The ThermaSolutions HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.

Device Description

ThermaSolutions' HurriChem Device Kit consists of the HurriChem Irrigation Wand and braided poly tubing. The HurriChem Device Kit is intended for use to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures. It is designed to lavage blood and tissue debris from the surgical site. The kit is to be used in conjunction with standard injection pumps. The kit is to be used only by physicians trained in the use of this device. The device is packaged and sterilized for single use only, and should be discarded after use according to the policy of the facility.

The HurriChem Device Kit consists of a stainless-steel wand and a length of braided poly tubing. The one end of the tubing attaches to the stainless-steel wand, and the other end of the tubing is intended to attach to a standard injection pump (not part of the device). The sterile fluid is delivered from the injection pump through the poly tubing and into the stainless-steel wand. The wand has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The irrigation using fluid droplets allows for maximum lavage of the area with a minimal amount of fluid.

AI/ML Overview

The provided text describes the ThermaSolutions HurriChem Device Kit, a laparoscopic irrigation device, and its substantial equivalence to a predicate device. However, the document does not contain details about specific acceptance criteria, reported device performance (beyond general statements of meeting requirements), sample sizes, ground truth establishment, or clinical study design elements that your request asks for.

The document explicitly states: "No clinical trials were performed on the HurriChem Device Kit." Instead, the submission relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.

Therefore, many of your requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

Cannot be fully provided. The document states: "All the tests demonstrate that the device meets the requirements of its pre-defined acceptance criteria and intended use." However, it does not list these pre-defined acceptance criteria or provide specific numerical performance results against them. It only mentions categories of tests performed (Biocompatibility, sterilization validation, packaging validation, shelf life, transportation testing, fit, function, performance).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The text does not disclose sample sizes for any of the non-clinical tests or the provenance of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Since no clinical trials or studies requiring expert ground truth establishment for a test set were conducted, this information is not present. The "ground truth" in this context would likely refer to engineering specifications and performance evaluations rather than clinical diagnoses. The document mentions "ThermaSolutions Engineering and Product Development teams evaluated fit, function, performance," implying internal company experts, but no specific number or qualifications are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. As no clinical studies with a test set requiring adjudication were conducted, this information is absent.

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

Not applicable. No MRMC study or AI component is mentioned.

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

Not applicable. This device is a physical laparoscopic irrigation kit; there is no algorithm or AI component involved in its function as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implied engineering standards/specifications. For the non-clinical tests, the "ground truth" would be established engineering requirements, test standards, and successful demonstration of function. No clinical ground truth (like pathology or outcomes data) was used because no clinical trials were performed.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" in the context of this device's non-clinical evaluation.

9. How the ground truth for the training set was established

Not applicable / Not provided. See above.

Summary of available information:

The K222575 submission for the HurriChem Device Kit relies on non-clinical testing and comparison to a legally marketed predicate device (DANNIK Laparoscopic Suction Irrigation System, K192643) to demonstrate substantial equivalence, rather than clinical trials. The non-clinical tests covered:

Biocompatibility
Sterilization validation
Packaging validation
Shelf life
Transportation testing
Fit, function, and performance evaluation by ThermaSolutions Engineering and Product Development teams.

The conclusion is that the device "meets the requirements of its pre-defined acceptance criteria and intended use" and is "as safe and effective as the predicate device" based on these non-clinical evaluations. However, the specific details of these acceptance criteria, test results against them, and quantitative data (like sample sizes) are not present in the provided FDA letter and 510(k) summary.

Summary

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December 6, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ThermaSolutions LLC Rhea Johny Regulatory Specialist 1889 Buerkle Road St. Paul, Minnesota 55110

Re: K222575

Trade/Device Name: HurriChem Device Kit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 9, 2022 Received: November 9, 2022

Dear Rhea Johny:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Colin K. C

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name HurriChem Device Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for the HurriChem Device Kit

Contact Information

ThermaSolutions LLC 1889 Buerkle Road St. Paul, MN 55110 USA Phone: +1.877.651.6100 Fax: Rhea Johny, Regulatory Specialist 4 March 2022

Information about the Device

Trade name: HurriChem Device Kit

Common name: laparoscopic irrigation

Classification name: Endoscope and accessories (21 CFR 876.1500, Product Code GCJ)

Substantially Equivalent Device

Legally marketed device: DANNIK Laparoscopic Suction Irrigation System (K192643)

Common name: laparoscopic irrigation

Classification name: Endoscope and accessories (21 CFR 876.1500, Product Code GCJ)

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Indication for Use

Description of the Device

Technological Characteristics of HurriChem Compared to Predicate Device

	HurriChem	DANNIK
Intended use:	Laparoscopic surgery	Same
Insertion via trocar:	Yes	Yes
Sterilization:	Ethylene Oxide	Same
Prescription only:	Yes	Yes

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Disposable:	Yes	Yes
Single use:	Yes	Yes
Biocompatibility	Yes	Yes
Electrosurgery capable:	No	No
Suction capable:	No	Yes
Fluid delivered by externalpump source:	Yes, not part of device	Yes, not part of device

	Materials
wand/probe:	Stainless steel	Same
tubing:	Braided polyurethane	PVC
hand piece w/valve:	None	Polycarbonate

Summary of Technological Difference in Irrigation Droplet Size

Both devices receive irrigation fluid via delivery from an external mechanical source. The wand (HurriChem) or probe (DANNIK Suction Irrigation) directs the irrigation fluid as determined by the physician. The HurriChem delivers the irrigation as small droplets of fluid. The DANNIK Suction Irrigation delivers the irrigation as a larger stream of fluid.

The HurriChem device's mechanical conversion of the fluid into droplets permits a small volume of fluid to be used for irrigation. The stainless-steel wand in the HurriChem device kits contains a nozzle with a micro-opening because the small opening converts and delivers the irrigation fluid in the form of droplets. The Suction Irrigation has a larger opening that delivers the irrigation fluid as a stream of fluid.

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Summary of Technological Difference in Suction

The HurriChem Device Kit is indicated for use to deliver sterile irrigation fluids to surqical sites during laparoscopic procedure. The device is not designed nor intended to provide suction or removal of fluid. Evacuation of fluid, if desired by the clinician, may be performed with laparoscopic suction or evacuation devices, drains or catheters.

Non-clinical Testing

A series of tests were performed to assess the safety and effectiveness of the HurriChem Device Kit to the predicate device. Biocompatibility, sterilization validation, packaging validation, shelf life and transportation testing were completed. Additionally, ThermaSolutions Engineering and Product Development teams evaluated fit, function, performance and equivalence of the device through a combination of human factors studies and bench testing. All the tests demonstrate that the device meets the requirements of its pre-defined acceptance criteria and intended use. The results of the non-clinical testing demonstrate that the HurriChem Device Kit is as safe and effective as the predicate device.

Clinical Testing

No clinical trials were performed on the HurriChem Device Kit.

Conclusion

The HurriChem Device Kit has the same intended use and application as the predicate device. The materials of the HurriChem Device Kit and the predicate device are equivalent. The difference in technical characteristics of the HurriChem's irrigation spray from DANNIK's irrigation stream does not raise different questions of safety and effectiveness. The non-clinical testing and performance evaluations show the ThermaSolutions HurriChem Device Kits is as safe and effective and meets the same expected performance as the DANNIK Suction Irrigation System. Therefore, the proposed HurriChem Device Kits is substantially equivalent to the predicate.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.