(257 days)
Not Found
No
The summary describes a mechanical laparoscopic access device and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an access port for instruments during laparoscopic surgery, not as a device that provides therapy or treatment directly.
No
The device is described as an access port for instruments and cameras during surgery, and its performance testing focuses on maintaining pneumoperitoneum and instrument maneuverability, not on diagnosing medical conditions.
No
The device description clearly states it is a physical device comprised of flexible polymer and a rigid plastic plate, with multiple physical ports for instruments and gas. It is a hardware device used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing access during minimally invasive laparoscopic abdominal surgery. This is a surgical device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a physical device for surgical access, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health, or screen for conditions. This device is a surgical tool.
N/A
Intended Use / Indications for Use
The InnoPort Laparoscopic Access Port is a sterile, single use device, intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
The Innovia InnoPort™ Laparoscopic Access Device is a sterile, single use device intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
Product codes
GCJ
Device Description
The InnoPort Laparoscopic Access Port is a sterile, single use laparoscopic access device comprised of flexible polymer and a rigid plastic plate. The InnoPort forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the infor system to provide intra-abdominal pneumoperitoneum, and a fifth port coulties of the insunprocedural smoke removal. The instrument ports are designed to accommodate 5 mm dinerer laparoscopic instruments while allowing full maneuverability without loss of neumperioneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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)
The performance and functional testing of the InnoPort Laparoscopic Access Port included bench and in vivo tests to verify its billity to maintain pneumoperitoneum with minimal leakage, allow introduction and manyvlation of instruments, and meet performance specifications. The testing demonstrated that the InnoPort Laparoscopic Access Port is substantially equivalent to its predicate device and it introduces no new safety or effectiveness issues when used as instructed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Innovia InnoPort™ Laparoscopic Access Port (K090677)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) SUMMARY
510(K) NUMBER: | K093783 |
---|---|
AUG 2 3 2010 | |
SUBMITTED BY: | Innovia LLC |
12415 SW 136 Avenue | |
Unit 3 | |
Miami, FL 33186 | |
305-378-2651 | |
CONTACT PERSON: | Bruce Weber |
Vice President, Clinical, Regulatory and Quality Assurance | |
DATE OF PREPARATION: | July 13, 2010 |
NAME OF DEVICE: | Laparoscopic Access Port |
CLASSIFICATION: | Laparoscope, General & Plastic Surgery (21CFR 876.1500) |
TRADE NAME: | InnoPort™ Laparoscopic Access Port |
PREDICATE DEVICE: · | Innovia InnoPort™ Laparoscopic Access Port (K090677) |
INTENDED USE: The InnoPort Laparoscopic Access Port is a sterile, single use device, intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
DEVICE DESCRIPTION: The InnoPort Laparoscopic Access Port is a sterile, single use laparoscopic access device comprised of flexible polymer and a rigid plastic plate. The InnoPort forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the infor system to provide intra-abdominal pneumoperitoneum, and a fifth port coulties of the insunprocedural smoke removal. The instrument ports are designed to accommodate 5 mm dinerer laparoscopic instruments while allowing full maneuverability without loss of neumperioneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.
PERFORMANCE DATA SUMMARY: The performance and functional testing of the InnoPort Laparoscopic Access Port included bench and in vivo tests to verify its billity to maintain pneumoperitoneum with minimal leakage, allow introduction and manyvlation of instruments, and meet performance specifications. The testing demonstrated that the InnoPort Laparoscopic Access Port is substantially equivalent to its predicate device and it introduces no new safety or effectiveness issues when used as instructed.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innovia LLC % Mr. Bruce Weber Vice President, Clinical, Regulatory and Quality Assurance 12415 SW 136 Avenue Miami, Florida 33186
AUG 2 3 2010
Re: K093783
Trade/Device Name: Innovia InnoPort™ Laparoscopic Access Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 13, 2010 Received: July 14, 2010
Dear Mr. Weber:
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.
2
Page 2 - Mr. Bruce Weber
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ko93783
Indications for Use
510(k) Number (if known): .
Device Name: Innovia InnoPort™ Laparoscopic Access Port
Indications for Use:
The Innovia InnoPort™ Laparoscopic Access Device is a sterile, single use device intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sien-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093783