(171 days)
Not Found
No
The description details a mechanical suction and irrigation device with no mention of computational analysis, learning, or adaptive capabilities.
No.
The device is used to assist visualization during laparoscopic surgery by flushing blood and tissue debris, not to provide therapeutic treatment to the patient.
No
The device is described as assisting in flushing blood and tissue debris from the operative site to aid visualization and evacuating debris, not for making a diagnosis.
No
The device description clearly outlines physical components like a hand piece, probe, tubing, and valves, 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 is to facilitate lavage during laparoscopic surgery by providing suction and irrigation functions to clear the operative site. This is a surgical tool used during a procedure on a patient's body.
- Device Description: The description details a surgical instrument with a handpiece, probe, and tubing for delivering fluids and aspirating material from the surgical site.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's health or condition.
- Performance Studies: The performance studies focus on physical, mechanical, and biocompatibility tests related to its function as a surgical tool, not on the accuracy or reliability of diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and supportive during surgery.
N/A
Intended Use / Indications for Use
The Unimax Suction Irrigation 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.
Product codes
GCJ
Device Description
The Unimax Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site.
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 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. It is a single use, disposable device and is sold sterile.
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
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimax Suction Irrication Set. The tests were conducted in accordance with IEC 60601-2-2 Medical electrical equipment -Part 2-2: Particular requirements for the safety of high frequency surgical equipment. All the test results demonstrate the performance of Unimax Suction Irrigation Set meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Unimax Suction Irrigation Set is as safe and effective as the predicate devices.
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
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.
0
Page 1 of 4
MAY 1 9 2011
Unimax Suction Irrigation Set
510(k) Summary
Type of Submission: 5.1
Traditional
| 5.2 | Submitter: | Unimax Medical Systems Inc. | |
|---|---|---|---|
| Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien City, | ||
| Taipei, Taiwan | |||
| Phone: | 886-2-89191698 | ||
| Fax: | 886-2-89191528 | ||
| Contact: | Sophia Chiu | ||
| Establishment Registration Number: | 3007791595 |
5.3 Identification of the Device:
| Proprietary/Trade name: | Unimax Suction Irrigation Set |
|---|---|
| Common Name: | Suction Irrigation |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Device Classification: | II |
| Regulation Number: | 876.1500 |
| Panel: | General & Plastic Surgery |
| Product Code: | GCJ |
5.4 Identification of the Predicate Device:
| Predicate Device Name: | GeniCon Laparoscopic Suction Irrigation | |
|---|---|---|
| Manufacturer: | Genicon | |
| 510(k) Number or Clearance Information: | K041967 |
5.5 Intended Use and Indications for Use of the subject device.
The Unimax Suction Irrigation 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.
1
Page 2 of 4
Unimax Suction Irrigation Set
5.6 Device Description
The Unimax Suction Irrigation Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site.
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 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. It is a single use, disposable device and is sold sterile.
5.7 Non-clinical Testing
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimax Suction Irrication Set. The tests were conducted in accordance with IEC 60601-2-2 Medical electrical equipment -Part 2-2: Particular requirements for the safety of high frequency surgical equipment. All the test results demonstrate the performance of Unimax Suction Irrigation Set meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Unimax Suction Irrigation Set is as safe and effective as the predicate devices.
5.8 Safety and Effectiveness
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
2
Page 3 of (4)
Unimax Suction Irrigation Set
5.9 Substantial Equivalence Determination
The Unimax Suction Irrigation Set submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GeniCon Laparoscopic Suction Irrigation which is the subject of K041967. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | Predicate Device
(GeniCon Laparoscopic Suction
Irrigation) | Proposed Device
(Unimax Medical Systems
Inc. Suction Irrigation Set) |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Similarity | | |
| Intended Use | The device 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. | Same |
| Specification | The device 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.
Reusable Monopolar Probe:
Description Size | Same |
3
Page 4 of (4)-
Unimax Suction Irrigation Set
510(k) Notification
| Spatula Probe | 5mm x 33cm | |
|---|---|---|
| J-Hook Probe | 5mm x 33cm | |
| L-Hook Probe | 5mm x 33cm | |
| Biocompatibility | Cytotoxicity test | Same |
| Intracutaneous test | ||
| Maximization sensitization test |
5.10 Conclusion
After analyzing bench tests, electrical safety testing data, it can be concluded that Unimax Suction Irrigation Set is as safe and effective as the predicate device.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 9 2011
Unimax Medical Systems, Inc. % AcmeBiotechs Co., Ltd. Mr. Michael Lee No. 45, Minsheng Rd., Danshui Town Taipei County, 251 Taiwan
Re: K103509
Trade/Device Name: Unimax Suction Irrigation Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 25, 2011 Received: April 25, 2011
Dear Mr. Lee:
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. 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
5
Page 2 - Mr. Michael Lee
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Aiz B. n h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Unimax Suction Irrigation Set
Indications.for Use
510(k) Number (if known):
Device Name: Unimax Suction Irrigation Set
Indications for Use:
The Unimax Suction Irrigation 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.
Prescription Use ________________ (Part 21 CFR 801 Subpart D)
. AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP. Ogden for mxm
(Director Sign Off)
Page 1 of _1
Division of Surgical, Orthopedic, and Restorative Devic
510(k) Number K103509
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