(134 days)
Not Found
No
The summary describes a standard insufflation device and does not mention any AI or ML capabilities. The software is described as "Major" level of concern, which is typical for devices controlling gas flow and pressure, but doesn't indicate AI/ML.
Yes
The device is used to create and maintain pneumoperitoneum during diagnostic or therapeutic laparoscopic procedures, which are medical interventions.
No
Explanation: The device creates and maintains pneumoperitoneum for laparoscopic procedures, facilitating visualization and operating space. It does not perform diagnostic functions such as analyzing data or identifying medical conditions.
No
The device description clearly states it is a CO2 insufflation device, which is a hardware device that injects gas. It also mentions specific insufflation tubes, which are hardware components. While software is mentioned as being verified and validated, the core function and description point to a physical 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 the device is for generating and maintaining pneumoperitoneum during laparoscopic procedures by filling the abdominal cavity with gas. This is a surgical procedure performed on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The device described does not perform any such tests on samples.
- Device Description: The description focuses on the mechanical function of injecting CO2 gas into the abdominal cavity to create space for surgery. This is a physical intervention, not a diagnostic test on a sample.
Therefore, the Insufflator (OPTO-IFL1000) is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures.
Product codes
HIF
Device Description
Insufflator (OPTO-IFL1000) is a CO2 insufflation device for creating and maintaining a pneumoperitoneum during laparoscopic examinations and operations. It is capable of establishing the surgical field of view and operating space. CO2 gas can be injected into abdominal cavity by the device, and the gas separates the abdominal wall from the internal organs of the abdominal cavity, forming a space for the operation and visual field. The device is to be used with the following insufflation tubes:
- OPTO-T1000H (with heating function)
- OPTO-T1000 (without heating function)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Edition 4.1 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- IEC 60601-1-8 Edition 2.2 Medical electrical equipment Part 1-8: General requirements for . basic safety and essential performance - Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical 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 verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The software for this device was considered a "Major" level of concern.
Performance testing were also conducted and demonstrate that the proposed system performs according to specifications and functions as intended. And the test result shows that the preset acceptance criteria are met.
-
- Gas Supply Indication
-
- Accuracy of the Pressure
-
- Accuracy of the Pressure-Under Leak Condition (Continuous leakage compensation testing)
-
- Overpressure Alarm
-
- Overpressure Reduction
-
- Under-pressure Replenishment (Transient leakage compensation testing)
-
- Accuracy of the Flow
-
- Heating Function
-
- Overheating Alarm
-
- Accuracy of Gas Consumption Display
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
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.
September 20, 2023
Guangdong OptoMedic Technologies, Inc. Weijuan Guo Regulatory Affairs Engineer Suite 503, Building A. Golden Valley Intellicreation Community, No. 2 Yonganbei Street, Daxu, Guicheng, Nanhai, Foshan, 528200 China
Re: K231342
Trade/Device Name: Insufflator (OPTO-IFL1000) Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: August 28, 2023 Received: August 28, 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.
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231342
Device Name Insufflator (OPTO-IFL1000)
Indications for Use (Describe)
The Insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic 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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3
Image /page/3/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular design on the left, followed by the word "OptoMedic" in black text. The circular design is made up of two curved lines that start and end at the same point, creating a circular shape. The word "OptoMedic" is written in a bold, sans-serif font.
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Date Prepared: September 14, 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 | |
| Primary Contact Person: | Weijuan 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: | Insufflator (OPTO-IFL1000) |
|---|---|
| Common or Usual Name: | Insufflator |
| Model: | OPTO-IFL1000 |
| Regulation Name: | Laparoscopic Insufflator |
| Regulation Number: | 21 CFR 884.1730 |
| Regulatory Class: | Class II |
| Product Code: | HIF |
III. Predicate Device
510(k) Number: K030837 40 L High Flow Insufflator F108 Product Name:
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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 design on the left, followed by the word "OptoMedic" in bold, black letters. The circular design appears to be made of three curved lines that overlap each other.
IV. Device Description
Insufflator (OPTO-IFL1000) is a CO2 insufflation device for creating and maintaining a pneumoperitoneum during laparoscopic examinations and operations. It is capable of establishing the surgical field of view and operating space. CO2 gas can be injected into abdominal cavity by the device, and the gas separates the abdominal wall from the internal organs of the abdominal cavity, forming a space for the operation and visual field. The device is to be used with the following insufflation tubes:
-
- OPTO-T1000H (with heating function)
-
- OPTO-T1000 (without heating function)
V. Indications for Use
The Insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures.
VI. Comparison of Technological Characteristics with The Predicate Device
| Description | Subject Device | Predicate Device (K030837) |
|---|---|---|
| Regulation Number | 21 C.F.R. § 884.1730 | 21 C.F.R. § 884.1730 |
| Product Code | HIF | HIF |
| Device class | Class II | Class II |
| Indication for use | The Insufflator (OPTO-IFL1000) is intended to | |
| generate and maintain | ||
| pneumoperitoneum by | ||
| filling the abdominal | ||
| cavity with gas to distend | ||
| it during diagnostic or | ||
| therapeutic laparoscopic | ||
| procedures. | The 40 L High Flow Insufflator | |
| F108 is a device intended to | ||
| facilitate the use of the | ||
| laparoscope by filling the | ||
| peritoneal cavity with gas to | ||
| distend it. | ||
| Prescription/ | ||
| Over-the-counter use | Prescription | Prescription |
| Distension | ||
| Medium | CO2 | CO2 |
| Pressure range: | 5-25 mmHg | 1-30 mmHg |
| Overpressure alarm | When the nominal | |
| pressure is exceeded by | ||
| more than 4 mmHg, | ||
| visual and audible | When the nominal pressure is | |
| exceeded by more than 4 | ||
| mmHg and with a pressure >29 | ||
| mmHg, visual and audible |
Table 1 General Comparison
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Image /page/5/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circle on the left, followed by the word "OptoMedic" in black, bold letters. The circle is a gradient of green and yellow, with the green on the bottom and the yellow on the top.
| Overheating alarm | At >41°C, visual and
acoustic alarm | At >42°C, a warning signal is
audible |
|-----------------------|----------------------------------------|------------------------------------------|
| Reprocessing Method | Steam sterilization | Steam sterilization |
| Dimensions
(WHD) | 370mm*410mm
*166.5mm | 267 x 138 x 410 (mm) |
| Weight | 11Kg (N.W.) | approx. 7 kg |
| Power supply | 110-240 V~ | 100-240 V~ |
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 Edition 4.1 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- IEC 60601-1-8 Edition 2.2 Medical electrical equipment Part 1-8: General requirements for . basic safety and essential performance - Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical 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 verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The software for this device was considered a "Major" level of concern.
Performance testing were also conducted and demonstrate that the proposed system performs according to specifications and functions as intended. And the test result shows that the preset acceptance criteria are met.
-
- Gas Supply Indication
-
- Accuracy of the Pressure
6
Image /page/6/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circle on the left side and the word "OptoMedic" in black on the right side. The circle is made up of two curved lines that form a complete circle, with the top line being a lighter shade of green than the bottom line.
-
- Accuracy of the Pressure-Under Leak Condition (Continuous leakage compensation testing)
-
- Overpressure Alarm
- న్. Overpressure Reduction
-
- Under-pressure Replenishment (Transient leakage compensation testing)
-
- Accuracy of the Flow
-
- Heating Function
-
- Overheating Alarm
-
- Accuracy of Gas Consumption Display
VIII. Conclusions
The performance testing demonstrate that the subject device is as safe and as effective as the legally marketed predicate device to support a substantial equivalence determination.