(125 days)
It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.
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.
The provided document is a 510(k) summary for a Laparoscope, which is a medical device for observation and imaging in abdominal surgery. It's a submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document describes the device's technical specifications and the tests conducted to prove its performance and safety, aligning them with the predicate device and relevant standards.
However, the document does not contain information related to an AI/ML-driven medical device. Specifically, there is no mention of a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics, or human reader performance with and without AI assistance. The tests described are for a physical medical device (laparoscope), focusing on electrical safety, packaging, biocompatibility, cleaning/disinfection/sterilization, and bench performance (optical and mechanical verification).
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided text does not describe such a device or study. The information requested (acceptance criteria, sample size, ground truth, experts, MRMC studies, etc.) is typically associated with the validation of AI/ML software as a medical device (SaMD) or AI-assisted medical devices, which is not the subject of this 510(k) submission.
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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.
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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
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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
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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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510(k) Summary
| Date Prepared: | April. 11st, 2023 |
|---|---|
| Manufacturer: | Hunan Endoso Life Technology Co., Ltd.4th floor, Building 10, Innovation and Entrepreneurship Center, 31Dongfeng Road, Heping Street, Xiangtan Economic DevelopmentDistrict, HuNan, China 411199 |
| Contact person: | Wang FuTitle: DirectorTel: (86) 0731-52331999Email: services@endoso.com.cnOr 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
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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 DeviceK201151 | Comparison | |
| K Number | who are familiar withendoscopic procedures. | surgical physicians who arefamiliar with endoscopicprocedures. | |
| Population | Adult | Adult | Same |
| Physical Characteristics | |||
| Maximum widthof 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 effectivedepth of field, theillumination spot should befilled with all direction ofview, and the illuminance at90% of the maximumdirection of view should beuniform. Select fourorthogonal azimuth in thisdirection of view for testing.Uniformity should be ≤25%. | Inspection within theeffective depth of field, theillumination spot should befilled with all direction ofview, and the illuminance at90% of the maximumdirection of view should beuniform. Select fourorthogonal azimuth in thisdirection of view for testing.Uniformity should be ≤25%. | Same |
| Patient Contacting Materials | |||
| General materialtype of mainpatient-contact part | Compliance with ISO10993-1 | Compliance withISO10993-1 | Same |
| Duration andtype of contact | "Surface -MucosalMembrane" with a contactduration of "Limited (< 24hours)" | "Surface -MucosalMembrane" with a contactduration of "Limited (< 24hours)" | Same |
| Subject Device | Predicate Device | Comparison | |
| K Number | -- | K201151 | |
| ng Materials | Optical GlassSapphireEpoxy Glue | Stainless Steel 316LOptical GlassSapphireEpoxy Glue | |
| Sterilization Methods | |||
| Number of Users | Reusable | Reusable | Same |
| Cleaning | Manual and Automated | Manual and Automated | Same |
| Disinfection | Manual and Automated | Manual and Automated | Same |
| Sterilization | Autoclave,STERRAD® 100NX | Autoclave,STERRAD® 100NX | Same |
| Sterility Assurance Level | 10-6 | 10-6 | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | Same |
| No Irritation to Skin | No Irritation to Skin | Same | |
| No significant evidence ofsensitization | No significant evidence ofsensitization | Same | |
| No pyrogen | No pyrogen | Same | |
| No acute Systemic Toxicity | No acute Systemic Toxicity | Same |
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510(k) Premarket Notification Submission Laparoscope
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510(k) Premarket Notification Submission Laparoscope
Summary of Testing:
| Test | Method | Result |
|---|---|---|
| Electrical Safety andEMC | • ANSI/AAMI ES:60601-1:2005/A2:2010• IEC 60601-2-18:2009 | PASS |
| Packaging | • ASTM D4169:2016 | PASS |
| Biocompatibility | • ISO 10993- 1:2018• ISO 10993-5:2009• ISO 10993- 10:2010• ISO 10993- 11:2017• FDA Guidance: Use of International Standard ISO10993-1 | PASS |
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510(k) Premarket Notification Submission Laparoscope
| Cleaning,Disinfection andSterilization | • AAMI TIR 12:2020• AAMI TIR 30: 2011/(R)2016• ISO 17664- 1:2021• ISO 17665-1: 2006FDA Guidance: Reprocessing Medical Devices in HealthCare Settings: Validation Methods and Labeling | PASS |
|---|---|---|
| Performance -Bench | • Optical and mechanical verification in accordance with deviceinput specifications and comparison to predicate device• ISO 8600- 1:2015• ISO 8600-3: 2019• ISO 8600-4: 2014• ISO 8600-7: 2012 | PASS |
| Design Validation | • IEC 62366-1:2020• In accordance with device user needs | PASS |
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Laparoscope is substantially equivalent to the predicate device.
§ 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.