The Helix Hydro-Jet is intended for the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as endoscopic surgery.

Device Description

The Helix Hydro-Jet is a hydraulic pressure delivery system that uses physiological saline to cut and dissect soft tissue.

AI/ML Overview

The provided 510(k) summary for the ERBE Helix Hydro-Jet describes the device's intended use and provides supporting documentation for an expansion of its indications to include neurosurgery. However, it does not present a formal table of acceptance criteria or a structured study designed to demonstrate performance against those criteria in a quantitative, statistical manner as would typically be seen for a new device or a more strictly defined performance claim.

Instead, the document relies on scientific and clinical literature to support the safety and effectiveness of the device for the expanded neurosurgical use. The "acceptance criteria" can be inferred from the reported findings about the device's performance in these studies.

Here's an attempt to structure the information based on your request, understanding that some aspects will be inferred or noted as "not applicable" given the nature of the submission (an expansion of intended use for an already cleared device, supported by existing literature rather than a de novo clinical trial with pre-defined statistical endpoints).

Acceptance Criteria and Device Performance

A formal table of acceptance criteria with specific quantitative thresholds is not explicitly provided in the submission. The "acceptance" of the device for expanded use in neurosurgery is based on qualitative findings from animal and human studies demonstrating its safety and efficacy.

Acceptance Criterion (Inferred)	Reported Device Performance
Safety: Minimal damage to surrounding tissues.	In neurosurgery, less tissue necrosis and edema can reduce post-operative neurological symptoms.
Safety: Preservation of critical structures.	The water jet is a non-thermal, selective instrument which preserves structures with higher fibrin content such as vessels, nerves, and ducts (including arachnoid membranes). Spared vessels as small as 0.3 mm (at 3-7 bars). Dissection of tissue without damage to the arachnoid membranes.
Safety: Reduced blood loss.	Sparing of vessels can result in less blood loss.
Safety: Absence of thermal damage.	Non-thermal modality. No thermal damage to surrounding tissue.
Safety: No increased risk of infection or tumor spreading.	Current results do not support the complications of a higher risk of infection, an increase of tumor recurrence, or tumor spreading.
Effectiveness: Accurate and successful dissection.	Applicable to malleable soft tissues (brain parenchyma or tumors). Cuts were extremely sharp and precise. Linear relationship between pressure and penetration depths established. Easy to handle.
Effectiveness: Precision in vital areas.	Efficacious in soft tissue dissection near vital structures where precision and less tissue trauma is paramount.
Effectiveness: Selective dissection.	Selective instrument that preserves structures with higher fibrin content due to its selectivity based on solidity/density. Optimal nozzle size (120 um) and technique virtually eliminated clogging/foaming.
Comparative Effectiveness (vs. CUSA): Reduced trauma.	Less edema formation and less intense microglial and astroglial reaction in rabbits. Less traumatic than ultrasonic aspirator.
Comparative Effectiveness (vs. CUSA): Specific advantages.	Enabled brain parenchyma tissue dissection and vessel coagulation without thermal damage. Dissection of tissue without damage to arachnoid membranes, where CUSA could not achieve these benefits.

Study Details

The submission consolidates findings from various scientific and clinical investigations, rather than presenting a single, dedicated pivotal study.

Sample size used for the test set and the data provenance:
- Animal Studies:
  - Porcine brain cadaveric tissue: Unspecified number of cadavers.
  - Rabbit Studies: 55 rabbits.
  - Provenance: Not explicitly stated, but likely from European research given the context of German industry (ERBE) and some phrasing. Retrospective (literature review findings).
- Human Studies:
  - Helix Hydro-Jet in general: Largest patient population reported was 75 patients (with various brain tumors and epilepsy).
  - Helix Hydro-Jet vs. CUSA: 102 humans.
  - Provenance: These appear to be findings from published literature, so retrospective. Country of origin not specified for all studies, but potentially European data given the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is based on observed surgical outcomes, pathological examination of tissues, and clinical assessments reported in published studies, rather than a separate expert consensus process for a new test set. The authors of the referenced studies and the practicing surgeons are the implicit experts.
Adjudication method for the test set: Not applicable. This was a review of existing scientific literature and clinical experience, not a de novo study with adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The comparative effectiveness assessment was against the Cavitational Ultrasonic Surgical Aspirator (CUSA) based on reported clinical outcomes and pathological findings from existing studies, not a reader-based MRMC study comparing human performance with and without AI.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a surgical tool, not an algorithm. Performance is inherently tied to human use.
The type of ground truth used:
- Animal Studies: Pathological examination of tissue (e.g., for necrosis, edema, microglial/astroglial reaction, vessel sparing, cut precision). Direct observation of dissection attributes (e.g., clogging, foaming, penetration depth).
- Human Studies: Clinical outcomes (e.g., post-operative neurological symptoms, blood loss, efficacy of dissection, ease of handling, absence of thermal damage, incidence of infection/recurrence). Pathological assessment from resected tissues or biopsies.
The sample size for the training set: Not applicable. This is a medical device, and the "training" refers to the development and refinement of the device attributes based on historical experience and testing, not a machine learning training set. The various animal and early human studies would have informally contributed to understanding the device's characteristics to refine its design and use.
How the ground truth for the training set was established: Not applicable in the machine learning sense. The "ground truth" for device development and refinement (the informal "training set") would have been established through iterative experimental results, surgeon feedback, and pathological analysis during the device's initial development and subsequent iterations, leading to features like the 120 µm nozzle and recommended pressure ranges.

Summary

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JAN 3 0 2004

510K SUMMARY

033590

ERBE USA, Inc. Submitted By: 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577

John Tartal Contact Person:

11/11/03 Date Prepared:

Water Jet Dissector Common Name:

Helix Hydro-Jet™ Trade/Proprietary Name:

Classification Name: Jet Lavage (21CFR880.5475)

FQH Product Code:

Legally Marketed Device: Helix Hydro-Jet

Note: This 510(k) is being submitted to expand the intended use for the Helix Hydro-Jet.

Device Description:

The Helix Hydro-Jet is a hydraulic pressure delivery system that uses physiological saline to cut and dissect soft tissue. A very detail description of the system can be found in the initial 510(k), Number K012464, Device Description 1-1.

Note: A summary of design control activities, risk analysis, verifications/validations, and biocompatibility can also be found respectively in Sections 4-1, 5-1, 6-1, 9-1, and 8-1 of the initial 510(k). Also, certifications and the declaration of conformity are in the first 510(k) Appendices A and B respectively.

Intended Use:

Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):

The modified device is the same as the predicate except for slight modifications to the unit's suction connector/tubing as well as the suction container and bag since the last 510(k) submission (K022613). The suction connector/tubing was change so that only

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510K SUMMARY

the tubing for the suction container/bag could be connected. Also, the confainer and bag were made larger from a 1,000 ml to 2,000 ml capacity (dimensional/size change). Changes to the label and labeling are apart of this submission (See IV-4 to IV-48). The suction connector/tubing, container, and bag were verified/validated in design control. Risk analysis also has been performed with regards to changing the part, component, and accessory.

The significant change involves the expansion of the indications as follows.

Addition of using the device to cut and dissect soft tissue in neurosurgery.

The change to the intended use is supported by scientific documentation provided in this Section as a part of Clinical Evaluations (See III-9).

Conclusion:

All available/known studies involving the Helix Hydro-Jet and like water jet equipment in conjunction with the expanded intended use has been provided in this submission (Note: An exhaustive literature search was performed.). The water jet is a non-thermal, selective instrument which preserves structures with higher fibrin content such as vessels, nerves, and ducts (including arachnoid membranes). With its accuracy and non-thermal modality damage to surrounding tissues is minimized. As a result, in neurosurgery less tissue necrosis and edema can reduce post-operative neurological symptoms. Furthermore, sparing of vessels can result in less blood loss. The clinical documentation provided demonstrates that the Helix Hydro-Jet may be used safely and effectively to cut/dissect soft tissue in neurosurgery. Summary of the studies are as follows.

Animal Studies

In experimental trials with porcine brain cadaveric tissue, scientists investigated nozzle sizes, pressures, penetration depths (based upon cutting distance and speed), and effects on various brain tissues. As a result, the attributes of the hand piece were better defined. The optimal size of the nozzle/helical water jet stream was found to be 120 um (Note: Current attribute of Helix Hydro-Jet Applicators) and with better technique as well as use of suction, clogging of an applicator and foaming at the surgical site obscuring visibility was virtually eliminated. Also with this jet stream size, linearity in regard to pressure and penetration depths was established. The studies showed brain parenchyma was well dissected using 3 to 12 bars (43.5 to 174 psi). Cuts were extremely sharp and precise. In surrounding tissue no disruption or vacuolization was seen. Depth of penetration was determined to be depended upon the density/consistency of the tissue dissected and ranged from 3 to 19 mm. Vessels as small as 0.3 mm were found to be spared between 3 and 7 bars (43.5 to 101.5 psi).

Human Studies

The Helix Hydro-Jet was used on patients with various brain tumors (e.g., gliomas, metastastic lesions, meningiomas, etc.) and epilepsy (Note: Published literature largest patient population was 75.). In general; the applicators were easy to handle,

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510K SUMMARY

dissections (separation and removal) were accurate/successful on malleable soft tissues (brain parenchyma or tumors), vessels in some cases were spared up to 25 bars (362.5 psi), and there was no thermal damage to surrounding tissue. In particular, the device was found to be efficacious in soft tissue dissection near vital structures where precision and less tissue trauma is paramount. However, due to the advantage of being selective based upon solidity/density, the device becomes harder to use on firmer masses or structures (e.g., to dissect tumor capsules, separate/remove dense tumors, cut fibrous appendages like trabecular structures, etc.). As a result, this issue was addressed as a precaution in the User Manual. Nonetheless, the Helix Hydro-Jet showed to be an effective tool and should be included in the neurosurgical armamentarium (Note: The higher risks of infection or tumor spreading due to the almost permanent water rinsing has been raised as a possible potential disadvantages of the device. However, current results do not support the complications of a higher risk of infection, an increase of turnor recurrence, or tumor spreading.).

Investigations Comparing Helix versus CUSA

Tissue trauma after neurosurgical procedures on 55 rabbits was investigated respectively with the Helix Hydro-Jet and Cavitational Ultrasonic Surgical Aspirator (CUSA). Neurosurgery was performed on the animals, and then they were sacrificed at various time points for tissue examination. At all time points, there was less edema formation as well as less intense microglial and astroglial reaction in neurological tissues of rabbits operated on with the Helix Hydro-Jet in comparison to the CUSA. As a result, the water jet has to be considered as less traumatic than the ultrasonic aspirator. Furthermore the Helix Hydro-Jet was compared to CUSA in neurosurgery on 102 humans. The Helix Hydro-Jet was used in combination with conventional methods in tissue dissection and aspiration. In comparison with CUSA, there were two specific advantages with the Helix Hydro-Jet (1) The waterjet enabled brain parenchyma tissue dissection and vessel coagulation without thermal damage to the remaining tissue as well as (2) dissection of tissue without damage to the arachnoid membranes. CUSA could not achieve these accolades concluding that in certain conditions the waterjet is more suitable.

In conclusion, the use of the Helix Hydro-Jet on soft tissue in neurosurgery was found to be safe and effective.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 5 0 2004

Mr. John Tartal Manager, Quality Assurance/Regulatory Affairs ERBE USA, Inc. 2225 Northwest Parkway Marietta, Georgia 30067

Re: K033590

Trade/Device Name: ERBE Helix Hydro-JetTM Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQII Dated: November 11, 2003 Received: November 10, 2003

Dear Mr. Tartal:

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 he 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 CHR 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 - Mr. John Tartal

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.

Sincerely yours,

Mark N Melkersen

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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Indications for Use

510(k) Number (If Known): K033590

Device Name: ERBE Helix Hydro-Jet™

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

fo Mark A. Milliken

Rossuration 3

K033590

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.