The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.

Device Description

The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. The HydroCision ArthroJet System with Cautery uses the same system as the FDA approved HydroCision ArthroJet System (K982266) with the addition of a bipolar cauterization function at the distal tip of the handpiece. The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p). The ArthroJet System with Cautery operates in a saline or Ringer's Lactate environment. The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.

AI/ML Overview

The HydroCision ArthroJet System with Cautery is a surgical device designed for cutting, tissue removal, and electrocauterization in articular body cavities. The 510(k) summary indicates that its substantial equivalence to predicate devices, rather than comprehensive performance studies with acceptance criteria, was the primary basis for its clearance.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a study. Instead, it relies on demonstrating substantial equivalence to existing legally marketed devices and compliance with voluntary standards.

Acceptance Criteria (Not explicitly stated, inferred from 510(k) process)	Reported Device Performance (as per document)
Safety and Effectiveness (Inferred)	"substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421)." "It is also substantially equivalent to the ArthroCare Electrosurgery System (K961323)..."
Functionality (Cutting and Tissue Removal)	"provides the same functions as the first predicate device, the HydroCision ArthroJet System (K982266)." "Both are used in arthroscopy to cut and remove tissues."
Functionality (Electrocauterization)	"provides the additional electrocautery function using bipolar energy to cauterize small vessels." "The electrocautery function and its intended use is the same as that provided by the Valleylab Electrosurgical Pencil (K861112)/Electrode (K791638) and the Kirwan Suction Coagulator (K965421)."
Compliance with Standards	"complies with the following voluntary standards: ANSI/AAMI HF18-1993, IEC 60601-2"
Compatibility	"compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p)."
Environmental Operation	"overates in a saline or Ringer's Lactate environment."
Protection from Electrical Hazards	"The hand piece and electrical connections are protected from the possibility of shorting should spillage of conductive fluid onto the unit occur."

2. Sample Size Used for the Test Set and Data Provenance

The document does not report any specific test set sample sizes or data provenance from a clinical study for the HydroCision ArthroJet System with Cautery. The clearance is based on substantial equivalence to predicate devices, which implies that the safety and effectiveness of the existing predicate devices provide the basis, rather than new clinical data from this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study involving a test set and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a surgical tool, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and AI assistance are irrelevant to its clearance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of the predicate devices. The device's performance is gauged against the functionalities and characteristics of these predicates.

8. The Sample Size for the Training Set

This information is not applicable as the document does not describe a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as the document does not describe a training set.

In summary, the 510(k) clearance for the HydroCision ArthroJet System with Cautery was primarily based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials with detailed performance data, acceptance criteria, or ground truth establishment as would be seen for new diagnostic or AI-driven systems. The focus was on comparing the new device's intended use, technological characteristics, and safety profiles to those of the predicates, along with compliance with relevant voluntary standards.

Summary

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OCT 2 5 1999

HYDROCISION, INC. 220 Ballardvale Street Wilmington, MA 01887 (978) 657- 0020

510K Summary

K993009

Sponsor Name HydroCision, Inc. 220 Ballardvale Street Willmington, MA 01887 978 657 0020

Device Name

Proprietary Name: HydroCision ArthroJet System with Cautery Common/Usual Name: Arthroscope and accessories Electrosurgical Cutting and Coagulation Device and Accessories Classification Name: Arthroscope and accessories Electrosurgical Cutting and Coagulation Device and Accessories

Identification of Predicate or Legally Marketed Device 3. The HydroCision ArthroJet System with Cautery substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421). It is also substantially equivalent to the ArthroCare Electrosurgery System (K961323) in that the ArthroCare unit provides all the above functions in the same unit and handpiece.

4. Device Description

The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p).

HydroCision Arthrojet System with Cautery 510K Summary Page 1 of 3

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HYDROCISION, INC. 220 Ballardvale Street Wilmington, MA 01887 (978) 657- 0020

The ArthroJet System with Cautery overates in a saline or Ringer's Lactate environment. These typical arthroscopic irrigation fluids are conductive and serve as a path for the electrical energy to return to the generator, as described. The hand piece and electrical connections are protected from the possibility of shorting should spillage of conductive fluid onto the unit occur.

The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.

Intended Use న్.

The intended use of the HydroCision ArthroJet System with Cauterv is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.

6. Comparison of Technological Characteristics

The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. It is substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266), the Valleylab Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421). It is also substantially equivalent to the ArthroCare Electrosurgery System (K963123) in that the ArthroCare unit provides all the above functions in the same unit and handpiece.

The HydroCision ArthroJet System with Cautery provides the same functions as the first predicate device, the HydroCision ArthroJet System (K982266). Both are used in arthroscopy to cut and remove tissues. They are the same device, with the exception that the HydroCision ArthroJet System with Cautery provides the additional electrocautery function using bipolar energy to cauterize small vessels that ooze during surgery. The electrocautery function and its intended use is the same as that provided by the Valleylab Electrosurgical Pencil (K861112)/Electrode (K791638) and the Kirwan Suction Coagulator (K965421).

HydroCision Arthrojet System with Cautery 510K Summary Page 2 of 3

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HYDROCISION, INC. 220 Ballardvale Street Wilmington, MA 01887 (978) 657- 0020

The mechanical action of the ArthroCare Electrosurgery System is different but it has been included as a predicate device to demonstrate the basis for a multiple function handpiece used for arthroscopic and general surgery.

1. Performance Testing
  The ArthroJet System with Cautery adds a cauterization function to the original HydroCision ArthroJet System (K982266).

HydroCision Inc. ArthroJet System with Cautery complies with the following voluntary standards:

ANSI/AAMI HF18-1993 IEC 60601-2

HydroCision Arthrojet System with Cautery 510K Summary Page 3 of 3

00063

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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three wavy lines, resembling a symbol or logo. The overall design is simple and official-looking.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 25 1999

Ms. Debbie Iampietro Consultant HydroCision, Inc. 220 Ballardvale Street Wilmington, Massachusetts 01887

Re: K993009 Trade Name: HydroCision ArthoJet System with Cautery Regulatory Class: II Product Code: HRX Dated: August 31, 1999 Received: September 7, 1999

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 vour 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,

Calix M. Witter, Ph.D., M.D.

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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510(k) Number (if known): K993009

HydroCision ArthroJet System with Cautery Device Name:

Indications For Use:

The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K993009	000010
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Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.