The HydroCision ArthroJet System with Cautery, TurboBurr and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.

Device Description

The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces with curette. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.

AI/ML Overview

This 510(k) summary describes a modification to an existing medical device, the HydroCision ArthroJet System. The primary focus of the document is to demonstrate substantial equivalence to a predicate device, rather than to establish new acceptance criteria through a comprehensive clinical study.

Therefore, many of the typical elements of an acceptance criteria and study report for a novel medical device are not applicable or explicitly stated in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Functionality with Added Curette: The modified device must perform its intended functions (cutting, ablation, removal of tissue/bone, control of bleeding) effectively and safely with the addition of the curette.	Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements. The FDA determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use, implying that its performance with the curette is acceptable and meets the expected safety and efficacy profile of similar devices. The document does not provide specific quantitative performance metrics (e.g., cutting rates, tissue removal efficiency, precision).
Substantial Equivalence: The modified device must be substantially equivalent to the predicate device (HydroCision ArthroJet System with Cautery and TurboBurr, K020688) in terms of intended use, technological characteristics, and performance.	Both the current and modified devices: - Have the same intended use (resection of tissue and bone in orthopedic procedures). - Use the same fundamental scientific technology (reusable power console, fluid jet technology, mechanical cutting, bipolar electrocautery, sterile disposable components). The primary difference is the addition of a Curette tool to the distal end of direct fluidjet handpieces. The FDA's 510(k) clearance confirms the determination of substantial equivalence.
Conformance to Design Input Requirements: All aspects of the device, including the new curette, must meet pre-defined design specifications.	Bench and cadaver testing were conducted to determine conformance to design input requirements. No specific failures or deviations are reported, implying successful conformance.
Safety: The device, including the modified components, must be safe for its intended use.	The FDA clearance letter implies that based on the provided information, the device meets the general controls provisions of the Act related to safety. No specific safety risks or mitigations are detailed in the provided text. Bench and cadaver testing would implicitly include safety assessments.

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

Sample Size for Test Set: The document states "Bench and cadaver testing were conducted." It does not specify the sample size for either the bench or cadaver tests (e.g., number of cadavers, number of tests performed on bench).
Data Provenance: The testing was conducted by HydroCision, Inc. (device sponsor). The location of the cadaver testing is not specified, nor is the country of origin. The study is retrospective in the sense that the data was generated specifically for this 510(k) submission, not from ongoing clinical use. It's not a prospective clinical trial.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For bench and cadaver testing of a surgical instrument, "ground truth" would likely be established through objective measurements (e.g., precise cuts, complete tissue removal, lack of damage to adjacent structures) assessed by engineers and potentially observed by or conducted under the guidance of orthopedic surgeons. However, this is not explicitly stated.

4. Adjudication Method for the Test Set

Given the nature of bench and cadaver testing for a surgical instrument, a formal "adjudication method" in the sense of multiple independent reviewers of diagnostic images is unlikely. Performance would typically be objectively measured against engineering specifications and clinical requirements. The document does not describe any formal adjudication method for the test results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images. This document describes a surgical tool, and the testing outlined (bench and cadaver) is focused on device functionality and safety, not on human interpretation of data.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Yes, in essence. The "Performance Testing" section states "Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements." This testing assesses the device's performance directly, independent of the human-in-the-loop performance in a clinical scenario (though a surgeon would operate it). It evaluates the inherent capabilities of the device itself. This is a standalone performance assessment in the context of a surgical instrument.

7. Type of Ground Truth Used

The ground truth for the bench and cadaver testing would be based on objective performance metrics and observations as defined by engineering specifications and surgical requirements. This would include:
- Successful completion of specified tasks: e.g., removal of tissue, drilling of bone to a certain depth/shape.
- Absence of mechanical failure: e.g., burr breaking, curette bending.
- Controlled application of energy: e.g., effective cautery without excessive thermal damage.
- Achieving desired surgical effects: e.g., smooth bone surfaces, clean tissue resection.
- These are akin to "functional ground truth" and "safety ground truth." It is not based on pathology, expert consensus on diagnostic interpretation, or long-term clinical outcomes data in the way a diagnostic device might be.

8. Sample Size for the Training Set

The document does not refer to a "training set." This terminology is common in machine learning and AI device development. This device is a mechanical surgical tool, not an AI/ML-driven device. Therefore, the concept of a training set as used in AI development is not applicable here.

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

As there is no "training set" for this mechanical device, this question is not applicable.

Summary

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

510K Summary of Safety and Effectiveness August 8, 2003 ArthroJet System with Cautery, TurboBurr, and Curette A Modification to the ArthroJet System with Cautery and TurboBurr

K032529

1. Sponsor Name

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

Device Name 2.

Proprietary Name: ArthroJet System with Cautery, TurboBurr, and Curette Common/Usual Name: Arthroscope and Accessories Classification name: Arthroscope and Accessories

Identification of Legally Marketed Device 3.

The modified HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is substantially equivalent in intended use to the HydroCision ArthroJet System with Cautery and TurboBurr (K020688).

Device Description 4.

1. Intended Use
  The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of

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soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.

1. Comparison of Technological Characteristics Both the current and modified devices:
- A. Have the same intended use

Both are intended for resection of tissue and bone in open and minimally invasive orthopedic procedures.

B. Use the same fundamental scientific technology
- a reusable power console unit
- fluid jet technology .
- mechanical cutting using sharpened steel .
- bipolar electrocautery .
- a sterile, disposable pump cartridge, handpiece and tubing assembly ● comprised of two principal components:
  - a high pressure fluid conduit with integral fluidjet nozzle .
  - a low pressure collection tube. .

The differences between the proposed HydroCision ArthroJet System with Cautery, Turbo Burr and Curette and the current HydroCision ArthroJet System with Cautery and TurboBurr (K020688) are:

Addition of Curette tool to the distal end of direct fluidjet handpieces 康
1. Performance Testing

Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, with three horizontal lines above it. The symbol is stylized and modern, representing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

HydroCision, Inc. c/o Ms. Debbie Iampietro ORC Consulting 7 Tiffany Hopkinton, MA 01748

Re: K032529

Trade/Device Name: HydroCision ArthroJet System with Cautery, TurboBurr and Curette Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 8, 2003 Received: August 21, 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. Iisting 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. 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 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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510(k) Number (if known): K032529

HydroCision ArthroJet System with Cautery, TurboBurr and Curette Device Name:

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
(Per 21 CFR 801.109) ✓

Over-The-Counter Use - - - -

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K032529 510(k) Number_

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.