LiVac Retractor System

K162445 · Livac Pty, Ltd. · GCJ · Oct 20, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162445
• Device Name: LiVac Retractor System
• Applicant: Livac Pty, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.

Device Story

The LiVac Retractor System is a soft silicone ring retractor used in laparoscopic surgery to elevate organs, such as the liver or spleen, to improve surgical site access. The device operates via negative pressure (suction); it is connected to an external facility suction source through a LiVac Connector and suction tubing. The system includes a LiVac Bevel accessory to facilitate use with 10-12 mm Hasson-type ports or single-incision laparoscopic ports. Unlike manual push-based retractors, the LiVac lifts organs from above using vacuum technology. It is a single-use, sterile device operated by surgeons in an OR setting. By maintaining apposition between organ surfaces and the diaphragm, it provides stable retraction, potentially reducing the need for manual retraction and improving visualization for the surgeon.

Clinical Evidence

Clinical evidence includes an open-label study conducted at two hospitals in Victoria, Australia, following ISO 14155-2011. The study evaluated the performance, safety, and tolerability of the LiVac Retractor and LiVac Bevel in patients undergoing upper abdominal single or multi-port laparoscopic surgery. Results confirmed that all primary and secondary performance and safety objectives were met, with no new risks identified. Additionally, four non-clinical animal studies (pigs) were conducted to evaluate the device in cholecystectomy and gastrectomy procedures, confirming successful retraction at pressures up to -500 mmHg.

Technological Characteristics

The device consists of a soft silicone ring, suction tubing, a rigid connector, and an optional silicone bevel accessory. It utilizes negative pressure (vacuum) for retraction. The device is supplied sterile via gamma irradiation. Biocompatibility is compliant with ISO 10993-1. Sterilization is validated per ISO 11137-1/-2/-3 and ISO 11737-1/-2. Shelf-life is validated per ISO 11607-1/-2.

Indications for Use

Indicated for use in laparoscopic procedures to elevate organs and tissue in patients requiring improved access and visualization of surgical sites during upper abdominal surgery.

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.

Predicate Devices

• Reveel Endoscopic Retractor (K133345)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 20, 2016

LiVac Pty Ltd % Mr. Stuart R. Goldman Emergo Global Consulting LLC 2500 Bee Cave, Building 1, Suite 300 Austin, Texas 78746

Re: K162445 Trade/Device Name: LiVac Retractor System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 1, 2016 Received: August 31, 2016

Dear Mr. Goldman:

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 CFR Part 807); labeling (21 CFR Part 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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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 and Part 809), 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" (21 CFR 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 -A

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

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### Indications for Use

510(k) Number (if known)

K162445

Device Name

LiVac Retractor System

Indications for Use (Describe)

The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# Section 5 510(k) Summary

#### 1. Submission sponsor

| Submission sponsor | Livac Pty Ltd |
|--------------------|--------------------------------------|
| Company Address | 8 Melaleuca Court, |
| | Warrnambool VICTORIA 3280, Australia |
| Contact details | Dr Anabela Correia, CEO |
| | Phone [phone] |
| | Email: [e-mail] |

#### 2. Submission correspondent

| Submission correspondent | Emergo Global Consulting LLC |
|--------------------------|------------------------------------------|
| | 2500 Bee Cave, |
| | Bldg 1 Suite 300 |
| | Austin, Texas 78746 USA |
| Contact details | Stuart R. Goldman |
| | |
| | Office: +1.512.327.9997 |
| | Email: [e-mail] |

#### Date Prepared 3.

Date Summary Prepared August 1, 2016

#### Device Identification 4.

| Type of 510(k) Submission | Traditional |
|---------------------------|----------------------------------|
| Trade or Proprietary Name | LiVac™ Retractor System (LiVac™) |
| Common or Usual Name | Retractor |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and Accessories |
| Product Code | GCJ |
| Class of Device | Class II |
| Panel | General & Plastic Surgery |

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#### ട. Legally Marketed Predicate Device

Reveel Endoscopic Retractor (K133345): Retraction Limited

#### Device Description 6.

The LiVac Retractor System is a soft silicone ring connected to suction tubing and is designed to maintain apposition between two substantially planar, conformable, solid organ surfaces, most typically the diaphragm and either lobe of liver, or spleen, thereby exposing the organs beneath. The system is comprised of three components: 1.) LiVac Retractor, 2.) LiVac Bevel, and 3.) LiVac Connector.

The suction tubing is connected to a sterile suction hose via the connector, which is positioned partially within the abdominal wall. The LiVac Connector can lie alongside a 12-15mm port within the secondary channel of the LiVac Bevel as per Hasson technique, or within a single incision laparoscopic port device.

#### Indications for Use Statement 7.

The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.

#### Substantial Equivalence Discussion 8.

The following table compares the LiVac Retractor to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities and differences to the predicate device.

| Device Name | LiVac<br>Retractor System | Reveel<br>Endoscopic Retractor | Similarities/Differences |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Sponsor | Livac Pty Ltd | Retraction Limited | - |
| 510(k) No. | To be determined | K133345 | - |
| Product Code | GCJ | GCJ | - |
| Classification Name | Laparoscope, general & plastic surgery | Laparoscope, general & plastic surgery | Same |
| Device Class | II | II | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Regulation<br>Description | Endoscope and accessories | Endoscope and accessories | Same |
| Indications for Use | The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites. | Reveel is designed as an organ and tissue retractor for the use in endoscopic procedures to elevate organs and tissues to provide better access as well as visualization of surgical sites. | Same |
| Prescription Use | Yes | Yes | Same |
| Device Name | LiVac<br>Retractor System | Reveel<br>Endoscopic Retractor | Similarities/Differences |
| Body Location | Abdominal | Abdominal | Same |
| Target Area | Liver and other organs and<br>tissues. | Liver and other organs and<br>tissues. | Same |
| Single Use | Yes | Yes | Same |
| Supplied Sterile | Yes (Gamma) | Yes (Gamma) | Same |
| Device Description | The LiVac Retractor is a soft<br>silicone ring connected to<br>suction tubing. The suction<br>tubing is connected to a large<br>calibre external (sterile)<br>suction hose via the LiVac<br>Connector. The LiVac<br>Retractor can be used as a<br>standalone device with a<br>laparoscopic multi-channel<br>single port or with a 12-15 mm<br>laparoscopic port. The LiVac<br>Bevel accessory is used to<br>facilitate use of the LiVac<br>Retractor with a 10-12 mm<br>"Hasson" type port inserted at<br>the umbilicus. | Reveel is a single use device<br>intended for mobilizing and<br>manoeuvring organs and<br>tissue during endoscopic<br>surgical procedures. It is<br>comprised of a proximal<br>handle, a rigid shaft and a<br>distal retraction surface. | LiVac and Reveel are manufactured<br>from different materials, and<br>therefore their biological<br>characteristics are different. LiVac<br>and Reveel are used under the same<br>conditions of use, but use different<br>deployment methods and different<br>principles of operation. They also<br>have different specifications,<br>properties and are different in design.<br>Therefore there are some differences<br>in their technical characteristics. |
| Mode of Operation<br>or Technical<br>Characteristics | Suction (negative pressure)<br>applied to the device by an<br>externally regulated suction<br>source by way of a suction<br>hose/adaptor in the facility;<br>i.e., vacuum technology. | Manual (positive pressure)<br>applied to the device by<br>hand. | Following insertion into the<br>abdominal cavity, the deployment<br>methods are different: The LiVac<br>Retractor lifts from above, whereas<br>the Reveel Retractor pushes from<br>below. The principles of operation<br>are also different: LiVac uses<br>objective regulated negative pressure,<br>Reveel use subjective manual<br>positive pressure. |
| Materials/Features/<br>Design Flexibility | Soft silicone ring connected to<br>suction tubing. Optional<br>accessory bevel (modified<br>Hasson design). Both material<br>and design are flexible. Rigid<br>connector used through or<br>alongside port. | Rigid metal central beam,<br>with "harp" shaped retraction<br>arm covered in high<br>coefficient of friction<br>composite material. Central<br>shaft is inflexible, arms have<br>two dimensional flexibility. | The LiVac Retractor is made of a<br>soft silicone, while the Reveel<br>Retractor is made from a rigid metal,<br>and therefore the products have<br>different specifications and<br>properties. |
| Biocompatibility<br>Testing | Per ISO 10993-1 | Per ISO 10993-1 | Similar |
| Sterilization Testing | Per ISO 11137-1<br>Per ISO 11737-1 | Per ISO 11137-1 | Similar |
| Shelf-Life<br>Testing | Per ISO 11607-1 | Not known | Not known |

Table 1 Substantial Equivalence Comparison Table

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#### 9. Performance Data – Bench

As part of demonstrating safety and effectiveness of the LiVac Retractor System, LiVac completed a number of tests on their device to demonstrate that it meets all design requirements for performance characteristics, biocompatibility, sterilization, shelf-life and risk. The LiVac Retractor System passed all testing in accordance with internal LiVac performance testing, as well as those international standards shown below to support substantial equivalence of the subject device.

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- . LiVac functional performance testing to demonstrate device retraction times: Pass
- Biocompatibility testing per ISO 10993 (Part 1, Part 5 and Part 10): Pass ●
- Sterilization validation per ISO 11137-1/-2/-3 and ISO 11737-1/-2: Pass .
- Packaging and Shelf-Life per ISO 11607-1/-2: Pass ●
- . Risk Analysis per ISO 14971: Completed with all risk mitigated to as low as possible

### 10. Performance Data - Animal

Livac conducted three non-clinical studies on pigs to evaluate the LiVac Retractor in laparoscopic surgery at the University of Melbourne (Australia), School of Veterinary Science - Animal laboratory. These studies demonstrated use of the LiVac Retractor in cholecystectomy and gastrectomy procedures. A fourth study was conducted by an independent surgeon in Italy. The LiVac retractor was successfully used for a cholecystectomy. The maximum pressure used was -500 mmHg.

### 11. Performance Data - Clinical

Livac conducted an open label study of the performance and safety of the LiVac Retractor in laparoscopic surgery at two hospitals in Victoria, Australia. The study was conducted in accordance with ISO 14155-2011. The primary objective of the study was to evaluate the performance of the LiVac Retractor in patients undergoing upper abdominal single or multi-port laparoscopic surgery, while the secondary objectives of the study were to evaluate the safety and tolerability of the LiVac Retractor; to evaluate the performance of the LiVac Bevel accessory to the LiVac Retractor, used in multiport procedures; and to evaluate the safety and tolerability of the LiVac Bevel used in multiport procedures.

The study provides evidence for the performance and safety of the LiVac Retractor and demonstrates that the use of the LiVac Retractor does not raise new questions of safety or effectiveness. Both primary and secondary performance objectives were achieved. Both primary and secondary safety objectives were achieved. No new risks were identified.

## 12. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device or the device has the same intended use and different technological characteristics provided it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device. The LiVac Retractor System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device, the Reveel Endoscopic Retractor (K133345), manufactured by Retraction Limited.