(88 days)
No
The 510(k) summary describes a purely mechanical surgical access port with irrigation capabilities. There is no mention of any software, data processing, or algorithmic functions that would indicate the presence of AI or ML.
No
The device is described as an irrigating cannula used to provide access for endoscopic instruments and irrigate trocar wound surfaces. Its function is to facilitate medical procedures and introduce fluids, not to directly treat a disease or condition.
No
The device is an irrigating cannula used to provide access for endoscopes and to irrigate or infuse trocar wound surfaces, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, disposable surgical access port made of materials like polyolefin shrink tubing, with a luer connector and holes for irrigation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an access port to body cavities for endoscopes and endoscopic accessories and for intraoperative irrigation or infusion. This is a surgical access device used during a procedure on the patient's body.
- Device Description: The description details a surgical access port inserted percutaneously into the peritoneal cavity. It's a physical device used for surgical access and delivery of fluids.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test samples like blood, urine, tissue, etc., outside the body.
The device is a surgical instrument used for access and irrigation during endoscopic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CA-Guard Irrigating Cannula is intended to provide an access port to body cavities for endoscopes and endoscopic accessories when intraoperative irrigation or infusion of trocar wound surfaces is desired. The cannula has been tested for compatibility with lidocaine and marcane. Saline and water may also be used as irrigants.
Product codes
OCX, GCJ
Device Description
The Irrigating Cannula is a non-toxic, sterile, single use, disposable surgical access port. The device is intended to be inserted percutaneously into the peritoneal cavity to provide access for endoscopic instruments. The cannula is intended to replace the cannula that is supplied with the United States Surgical Versaport® 11mm Trocar System.
The proximal end of the cannula is equipped with a female luer connector. The luer communicates with 6 longitudinal grooves on the surface of the inner member of the cannula. The inner member is covered with polyolefin shrink tubing. An array of twenty-four (24) holes deliver infusate to the compromised tissue surfaces of the trocar wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities (specifically peritoneal cavity mentioned for insertion)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare workers (inferred from mention of "needle sticks")
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 of the device was characcterized and compared to that of the predicate utilizing 5 tests. Additionally, the cannula was tested for compatibility with the indicated infusates. The tests demonstrated the Irrigating Cannula is substantially equivalent to the masula manufactured and marketed by the United States Surgical Corporation as part of the Versaport® Trocar System pursuant to 510(k) K954108. The materials of construction have been carefully selected for their long history of biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. 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
CA-GUARD, LTD. Mr. Al Weisenborn Official Correspondent 19526 East Lake Drive Miami. FL 33015
.JUL 2 7 2015
Re: K020614 Trade/Device Name: Irrigating Cannula Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX, GCJ Dated (Date on orig SE Itr): February 21, 2002 Received (Date on orig SE ltr): February 25, 2002
Dear Mr. Weisenborn,
This letter corrects our substantially equivalent letter of May 24, 2002.
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
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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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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), please contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Inclications for Use
Page_1 of 1
510(k) Number (if known): K020614
Device Name: Irrigating Cannula
Indications for Use:
Irrigating Cannula is in-CA-Guard The tended to provide an access port to body cavities for endoscopes and endoscopic accessories when intraoperative irrigation or infusion of trocar wound surfaces is desired.
Daniel A. Skadsen
(Division Sign-Off) Division of Reproductive, At and Radiological Devices 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _/
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
CA-Guard, LTD.
610 E. Olympia Ave · Punta Gorda, FL 33950
Revised: May 23, 2002
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MAY 2 4 2002
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Summary of Safety and Effectiveness for the Irrigating Cannula
Submitted by CA-Guard, LTD. 610 E. Olympia Ave Punta Gorda, FL 33950 Phone: (941) 833-1102
| Contact Person: | Al Weisenborn |
|---|---|
| Device Trade Name: | Irrigating Cannula |
| Common Name: | Cannula |
| Classification Name: | Endoscopes and Accessories, per 21 CFR §876.1500 |
Identification of a Legally Marketed Predicate Device
The Irrigating Cannula is substantially equivalent to the cannula manufactured and marketed by the United States Surgical Corporation as part of the Versaport® Trocar System pursuant to 510(k) K954108.
General Description
The Irrigating Cannula is a non-toxic, sterile, single use, disposable surgical access port. The device is intended to be inserted percutaneously into the peritoneal cavity to provide access for endoscopic instruments. The cannula is intended to replace the cannula that is supplied with the United States Surgical Versaport® 11mm Trocar System.
The proximal end of the cannula is equipped with a female luer connector. The luer communicates with 6 longitudinal grooves on the surface of the inner member of the cannula. The inner member is covered with polyolefin shrink tubing. An array of twenty-four (24) holes deliver infusate to the compromised tissue surfaces of the trocar wound.
Intended Use
The CA-Guard Irrigating Cannula is intended to provide an access port to body cavities for endoscopes and endoscopic accessories when intraoperative irrigation or infusion of trocar wound surfaces is desired. The cannula has been tested for compatibility with lidocaine and marcane. Saline and water may also be used as irrigants. The CA-Guard Irrigating Cannula is inherently a needleless system and therefore, minimizes the possibility of "needle sticks" for healthcare workers, in accordance with the Needlestick Safety and Prevention Act of 2000.
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The CA Guard Irrigating Cannula is designed to be mechanically compatible with all components of the United States Surgical Versaport® 11mm Trocar System using the 5 mm PLUS SEAL.
Summary of Technological Characteristics
The Irrigating Cannula was compared to the predicate device using 14 points of comparison and found to be equivalent.
Summary of Performance Data
Performance of the device was characcterized and compared to that of the predicate utilizing 5 tests. Additionally, the cannula was tested for compatibility with the indicated infusates. The tests demonstrated the Irrigating Cannula is substantially equivalent to the masula manufactured and marketed by the United States Surgical Corporation as part of the Versaport® Trocar System pursuant to 510(k) K954108. The materials of construction have been carefully selected for their long history of biocompatibility.
Since the Irrigating Cannula embodies technological characteristics essentially identical to those of the predicate device, we believe the device is safe and effective and that it performs as well as or better than the predicate device. The device has been designed and developed utilizing design control methods in compliance with the QSR. The Irrigating Cannula will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.