(10 days)
Not Found
Not Found
No
The description focuses on basic video system components and functionality, with no mention of AI or ML.
No
The device is described as an "accessory" for visualization during endoscopic procedures, providing a video system but not directly treating a disease or condition.
No
The device is an accessory for visualization during endoscopic procedures, providing video output of the surgical site. It does not perform any diagnostic analysis or interpretation on its own.
No
The device description explicitly lists multiple hardware components including a Video System Controller, Camera Heads, Heads-up Display, Battery Charger, and Universal Power Supply. It also describes the physical connection and use of these components during a procedure.
Based on the provided text, the CardioVations Portable Video System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CardioVations System's Function: The CardioVations Portable Video System is described as an accessory for endoscopic procedures. Its primary function is to provide visualization during these procedures by capturing video images from inside the body. It does not analyze or test biological specimens.
- Intended Use: The intended use clearly states it's for providing visualization during endoscopic procedures, not for analyzing samples.
Therefore, the CardioVations Portable Video System falls under the category of a medical device used for visualization during surgical or diagnostic procedures, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical testing was conducted to demonstrate that the CardioVations Portable Video System performed as clinically intended. In a pre-clinical evaluation, the essential performance characteristic assessed was the ability of the system to produce a quality video image in terms of color, clarity, brightness and contrast. The results of the testing concluded that video image quality of the new device is comparable to the predicate device.
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.
Not Found
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
AUG - 8 2003
K 032339 1/3
SECTION 8
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of
Safety and
Effectiveness | Information supporting claims of substantial equivalence,
as defined under the Federal Food, Drug and Cosmetic Act
respecting safety and effectiveness is summarized below.
For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule
"...510(k) Summaries and 510(k) Statements..." (21 CFR
807) and can be used to provide a substantial equivalence
summary to anyone requesting it from the Agency. |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Peter Cecchini
Manager, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151
Telephone: 908-218-2457 |
| Date | July 24, 2003 |
| Device Name | Classification Name: Accessory to an endoscope
Common Name: Endoscopic Camera System
Proprietary Name: CardioVations Portable Video System |
| Device
Description | 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 |
| | Continued on next page |
| Device
Description
(Con't) | 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. |
| Intended Use | 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. |
| Indications Statement | 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. |
| Technological
Characteristics | The new device has similar technological characteristics
as the predicate device. Both the new and the predicate
device are video cameras intended as endoscopic
accessories. Both devices can be connected to a monitor to
provide visualization of the surgical field. The new device
is battery operated with a portable camera controller that
can be worn by the user. The predicate device is powered
by line voltage and the controller is mounted on a cart in
the operating room. |
| Performance Data
for New Device | The CardioVations Portable Video System will be tested
compliance with the electrical standards, International
Electrotechnical Commission, IEC 60601-1-2 and IEC
60601-2-18, Particular Requirements for Safety of
Endoscopic Equipment. |
| | Pre-clinical testing was conducted to demonstrate that the
CardioVations Portable Video System performed as
clinically intended. In a pre-clinical evaluation , the
essential performance characteristic assessed was the
ability of the system to produce a quality video image in
terms of color, clarity, brightness and contrast. The results
of the testing concluded that video image quality of the new
device is comparable to the predicate device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21
CFR 807) and the information provided herein, we
conclude that the new device is substantially equivalent to
the Predicate Devices under the Federal Food, Drug, and
Cosmetic Act. |
1
K832339 2/3
SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
Page 8-2
2
Ko32339 3/3
SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
Page 8-3
3
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.
4
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
5
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 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. |
(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