(281 days)
The HumiGard™ Surgical Humidification System is intended to warm and humidify carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery.
The HumiGard™ Surgical Humidification System is designed to warm and humidify carbon dioxide (CQ>) gas after it leaves a commercially available insufflator (used to requlate the supply of CO2 gas into the intended body cavity) and thereafter maintain the CO2 gas in a warmed and humidified condition to the point of delivery into the patient's peritoneum via heated tubing.
The HumiGard™ Surgical Humidification System is comprised of a reusable Humidifier (SH870 Humidifier), supply voltage cord (115V or 230V) and the single use, sterile Humidified Insufflation Kit (ST520).
The ST520 Insufflation Kit is ETO sterilized (SAL 10th) and provides all of the necessary components needed to deliver the heated, humidified CO2 gas during laparoscopic surgical procedures, including the insufflation tube, chamber, dry-line/filter assembly, funnel, and optional barb connector.
The SH870 Humidifier contains embedded software that controls the operation of the humidifier power and functions.
The HumiGard™ system conditions the CO2 gas by using a water-filled chamber that is seated on a heater plate on the humidifier. Once the heater plate warms to the target temperature, the heated water in the chamber produces vapour that humidifies the gas as it passes through the chamber. The surgical humidifier also provides power to the heating element (i.e., the heaterwire) within the heated insufflation tube to maintain the desired heat and humidity of the CO2 gas as it travels from the chamber to the patient interface (trocar/cannula).
The provided text describes a 510(k) premarket notification for the HumiGard™ Surgical Humidification System. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving acceptance criteria for an AI/ML powered device.
Therefore, many of the requested details, such as those pertaining to AI/ML specific studies, human reader performance, training data, and expert consensus for ground truth, are not available in the provided document.
However, I can extract information related to the device's performance verification testing and the acceptance criteria implicitly demonstrated by that testing.
Here's a breakdown of what can be extracted and what cannot:
Information Available:
- Acceptance Criteria (Implicit through Performance Testing Categories): The document states that "Performance verification testing of the HumiGard™ system consisted of temperature output, humidity output, flow rate, leak rate, compliance, maximum delivered enthalpy, surface temperature of the tubing, condensation, and outlet connection strength. The verification testing demonstrated that the device performs as intended and met appropriate acceptance criteria." While the specific numerical acceptance criteria are not explicitly listed in a table, the types of performance metrics evaluated serve as the implicit acceptance criteria categories.
- Reported Device Performance (Comparative): The "Technical Specifications" table provides comparative performance data between the HumiGard™ system and the predicate device for some metrics.
- Sample Size for Test Set: Not explicitly stated as a "sample size" in the context of an AI/ML test set, but testing was performed on the device.
- Data Provenance (Implicit): The testing was conducted by the manufacturer, Fisher & Paykel Healthcare, which is based in New Zealand. The data is from non-clinical performance verification testing.
- Ground Truth Type: For the device's functional performance, the "ground truth" would be established by validated measurement instruments and standardized testing protocols, measuring direct physical outputs (temperature, humidity, flow, etc.).
Information NOT Available (Relevant to AI/ML context, not applicable to this device type):
- Explicit table of acceptance criteria with reported device performance (numerical values for all tests): The document lists categories of tests, but not specific pass/fail thresholds or the exact numerical results for all of them.
- Number of experts used to establish ground truth & qualifications: This is not an AI/ML diagnostic device, so expert consensus on medical images/data is not relevant for the ground truth of its physical performance.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as this is a physical medical device, not a diagnostic AI tool.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable.
- Standalone (algorithm only) performance: Not applicable; this is a physical device.
- Sample size for training set & how ground truth was established for training set: Not applicable, as this is not an AI/ML device that requires training data in the typical sense.
Based on the provided text, here is the information that can be extracted, framed within the context of the device's non-clinical performance verification:
Device: HumiGard™ Surgical Humidification System
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance (Comparative where available):
| Acceptance Criteria (Performance Metric) | Device Performance (HumiGard™ Surgical Humidification System) | Reported Performance of Predicate Device (Lexion Medical Insuflow Device) | Comments/Acceptance Outcome |
|---|---|---|---|
| Temperature Output | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Humidity Output | At 32.1 °C | At 32.4 °C | "Difference is not clinically significant." Meets appropriate acceptance criteria. |
| Flow Rate (Achieved) | 15 L/min | 7-8 L/min | "Achieved flow rate does not introduce any different questions of safety or effectiveness as both devices are capable of operation within the flow parameters of commercially available insufflators." Met appropriate acceptance criteria. |
| Flow Rate (Maximum Input) | ≤ 45 L/min | 40 L/min | "Equivalent." Met appropriate acceptance criteria. |
| Leak Rate | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Compliance | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Maximum Delivered Enthalpy | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Surface Temperature of Tubing | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Condensation | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Outlet Connection Strength | Tested | Not explicitly stated | Met appropriate acceptance criteria |
| Biocompatibility | Results acceptable (Cytotoxicity, Irritation, Sensitization) | Not explicitly stated | Acceptable |
| Software Verification & Validation | Complete and acceptable (for "moderate" level of concern software) | N/A | Acceptable |
| Electrical Safety (IEC 60601-1) | Conforms | N/A | Conforms |
| EMC (IEC 60601-1-2) | Conforms | N/A | Conforms |
| Sterilization Packaging (ISO 11607) | Conforms | N/A | Conforms |
| ETO Sterilization (ISO 11135) | Conforms | N/A | Conforms |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly quantified with a numerical sample size (e.g., "N units tested"). The document states that "Performance verification testing" was conducted, implying sufficient units were tested to demonstrate performance.
- Data Provenance: The testing was non-clinical performance verification testing conducted by the manufacturer, Fisher & Paykel Healthcare, based in New Zealand. It is retrospective in the sense that results are reported after the testing was completed.
3. Number of Experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable in the context of this device. The "ground truth" for the device's physical performance (e.g., temperature, humidity) would be established by calibrated measurement equipment and standardized methods, not by expert human interpretation like in diagnostic AI/ML.
4. Adjudication method for the test set:
- Not applicable as the testing involves direct physical measurements against predefined specifications, not subjective human evaluation requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (surgical humidification system), not an AI/ML diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, and its performance is evaluated as a complete system, not as a standalone algorithm.
7. The type of ground truth used:
- For the performance testing, the ground truth was based on objective, quantitative measurements obtained via calibrated testing equipment and adherence to established engineering and medical device standards (e.g., IEC 60601-1, ISO 10993).
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML product developed through machine learning from a training dataset. It's a manufactured physical product.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML model for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2017
Fisher & Paykel Healthcare Nicole Senasac Senior Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki, Auckland 2013 New Zealand
Re: K162582
Trade/Device Name: HumiGard™ Surgical Humidification System Regulation Number: 21 CFR& 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: May 16, 2017 Received: May 25, 2017
Dear Nicole Senasac:
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. 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 mav 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are well-defined, and the contrast between the text and the background is high, making it easily readable.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K162582
Device Name HumiGard™ Surgical Humidification System
Indications for Use (Describe)
The HumiGard Surgical Humidification System is intended to warm and humidity carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|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
| Contact person/submitter | Nicole Senasac | |
|---|---|---|
| Senior Regulatory Affairs Specialist | ||
| Date prepared | 8 May 2017 | |
| Contact details | 15 Maurice Paykel Place | |
| East Tamaki | ||
| Auckland 2013, New Zealand | ||
| Telephone: +64 9 574 0100 | ||
| Trade name | HumiGard™ Surgical Humidification System | |
| Common name | Laparoscopic insufflator | |
| Classification name | Insufflator, laparoscopic | |
| 21 CFR, 884.1730 | ||
| Product Code HIF | ||
| Class II | ||
| Predicate device | Lexion Medical Insuflow Device, Model 6198 (K063546)The predicate device has not been subject to a designrelated recall. |
1.1. Device Description
The HumiGard™ Surgical Humidification System is designed to warm and humidify carbon dioxide (CQ>) gas after it leaves a commercially available insufflator (used to requlate the supply of CO2 gas into the intended body cavity) and thereafter maintain the CO2 gas in a warmed and humidified condition to the point of delivery into the patient's peritoneum via heated tubing.
The HumiGard™ Surgical Humidification System is comprised of a reusable Humidifier (SH870 Humidifier), supply voltage cord (115V or 230V) and the single use, sterile Humidified Insufflation Kit (ST520).
The ST520 Insufflation Kit is ETO sterilized (SAL 10th) and provides all of the necessary components needed to deliver the heated, humidified CO2 gas during laparoscopic surgical procedures, including the insufflation tube, chamber, dry-line/filter assembly, funnel, and optional barb connector.
The SH870 Humidifier contains embedded software that controls the operation of the humidifier power and functions.
The HumiGard™ system conditions the CO2 gas by using a water-filled chamber that is seated on a heater plate on the humidifier. Once the heater plate warms to the target temperature, the heated water in the chamber produces vapour that humidifies the gas as it passes through the chamber. The surgical humidifier also provides power to the heating element (i.e., the heaterwire) within the heated insufflation tube to maintain the desired heat and humidity of the CO2 gas as it travels from the chamber to the patient interface (trocar/cannula).
1.2. Intended Use
The HumiGard™ Surgical Humidification System is intended to warm and humidify carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery.
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| Table 1-2 | |||
|---|---|---|---|
| Indications for use and intended use | |||
| Indications foruse | The HumiGard™ SurgicalHumidification System isintended to warm andhumidify carbon dioxidegas from an insufflatorprior to entry into thesurgical cavity duringlaparoscopic surgery. | The Lexion MedicalInsufiow® device is anaccessory to aninsufflator intended toheat, humidify and filter agas stream used forinflation duringlaparoscopic surgery. | Identical - humidification ofCO2 gas used inlaparoscopic surgicalprocedures |
| Intended use | The HumiGard™ SurgicalHumidification System isintended to warm andhumidify carbon dioxidegas from an insufflatorprior to entry into thesurgical cavity duringlaparoscopic surgery. | The Lexion MedicalInsufiow® device is anaccessory to aninsufflator intended toheat, humidify and filter agas stream used forinflation duringlaparoscopic surgery. | Identical - humidification ofCO2 gas used inlaparoscopic surgicalprocedures |
Device Materials 1.3.
A summary of the patient contact materials contained in ST520 insufflation kit is provided below in Table 1-2.
| Nature of Body Contact | ||||
|---|---|---|---|---|
| Component | Material type | Contact | Duration | |
| 1 | Elbow insufflationNo port | HDPE | Tissue/ Bone/ Dentin | Limited |
| 2 | Heaterwiresocket | HDPE | Tissue/ Bone/ Dentin | Limited |
| 3 | Heaterwire(Insulation) | HDPE | Tissue/ Bone/ Dentin | Limited |
| 4 | Luer connectorboss | HDPE | Skin | Limited |
| 5 | Luer connectormale | Polycarbonate | Tissue/ Bone/ Dentin | Limited |
| 6 | Luer connectorlock ring | Polycarbonate | Skin | Limited |
| 7 | Tube innersmoothinsufflation | Polyolefin Elastomer | Tissue/ Bone/ Dentin | Limited |
| 8 | Tube outerinsufflation | LDPE | Skin | Limited |
| 9 | Band Insufflationtube | Tyvek/Nylon film | No contact | Not applicable |
| 10 | HEPA Filter | PP | Tissue/ Bone/ Dentin | Limited |
| 11 | 15Male - 8mmconnector | Styrene-ButadieneCopolymer | Tissue/ Bone/ Dentin | Limited |
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| Component | Material type | Nature of Body Contact | ||
|---|---|---|---|---|
| Contact | Duration | |||
| 12 | 1m PVC Tubing | PVC | Tissue/ Bone/ Dentin | Limited |
| 13 | 22Female - 8mmconnector | Styrene-ButadeneCopolymer | Tissue/ Bone/ Dentin | Limited |
| Glue (Note2) | Medical deviceadhesive | Tissue/ Bone/ Dentin | Limited | |
| 14 | ChamberMoulded | Blend of K-resin & PS | Tissue/ Bone/ Dentin | Limited |
| 15 | Gasket Santoprne200Ser BseMk2 | TPE | Tissue/ Bone/ Dentin | Limited |
| 16 | Base SftAnodised MR200Series | Aluminium | Tissue/ Bone/ Dentin | Limited |
| 17 | Printing | Ink | No contact | Not applicable |
| 18 | Adaptor 22M/15FBarb Surgical | Blend of K-resin &Styron | Tissue/ Bone/ Dentin | Limited |
| 19 | Tube Silicon4.8mm dia | Silicon | Tissue/ Bone/ Dentin | Limited |
| 20 | Funnel | PP | Tissue/ Bone/ Dentin | Limited |
Technological Characteristics Comparison 1.4.
The primary differences between the HumiGard™ system and predicate Insuflow device are the point at which the water is humidified and the method used to humidify the CO2 gas.
The HumiGard™ system humidifies the CO2 gas proximal to the gas source, while the gas is humidified proximal to the patient with the Insuflow device.
The HumiGard™ system conditions the gas from the control unit by using a water-filled chamber that is seated on a heating plate. Once the heater plate warms to the target temperature, the heated water in the chamber produces vapour that humidifies the CO2 gas as it passes through the chamber. The Insuflow laparoscopic gas conditioning device provides humidification directly within the disposable filter heater/humidifier tubing set. The tubing set includes a heating mechanism, a small water chamber, and a "wick" of moistened material through which the heated CO2 gas passes and is thus humidified.
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| Technical Specifications | |||
|---|---|---|---|
| Design / technologicalcharacteristic forcomparison | Subject device(HumiGard™ SurgicalHumidificationSystem) | Predicate device(Insuflow Device,Model 6198) | Comments |
| Chamber capacity | 180 mL | 10 mL | Capacity does notintroduce any differentquestions of safety oreffectiveness as thecapacity iscommensurate with thesize of the respectivewater chambers. |
| HumidificationElement Position | Proximal to the gassource | Proximal to the patient | The humidificationelement position doesnot introduce anydifferent questions ofsafety or effectivenessas it has no impact onthe humidity outputperformance.HumiGard and Insuflowprovide equivalentrelative humidity andoutput temperature. |
| Humidity Performance | At 32.1 °C | At 32.4 °C | Difference is notclinically significant |
| Maximum Input FlowRate | ≤ 45 L/min | 40 L/min | Equivalent |
| Achieved Flow Rate | 15 L/min | 7-8 L/min | Achieved flow rate doesnot introduce anydifferent questions ofsafety or effectivenessas both devices arecapable of operationwithin the flowparameters ofcommercially availableinsufflators |
1.5. Non-Clinical Performance Data
Testing for the HumiGard™ system was conducted in accordance with the following standards:
| Standard | Title |
|---|---|
| IEC 60601-1:2005 +A1:2012 (Ed 3.1) | Medical Electrical Equipment - Part 1: General requirements for basicsafety and essential performance |
| IEC60601-1-2:2007 | Medical electrical equipment — Part 1-2: General requirements for basicsafety and essential performance — Collateral standard: Electromagneticcompatibility — Requirements and tests |
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process |
| ISO 10993-10: 2010 | Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization |
| ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices -- Part 5: Tests for In Vitrocytotoxicity |
| ANSI/AAMI/ISO11607-1:2006 | Packaging for terminally sterilized medical devices. Requirements formaterials, sterile barrier systems and packaging systems |
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| ANSI/AAMI/ISO11607-2:2006 | Packaging for terminally sterilized medical devices -- Part 2: Validationrequirements for forming, sealing and assembly processes |
|---|---|
| ISO 11737-2:2009 | |
| ISO 11135:2014 |
Test results demonstrate that the HumiGard™ system conforms to the above-referenced standards.
Biocompatibility evaluation of cytotoxicity, irritation and sensitization for the ST520 kit was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 2016). The results of the biocompatibility testing were acceptable.
The HumiGard™ system software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since it a failure of the device software could result in minor injury prior to mitigation of hazards, either to a patient or to a user of the device. The software validation documentation provided was complete and acceptable.
Performance verification testing of the HumiGard™ system consisted of temperature output, humidity output, flow rate, leak rate, compliance, maximum delivered enthalpy, surface temperature of the tubing, condensation, and outlet connection strength. The verification testing demonstrated that the device performs as intended and met appropriate acceptance criteria.
The results of the comparative bench testing demonstrate that the performance of the HumiGard™ system with respect to these key performance characteristics are comparable to the predicate Insuflow device.
1.6. Clinical Performance Data
Substantial equivalence was did not include an assessment of clinical performance data.
1.7. Conclusions
Based on the same intended use, different technological characteristics that do not raise different questions of safety and effectiveness and acceptable performance testing, the HumiGard™ Surgical Humidification System is as safe, as effective, and performs as well as the predicate Insuflow device.
§ 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.