(59 days)
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML terms or functionalities.
No.
The device's intended use is to deliver irrigation and evacuate waste during surgery to aid visualization, not to treat a disease or condition.
No
The device is described as a surgical tool for irrigation and aspiration during laparoscopic procedures, designed to aid visualization and remove debris. There is no mention of the device being used to diagnose conditions or process diagnostic data.
No
The device description clearly outlines physical components like a grip body, valves, a probe, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during laparoscopic surgical procedures to deliver irrigation fluid and evacuate debris. This is a direct surgical tool used on the patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a physical tool with tubing, valves, and a probe for use in a surgical setting. It doesn't mention any components or functions related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples, providing diagnostic results, or any other characteristics typically associated with IVD devices.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Suction Trrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.
Product codes
GCJ
Device Description
The Disposable Suction Irrigation Tubing Set consists of a grip body equipped with two trumpet style valves, a probe, and connecting lines of tubing; one set designed to attach a supply of irrigation normal saline, and the other designed to attach to suction equipment (aspiration pump). The valves allow for control of irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. The device is packaged as sterile with a shelf life of 3 years and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical sites (during laparoscopic procedures), abdomen
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
A series of nonclinical bench tests were performed to assess the safety and effectiveness of the Advamedix Suction Irrigation Tubing Sets. All tests were conducted utilizing devices post sterilization, and post accelerated aging. The performance testing conducted on the subject device and predicate device are listed below:
- . Air tightness test
- . Smooth test
- . Tensile strength test
- Tubing collapse test
- . Irrigation fluid / aspiration fluid flow test
Key Metrics
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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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2024
Advamedix, GmbH % Marianne Jacklyn President and Principal Consultant TRAXN Consulting LLC 1235 Swift Shore Circle West Linn, Oregon 97068
Re: K242927
Trade/Device Name: Suction Irrigation Tubing Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 24, 2024 Received: September 24, 2024
Dear Marianne Jacklyn:
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.
1
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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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-regulatory
2
assistance/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,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.11.22 13:02:14 -05'00'
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
3
Indications for Use
510(k) Number (if known) K242927
Device Name Suction Irrigation Tubing Set
Indications for Use (Describe)
The Disposable Suction Trrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.
| 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
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
1 Contact Details: 21 CFR 807.92(a)(1)
| Applicant Name | Advamedix, GmbH |
|---|---|
| Applicant Address | Greschbachstr 3/3, OG Karlsruhe 76229 |
| Germany | |
| Applicant Contact Telephone | Phone: +49 721 94552 |
| Applicant Contact | Dr. Islam Abed, Director |
| Applicant Contact Email | abed@advamedix.net |
| Correspondent Name | TRAXN Consulting LLC |
| Correspondent Address | 1235 Swift Shore Circle, West Linn, Oregon 97068 |
| United States | |
| Correspondent Contact Telephone | (503) 729-9633 |
| Correspondent Contact | Ms. Marianne D. Jacklyn |
| Correspondent Contact Email | mjacklyn@traxnconsulting.com |
Device Name: 21 CFR 807.92(a)(2) 2
| Trade Name | Suction Irrigation Tubing Set |
|---|---|
| Common Name | Tubing |
| Classification Name | Endoscope and Accessories |
| Regulation Number | 876.1500 |
| Product Code(s) | GCJ |
Legally Marketed Predicate Devices: 21 CFR 807.92(a)(3) 3
K141592, Unimicro Suction Irrigation Tubing Set
- Device Description Summary: 21 CFR 807.92(a)(4) ব
The Disposable Suction Irrigation Tubing Set consists of a grip body equipped with two trumpet style valves, a probe, and connecting lines of tubing; one set designed to attach a supply of irrigation normal saline, and the other designed to attach to suction equipment (aspiration pump). The valves allow for control of irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the
5
operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. The device is packaged as sterile with a shelf life of 3 years and is for single use only.
- 5 Intended Use/Indications for Use: 21 CFR 807.92(a)(5)
The Disposable Suction Irrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.
| Device & Predicate
| Device(s) | K242927 | K141592 |
|---|---|---|
| Indications for Use | The Disposable Suction Irrigation | |
| Tubing Set is indicated for use in | ||
| patients undergoing a laparoscopic | ||
| surgical procedure. It is designed to | ||
| deliver sterile irrigation normal saline | ||
| to surgical sites during laparoscopic | ||
| procedures and to evacuate blood, | ||
| tissue debris, and smoke from the | ||
| surgical site to aid visualization. | The Unimicro Suction Irrigation Tubing | |
| set is available with an array of probe | ||
| designs to facilitate lavage during | ||
| laparoscopic surgery. This device has | ||
| applications in laparoscopic gynecologic, | ||
| general, thoracic and urology | ||
| procedures to provide suction and | ||
| irrigation functions to help flush blood | ||
| and tissue debris from the operative site | ||
| during laparoscopy to aid visualization. | ||
| Principles of | ||
| Operation | The Disposable Suction Irrigation | |
| Tubing is a sterile, single-use and | ||
| multifunctional instrument which | ||
| achieves two functions in one device. | ||
| This device is available both in a 5mm | ||
| and 10mm instrumentation with | ||
| double spike tubing. The device | ||
| depends on a laparoscopic operation | ||
| pump to supply power, including | ||
| irrigation and suction. There are two | ||
| series: one that can aspirate the smoke | ||
| out of the abdomen produced in | ||
| laparoscopic surgical procedures with | ||
| the negative pressure suction | ||
| equipment, and other that cannot | ||
| evacuate the smoke. | The suction irrigation set consists of a | |
| hand piece equipped with two trumpet | ||
| style valves, a probe, and connecting | ||
| lines of tubing, one set designed to | ||
| attach to a supply of irrigation fluid, and | ||
| the other designed to attach to an | ||
| aspiration pump. The valves allow | ||
| controlled irrigation and aspiration | ||
| during a surgical procedure. The hand | ||
| piece of the suction irrigator is designed | ||
| to allow instruments to be introduced | ||
| through the suction irrigation probe to | ||
| reach the operative site. The instrument | ||
| adapter is adjustable to allow a variety | ||
| of instruments and diameters. | ||
| Main Components | Probe, handpiece, connecting lines of | |
| tubing | Probe, handpiece, connecting lines of | |
| tubing | ||
| Models | Suction Irrigation Set | Suction Irrigation Set |
| Device & Predicate | ||
| Device(s) | K242927 | K141592 |
| Suction Irrigation Set With Smoke | ||
| Evacuation | Suction Irrigation Set With Smoke | |
| Evacuation | ||
| Dimensions | ||
| (Overall) | Outer Diameter: 5.2 mm – 10.2 mm | Outer Diameter: 5.2 mm – 10.2 mm |
| Inner Diameter: 4.6 mm – 9.2 mm | Inner Diameter: 4.6 mm – 9.2 mm | |
| Length: 280 mm - 450 mm | Length: 280 mm - 450 mm |
Technological Comparison: 21 CFR 807.92(a)(6) ട
6
Non-clinical Tests Summary 21 CFR 807.92(b) 7
A series of nonclinical bench tests were performed to assess the safety and effectiveness of the Advamedix Suction Irrigation Tubing Sets. All tests were conducted utilizing devices post sterilization, and post accelerated aging. The performance testing conducted on the subject device and predicate device are listed below:
- . Air tightness test
- . Smooth test
- . Tensile strength test
- Tubing collapse test
- . Irrigation fluid / aspiration fluid flow test
Conclusion from nonclinical tests (21 CFR 807.92(b)(3)) 8
The conclusions drawn from the technological comparison and nonclinical testing demonstrate that the proposed subject devices raise no new questions of safety or effectiveness, and substantially equivalent in terms of safety and effectiveness as the legally marketed predicate devices for the proposed indications for use.