(125 days)
Not Found
No
The summary describes a standard optical laparoscope and its function of transmitting images for processing and display. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The "image processing" mentioned is a standard function of camera systems and does not imply AI/ML.
No
The device is described as being used for observation and imaging, and to "visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy." While it can be used during therapy (surgical procedures), its function is solely for imaging and visualization, not for directly delivering therapeutic action.
Yes
Explanation: The device description states that laparoscopes are used for "examination, diagnosis or therapy," and the intended use mentions "observation and imaging." These functions include diagnostic purposes, even if therapy is also a goal.
No
The device description explicitly states it is a "Laparoscope," which is a tubular optical instrument, indicating it is a hardware device. While it mentions image processing, this is done by a separate camera system, and the core device is the physical laparoscope.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description clearly states that the Laparoscope is a tubular optical instrument used to visualize or image a patient's anatomy during surgery by entering the human body. It is used for observation and imaging within the body.
Therefore, since the device is used inside the body for direct visualization and imaging during surgery, it does not fit the definition of an In Vitro Diagnostic. It is a surgical imaging device.
N/A
Intended Use / Indications for Use
It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Laparoscope (Model: 4KA0、4KA0R、4KA30、4KA30R、4KA45、4KA45R) is used in medical institutions. Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then forms and relays the image of the surgical site to a camera system for processing and display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Adult
Intended User / Care Setting
Used in a hospital environment by trained surgical physicians who are familiar with endoscopic procedures.
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)
Electrical Safety and EMC:
Method:
• ANSI/AAMI ES:60601-1:2005/A2:2010
• IEC 60601-2-18:2009
Result: PASS
Packaging:
Method:
• ASTM D4169:2016
Result: PASS
Biocompatibility:
Method:
• ISO 10993- 1:2018
• ISO 10993-5:2009
• ISO 10993- 10:2010
• ISO 10993- 11:2017
• FDA Guidance: Use of International Standard ISO10993-1
Result: PASS
Cleaning, Disinfection and Sterilization:
Method:
• AAMI TIR 12:2020
• AAMI TIR 30: 2011/(R)2016
• ISO 17664- 1:2021
• ISO 17665-1: 2006
FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Result: PASS
Performance - Bench:
Method:
• Optical and mechanical verification in accordance with device input specifications and comparison to predicate device
• ISO 8600- 1:2015
• ISO 8600-3: 2019
• ISO 8600-4: 2014
• ISO 8600-7: 2012
Result: PASS
Design Validation:
Method:
• IEC 62366-1:2020
• In accordance with device user needs
Result: PASS
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 16, 2023
Hunan Life Technology Co., Ltd. Fu Wang Official Correspondent 4th floor, Building 10, Innovation and Entrepreneurship Center, 31 Dongfeng Road, Heping Street, Xiangtan Economic D HuNan, 411199 China
Re: K231725
Trade/Device Name: Laparoscope (4KA0, 4KA0R, 4KA30R, 4KA30R, 4KA45, 4KA45R) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 11, 2023 Received: September 11, 2023
Dear Fu Wang:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore - Date: 2023.10.16
08:26:23 -04'00'
Mark Trumbore, Ph.D. Assistant Director
2
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
3
Indications for Use
510(k) Number (if known) K231725
Device Name
Laparoscope (4KA04KA0R4KA304KA30R4KA454KA45R)
Indications for Use (Describe)
It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
| Date Prepared: | April. 11st, 2023 |
|---|---|
| Manufacturer: | Hunan Endoso Life Technology Co., Ltd. |
| 4th floor, Building 10, Innovation and Entrepreneurship Center, 31 | |
| Dongfeng Road, Heping Street, Xiangtan Economic Development | |
| District, HuNan, China 411199 | |
| Contact person: | Wang Fu |
| Title: Director | |
| Tel: (86) 0731-52331999 | |
| Email: services@endoso.com.cn | |
| Or wangfu@endoso.com.cn | |
| Identification of the Device: | |
| Proprietary/Trade Name: | Laparoscope |
| Model: | 4KA0、4KA0R、4KA30、4KA30R、4KA45、4KA45R |
| Common name: | Laparoscope |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | GCJ |
| Device Class: | Class II |
| Review Panel: | General & Plastic Surgery |
Identification of the Legally Marketed Predicate Device:
| Trade Name: | O-Mec Laparoscopes 690 Series |
|---|---|
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulatory Number: | 21 CFR Part 876.1500 |
| Product Code: | GCJ |
| Device Class: | Class II |
| Review Panel: | General & Plastic Surgery |
| Submitter/510(k) Holder: | Qingdao O-Mec Medical Technology Co., Ltd. |
| Clearance: | K201151 |
This predicate has not been subject to a design-related recall.
Device Description:
The Laparoscope (Model: 4KA0、4KA0R、4KA30、4KA30R、4KA45、4KA45R) is used in medical institutions. Laparoscopes are tubular optical instruments used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The Laparoscope transmits light in both the visible and near infrared spectrum to illuminate and image the anatomy, then
5
forms and relays the image of the surgical site to a camera system for processing and display.
Indications for Use:
It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.
Substantial Equivalence:
The Laparoscope employs the same fundamental scientific technology as its predicate device, as below table:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| K Number | -- | K201151 | |
| Name | Laparoscope | O-Mec 690 Series Laparoscopes | / |
| Model | 4KA0、4KA0R、4KA30、4KA30R、4KA45、4KA45R | 690-331000H, 690-331030H, 690-300500H, 690-300530H | / |
| Manufacturer | Hunan Endoso Life Technology Co., Ltd. | QINGDAO O-MEC MEDICAL TECHNOLOGY CO., LTD. | / |
| Classification Name | Laparoscope, General & Plastic Surgery | Laparoscope, General & Plastic Surgery | Same |
| Product Code | GCJ | GCJ | Same |
| Indications For Use | |||
| Intended Use | It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound. | The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-331030H, 690-300500H, 690-300530H) are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. | Similar |
| Working place/User | Use in a hospital environment by trained surgical physicians | Use in a hospital environment by trained | Same |
| Subject Device | Predicate Device | ||
| K201151 | Comparison | ||
| K Number | who are familiar with | ||
| endoscopic procedures. | surgical physicians who are | ||
| familiar with endoscopic | |||
| procedures. | |||
| Population | Adult | Adult | Same |
| Physical Characteristics | |||
| Maximum width | |||
| of insertion section | $Φ$ 10mm | $Φ$ 10.1mm | Similar |
| Working length | 345mm±3%. | 334mm | Similar |
| Optical Characteristics | |||
| Field of view | 80°±15% | 75° | Similar |
| Direction of view | 30 | 30° | Same |
| Clear Observation Range | 3mm~200mm | 25-150mm | Similar |
| Resolution power | 7lp/mm | 7lp/mm | Same |
| Lighting Edge Uniformity | Inspection within the effective | ||
| depth of field, the | |||
| illumination spot should be | |||
| filled with all direction of | |||
| view, and the illuminance at | |||
| 90% of the maximum | |||
| direction of view should be | |||
| uniform. Select four | |||
| orthogonal azimuth in this | |||
| direction of view for testing. | |||
| Uniformity should be ≤25%. | Inspection within the | ||
| effective depth of field, the | |||
| illumination spot should be | |||
| filled with all direction of | |||
| view, and the illuminance at | |||
| 90% of the maximum | |||
| direction of view should be | |||
| uniform. Select four | |||
| orthogonal azimuth in this | |||
| direction of view for testing. | |||
| Uniformity should be ≤25%. | Same | ||
| Patient Contacting Materials | |||
| General material | |||
| type of main | |||
| patient-contact part | Compliance with ISO10993-1 | Compliance with | |
| ISO10993-1 | Same | ||
| Duration and | |||
| type of contact | "Surface -Mucosal | ||
| Membrane" with a contact | |||
| duration of "Limited ( |