(50 days)
Not Found
No
The summary describes a mechanical retractor system and does not mention any AI or ML components or functionalities.
No
The device is a surgical retractor used for manipulation during laparoscopic procedures, not for therapeutic treatment of a condition.
No
Explanation: The device is described as an organ and tissue retractor for use in laparoscopic procedures, designed to elevate organs and tissue and provide improved access and visualization of surgical sites. Its function is to facilitate surgery, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components (silicone ring, suction tubing, bevel, connector) and their function in a laparoscopic procedure, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "elevate organs and tissue to provide improved access and visualisation of surgical sites" during laparoscopic procedures. This is a mechanical function performed directly on the patient's body during surgery.
- Device Description: The description details a physical device (silicone ring, tubing, connectors) used for retraction, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used for physical manipulation during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data – Bench:
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.
- 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
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
1
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
2
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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Form Approved: OMB No. 0910-0120
3
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 |
4
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
Retractor System | Reveel
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
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
Retractor System | Reveel
Endoscopic Retractor | Similarities/Differences |
| Body Location | Abdominal | Abdominal | Same |
| Target Area | Liver and other organs and
tissues. | Liver and other organs and
tissues. | Same |
| Single Use | Yes | Yes | Same |
| Supplied Sterile | Yes (Gamma) | Yes (Gamma) | Same |
| Device Description | The LiVac Retractor is a soft
silicone ring connected to
suction tubing. The suction
tubing is connected to a large
calibre external (sterile)
suction hose via the LiVac
Connector. The LiVac
Retractor can be used as a
standalone device with a
laparoscopic multi-channel
single port or with a 12-15 mm
laparoscopic port. The LiVac
Bevel accessory is used to
facilitate use of the LiVac
Retractor with a 10-12 mm
"Hasson" type port inserted at
the umbilicus. | Reveel is a single use device
intended for mobilizing and
manoeuvring organs and
tissue during endoscopic
surgical procedures. It is
comprised of a proximal
handle, a rigid shaft and a
distal retraction surface. | LiVac and Reveel are manufactured
from different materials, and
therefore their biological
characteristics are different. LiVac
and Reveel are used under the same
conditions of use, but use different
deployment methods and different
principles of operation. They also
have different specifications,
properties and are different in design.
Therefore there are some differences
in their technical characteristics. |
| Mode of Operation
or Technical
Characteristics | Suction (negative pressure)
applied to the device by an
externally regulated suction
source by way of a suction
hose/adaptor in the facility;
i.e., vacuum technology. | Manual (positive pressure)
applied to the device by
hand. | Following insertion into the
abdominal cavity, the deployment
methods are different: The LiVac
Retractor lifts from above, whereas
the Reveel Retractor pushes from
below. The principles of operation
are also different: LiVac uses
objective regulated negative pressure,
Reveel use subjective manual
positive pressure. |
| Materials/Features/
Design Flexibility | Soft silicone ring connected to
suction tubing. Optional
accessory bevel (modified
Hasson design). Both material
and design are flexible. Rigid
connector used through or
alongside port. | Rigid metal central beam,
with "harp" shaped retraction
arm covered in high
coefficient of friction
composite material. Central
shaft is inflexible, arms have
two dimensional flexibility. | The LiVac Retractor is made of a
soft silicone, while the Reveel
Retractor is made from a rigid metal,
and therefore the products have
different specifications and
properties. |
| Biocompatibility
Testing | Per ISO 10993-1 | Per ISO 10993-1 | Similar |
| Sterilization Testing | Per ISO 11137-1
Per ISO 11737-1 | Per ISO 11137-1 | Similar |
| Shelf-Life
Testing | Per ISO 11607-1 | Not known | Not known |
Table 1 Substantial Equivalence Comparison Table
5
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.
6
- . 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.