K Number

Device Name

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

Manufacturer

FISHER & PAYKEL HEALTHCARE

Date Cleared

2017-06-23

(281 days)

Product Code

HIF

Regulation Number

884.1730

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.

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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K063546

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions embedded software for control but does not indicate any use of AI or ML for decision-making or analysis. The performance studies focus on standard engineering and biocompatibility testing, not AI/ML model validation.

Therapeutic

No
The device warms and humidifies gas for surgical procedures, it does not directly treat a disease or condition in a therapeutic manner.

Diagnostic

The device is described as warming and humidifying carbon dioxide gas for laparoscopic surgery, which is a supportive function during a surgical procedure, not a diagnostic one. It does not identify a disease, condition, or provide information for diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is comprised of reusable hardware components (Humidifier, supply voltage cord) and single-use hardware components (Insufflation Kit with various parts). While it contains embedded software, it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to warm and humidify carbon dioxide gas for insufflation during laparoscopic surgery. This is a process that directly interacts with the patient's body cavity, not with samples taken from the body.
Device Description: The device conditions gas before it enters the patient. It does not analyze or test any biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. The device's function is purely related to preparing a gas for introduction into the body.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HumiGard™ system does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

HIF

Device Description

The HumiGard™ Surgical Humidification System is designed to warm and humidify carbon dioxide (CO2) gas after it leaves a commercially available insufflator (used to regulate 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

surgical 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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K063546

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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.

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

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 design
related recall.

1.1. Device Description

The SH870 Humidifier contains embedded software that controls the operation of the humidifier power and functions.

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.

Table 1-2
Indications for use and intended use
Indications for
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.	The Lexion Medical
Insufiow® device is an
accessory to an
insufflator intended to
heat, humidify and filter a
gas stream used for
inflation during
laparoscopic surgery.	Identical - humidification of
CO2 gas used in
laparoscopic surgical
procedures
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.	The Lexion Medical
Insufiow® device is an
accessory to an
insufflator intended to
heat, humidify and filter a
gas stream used for
inflation during
laparoscopic surgery.	Identical - humidification of
CO2 gas used in
laparoscopic surgical
procedures

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 insufflation
No port	HDPE	Tissue/ Bone/ Dentin	Limited
2	Heaterwire
socket	HDPE	Tissue/ Bone/ Dentin	Limited
3	Heaterwire
(Insulation)	HDPE	Tissue/ Bone/ Dentin	Limited
4	Luer connector
boss	HDPE	Skin	Limited
5	Luer connector
male	Polycarbonate	Tissue/ Bone/ Dentin	Limited
6	Luer connector
lock ring	Polycarbonate	Skin	Limited
7	Tube inner
smooth
insufflation	Polyolefin Elastomer	Tissue/ Bone/ Dentin	Limited
8	Tube outer
insufflation	LDPE	Skin	Limited
9	Band Insufflation
tube	Tyvek/
Nylon film	No contact	Not applicable
10	HEPA Filter	PP	Tissue/ Bone/ Dentin	Limited
11	15Male - 8mm
connector	Styrene-Butadiene
Copolymer	Tissue/ Bone/ Dentin	Limited

	Component	Material type	Nature of Body Contact
			Contact	Duration
12	1m PVC Tubing	PVC	Tissue/ Bone/ Dentin	Limited
13	22Female - 8mm
connector	Styrene-Butadene
Copolymer	Tissue/ Bone/ Dentin	Limited
	Glue (Note

```
                | Medical device
```

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.

Technical Specifications
Design / technological
characteristic for
comparison	Subject device
(HumiGard™ Surgical
Humidification
System)	Predicate device
(Insuflow Device,
Model 6198)	Comments
Chamber capacity	180 mL	10 mL	Capacity does not
introduce any different
questions of safety or
effectiveness as the
capacity is
commensurate with the
size of the respective
water chambers.
Humidification
Element Position	Proximal to the gas
source	Proximal to the patient	The humidification
element position does
not introduce any
different questions of
safety or effectiveness
as it has no impact on
the humidity output
performance.
HumiGard and Insuflow
provide equivalent
relative humidity and
output temperature.
Humidity Performance	At 32.1 °C	At 32.4 °C	Difference is not
clinically significant
Maximum Input Flow
Rate	≤ 45 L/min	40 L/min	Equivalent
Achieved Flow Rate	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

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 basic
safety and essential performance
IEC60601-1-2:2007	Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral standard: Electromagnetic
compatibility — Requirements and tests
ISO 10993-1:2009	Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process
ISO 10993-10: 2010	Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization
ISO 10993-5:2009/(R)
2014	Biological evaluation of medical devices -- Part 5: Tests for In Vitro
cytotoxicity
ANSI/AAMI/ISO11607-1:
2006	Packaging for terminally sterilized medical devices. Requirements for
materials, sterile barrier systems and packaging systems

| ANSI/AAMI/ISO11607-2:
2006 | Packaging for terminally sterilized medical devices -- Part 2: Validation
requirements 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.

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.