(226 days)
Not Found
No
The description focuses on standard image processing for visualization and documentation, and there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is used for visualization, image recording and documentation, not for treating any medical condition.
No
Explanation: The device is described as an "Endoscopic Camera System" intended for "visualization, image recording and documentation during laparoscopic procedures." Its function is to provide real-time visible imaging, similar to conventional imaging systems used in surgical endoscopy. There is no mention of the device analyzing images or data to provide a diagnosis or aid in diagnosis.
No
The device description explicitly states that the system comprises hardware components including an Image Processing Unit, Camera Head (with objective lens), power supply cord, and video cables. It also mentions the Camera Head has an integrated cable and connects to the Image Processing Unit via a LEMO interface. While software is mentioned as being validated, the core functionality relies on these physical components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "visualization, image recording and documentation during laparoscopic procedures." This describes a system used for direct observation and recording of internal body structures during surgery.
- Device Description: The description details a system that captures optical images from a laparoscope and converts them into electronic signals for display on a monitor. This is a system for real-time visual guidance during a procedure.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze biological specimens. It processes optical images of internal anatomy in vivo (within the body).
The device is clearly intended for use during a surgical procedure to provide visual information to the surgeon, which is characteristic of a surgical imaging system, not an IVD.
N/A
Intended Use / Indications for Use
Image Processing Unit is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
Product codes
GCJ
Device Description
The Endoscopic Camera System comprises the Image Processing Unit, the Camera Head (including the objective lens), power supply cord and video cables. The Camera Head with integrated cable can be connected to the Image Processing Unit through the LEMO interface.
During surgical procedures, the Endoscopic Camera System is used to provide real-time visible imaging similar to that provided by conventional imaging system used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflected light is collected by a variety of laparoscopes that are attached to the camera head via equipment coupler. The camera head receives optical image from the connected laparoscope and converts optical image into electronic signal using the incorporated image sensor. The Image Processing Unit serves as the control center of the system and should be connected to a compatible light source in order to provide visualization. It can be connected to a 4K video monitor via one of the video cables provided to display image in real time: DVI cable, HDMI cable, 12G-SDI cable, and 3G-SDI cable.
The proposed system is a reusable device and provided non-sterile. The Camera Head should be cleaned and high-level disinfected prior to the first use and after every subsequent use. The recommended compatible Light Source is OPTO-LED104K (510k exempted, product code: NTN).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
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
Not Found
Summary of Performance Studies
Non clinical tests were conducted to verify that the proposed device met all design specifications as is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ANSI/AAMI ES 60601-1: 2005+A2 (R2012) +A1 Medical Electrical Equipment- Part 1: . General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic . safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for . the basic safety and essential performance of endoscopic equipment
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and . Systems.
- AAMI TIR 30:2016 A compendium of processes, materials, test methods, and acceptance . criteria for cleaning reusable medical devices
- AAMI TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing . in health care facilities: A guide for medical device manufacturers
The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the following guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
Performance testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended.
Key Metrics
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Guangdong OptoMedic Technologies, Inc. Jane Guo Regulatory Affairs Manager Suite 503, Building A. Golden Valley Intellicreation Community. No. 2 Yonganbei Street Foshan, Guangdong 528200 China
February 2, 2023
Re: K221781
Trade/Device Name: Image Processing Unit, Model: OPTO-CAM104K; Camera Head, Model: OPTO-CHD104KH Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 4, 2023 Received: January 5, 2023
Dear Jane Guo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin K. Chen -S
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221781
Device Name Image Processing Unit: OPTO-CAM104K; Camera Head: OPTO-CHD104KH
Indications for Use (Describe)
Image Processing Unit is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow swirl on the left, followed by the word "OptoMedic" in black, bold font. The logo is simple and modern, and it is likely used to represent a company that specializes in eye care.
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Date Prepared: July 13, 2022
I. General Information
| 510(k) Submitter/Owner: | Guangdong OptoMedic Technologies, Inc. |
|---|---|
| Suite 503, Building A, Golden Valley Intellicreation Community, | |
| No. 2 Yonganbei Street, Daxu, Guicheng, Nanhai, Foshan, | |
| Guangdong, 528200, P.R. China | |
| Establishment Registration Number: | Not yet registered |
| Primary Contact Person: | Jane Guo |
| Regulatory Affairs Engineer | |
| Tel: +86 (757) 8670 2920 | |
| Email: guoweijuan@optomedic.com | |
| Secondary Contact Person: | Alice Lau |
| Regulatory Affairs Engineer | |
| Tel: +86 (757) 8670 2920 | |
| Email: liuli@optomedic.com |
II. Device Identification
| Device Trade Name: | Image Processing Unit; Camera Head |
|---|---|
| Common or Usual Name: | Endoscopic Camera System |
| Model: | Image Processing Unit: OPTO-CAM104K |
| Camera Head: OPTO-CHD104KH | |
| Regulation Name: | Endoscopes and accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product Code: | GCJ |
III. Predicate Device
510(k) Number: K131953
006_6.0_510(k)_Summary
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Image /page/4/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the text "OptoMedic" in a bold, sans-serif font. The "Opto" portion of the text is in a lighter shade of gray, while the "Medic" portion is in a darker, almost black shade of gray.
Product Name: Imagel SPIES
The predicate device has not been subject to a design-related recall.
IV. Device Description
The Endoscopic Camera System comprises the Image Processing Unit, the Camera Head (including the objective lens), power supply cord and video cables. The Camera Head with integrated cable can be connected to the Image Processing Unit through the LEMO interface.
During surgical procedures, the Endoscopic Camera System is used to provide real-time visible imaging similar to that provided by conventional imaging system used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflected light is collected by a variety of laparoscopes that are attached to the camera head via equipment coupler. The camera head receives optical image from the connected laparoscope and converts optical image into electronic signal using the incorporated image sensor. The Image Processing Unit serves as the control center of the system and should be connected to a compatible light source in order to provide visualization. It can be connected to a 4K video monitor via one of the video cables provided to display image in real time: DVI cable, HDMI cable, 12G-SDI cable, and 3G-SDI cable.
The proposed system is a reusable device and provided non-sterile. The Camera Head should be cleaned and high-level disinfected prior to the first use and after every subsequent use. The recommended compatible Light Source is OPTO-LED104K (510k exempted, product code: NTN).
V. Indications for Use
Image Processing Unit (hereafter referred to as "IPU") is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.
| Description | Subject Device | Predicate Device (K131953) |
|---|---|---|
| Regulation Number | 21 CER 876.1500 | 21 CER 876.1500 |
| Product Code | GCJ | FET |
| Device class | Class II | Class II |
| Indication for use | Image Processing Unit | |
| (hereafter referred to as “IPU”) | ||
| is intended to be used with | ||
| compatible laparoscopes, | ||
| camera heads, light sources, | ||
| monitors, and other ancillary | ||
| equipment for visualization, | The Imagel SPIES is a camera control | |
| unit (CCU) for use with camera heads or | ||
| video endoscopes for visualization, | ||
| image recording and documentation | ||
| during general endoscopic and | ||
| microscopic procedures. | ||
| image recording and | ||
| documentation during | ||
| laparoscopic procedures. | ||
| Endoscopic Camera Head is | ||
| intended to be used with | ||
| compatible laparoscopes, | ||
| image processing unit, and | ||
| other ancillary equipment for | ||
| visualization, image recording | ||
| and documentation during | ||
| laparoscopic procedures. | ||
| Prescription/ | ||
| Over-the-counter | ||
| use | Prescription | Prescription |
| Testing | ANSI/AAMI ES 60601-1: | |
| 2005+A2 (R2012) +A1 | ||
| IEC 60601-1-2:2014 | ||
| IEC 60601-2-18:2009 | ||
| ASTM D4169-16 | ||
| AAMI TIR 30:2016 | ||
| AAMI TIR 12:2020 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| Dimensions | IPU: | |
| 422mm(L)×370mm(W)×149 | ||
| mm(H) | ||
| Camera Head: | ||
| 92mm(L)×39mm(W)×50mm( | ||
| H) | Image1 S Connect TC200 : | |
| 30.5cm×5.4cm×32.0cm (W×H×D) | ||
| TH 100&TH 101: | ||
| 100mm×48mm×38mm(L×H×W) | ||
| TH 103: | ||
| 88mm×47mm×35mm(L×H×W) | ||
| TH 104: | ||
| 100mm×49mm×39mm(L×H×W) | ||
| Weight | IPU: 9Kg±15% | |
| Camera Head: 400(g)±20 | Image1 S Connect TC200: 2.1kg | |
| Image1 S H3-Link TC300: 1.86kg | ||
| Image1 S X-Link TC301: 1.86kg | ||
| TH100: 270g | ||
| TH101: 270g | ||
| TH103: 227g | ||
| TH104: 299g | ||
| Power supply | 110-240V AC, 50/60Hz | 100-120VAC, 50/60Hz |
| 200-240VAC, 50/60Hz | ||
| Video Output | 3G-SDI×4 | |
| HDMI ×1 | ||
| DVI ×1 | 2×DVI-D | |
| 1×3G-SDI | ||
| 12G-SDI ×1 | ||
| Signal | ||
| format | output | 4096×2160p, 3840×2160p, 1920×1080p, 50/60Hz |
| 1920×1080p,50Hz/60Hz | ||
| Sensor | 4K CMOS sensor assembly | |
| 3×1/3" |
VI. Comparison of Technological Characteristics with The Predicate Device
Table 1 General Comparison
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Image /page/5/Picture/0 description: The image shows the word "OptoMedic" in a bold, sans-serif font. The "O" in "Opto" is stylized with a green and yellow gradient circle that is open on the right side. The rest of the letters are black.
.
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Image /page/6/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular design on the left, followed by the text "OptoMedic" in black. The circular design has a gradient of green, with the top being a lighter shade and the bottom being a darker shade. The text is in a bold, sans-serif font.
The differences technological characteristics do not raise different questions of safety and effectiveness.
VII. Performance data
Non clinical tests were conducted to verify that the proposed device met all design specifications as is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ANSI/AAMI ES 60601-1: 2005+A2 (R2012) +A1 Medical Electrical Equipment- Part 1: . General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic . safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for . the basic safety and essential performance of endoscopic equipment
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and . Systems.
- AAMI TIR 30:2016 A compendium of processes, materials, test methods, and acceptance . criteria for cleaning reusable medical devices
- AAMI TIR 12:2020 Designing, testing, and labeling reusable medical devices for reprocessing . in health care facilities: A guide for medical device manufacturers
The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the following guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
Performance testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended.
VIII. Conclusions
The performance testing summarized above supports a substantial equivalence determination. The performance testing demonstrate that the subject device is as safe and as effective as the legally marketed predicate device.