(57 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithms.
No.
A therapeutic device is one that treats a disease or condition. This device is used to facilitate lavage during surgery by aiding in flushing blood and tissue debris from the surgical site, which is a supportive surgical tool function rather than a direct therapeutic action on a disease.
No
Explanation: The device is described as a suction/irrigation device used to facilitate lavage during surgery by flushing blood and tissue debris from the surgical site. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly outlines physical components such as a hand piece, valves, a probe, and tubing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a suction/irrigation device to facilitate lavage during laparoscopic and general surgery. This is a surgical tool used during a procedure, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical device with valves, a probe, and tubing for delivering fluids and aspirating debris from a surgical site. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) for diagnostic purposes. The device's function is purely mechanical – flushing and removing material from the surgical field.
- Performance Studies: The performance studies focus on biocompatibility, anti-vacuity, anti-flat tube, handle button pressure, and sterilization. These are all relevant to a surgical device, not an IVD. IVD performance studies would typically involve metrics like sensitivity, specificity, accuracy, etc., related to the analysis of biological samples.
In summary, the device's purpose and function are entirely focused on assisting in surgical procedures by managing fluids and debris at the surgical site, which is not the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Suction Irrigation is indicated for general purpose use as suction/irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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 suction irrigation set 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 while 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility summary:
Because the stainless steel and Plasticized Polyvinyl Chloride Compound (PVC) are standard materials for current suction irrigation on the market, they have been thoroughly tested in the past for biocompatibility. The product has passed the biocompatibility test for cytotoxicity, intracutaneous irritation, skin sensitization, and pyrogen.by following ISO 10993.
Therefore, as the contact time for the device is short (TWSC. Therefore, the anti-vacuity capability of TWSC is the best: the second is Unimax.
(2) Anti-flat tube test : Based on the experiment result, under the suction pressure between 400 and 760 mmHg, there is no flat tube situation.
(3) Handle button pressure test: Based on the handle button pressure test and experiment result. the anti-pressure leak capability of is the worse; but the capability is correspond with product specification.
Sterilization and Bio Burden Test Summary:
The sterilization validation of gamma irradiation for Disposable Suction Irrigation was successful and had met the requirements of ISO 11137-2:2012 VD max25 method on substantiation of 25kGy as a sterilization dose. This study therefore supports the multiple batch products to be irradiated at the sterilization dose kGy for a SAL of 10-9.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest a sense of community and care. The profiles are black and the text is black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2015
TAIWAN SURGICAL CORPORATION Ms. Celine Haung Regulatory Specialist 3F., No.12, Sec.2, Sheng Yi Road Zhubei City Hsinchu County 30261 Taiwan
Re: K150253
Trade/Device Name: Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm Regulation Number: 21CFR 876.1500 Regulation Name: Endoscope & Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 4, 2015 Received: February 6, 2015
Dear Ms. Haung:
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 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
1
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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150253
Device Name
Disposable Suction Irrigation, 330mm Disposable Suction Irrigation, 450mm
Indications for Use (Describe)
Suction Irrigation is indicated for general purpose use as suction/irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| CITVATO | ||||
|---|---|---|---|---|
| Disposable | 510(k) Summary | page | 5-2 | |
| Product | Suction Irrigation | Version | 1.0 |
510(k) Summary
The assigned 510(K) number: K150253 Date Prepared: 1/30/2015
SUBMITTER I.
Submitter:
TAIWAN SURGICAL CORPORATION Address: 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302, Taiwan Phone Number: +886-3-65881129 Fax Number: +886-3-6588355 Contact Person: Celine Huang Email: celine(@taiwansurgical.com.tw Phone Number: +886-3-6588129 ext. 251 Fax Number: +886-3-3588355
II. DEVICE
Trade Name:
- . Disposable Suction Irrigation, 330mm
- Disposable Suction Irrigation, 450mm .
Common Name and Classification:
Table 1. Common Name and Classification
| No. | Common Name | Product Code | Classification | Regulation
Section | Panel |
|-----|----------------------------------|--------------|----------------|-----------------------|------------------------------|
| 1 | Disposable Suction
Irrigation | GCJ | II | 876.1500 | Endoscope and
accessories |
III. PREDICATE DEVICE
Predicate device 1: UNIMAX MEDICAL SYSTEM INC., K103509
4
| Image: Taiwan Surgical logo | ||||
|---|---|---|---|---|
| Product | Disposable | |||
| Suction Irrigation | 510(k) Summary | page | 5-3 | |
| Version | 1.0 |
| Table 2. Predicate Device Identification |
|---|
| ------------------------------------------ |
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | |
| Disposable Suction | |||
| Irrigation | UNIMAX SUCTION IRRIGATION | ||
| SET | UNIMAX | K103509 |
IV. DEVICE DESCRIPTION
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 suction irrigation set 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 while 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.
v. INDICATIONS FOR USE
Suction Irrigation is indicated for general purpose use as suction irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.
VI. PRODUCT SPECIFICATION
Suction irrigation 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 inspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure. For Model TSI-545, the length of the stainless steel tube is 450mm while the length of the stainless steel tube is 330mm for Model TSI-533. The irrigation pressure is from 0 to 760mmHg while the suction pressure is from 0 to 600mmHg.
5
| Image: Taiwan Surgical logo | ||||
|---|---|---|---|---|
| Product | Disposable | |||
| Suction Irrigation | 510(k) Summary | page | 5-4 | |
| Version | 1.0 |
VII. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PRIDICATE DEVICE
| Item | Candidate Device | Predicate Device | ||
|---|---|---|---|---|
| Disposable Suction | ||||
| Irrigation | Unimax Suction | |||
| Irrigation Set | ||||
| 1 | Spec. | Design Description | Suction irrigation | |
| 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 inspiration pump. | ||||
| The valves allow | ||||
| controlled irrigation | ||||
| and aspiration | ||||
| during a surgical | ||||
| procedure. | Same | |||
| Length of steel tube | 350mm/470mm | 350mm/470mm | ||
| OD of steel tube | 5mm | Same | ||
| PVC soft tube | 2900mm | 2900mm | ||
| 2 | Function | Anti-vacuity test | Pass | Pass |
| Anti-flat tube test | No flat tube | No flat tube | ||
| Handle button | ||||
| pressure test | 760 mmHg | 760 mmHg |
Table 3. Specification comparison table
6
Taiwan Surgical®
| Product | Disposable
Suction Irrigation | 510(k) Summary | | page | 5-5 |
|---------|----------------------------------|----------------|--|---------|-----|
| | | | | Version | 1.0 |
| 3 | Biocompatibility | | Cytotoxicity Test
Intracutaneous test
Maximization
sensitization test | Same |
|---|------------------|----------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | Regulatory | Classification | class II
876.1500 | Same |
| | | | | Same |
| | | | Intended Use | Suction Irrigation is
indicated for general
purpose use as
suction/irrigation
device to facilitate
lavage during
laparoscopic
gynecologic surgery,
general surgery,
thoracic surgery and
urology. The device
functions to aid
flushing blood and
tissue debris from
the surgical site. |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| 5 | | | Package | A pouches with
protective cover |
7
| Image: Taiwan Surgical logo | ||||
|---|---|---|---|---|
| Product | Disposable | |||
| Suction Irrigation | 510(k) Summary | page | ||
| Version | 5-6 | |||
| 1.0 |
VIII. PERFORMANCE DATA
- 0 Biocompatibility summary:
Because the stainless steel and Plasticized Polyvinyl Chloride Compound (PVC) are standard materials for current suction irrigation on the market, they have been thoroughly tested in the past for biocompatibility. The product has passed the biocompatibility test for cytotoxicity, intracutaneous irritation, skin sensitization, and pyrogen.by following ISO 10993.
Therefore, as the contact time for the device is short (TWSC. Therefore, the anti-vacuity capability of TWSC is the best: the second is Unimax.
(2) Anti-flat tube test : Based on the experiment result, under the suction pressure between 400 and 760 mmHg, there is no flat tube situation.
(3) Handle button pressure test: Based on the handle button pressure test and experiment result. the anti-pressure leak capability of is the worse; but the capability is correspond with product specification.
0 Sterilization and Bio Burden Test Summary:
The sterilization validation of gamma irradiation for Disposable Suction Irrigation was successful and had met the requirements of ISO 11137-2:2012 VD max25 method on substantiation of 25kGy as a sterilization dose. This study therefore supports the multiple batch products to be irradiated at the sterilization dose kGy for a SAL of 10-9.
IX. CONCULSIONS
The Taiwan Surgical Disposable Suction Irrigation has the same intended use and same basic technology as the predicate device, thus is able to achieve same effectiveness and safety as the predicate device.