The Helix Hydro-Jet is intended for the cutting and dissection of soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as laparoscopic 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 text describes a 510(k) submission for a medical device called the Helix Hydro-Jet™, a water jet dissector. This submission focuses on expanding the intended use of the device and adding supporting applicators, rather than introducing a completely new device. As such, the information typically found in studies proving device performance against acceptance criteria for novel devices is not present. Instead, the submission relies on demonstrating substantial equivalence to a predicate device and providing scientific documentation to support the expanded indications for use.

Therefore, many of the requested categories (acceptance criteria, reported device performance, sample sizes used for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) cannot be directly extracted from the provided text for a de novo device performance study.

However, I can extract information related to the device and its intended use, and discuss how the justification for the expanded use is presented.

Here's a breakdown of what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance (as inferred from the context of a 510(k) submission for expanded use):

For a 510(k) submission seeking an expanded indication for an already cleared device, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating that the modifications (expanded use, new applicators) do not adversely affect the safety or effectiveness, and that the device remains substantially equivalent to the predicate. The performance is assessed relative to its established safety and efficacy for the original indications, with specific attention to the new use cases.

Acceptance Criteria (Inferred for Expanded Use)	Reported Device Performance (as presented in the summary)
Safety: Device modifications and expanded use must not introduce new, unacceptable risks or increase existing risks.	"The modified structural and dimensional features of the added applicators do not adversely affect the safety or effectiveness of the Helix Hydro-Jet." (Conclusion statement)
Effectiveness: Device must continue to perform its intended cutting and dissection function effectively in the expanded use cases (Total Mesorectal Excision and laparoscopic surgery).	"The clinical documentation provided demonstrates that the Helix Hydro-Jet may be used safely and effectively to cut/dissect soft tissue that is in close proximity of the abdomen [Note: Shown by use in Total Mesorectal Excision (TME)]. The evaluations also show that system can be used in laparoscopic procedures for the target tissues with regards to safety and efficacy." (Conclusion statement)
Substantial Equivalence: The modified device must be substantially equivalent to a predicate device, particularly regarding its safety and effectiveness for the expanded indications.	"The modified device is the same as the predicate except for a slight expansion of the intended use and the addition of supporting applicators." (Similarities and Differences) "All available/known studies involving the Helix Hydro-Jet and like water jet equipment in conjunction with the expanded intended use have been provided..." "The use of the Helix Hydro-Jet in TME was found to be better in comparison to other approved equipment. Greater visibility and tissue selectivity with the water jet system." (Conclusion statement)
Applicator Performance: New applicators must function as intended and safely support the expanded indications.	"The applicators have been verified/validated in design control. Risk analysis also has been performed with regards to the features." (Similarities and Differences)

Detailed Information on Studies (Based on Provided Text):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "All available/known studies involving the Helix Hydro-Jet and like water jet equipment in conjunction with the expanded intended use have been provided in this submission." This suggests a reliance on existing literature and clinical evaluations rather than a newly conducted, specific clinical trial with a defined sample size for this 510(k).
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be "clinical evaluations" and references to "scientific documentation" provided in Section 111-9 (which is not included in the provided text). The mention of "Total Mesorectal Excision (TME)" suggests clinical application in surgical settings. It is likely a combination of retrospective analyses of existing clinical data and literature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The clinical evaluations mentioned likely involved expert surgeons or medical professionals, but their number and specific qualifications are not detailed in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of a 510(k) for expanded use, it's unlikely a formal adjudication process akin to image-based diagnostic studies was performed. The "clinical evaluations" and "scientific documentation" would have been reviewed by the submitter and then by the FDA.
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:
- No. This is not an AI-assisted diagnostic device. The device is a surgical tool. The text mentions: "The use of the Helix Hydro-Jet in TME was found to be better in comparison to other approved equipment. Greater visibility and tissue selectivity with the water jet system." This indicates a comparative assessment, but not an MRMC study in the context of diagnostic performance or AI assistance. The "effect size" is qualitative (better visibility, tissue selectivity) rather than a quantitative measure of improved human performance with AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For surgical devices, "ground truth" for effectiveness often relates to surgical outcomes, successful tissue dissection, minimal collateral damage, and patient recovery. For safety, it would involve complication rates. The text refers to "clinical documentation" and "evaluations" demonstrating safety and efficacy, implying clinical observations and potentially pathology reports on excised tissue, as well as patient outcomes. Specific details are not provided.
The sample size for the training set:
- Not applicable in the context of device performance studies presented here. "Training set" typically refers to machine learning algorithms. The device's design and engineering would have gone through verification and validation activities (mentioned in the "Device Description" as being in the previous 510(k) K012464, Section 6-1), but this isn't a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable.

Summary

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510K SUMMARY

Submitted By:

ERBE USA, Inc. 2225 Northwest Parkway Marietta, GA 30067

Tel: 770-955-4400 Fax: 770-955-2577

OCT 2 5 2002

022613

John Tartal Contact Person:

08/05/02 Date Prepared:

Common Name: Water Jet Dissector

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 modestly expand the intended use for the Helix Hydro-Jet. There are three additional applicators in this 510(k) that would support the added indications. They were also included in the previous 510(k) [K012464] but were removed when the intended use was limited.

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 previous 510(k), 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 previous 510(k). Also, certifications and the declaration of conformity are in the former 510(k) Appendices A and B respectively.

Intended Use *:

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

*Modified 10/18/02 per request by FDA.

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510K SUMMARY

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 a slight expansion of the intended use and the addition of supporting applicators.

The difference to the indication is:

1. Cutting and dissection of soft tissue in the abdomen including Total Mesorectal Excision (TME)* {Change from just using the device in the Abdomen} and
1. Laparoscopic use in treating the target tissue (Change from just using the device in open surgerv).

The modest change to the intended use is supported by scientific documentation provided in this Section as apart of Clinical Evaluations (See 111-9).

Collectively the added applicators are different in that:

1. One of the applicators has a handle and a flexible tip,
1. The maximum cannula length changed from 300 to 336 mm, and
1. One of the applicators has a hook.

The additional features in having a handle, flexible tip, hook, and/or being slightly longer provide surgeon's applicators that would especially be useful in hard to reach areas as well as for laparoscopic use in or near the abdomen. The applicators have been verified/validated in design control. Risk analysis also has been performed with regards to the features.

Conclusion:

All available/known studies involving the Helix Hydro-Jet and like water jet equipment in conjunction with the expanded intended use have been provided in this submission (Note: An exhaustive literature search was performed.). The clinical documentation provided demonstrates that the Helix Hydro-Jet may be used safely and effectively to cut/dissect soft tissue that is in close proximity of the abdomen [Note: Shown by use in Total Mesorectal Excision (TME)]. The evaluations also show that system can be used in laparoscopic procedures for the target tissues with regards to safety and efficacy. Finally, the modified structural and dimensional features of the added applicators do not adversely affect the safety or effectiveness of the Helix Hydro-Jet.

The use of the Helix Hydro-Jet in TME was found to be better in comparison to other approved equipment. Greater visibility and tissue selectivity with the water jet system

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:・・

Characteristics	Modified Device	Predicate Device
Manufacturer	Andreas PeinMedizintechnik GmbH	Andreas PeinMedizintechnik GmbH
510(k) Applicant	ERBE USA, Inc.*	Andreas PeinMedizintechnik GmbH
Device Name	Water Jet Dissector	Water Jet Dissector
Trade Name	Helix Hydro-Jet™	Helix Hydro-Jet
510(k) Number		K012464
Indications For Use	The Helix Hydro-Jet isintended for the cuttingand dissection of softtissue such as the liver,kidney, etc. within theabdomen, including TotalMesorectal Excision(TME), in open as well aslaparoscopic surgery.	The Helix Hydro-Jet isintended for the cuttingand dissection of softtissue such as the liverand kidney in openabdominal surgery.
Items of the System	Unit, Suction Container,Power Cord, Foot Pedal,Fluid Cartridge, Appli-cators, and Suction Bag	Unit, Suction Container,Power Cord, Foot Pedal,Fluid Cartridge, Appli-cators, and Suction Bag
Materials	No Change [See thespecific contactingmaterials in previous510(k)- K012464, 8-1.]	No Change [See thespecific contactingmaterials in previous510(k)- K012464, 8-1.]
Physical and Dimensional Attributes
• Unit, SuctionContainer, Power Cord,and Foot Pedal(Reusable) as well asFluid Cartridge, andSuction Bag (SingleUse)	No Change [See thephysical and dimensionalattributes in previous510(k)- K012464, 1-7 to1-21.]	No Change [See thephysical and dimensionalattributes in previous510(k)- K012464, 1-7 to 1-21.]
Characteristics	Modified Device	Predicate Device
• Applicators	With and Without aHandle; With and WithoutSuction or SuctionControl; Straight, Bayonetor Angled Cannula;Cannula Outer DiameterRange: 1.6 to 6 mm;Cannula Length Range:60 to 336 mm; Sheath:Pliable or Rigid; Tip:Rigid, Flexible, Straight,Curved, and/or Hooked;Delivered Jet Stream:Straight or Spatula Shape	With and Without Suctionor Suction Control;Straight , Bayonet, orAngled Cannula; CannulaOuter Diameter Range:1.6 to 6 mm; CannulaLength Range: 60 to 300mm; Sheath: Pliable orRigid; Tip: Straight orCurved; Delivered JetStream: Straight orSpatula Shape
Energy Delivered	Pressurized Sterile Salinethat Cuts and Dissects	Pressurized Sterile Salinethat Cuts and Dissects
Pressure and SuctionRanges as well as JetDiameter	1 to 2,175 psi; 0 to -11.6psi; 120 um	1 to 2,175 psi; 0 to -11.6psi; 120 um
Target Population	Patients Requiring Openor Laparoscopic Surgeryin and around theAbdomen	Patients Requiring OpenAbdominal Surgery
Anatomical Sites	Soft Tissue within theAbdomen including TME	Soft Tissue in theAbdomen
Condition Provided and Method of Sterilization As Applicable
• Unit, SuctionContainer, Power Cord,Foot Pedal, andSuction Bag	Non-Sterile	Non-Sterile
• Fluid Cartridge	Sterile/Gamma Radiation	Sterile/Gamma Radiation
• Applicator	Sterile/Ethylene Oxide	Sterile/Ethylene Oxide
Use Condition
• Unit, SuctionContainer, Power Cord,and Foot Pedal	Reusable	Reusable
• Fluid Cartridge,Applicator, and SuctionBag	Disposable (Single Use)	Disposable (Single Use)

. .

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COMPARISON TABLE

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle head facing right, with three lines representing feathers or wings extending from the head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 2 5 2002

Re: K022613

Trade/Device Name: Helix Hydro-Jet™ Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH Dated: August 5, 2002 Received: August 6, 2002

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 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 - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Miriam C. Provost

( or 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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NUMBER (IF KNOWN) : , KO22613 510 (k) Helix Hydro-Jet™ DEVICE NAME:

INDICATIONS FOR USE:

Muriam C. Provost

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

510(k) Number K022613

(PLEASE DO NOT WRITE BELOW THIS DINE-CONTINUE ON ANOTHER P. IF NEBDED.)

Concurrence or coRH, office of Device Evaluation (ODD)

Preseription Use (Per 21 CER 801.109)

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Over - The - Counter -(Optional Forma

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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.