(121 days)
The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and reposition the placement of an endoscope during a surgical procedure by simple movements of a control handle. This camera controller eliminates the need for the surgeon to continually hold the endoscope during a surgical procedure.
This document, K102179, describes the 510(k) summary for the CareFusion EnView™ Camera Controller, a mechanical surgical device intended to hold rigid endoscopes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing specific performance metrics or acceptance criteria for the EnView™ camera controller itself.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Operational Performance & Conformance to Design Specifications | Testing was performed under various conditions to assess design performance and conformance to design specifications. (Specific details or quantitative results are not provided.) |
| Biocompatibility Standards | The EnView™ camera controller met ISO 10993:2003 (Biological evaluation of medical devices) standards. |
| Sterilization & Reprocessing Standards | The EnView™ camera controller met ISO 17664:2004 (Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices) standards. |
| Electrical Safety Standards | IEC 60601 testing was not required due to the mechanical and hydraulic mode of operation, similar to the predicate device (V.Mueller Camera Controller). |
| Substantial Equivalence (Operation, Design, Materials, Mfg.) | Substantially equivalent in operation, design, materials, and manufacturing characteristics as the V.Mueller Camera Controller and Storage Cart (K093616). |
| Substantial Equivalence (Indications for Use) | Substantially equivalent with respect to indications for use as the Prosurgics Freehand (K090340). |
| Safety and Efficacy | Equivalent in safety and efficacy to the legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The document states, "Clinical studies were not required." The non-clinical testing mentioned does not specify a "test set" in the context of clinical data. It refers to various conditions for design performance and conformance.
- Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing would have been conducted by the manufacturer, CareFusion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No clinical studies or human expert evaluations for ground truth are mentioned.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical trials or expert adjudication processes were described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not applicable. This device is a mechanical camera controller, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a mechanical tool operated by a surgeon, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- Not applicable. The approval is based on substantial equivalence to predicate devices and non-clinical engineering/materials testing against ISO standards, not clinical ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set or ground truth in that context is relevant for this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the non-clinical testing performed by CareFusion. The primary method for proving the device meets acceptance criteria (which are largely implicit based on substantial equivalence) is through:
- Design Performance and Conformance to Design Specifications Testing: This would involve engineering tests to ensure the mechanical parts function as intended, can hold endoscopes of specified diameters, and allow for proper manipulation. Details such as specific forces, movements, or durability tests are not provided in this summary.
- Adherence to International Standards: The device was tested and met:
- ISO 10993:2003: This series of standards deals with the biological evaluation of medical devices, ensuring the materials used are biocompatible and do not pose a toxicological risk when in contact with tissues.
- ISO 17664:2004: This standard provides information for the processing (cleaning, disinfection, sterilization) of re-usable medical devices. This confirms the device can be properly sterilized for safe re-use.
- Substantial Equivalence Argument: The core of the 510(k) submission is the demonstration that the EnView™ camera controller is "substantially equivalent" to two legally marketed predicate devices:
- V.Mueller Camera Controller with Storage Cart (K093616): Substantially equivalent in operation, design, materials, and manufacturing characteristics. This implies that the engineering and material science aspects are comparable.
- Prosurgics Freehand (K090340): Substantially equivalent with respect to indications for use. This means it can be used for the same surgical procedures and purposes.
Conclusion:
The K102179 submission for the CareFusion EnView™ Camera Controller relies on non-clinical testing against design specifications and international standards (ISO 10993, ISO 17664), alongside a robust argument for substantial equivalence to existing predicate devices. No clinical studies, expert consensus, or AI-related performance metrics were involved or required for its 510(k) clearance due to its nature as a mechanical surgical accessory.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circle with a stylized image of a person inside, followed by the word "CareFusion" in a sans-serif font. The logo is black and white.
K102179
CareFusion EnView™ Camera Controller 510(k) Summary
DEC - 2 2010
- Submitter: CareFusion 6215 Ferris Square, Suite 100 San Diego, CA 92121
- Patricia Avers Contact Person: Regulatory Affairs
- Date Prepared: July 30, 2010
- EnView™ Trade Name:
- Common Name: Camera controller
ll
- 78 OCV. Endoscope Holder and Accessories Classification: 21 CFR §876.1500
- Class:
- V.Mueller Camera Controller with Storage Cart, K093616 Predicate Devices: Prosurgics Freehand, K090340
- Intended Use: The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures.
A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
- Device Description: The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and
{1}------------------------------------------------
| reposition the placement of an endoscope during a surgicalprocedure by simple movements of a control handle. Thiscamera controller eliminates the need for the surgeon tocontinually hold the endoscope during a surgicalprocedure. | |
|---|---|
| SubstantialEquivalence: | The EnView™ camera controller is substantially equivalentin operation, design, materials, and manufacturingcharacteristics as the V.Mueller Camera Controller andStorage Cart, and is substantially equivalent with respect toindications for use as the Prosurgics Freehand. |
| Non-ClinicalTesting: | Testing was performed under various conditions to assessthe design performance and conformance to designspecifications. In addition, the EnView™ camera controllermet ISO 10993:2003 and ISO 17664:2004 standards. Aswith the V.Mueller Camera Controller, IEC 60601 testingwas not required for the EnView camera controller due tothe mechanical and hydraulic mode of operation. |
| Clinical Testing: | Clinical studies were not required as the EnView™ cameracontroller is substantially equivalent to the legally marketedpredicate devices with respect to operation and indicationsfor use. |
| Safety andEfficacy: | The EnView™ camera controller is equivalent in safety andefficacy to the legally marketed predicate devices. |
ﺑ
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three stripes emanating from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CareFusion % Ms. Patricia Avers 6215 Ferris Square, Suite 100 San Diego, California 92121
.
DEC - 2 2010
Re: K102179
Trade/Device Name: EnView™ camera controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCV Dated: October 12, 2010 Received: October 14, 2010
Dear Ms. Ayers:
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.
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
{3}------------------------------------------------
Page 2 - Ms. Patricia Avers
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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 yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indication for Use Statement
510(k) Number (if known): Pending K I O 21 79
DEC = 2 2010
Device Name: EnView™ camera controller
The EnView™ camera controller is intended for use by Indications for Use: surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures.
A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectorny, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
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 RP Beale for nkm
Division Sign Off
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102179
0010 ..............................................................................................................................................................................
§ 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.