(90 days)
No
The 510(k) summary describes a rigid endoscope that transmits optical images. There is no mention of AI, ML, or any advanced image processing beyond basic signal conversion for display. The performance studies focus on meeting design specifications and equivalence to predicate devices, not on AI/ML performance metrics.
Yes
The "Intended Use / Indications for Use" section states that the laparoscopes are intended to be used by trained healthcare professionals in "diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the OptoMedic Laparoscopes are "intended to be used by trained healthcare professional in diagnostic and therapeutic procedures."
No
The device description explicitly states that the OptoMedic laparoscopes are "rigid endoscopes" and describes their physical components (lenses, tubular structure, insertion widths, working lengths, directions of view). This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs." This involves directly viewing and potentially operating on internal body structures.
- Device Description: The description confirms it's a "rigid endoscope" used as a "viewing system for examining an inner part of the body."
- Mechanism: The device uses light to illuminate tissue and capture images for display on a monitor. This is a direct visualization method.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide diagnostic information. This device operates inside the body.
The device is a surgical endoscope used for visualization and potentially assisting in surgical procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.
Product codes
GCJ
Device Description
The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°). The specifications of the proposed laparoscopes are listed in Table 1.
Mentions image processing
The illumination light enters the laparoscope from the light guide cable, and exits from objective lens to irradiate the tissue. The light reflected by the tissue is collected and transmitted by the laparoscope compatible with a camera head. The image information is converted into an image signal through the camera head and finally displayed on the monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and peritoneal cavities including the female reproductive organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional
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 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for • the basic safety and essential performance of endoscopic equipment
- ISO 8600-1-2015 General requirements ●
- ISO 8600-3-2019 Determination of field of view and direction of view of endoscopes with . optics
- ISO 8600-4-2014 Determination of maximum width of insertion portion .
- ISO 8600-5-2020 Determination of optical resolution of rigid endoscopes with optics .
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin ● sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicity
- ISO 10993-23:2021Biological evaluation of medical devices Part 23: Tests for irritation .
- 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
Performance testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended. 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.
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.
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 & 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.
July 6, 2023
Guangdong OptoMedic Technologies, Inc. Weijuan Guo Regulatory Affairs Engineer Suite 503, Building A, Golden Valley Intellicreation Community, No. 2 Yonganbei Street Foshan, 528200 China
Re: K231003
Trade/Device Name: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 9, 2023 Received: June 9, 2023
Dear Weijuan 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.
1
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 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 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 -S Date: 2023.07.06
10:45:39-04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
K231003
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Page 1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
Indications for Use (Describe)
The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of the word "OptoMedic" in a bold, sans-serif font. The "Opto" portion of the word is in a lighter shade of green, while the "Medic" portion is in black. To the left of the word "OptoMedic" is a green circle that is not fully closed.
Traditional 510(k) Premarket Notification K231003 Laparoscope
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Date Prepared: March 31, 2023
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 | |
| Contact Person: | Jane Guo |
| Regulatory Affairs Engineer | |
| Tel: +86 (757) 8670 2920 | |
| Email: guoweijuan@optomedic.com |
II. Device Identification
| Device Trade Name: | Laparoscope |
|---|---|
| Common or Usual Name: | Laparoscope |
| Model: | 21033FA, 21033FC, 21033WA, 21033WC, |
| 20533WA, 20533WC, 20533FA, 20533FC | |
| Regulation Name: | Endoscopes and accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product Code: | GCJ |
III. Predicate Device
| Primary Predicate Device | 510(k) Number: | K223923 |
|---|---|---|
| Product Name: | HOPKINS Telescopes | |
| Secondary Predicate Device | 510(k) Number: | K201151 |
| Product Name: | O-Mec Laparoscopes 690 Series |
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Image /page/4/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular design on the left, followed by the word "OptoMedic" in bold, black letters. The circular design appears to be an abstract representation of an eye or lens.
Page 2 of 5
IV. Device Description
The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°). The specifications of the proposed laparoscopes are listed in Table 1.
| No. | Model | Direction of View | Maximum Insertion Portion Width | Working Length |
|---|---|---|---|---|
| 1 | 21033FA | 0° | 10.1mm | 330mm |
| 2 | 21033FC | 30° | 10.1mm | 330mm |
| 3 | 21033WA | 0° | 10.1mm | 330mm |
| 4 | 21033WC | 30° | 10.1mm | 330mm |
| 5 | 20533FA | 0° | 5.6mm | 310mm |
| 6 | 20533FC | 30° | 5.6mm | 310mm |
| 7 | 20533WA | 0° | 5.6mm | 310mm |
| 8 | 20533WC | 30° | 5.6mm | 310mm |
| Table 1 Model Specifications | |
|---|---|
| -- | ------------------------------ |
V. Indications for Use
The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.
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Image /page/5/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the word "OptoMedic" in black font. The font is sans-serif and appears to be bolded.
.
VI. Comparison of Technological Characteristics with The Predicate Device
| Description | Subject Device (K231003) | Primary Predicate Device (K223923) | Secondary Predicate Device (K201151) |
|---|---|---|---|
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | GCJ, HET, NMH | GCJ | GCJ |
| Device class | Class II | Class II | Class II |
| Indication for use | The OptoMedic Laparoscopes | ||
| are intended to be used for | |||
| endoscopy and | |||
| endoscopic surgery within the | |||
| thoracic and peritoneal cavities | |||
| including the female | |||
| reproductive organs. | |||
| The OptoMedic Laparoscopes | |||
| are intended to be used by | |||
| trained healthcare professional | |||
| in diagnostic and therapeutic | |||
| procedures. | For telescopes with | ||
| diameter ranging from | |||
| 3mm-5mm: | |||
| The HOPKINS Telescopes | |||
| are intended to provide | |||
| visualization during | |||
| laparoscopy, thoracoscopy | |||
| and general surgery in | |||
| adults and pediatrics. | |||
| For telescopes with | |||
| diameter ranging from | |||
| 5.5mm- 11mm: | |||
| The HOPKINS Telescopes | |||
| are intended to provide | |||
| visualization during | |||
| laparoscopy, thoracoscopy | |||
| and general surgery in | |||
| adults. | 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. | |||
| Prescription/ | |||
| Over-the-counter use | Prescription | Prescription | Prescription |
| Single use /Reusable | Reusable | Reusable | Reusable |
| Principle of | |||
| operation | The illumination light enters the | ||
| laparoscope from the light guide | |||
| cable, and exits from objective | |||
| lens to irradiate the tissue. The | |||
| light reflected by the tissue is | |||
| collected and transmitted by the | |||
| laparoscope compatible with a | |||
| camera head. The image | |||
| information is converted into an | |||
| image signal through the camera | |||
| head and finally displayed on | |||
| the monitor. | The HOPKINS Telescopes | ||
| are rigid telescopes that | |||
| utilize the rod lens | |||
| technology. At the distal | |||
| end of the telescope's shaft | |||
| is the lens and the other | |||
| end of the shaft is attached | |||
| to the eyepiece. | |||
| Throughout the central | |||
| lumen of the HOPKINS | |||
| Telescopes, optical glass | |||
| rods are used to transmit | |||
| and magnify | |||
| the image received from | The illumination light | ||
| enters the laparoscope from | |||
| the light guide cable, and | |||
| exits from objective lens to | |||
| irradiate the tissue. The | |||
| light reflected by the tissue | |||
| is collected and transmitted | |||
| by the laparoscope | |||
| compatible with a camera | |||
| head. The image | |||
| information is converted | |||
| into an image signal | |||
| through the camera head | |||
| and finally displayed on the | |||
| the lens. | monitor. | ||
| Physical Characteristics | |||
| Endoscope Type | Rigid endoscope | Rigid endoscope | Rigid endoscope |
| Working Length | 310mm, 330mm | 18cm- 50cm | 331mm, 334mm, 301mm, 303mm |
| Maximum insertion | |||
| portion width | 5.6mm, 10.1mm | 3mm- 11mm | 10.1mm, 5.5mm |
| Optical Characteristics | |||
| Direction of View | 0°, 30° | 0°, 6°, 30°, 45° | 0°, 30° |
| Field of View | 68°, 75° | 55°- 80° | 75° |
| Light source | External | External | External |
| Reprocessing Methods | |||
| Cleaning | Manual, Automatic | Manual, Automatic | Manual |
| Sterilization | Steam sterilization | ||
| /Low temperature plasma | |||
| sterilization | Steam (prevacuum), | ||
| STERRAD 100S, | |||
| STERRAD NX, | |||
| STERRAD 100NX, | |||
| STERIS VPRO1, VPRO 1 Plus | Autoclavable |
Table 2 General Comparison
.
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Image /page/6/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the word "OptoMedic" in bold, black letters. The circular graphic appears to be a stylized representation of an eye or lens.
Traditional 510(k) Premarket Notification K231003 Laparoscope
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 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for • the basic safety and essential performance of endoscopic equipment
- ISO 8600-1-2015 General requirements ●
- ISO 8600-3-2019 Determination of field of view and direction of view of endoscopes with . optics
- ISO 8600-4-2014 Determination of maximum width of insertion portion .
- ISO 8600-5-2020 Determination of optical resolution of rigid endoscopes with optics .
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin ● sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicity
- ISO 10993-23:2021Biological evaluation of medical devices Part 23: Tests for irritation .
7
K231003
Image /page/7/Picture/1 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic to the left of the company name. The company name is written in a bold, sans-serif font, with "Opto" in black and "Medic" in black.
Traditional 510(k) Premarket Notification K231003 Laparoscope
- 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
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.