(50 days)
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.
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.
This document describes results from a 510(k) premarket notification for the LiVac Retractor System. It includes information on performance data, but it does not contain specific acceptance criteria, reported device performance metrics in a table format, nor details about sample sizes, data provenance, ground truth establishment, or expert involvement for a study proving device meets acceptance criteria.
The document states: "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."
However, the specific "design requirements for performance characteristics" that would serve as acceptance criteria are not explicitly detailed with quantitative targets. Instead, a series of "Pass" results are listed for functional performance, biocompatibility, sterilization, packaging/shelf-life, and risk analysis.
Here's an attempt to answer the questions based on the provided text, acknowledging the significant gaps in information for many points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Functional performance (device retraction times) | Pass |
| Biocompatibility (per ISO 10993) | 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 |
| Performance and safety in laparoscopic surgery | Both primary and secondary performance objectives were achieved. Both primary and secondary safety objectives were achieved. No new risks were identified. |
Note: The document only states "Pass" or "objectives were achieved" without providing the specific quantitative criteria that define a "Pass" or what those objectives numerically were.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Performance Data (Test Set): No specific sample sizes for bench tests are provided.
- Animal Studies (Test Set): "three non-clinical studies on pigs" and "A fourth study was conducted by an independent surgeon in Italy." Data provenance: University of Melbourne (Australia), School of Veterinary Science - Animal laboratory, and Italy. These were prospective studies.
- Clinical Study (Test Set): "an open label study of the performance and safety of the LiVac Retractor in laparoscopic surgery at two hospitals in Victoria, Australia." This was a prospective study. No specific number of patients (sample size) is provided for the clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Bench/Animal Studies: Not applicable in the context of expert ground truth. Performance was evaluated through direct observation and measurement in these studies.
- Clinical Study: The study was open label, and both performance and safety objectives were evaluated. While presumably surgeons were involved in assessing performance and safety, the document does not specify the number or qualifications of experts used to establish any formal "ground truth" or expert consensus in the typical sense for a diagnostic device. The outcomes were likely observed and recorded by the surgical team and researchers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Bench/Animal Studies: Not applicable.
- Clinical Study: The document does not provide any information regarding an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes a medical device (a retractor) and its performance, not an AI or diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers improving with AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is for a medical device (retractor), not an algorithm or AI. Therefore, a standalone algorithm-only performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Performance: Direct measurement and observation of device function.
- Animal Studies: Direct observation of device use during surgical procedures in animals, and evaluation of surgical outcomes.
- Clinical Study: "Performance and safety of the LiVac Retractor in patients undergoing upper abdominal single or multi-port laparoscopic surgery." The ground truth here would be the observed events and outcomes during surgery, as monitored by the surgical team, and potentially patient follow-up data. This is akin to outcomes data or direct observation of device performance and patient safety.
8. The sample size for the training set
This document does not describe any training set. The studies mentioned are focused on demonstrating the performance and safety of a physical medical device (retractor) through testing, not on training a model.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
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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 (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" (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 (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 -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)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 +61 412003606 | |
| Email: anabela@livac.com.au |
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: projectmanagement@emergogroup.com |
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 | LiVacRetractor System | ReveelEndoscopic 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 |
| RegulationDescription | 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 | LiVacRetractor System | ReveelEndoscopic Retractor | Similarities/Differences |
| Body Location | Abdominal | Abdominal | Same |
| Target Area | Liver and other organs andtissues. | Liver and other organs andtissues. | Same |
| Single Use | Yes | Yes | Same |
| Supplied Sterile | Yes (Gamma) | Yes (Gamma) | Same |
| Device Description | The LiVac Retractor is a softsilicone ring connected tosuction tubing. The suctiontubing is connected to a largecalibre external (sterile)suction hose via the LiVacConnector. The LiVacRetractor can be used as astandalone device with alaparoscopic multi-channelsingle port or with a 12-15 mmlaparoscopic port. The LiVacBevel accessory is used tofacilitate use of the LiVacRetractor with a 10-12 mm"Hasson" type port inserted atthe umbilicus. | Reveel is a single use deviceintended for mobilizing andmanoeuvring organs andtissue during endoscopicsurgical procedures. It iscomprised of a proximalhandle, a rigid shaft and adistal retraction surface. | LiVac and Reveel are manufacturedfrom different materials, andtherefore their biologicalcharacteristics are different. LiVacand Reveel are used under the sameconditions of use, but use differentdeployment methods and differentprinciples of operation. They alsohave different specifications,properties and are different in design.Therefore there are some differencesin their technical characteristics. |
| Mode of Operationor TechnicalCharacteristics | Suction (negative pressure)applied to the device by anexternally regulated suctionsource by way of a suctionhose/adaptor in the facility;i.e., vacuum technology. | Manual (positive pressure)applied to the device byhand. | Following insertion into theabdominal cavity, the deploymentmethods are different: The LiVacRetractor lifts from above, whereasthe Reveel Retractor pushes frombelow. The principles of operationare also different: LiVac usesobjective regulated negative pressure,Reveel use subjective manualpositive pressure. |
| Materials/Features/Design Flexibility | Soft silicone ring connected tosuction tubing. Optionalaccessory bevel (modifiedHasson design). Both materialand design are flexible. Rigidconnector used through oralongside port. | Rigid metal central beam,with "harp" shaped retractionarm covered in highcoefficient of frictioncomposite material. Centralshaft is inflexible, arms havetwo dimensional flexibility. | The LiVac Retractor is made of asoft silicone, while the ReveelRetractor is made from a rigid metal,and therefore the products havedifferent specifications andproperties. |
| BiocompatibilityTesting | Per ISO 10993-1 | Per ISO 10993-1 | Similar |
| Sterilization Testing | Per ISO 11137-1Per ISO 11737-1 | Per ISO 11137-1 | Similar |
| Shelf-LifeTesting | 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.
§ 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.