(59 days)
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 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.
The provided text describes a 510(k) premarket notification for a medical device called "Suction Irrigation Tubing Set." This type of submission is for medical devices, not AI/machine learning (ML) enabled devices. The document does not contain any information about acceptance criteria or studies involving AI/ML performance, human readers, ground truth establishment for AI/ML, or training/test sets for AI/ML models.
Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML, as the provided document pertains to a traditional medical device (Suction Irrigation Tubing Set) and its physical properties and functionality.
The document discusses:
- Device Name: Suction Irrigation Tubing Set
- Regulation Number & Name: 21 CFR 876.1500, Endoscope And Accessories
- Product Code: GCJ
- Indications for Use: Used in laparoscopic surgical procedures to deliver sterile irrigation and evacuate fluids/debris/smoke.
- Device Description: Consists of a grip body with valves, a probe, and connecting tubing for irrigation and suction.
- Predicate Device: K141592, Unimicro Suction Irrigation Tubing Set
- Non-clinical Tests Performed: Air tightness, smooth test, tensile strength, tubing collapse, irrigation/aspiration fluid flow test. These are typical physical and performance tests for medical tubing, not AI/ML performance metrics.
- Conclusion: The device is substantially equivalent to the predicate device, raising no new questions of safety or effectiveness based on technological comparison and nonclinical testing.
None of this information relates to the typical acceptance criteria or study methodologies used for AI/ML medical devices (sensitivity, specificity, AUROC, MRMC studies, expert adjudication for image interpretation, etc.).
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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.
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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
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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
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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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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 76229Germany |
| 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 97068United 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
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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 & PredicateDevice(s) | K242927 | K141592 |
|---|---|---|
| Indications for Use | The Disposable Suction IrrigationTubing Set is indicated for use inpatients undergoing a laparoscopicsurgical procedure. It is designed todeliver sterile irrigation normal salineto surgical sites during laparoscopicprocedures and to evacuate blood,tissue debris, and smoke from thesurgical site to aid visualization. | The Unimicro Suction Irrigation Tubingset is available with an array of probedesigns to facilitate lavage duringlaparoscopic surgery. This device hasapplications in laparoscopic gynecologic,general, thoracic and urologyprocedures to provide suction andirrigation functions to help flush bloodand tissue debris from the operative siteduring laparoscopy to aid visualization. |
| Principles ofOperation | The Disposable Suction IrrigationTubing is a sterile, single-use andmultifunctional instrument whichachieves two functions in one device.This device is available both in a 5mmand 10mm instrumentation withdouble spike tubing. The devicedepends on a laparoscopic operationpump to supply power, includingirrigation and suction. There are twoseries: one that can aspirate the smokeout of the abdomen produced inlaparoscopic surgical procedures withthe negative pressure suctionequipment, and other that cannotevacuate the smoke. | The suction irrigation set consists of ahand piece equipped with two trumpetstyle valves, a probe, and connectinglines of tubing, one set designed toattach to a supply of irrigation fluid, andthe other designed to attach to anaspiration pump. The valves allowcontrolled irrigation and aspirationduring a surgical procedure. The handpiece of the suction irrigator is designedto allow instruments to be introducedthrough the suction irrigation probe toreach the operative site. The instrumentadapter is adjustable to allow a varietyof instruments and diameters. |
| Main Components | Probe, handpiece, connecting lines oftubing | Probe, handpiece, connecting lines oftubing |
| Models | Suction Irrigation Set | Suction Irrigation Set |
| Device & PredicateDevice(s) | K242927 | K141592 |
| Suction Irrigation Set With SmokeEvacuation | Suction Irrigation Set With SmokeEvacuation | |
| 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
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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.
§ 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.