Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm

K150253 · Taiwan Surgical Corporation · GCJ · Apr 1, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150253
• Device Name: Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
• Applicant: Taiwan Surgical Corporation
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

Disposable suction irrigation set; consists of hand piece with two trumpet-style valves, probe, and connecting tubing. Connects to external irrigation fluid supply and aspiration pump. Used in laparoscopic and general surgery; operated by surgeons/clinical staff. Valves provide controlled irrigation and aspiration to clear blood, tissue debris, and smoke from surgical sites. Hand piece allows introduction of instruments through probe to operative site. Adjustable instrument adapter accommodates various instrument diameters. Single-use, sterile device; provides mechanical lavage and evacuation capabilities to improve surgical site visualization and cleanliness.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, intracutaneous irritation, skin sensitization, pyrogenicity per ISO 10993), anti-vacuity, anti-flat tube, and handle button pressure tests. Sterilization validated via gamma irradiation per ISO 11137-2:2012.

Technological Characteristics

Materials: Stainless steel and plasticized polyvinyl chloride (PVC). Design: Hand piece with two trumpet-style valves, probe, and tubing. Dimensions: 330mm and 450mm tube lengths. Pressure: Irrigation 0-760 mmHg; Suction 0-600 mmHg. Sterilization: Gamma irradiation (SAL 10^-6).

Indications for Use

Indicated for patients undergoing laparoscopic or general surgery requiring lavage to flush blood and tissue debris from the surgical site.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• UNIMAX SUCTION IRRIGATION SET (K103509)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax Number: [phone] Contact Person: Celine Huang Email: celine(@taiwansurgical.com.tw Phone Number: [phone] ext. 251 Fax Number: [phone]

## 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<br>Section | Panel |
|-----|----------------------------------|--------------|----------------|-----------------------|------------------------------|
| 1 | Disposable Suction<br>Irrigation | GCJ | II | 876.1500 | Endoscope and<br>accessories |

## III. PREDICATE DEVICE

Predicate device 1: UNIMAX MEDICAL SYSTEM INC., K103509

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| Image: Taiwan Surgical logo | | | | |
|-----------------------------|----------------------------------|-----------------------|---------|-----|
| Product | Disposable<br>Suction Irrigation | <b>510(k) Summary</b> | page | 5-3 |
| | | | Version | 1.0 |

| Table 2. Predicate Device Identification |
|------------------------------------------|
|------------------------------------------|

| Subject Device | Predicate Device | | |
|----------------------------------|----------------------------------|--------------|---------------|
| | Predicate Device | Manufacturer | 510(k) Number |
| Disposable Suction<br>Irrigation | UNIMAX SUCTION IRRIGATION<br>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.

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| Image: Taiwan Surgical logo | | | | |
|-----------------------------|----------------------------------|----------------|---------|-----|
| Product | Disposable<br>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<br>Irrigation | Unimax Suction<br>Irrigation Set | |
| 1 | Spec. | Design Description | Suction irrigation<br>consists of a hand<br>piece equipped with<br>two trumpet style<br>valves, a probe, and<br>connecting lines of<br>tubing, one set<br>designed to attach to<br>a supply of irrigation<br>fluid, and the other<br>designed to attach to<br>an inspiration pump.<br>The valves allow<br>controlled irrigation<br>and aspiration<br>during a surgical<br>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<br>pressure test | 760 mmHg | 760 mmHg |

Table 3. Specification comparison table

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# Taiwan Surgical®

| Product | Disposable<br>Suction Irrigation | 510(k) Summary | | page | 5-5 |
|---------|----------------------------------|----------------|--|---------|-----|
| | | | | Version | 1.0 |

| 3 | Biocompatibility | | Cytotoxicity Test<br>Intracutaneous test<br>Maximization<br>sensitization test | Same |
|---|------------------|----------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | Regulatory | Classification | class II<br>876.1500 | Same |
| | | | | Same |
| | | | Intended Use | Suction Irrigation is<br>indicated for general<br>purpose use as<br>suction/irrigation<br>device to facilitate<br>lavage during<br>laparoscopic<br>gynecologic surgery,<br>general surgery,<br>thoracic surgery and<br>urology. The device<br>functions to aid<br>flushing blood and<br>tissue debris from<br>the surgical site. |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| 5 | | | Package | A pouches with<br>protective cover |

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| Image: Taiwan Surgical logo | | | | |
|-----------------------------|----------------------------------|----------------|-----------------|------------|
| Product | Disposable<br>Suction Irrigation | 510(k) Summary | page<br>Version | 5-6<br>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 (<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.