surgery FluidJet System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQH Dated: February 14, 2003 Received: February 24, 2003

Dear Ms Iampietro:

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 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.

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Page 2 - Ms. Debbie Iampietro

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 (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for HydroCision. The logo is in black and white and features the company name in a stylized font. Below the company name is the tagline "The Leader in Hydrosurgery" in a smaller font. There is a registered trademark symbol next to the company name.

510(k) Number (if known): __ KO2/ K13_________________________________________________________________________________________________________________________________________

Device Name:

HydroCision General Surgery FluidJet System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR ಲಿ Over-The-Counter Use _______________ (Per 21 CFR 801.109) on Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K021813

HydroCision, Inc. 100 Burtt Road G01, Andover, MA 01810 Telephone (978) 474-9300 · Fax (978) 474-5037 www.hydrocision.com

Regulation Number and Section

§ 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.