(10 days)
The CardioVations Portable Video System is intended to be used as an accessory in any endoscopic procedures that require a viewing distance up to 2 inches (5cm), when used with many rigid B-Style (32mm diameter eyecup) endoscopes.
The CardioVations Portable Video System is designed to be used as an accessory in any endoscopic procedures that require a viewing distance up to 2 inches (5cm), when used with many rigid B-Style (32mm diameter eyecup) endoscopes.
The CardioVations Portable Video System is a self contained system that is used as an endoscopic accessory to provide visualization during any endoscopic procedure that requires a viewing distance up to 2 inches (5 cm), when used with many B-style eyecup rigid endoscopes. The system consists of the following components:
• Video System Controller (Pack)
• Camera Heads (PAL, NTSC) with Light Source and Cable (Umbilical)- as one unit
• Heads-up Display (serves as a monitor or can be connected to a monitor).
• Battery Charger and Universal Power Supply
There are three main components of the Cardio Vations Portable Video System. These components are the Video System Controller (camera control unit) that is powered by a lithium ion rechargeable battery pack and worn by the user under the sterile gown, a Video Display (Heads-Up Video Display or standard monitor display) description and camera head (two, NTSC or PAL) and compact light source and cable. Only the camera head, light source and connection cable can be sterilized.
The Video System Controller provides power to the camera head and light source through the umbilical cable. The camera and light source is connected to an endoscope for visualization. In use, the camera, light source and cable are brought to the sterile field after being sterilized. The user connects them to a sterile endoscope and passes the cable off to a circulating nurse using appropriate sterile technique. The circulating nurse connects the cable to the control unit and turns the power on. The user then focuses the camera and white balances the unit by pressing the push and lock white balance button. The camera control unit and batteries are designed to be reused indefinitely, while the camera head can be reused 34 times before it needs to be replaced.
The provided text describes the CardioVations Portable Video System, an endoscopic accessory. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with electrical standards IEC 60601-1-2 and IEC 60601-2-18. | The device will be tested for compliance with these standards (indicating testing was planned or ongoing, not explicitly stated as concluded and met in this summary). |
| Ability to produce a quality video image (color, clarity, brightness, contrast) comparable to the predicate device. | Pre-clinical testing concluded that the video image quality of the new device is comparable to the predicate device in terms of color, clarity, brightness, and contrast. This implies the device met the implicit acceptance criteria of being "comparable." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the pre-clinical evaluation. It refers to a "pre-clinical evaluation" without specifying the number of tests performed or the number of units tested. The data provenance is not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The pre-clinical evaluation focused on comparing the new device's video image quality to a predicate device, but it doesn't detail the method of assessment for "comparability," nor does it mention the use of experts for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC study was conducted or mentioned. The device is an endoscopic camera system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a video system, not an algorithm. Performance is intrinsically tied to human use for visualization.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the pre-clinical evaluation was based on comparison to a predicate device's video image quality in terms of color, clarity, brightness, and contrast. It was not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather a direct comparative assessment of visual output.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI/ML algorithm that requires a training set.
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AUG - 8 2003
K 032339 1/3
SECTION 8
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary ofSafety andEffectiveness | Information supporting claims of substantial equivalence,as defined under the Federal Food, Drug and Cosmetic Actrespecting safety and effectiveness is summarized below.For the convenience of the Reviewer, this summary isformatted in accordance with the Agency's final rule"...510(k) Summaries and 510(k) Statements..." (21 CFR807) and can be used to provide a substantial equivalencesummary to anyone requesting it from the Agency. |
|---|---|
| Contact | Peter CecchiniManager, Regulatory AffairsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151Telephone: 908-218-2457 |
| Date | July 24, 2003 |
| Device Name | Classification Name: Accessory to an endoscopeCommon Name: Endoscopic Camera SystemProprietary Name: CardioVations Portable Video System |
| DeviceDescription | The CardioVations Portable Video System is a selfcontained system that is used as an endoscopic accessory toprovide visualization during any endoscopic procedure thatrequires a viewing distance up to 2 inches (5 cm), when |
| Continued on next page | |
| DeviceDescription(Con't) | used with many B-style eyecup rigid endoscopes. Thesystem consists of the following components:• Video System Controller (Pack)• Camera Heads (PAL, NTSC) with Light Sourceand Cable (Umbilical)- as one unit• Heads-up Display (serves as a monitor or can beconnected to a monitor).• Battery Charger and Universal Power Supply |
| There are three main components of the Cardio VationsPortable Video System. These components are the VideoSystem Controller (camera control unit) that is powered bya lithium ion rechargeable battery pack and worn by theuser under the sterile gown, a Video Display (Heads-UpVideo Display or standard monitor display) description andcamera head (two, NTSC or PAL) and compact light sourceand cable. Only the camera head, light source andconnection cable can be sterilized. | |
| The Video System Controller provides power to the camerahead and light source through the umbilical cable. Thecamera and light source is connected to an endoscope forvisualization. In use, the camera, light source and cable arebrought to the sterile field after being sterilized. The userconnects them to a sterile endoscope and passes the cableoff to a circulating nurse using appropriate steriletechnique. The circulating nurse connects the cable to thecontrol unit and turns the power on. The user then focusesthe camera and white balances the unit by pressing the pushand lock white balance button. The camera control unitand batteries are designed to be reused indefinitely, whilethe camera head can be reused 34 times before it needs tobe replaced. | |
| Intended Use | The CardioVations Portable Video System is intended to beused as an accessory in any endoscopic procedures thatrequire a viewing distance up to 2 inches (5cm), when usedwith many rigid B-Style (32mm diameter eyecup)endoscopes. |
| Indications Statement | The CardioVations Portable Video System is designed tobe used as an accessory in any endoscopic procedures thatrequire a viewing distance up to 2 inches (5cm), when usedwith many rigid B-Style (32mm diameter eyecup)endoscopes. |
| TechnologicalCharacteristics | The new device has similar technological characteristicsas the predicate device. Both the new and the predicatedevice are video cameras intended as endoscopicaccessories. Both devices can be connected to a monitor toprovide visualization of the surgical field. The new deviceis battery operated with a portable camera controller thatcan be worn by the user. The predicate device is poweredby line voltage and the controller is mounted on a cart inthe operating room. |
| Performance Datafor New Device | The CardioVations Portable Video System will be testedcompliance with the electrical standards, InternationalElectrotechnical Commission, IEC 60601-1-2 and IEC60601-2-18, Particular Requirements for Safety ofEndoscopic Equipment. |
| Pre-clinical testing was conducted to demonstrate that theCardioVations Portable Video System performed asclinically intended. In a pre-clinical evaluation , theessential performance characteristic assessed was theability of the system to produce a quality video image interms of color, clarity, brightness and contrast. The resultsof the testing concluded that video image quality of the newdevice is comparable to the predicate device. | |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21CFR 807) and the information provided herein, weconclude that the new device is substantially equivalent tothe Predicate Devices under the Federal Food, Drug, andCosmetic Act. |
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SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ethicon, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K032339
Trade/Device Name: CardioVations Portable Video System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 28, 2003 Received: July 29, 2003
Dear Mr. Mosenkis:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.
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Page 2 - Mr. Robert Mosenkis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number (if known): | K032339 |
|---|---|
| Device Name: | CardioVations Portable Video System |
| Indications for Use: | The CardioVations Portable Video System is designed to be usedas an accessory in any endoscopic procedures that require aviewing distance up to 2 inches (5cm), when used with many rigidB-style (32mm diameter eyecup) endoscopes. |
(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 1-2-9G)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
CardioVations Portable Video systems) Num ETHICON, Inc
iii
§ 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.