(103 days)
Not Found
No
The device description and performance studies focus on mechanical function and fluid delivery, with no mention of AI or ML technologies.
Yes
The device is used to deliver sterile irrigation fluids and lavage blood and tissue debris from surgical sites during laparoscopic procedures, which are medical interventions aimed at treating or managing a health condition.
No
The device is designed for delivering irrigation fluids and lavaging debris during laparoscopic procedures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of physical components: a stainless-steel wand and braided poly tubing. It also mentions internal mechanics within the wand. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the ThermaSolutions HurriChem Device Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris. This is a direct surgical intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical tool (wand and tubing) used to deliver fluid during surgery. It does not analyze or test biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.) for diagnostic purposes. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (such as blood, tissue, urine, etc.) to provide information for diagnostic, monitoring, or screening purposes. The HurriChem Device Kit's function is purely procedural and therapeutic (cleaning the surgical site), not diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical sites during laparoscopic procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained in the use of this device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
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)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
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
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.
Description of the Device
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.
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 external | ||
| pump 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.