(134 days)
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.
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)
The provided document is a 510(k) summary for the Insufflator (OPTO-IFL1000) from Guangdong OptoMedic Technologies, Inc. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to answer many of the specific questions about the device's acceptance criteria and the study proving it meets those criteria, particularly for an AI/ML-based medical device.
The document states: "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." It then lists several performance tests, but it does not specify what those "preset acceptance criteria" are numerically, nor does it provide the reported device performance values against these criteria. Furthermore, it does not describe a study involving "human readers" or "AI assistance," as this is an insufflator, not an imaging analysis AI.
Therefore, many of the questions cannot be answered from the provided text. I will answer what is available and indicate where information is missing.
Acceptance Criteria and Study for Insufflator (OPTO-IFL1000)
Based on the provided document, the device is an Insufflator (OPTO-IFL1000), which is a physical medical device designed to create and maintain pneumoperitoneum during laparoscopic procedures, not an AI/ML-based diagnostic or imaging device. Therefore, questions related to AI performance, human readers, ground truth establishment by experts, and training/test set sample sizes for AI models are not applicable to the information presented for this specific device.
The document discusses "Performance data" and lists various tests conducted to verify the device met all design specifications and is substantially equivalent to a predicate device. The "acceptance criteria" are generally implied to be satisfaction of these test specifications and compliance with relevant standards.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not provide a table with specific numerical acceptance criteria or the numerically reported device performance for these tests. It only states that "the preset acceptance criteria are met."
Below is a table of the performance tests mentioned, with the understanding that specific numerical criteria and results are not detailed in the provided text.
| Performance Test Item | Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|
| 1. Gas Supply Indication | Met specifications | Met specifications |
| 2. Accuracy of the Pressure | Met specifications | Met specifications |
| 3. Accuracy of the Pressure-Under Leak Condition (Continuous leakage compensation testing) | Met specifications | Met specifications |
| 4. Overpressure Alarm | Alarm triggers as specified (e.g., >4 mmHg beyond nominal) | Alarm triggers as specified |
| 5. Overpressure Reduction | System reduces pressure effectively as specified | System reduces pressure effectively |
| 6. Under-pressure Replenishment (Transient leakage compensation testing) | System replenishes gas effectively as specified | System replenishes gas effectively |
| 7. Accuracy of the Flow | Met specifications | Met specifications |
| 8. Heating Function | Functions within specified temperature range | Functions within specified range |
| 9. Overheating Alarm | Alarm triggers as specified (e.g., at >41°C) | Alarm triggers as specified |
| 10. Accuracy of Gas Consumption Display | Met specifications | Met specifications |
2. Sample size used for the test set and the data provenance
For a physical device like an insufflator, "test set" and "data provenance" (country of origin, retrospective/prospective) are typically not relevant in the same way they are for AI/ML models using patient data. The "test set" would refer to the specific Insufflator (OPTO-IFL1000) unit(s) used for the described performance and safety testing. The document does not specify the number of units tested. The provenance of the testing itself is implied to be conducted by the manufacturer, Guangdong OptoMedic Technologies, Inc., in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is applicable to AI/ML devices that interpret data (e.g., medical images) where expert consensus is used to establish ground truth. For a physical device like an insufflator, "ground truth" pertains to its functional performance characteristics, which are measured using validated test methods and equipment, not by human expert interpretation of device output in the same way. Therefore, this information is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device performance test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an insufflator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. Its performance is inherent to its physical and software functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, "ground truth" would be established by:
- Compliance with recognized standards: Such as ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, AAMI TIR 30, AAMI TIR 12.
- Engineering specifications and measurements: Direct measurement of pressure, flow, temperature, alarm triggers, etc., against predefined engineering tolerances and clinical requirements.
- Software verification and validation: Testing to ensure the software functions as intended to control the device and its safety features.
The document states that "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." This indicates that software functionality, which dictates much of the device's "ground truth" operation, was rigorously tested.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable.
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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.
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.
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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
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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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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 togenerate and maintainpneumoperitoneum byfilling the abdominalcavity with gas to distendit during diagnostic ortherapeutic laparoscopicprocedures. | The 40 L High Flow InsufflatorF108 is a device intended tofacilitate the use of thelaparoscope by filling theperitoneal cavity with gas todistend it. |
| Prescription/Over-the-counter use | Prescription | Prescription |
| DistensionMedium | CO2 | CO2 |
| Pressure range: | 5-25 mmHg | 1-30 mmHg |
| Overpressure alarm | When the nominalpressure is exceeded bymore than 4 mmHg,visual and audible | When the nominal pressure isexceeded by more than 4mmHg and with a pressure >29mmHg, 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 andacoustic alarm | At >42°C, a warning signal isaudible |
|---|---|---|
| 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
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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.
§ 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.