(57 days)
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.
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.
The provided text describes a 510(k) summary for the "Disposable Suction Irrigation" device by Taiwan Surgical Corporation. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves specific acceptance criteria for a novel device. Therefore, a direct mapping to all requested points is not fully possible as the nature of the submission is different from a typical de novo study evaluating a new device's performance against predefined metrics.
However, based on the information provided, I can extract and infer some details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and relevant standards. The "performance" here refers to the device meeting these criteria, often by being "same" as the predicate or passing specific tests.
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Design/Specification | Design Description | Same as Predicate device |
| Length of steel tube (350mm/470mm) | Matches Predicate (350mm/470mm), but elsewhere stated as 330mm/450mm for subject device, implying a range is acceptable. | |
| OD of steel tube (5mm) | Same as Predicate | |
| PVC soft tube (2900mm) | Same as Predicate | |
| Functional Performance | Anti-vacuity test | Passed. "TWSC is the best; the second is Unimax." (Implies better than predicate) |
| Anti-flat tube test | Passed. "No flat tube situation under 400-760 mmHg suction pressure." | |
| Handle button pressure test | Passed. "The capability is correspond with product specification." (Implies meeting spec despite being "worse" than something unstated) | |
| Biocompatibility | Cytotoxicity Test | Passed (following ISO 10993) |
| Intracutaneous test | Passed (following ISO 10993) | |
| Maximization sensitization test | Passed (following ISO 10993) | |
| Pyrogen test | Passed (following ISO 10993) | |
| Sterilization | Sterilization Dose (25kGy) | Passed, met ISO 11137-2:2012 VD max25 for SAL of 10-9 |
| Safety and Effectiveness | Same intended use as predicate | Same as Predicate |
| Same basic technology as predicate | Same as Predicate | |
| Achieves same effectiveness | Concluded to achieve same effectiveness as predicate | |
| Achieves same safety | Concluded to achieve same safety as predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for tests. It details "bench report" findings, meaning the testing was likely conducted in a lab setting. The provenance of the data is from Taiwan Surgical Corporation's internal testing as part of their 510(k) submission. The type of data is prospective as it involves tests specifically conducted for this submission, not retrospective analysis of past data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. For a device like this, the "ground truth" often relates to meeting engineering specifications or established biological safety standards, which are typically assessed by qualified technicians or engineers, rather than clinical experts like radiologists for image-based diagnostics.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to resolve discrepancies, which does not appear to be the primary focus of this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The "Disposable Suction Irrigation" is a surgical tool, and its effectiveness is determined by its functional performance and safety, not by human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical tool and not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications: Meeting predefined physical dimensions, pressure tolerances, and functional requirements.
- Established Standards: Adherence to international standards like ISO 10993 for biocompatibility and ISO 11137-2:2012 for sterilization.
- Predicate Device Comparison: The predicate device (UNIMAX MEDICAL SYSTEM INC., K103509) serves as a benchmark for comparison, implying its established safety and effectiveness forms part of the "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train AI models. This device is a physical product, not an AI/software device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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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
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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
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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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| 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 | RegulationSection | Panel |
|---|---|---|---|---|---|
| 1 | Disposable SuctionIrrigation | GCJ | II | 876.1500 | Endoscope andaccessories |
III. PREDICATE DEVICE
Predicate device 1: UNIMAX MEDICAL SYSTEM INC., K103509
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| Image: Taiwan Surgical logo | ||||
|---|---|---|---|---|
| Product | DisposableSuction 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 SuctionIrrigation | UNIMAX SUCTION IRRIGATIONSET | 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.
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| Image: Taiwan Surgical logo | ||||
|---|---|---|---|---|
| Product | DisposableSuction 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 SuctionIrrigation | Unimax SuctionIrrigation Set | |||
| 1 | Spec. | Design Description | Suction irrigationconsists of a handpiece equipped withtwo trumpet stylevalves, a probe, andconnecting lines oftubing, one setdesigned to attach toa supply of irrigationfluid, and the otherdesigned to attach toan inspiration pump.The valves allowcontrolled irrigationand aspirationduring a surgicalprocedure. | 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 buttonpressure test | 760 mmHg | 760 mmHg |
Table 3. Specification comparison table
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Taiwan Surgical®
| Product | DisposableSuction Irrigation | 510(k) Summary | page | 5-5 | |
|---|---|---|---|---|---|
| Version | 1.0 |
| 3 | Biocompatibility | Cytotoxicity TestIntracutaneous testMaximizationsensitization test | Same | |
|---|---|---|---|---|
| 4 | Regulatory | Classification | class II876.1500 | Same |
| Same | ||||
| Intended Use | Suction Irrigation isindicated for generalpurpose use assuction/irrigationdevice to facilitatelavage duringlaparoscopicgynecologic surgery,general surgery,thoracic surgery andurology. The devicefunctions to aidflushing blood andtissue debris fromthe surgical site. | |||
| 5 | Package | A pouches withprotective cover |
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| Image: Taiwan Surgical logo | ||||
|---|---|---|---|---|
| Product | DisposableSuction Irrigation | 510(k) Summary | pageVersion | 5-61.0 |
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 (<24 hour) with the body and the biocompatibility has proved that device will not cause any cytotoxicity, intracutaneous irritation, skin sensitization, or pyrogen reaction to the body.
● Performance Testing summary:
As the Bench report for Disposable Suction Irrigation concludes that :
(1) Anti-Vacuity test: Unimax >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.
§ 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.