(52 days)
The Innovia 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 InnoPort™ Laparoscopic Access Port is a sterile, single use laparoscopic access device made of a flexible Quatromer polymer combined with polycarbonate and polyurethane components. It 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 insufflation system to provide intra-abdominal pneumoperitoneum. The instrument ports are designed to accommodate 5 mm diameter laparoscopic instruments while allowing full maneuverability without loss of pneumoperitoneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.
I am designed to extract and analyze information related to medical device acceptance criteria and performance studies. However, the provided document (K090677) describes a Laparoscopic Access Port, which is a physical surgical device, not a software-based AI device.
Therefore, the concepts of "acceptance criteria for an AI device," "device performance in a study proving AI acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "training set size," and "ground truth for training set" are not applicable to this document.
The document discusses performance and functional testing for the physical laparoscopic device, including bench and in vivo tests to verify its ability to:
- Maintain pneumoperitoneum with minimal leakage.
- Allow introduction and manipulation of instruments.
- Meet performance specifications.
It concludes that the device is "substantially equivalent" to its predicate device and introduces "no new safety or effectiveness issues." This is the standard for 510(k) clearances for physical devices, focusing on safety and equivalence rather than AI-specific performance metrics.
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090677
Page 1 of 1.
510(k) SUMMAR Y
510(K) NUMBER:
SUBMITTED BY:
MAY 7 2009
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:
NAME OF DEVICE:
CLASSIFICATION:
TRADE NAME:
PREDICATE DEVICE:
May 6, 2009
Laparoscopic Access Port
Laparoscope, General & Plastic Surgery (21CFR 876.1500)
InnoPort™ Laparoscopic Access Port
Advanced Surgical Concepts TriPort Laparoscopic Access Device (K073719)
Ethicon Endopath Blunt Tip Trocar (K032676)
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 made of a flexible Quatromer polymer combined with polycarbonate and polyurethane components. It 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 insufflation system to provide intra-abdominal pneumoperitoneum. The instrument ports are designed to accommodate 5 mm diameter laparoscopic instruments while allowing full maneuverability without loss of pneumoperitoneum. 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 ability to maintain pneumoperitoneum with minimal leakage, allow introduction and manipulation 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three arms reaching upwards, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2009
Innovia LLC % Mr. Bruce Weber VP. Clinical, Regulatory and QA 12415 SW 136 Avenue, Unit 3 Miami, Florida 33186
Re: K090677
Trade/Device Name: Innovia InnoPort™ Laparoscopic Access Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 30, 2009 Received: June 30, 2009
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 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 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.
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Page 2 - Mr. Bruce Weber
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
David Krone
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K090677
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)
Neil H. Ogden Forman
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K090677
§ 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.