(119 days)
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI or ML components or algorithms.
No
The device is designed to deliver irrigation fluids and lavage debris during laparoscopic procedures, which are supportive functions for a surgical procedure, rather than directly treating a disease or condition.
No
The device is designed to deliver sterile irrigation fluids and lavage blood and tissue debris from surgical sites, which are therapeutic and cleaning functions, not diagnostic.
No
The device description clearly outlines a physical, sterile, single-use stainless steel cannula with a polymer handle and tubing, designed for delivering fluids during laparoscopic procedures. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Function: The REGER Nebulizer Irrigation Cannula is used inside the body during a surgical procedure to deliver fluids and remove debris. It does not analyze any biological samples in vitro.
The device description and intended use clearly indicate it's a surgical instrument used for irrigation and lavage during laparoscopic procedures, which is an in vivo application.
N/A
Intended Use / Indications for Use
The REGER Nebulizer Irrigation Cannula 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
The REGER Medizintechnik Nebulizer Irrigation Cannula is a sterile, single use stainless steel cannula with a polymer handle that is intended to nebulize irrigation fluids into the body during laparoscopic procedures. The sterile irrigation fluid is delivered from an injection pump (not provided) through the polymer tubing and into the stainless-steel shaft. The shaft has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The REGER Medizintechnik Nebulizer Irrigation Cannula is designed with a precision orifice at the tip for the deployment of a precise nebulized spray of irrigation solution into the laparoscopic cavity.
The REGER Medizintechnik Nebulizer Irrigation Cannula is straight and measures between 243-245 mm from Tip to the end of the handle with a shaft diameter ranging from 3.0 - 8.0 mm. The orifice at the head of the cannula shaft ranges in diameter of 0.17mm to 0.2mm. The REGER Medizintechnik Nebulizer Irrigation Cannula also contains a 10' flexible 3.15mm outer diameter polymer tube at the handle end for attachment to attached to irrigation fluid injection pump (not provided) via a luer fitting.
The REGER Nebulizer Irrigation Cannula device is fabricated with biocompatible stainless steel and biocompatible polymers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility Testing
The patient contact polymers and stainless steel were evaluated against the international standard ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Guidance Document entitled, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
The battery of testing included:
- Cytotoxicity
- Sensitization
- Irritation .
- Acute System Toxicity
- Material Mediated Pyrogenicity
Functional Testing
The REGER Nebulizer Irrigation Cannula Device was tested for various functional tests and shown to be substantially equivalent to the Therma Solutions HurriChem predicate device (K222575):
- Irrigation Flow Rate
- Irrigation Spray Angle
- . Irrigation Spray Droplet Size
- . Irrigation Spray Form
- . Irrigation Spray Force
- . Irrigation and Lavage Testing (Box Testing with Ink)
- Irrigation and Lavage Testing (Box Testing with Tissue)
Clinical Studies
No clinical studies were performed to support safety or effectiveness of the subject device.
Key results: The nonclinical testing demonstrates that the subject device is as safe and effective and performs as well as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Therma Solutions HurriChem, K222575
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.
0
Image /page/0/Picture/0 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.
September 29, 2023
REGER Medizintechnik, GmbH % Kr. Kenneth K. Kleinhenz, MBA Principal Official Correspondent QSR Consulting 4141 Elm Road Hudson, Michigan 49247
Re: K231622
Trade/Device Name: REGER Nebulizer Irrigation Cannula Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 6, 2023 Received: September 8, 2023
Dear Mr. Kleinhenz:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.09.29
13:43:08 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231622
Device Name REGER Nebulizer Irrigation Cannula
Indications for Use (Describe)
The REGER Nebulizer Irrigation Cannula 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) |
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4
K231622 510(k) Summary
Date Prepared: 27 September 2023
I. SUBMITTER
Manufacturer Name:
REGER Medizintechnik, GmbH Gewerbestrasse 10 Villingendorf, Germany 78667
Mfg. Establishment Registration Number: First premarket notification. Company to register with FDA within 30 days of 510(k) clearance.
| Official Contact: | Mr. Kenneth K. Kleinhenz, MBA |
|---|---|
| Principal | |
| QSR Consulting | |
| 4141 Elm Rd. | |
| Hudson, MI 49247 | |
| Telephone (619) 244-9573 | |
| Kleinhenz64@gmail.com |
II. DEVICE
| Name of Device: | REGER Nebulizer Irrigation Cannula |
|---|---|
| Common or Usual Name: | Laparoscope, General and Plastic Surgery |
| Classification Name | Endoscope and Accessories (21 CFR 876.1500) |
| Regulatory Class: Product Code: | GCJ |
| 510(K) Identification: | K231622 |
III. PREDICATE DEVICE
Therma Solutions HurriChem, K222575
5
IV. DEVICE DESCRIPTION
Design Characteristics
The REGER Medizintechnik Nebulizer Irrigation Cannula is a sterile, single use stainless steel cannula with a polymer handle that is intended to nebulize irrigation fluids into the body during laparoscopic procedures. The sterile irrigation fluid is delivered from an injection pump (not provided) through the polymer tubing and into the stainless-steel shaft. The shaft has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The REGER Medizintechnik Nebulizer Irrigation Cannula is designed with a precision orifice at the tip for the deployment of a precise nebulized spray of irrigation solution into the laparoscopic cavity.
The REGER Medizintechnik Nebulizer Irrigation Cannula is straight and measures between 243-245 mm from Tip to the end of the handle with a shaft diameter ranging from 3.0 - 8.0 mm. The orifice at the head of the cannula shaft ranges in diameter of 0.17mm to 0.2mm. The REGER Medizintechnik Nebulizer Irrigation Cannula also contains a 10' flexible 3.15mm outer diameter polymer tube at the handle end for attachment to attached to irrigation fluid injection pump (not provided) via a luer fitting.
Material Composition
The REGER Nebulizer Irrigation Cannula device is fabricated with biocompatible stainless steel and biocompatible polymers.
V. INDICATIONS FOR USE
The REGER Nebulizer Irrigation Cannula device 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The REGER Nebulizer Irrigation Cannula Device shares indications for use and design principles with the following predicate device: Therma Solutions HurriChem; a Class II medical device that was cleared for marketing in the United States under K222575.
6
Design and Materials
The REGER Nebulizer Irrigation Cannula device is substantially equivalent to the Therma Solutions HurriChem predicate device (K222575) in the following respects:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | REGER | ||
| Medizintechnik | |||
| Nebulizer Irrigation | |||
| Cannula | Therma Solutions | ||
| HurriChem | |||
| (K222575) | Substantially | ||
| Equivalent | |||
| Device Description | Stainless steel cannula | ||
| with small nebulizing | |||
| outlet hole at the front | |||
| and a flexible polymer | |||
| tube at the back end to | |||
| connect to irrigation fluid | |||
| source / reservoir via a | |||
| luer connection. The | |||
| shaft has internal | |||
| mechanics that deliver | |||
| the irrigation fluid as | |||
| microscopic droplets in a | |||
| fine mist into the body | |||
| during laparoscopic | |||
| procedures. | Stainless steel cannula | ||
| with small nebulizing | |||
| outlet hole at the front and | |||
| a flexible polymer tube at | |||
| the back end to connect to | |||
| irrigation fluid source / | |||
| reservoir via a luer | |||
| connection. The shaft has | |||
| internal mechanics that | |||
| deliver the irrigation fluid | |||
| as microscopic droplets in | |||
| a fine mist into the body | |||
| during laparoscopic | |||
| procedures. | Yes | ||
| Indications for Use | The Reger Nebulizer | ||
| Irrigation Cannula 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. | 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. | Yes | ||
| (Same) | |||
| Criteria | Subject Device | Predicate Device | Substantially |
| Equivalent | |||
| REGER | |||
| Medizintechnik | |||
| Nebulizer Irrigation | |||
| Cannula | Therma Solutions | ||
| HurriChem | |||
| (K222575) | |||
| Design and Materials | |||
| Dimensions | |||
| Shaft Length | 201-203 mm | 206 mm | Yes |
| Shaft and Handle | |||
| Length | 243-245 mm | n.a. | Yes |
| Handle (OD) | 12 mm | n.a. | Yes |
| Cannula Head OD | 3.0-10.3 mm | 9.6 mm | Yes |
| Cannula Nozzle (OD) | 0.17-0.20 mm | 0.19 mm | Yes |
| Cannula Shaft (OD) | 3.0 - 8.0 mm | 8.00 mm | Yes |
| Performance | |||
| Pressure at Nozzle Tip | 116 - 261 psi | 203 - 217 psi | Yes |
| Flow Rate | 0.5 - 1.5 mL/sec | 0.5 - 1.0 mL/sec | Yes |
| Flexible High | |||
| Pressure Tubing (OD) | 3.15 mm | 3.5 mm | Yes |
| Flexible High | |||
| Pressure Tubing (ID) | 1.65 mm | 1.80 mm | Yes |
| Tubing Connector | Luer Fitting, Male | Luer Fitting, Male | Yes |
| Average Droplet Size | 20 - 35 micron | 21 - 22 micron | Yes |
| Materials | |||
| Cannula Shaft | Stainless Steel | Stainless Steel | Yes |
| Flexible High | |||
| Pressure Tubing | Polyurethane | Polyurethane | Yes |
| Features | |||
| Disposable | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Luer Connection | Yes | Yes | Yes |
| Sterilization | |||
| Methodology | |||
| EO Gas | Yes | Yes | Yes |
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | Yes |
| Product Code | GCI | GCI | Yes |
7
8
VII. PERFORMANCE DATA
Biocompatibility Testing
The patient contact polymers and stainless steel were evaluated against the international standard ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Guidance Document entitled, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
The battery of testing included:
- Cytotoxicity
- Sensitization
- Irritation .
- Acute System Toxicity
- Material Mediated Pyrogenicity ●
Functional Testing
The REGER Nebulizer Irrigation Cannula Device was tested for various functional tests and shown to be substantially equivalent to the Therma Solutions HurriChem predicate device (K222575):
- Irrigation Flow Rate
- Irrigation Spray Angle
- . Irrigation Spray Droplet Size
- . Irrigation Spray Form
- . Irrigation Spray Force
- . Irrigation and Lavage Testing (Box Testing with Ink)
- Irrigation and Lavage Testing (Box Testing with Tissue) ●
Clinical Studies
No clinical studies were performed to support safety or effectiveness of the subject device.
VIII. CONCLUSIONS
The nonclinical testing demonstrates that the subject device is as safe and effective and performs as well as the legally marketed predicate device.