The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to < 30 days. The recommended pediatric weight range is 11 kg to 35 kg. The recommended tidal volume is 75 to 250 ml.

Device Description

The Inter-Therm Mini Pediatric is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated, humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has a 22F/15M connector at the machine end and a 22M/15F connector at the patient end.

The Inter-Therm Mini Pediatric angled HMEF is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has an angled 15M machine connecter end, eliminating the need to use an elbow in the breathing circuit. The patient end is a straight 22M/15F connector.

AI/ML Overview

This document describes the safety and effectiveness summary for two medical devices: the Inter-Therm Mini Pediatric HMEF sterile (Product # 1331030S) and the Inter-Therm Mini Pediatric angled HMEF sterile (Product # 1332030S). Both are Heat and Moisture Exchanger Filters (HMEFs) designed for passive humidification and bacterial/viral filtration in pediatric patients under mechanical ventilation or anesthesia. The submission seeks substantial equivalence to the Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small - K941381- Hygroboy).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table against a predicate device. For the purpose of this analysis, the "Acceptance Criteria" are implicitly defined by the performance characteristics of the predicate device (DAR Infant - Pediatric Electrostatic Filter HME - K941381), signifying that the new devices should perform similarly or better. The "Reported Device Performance" refers to the values for the new Intersurgical devices.

Characteristic Compared	Acceptance Criteria (Predicate: DAR Infant - Pediatric Electrostatic Filter HME)	Reported Device Performance (Inter-Therm Mini Pediatric HMEF sterile)	Reported Device Performance (Inter-Therm Mini Pediatric angled HMEF sterile)
Intended Use:
Target Population	Pediatric patients mechanically ventilated requiring heated humidified air	Pediatric patients mechanically ventilated requiring heated humidified air	Pediatric patients mechanically ventilated requiring heated humidified air
Indications for Use	Provide heated humidified air, prevent cross-contamination, CO2 monitoring possible. Single patient use, max 24 hours. Only for pediatric patients and prescribed by a physician.	Reduce bacterial/viral transmission, reduce heat/humidity loss. Single patient use, max 24 hours, change daily with long-term ventilators (>24h to <30d). Recommended pediatric weight: 11-35 kg. Recommended tidal volume: 75-250 ml.	Reduce bacterial/viral transmission, reduce heat/humidity loss. Single patient use, max 24 hours, change daily with long-term ventilators (>24h to <30d). Recommended pediatric weight: 11-35 kg. Recommended tidal volume: 75-250 ml.
Where used	Hospital	Hospital	Hospital
Product Labeling	DAR Infant - Pediatric Electrostatic Filter HME (Small)	Inter-Therm HMEF Mini Pediatric	Inter-Therm HMEF Mini Angled Pediatric
Single Use or Reusable?	Single patient use for 24 hours	Single patient use for 24 hours	Single patient use for 24 hours
Design and Performance:
Compressible Volume (ml)	29.5	28	29
Moisture Return @ 250ml TV (mg/L)	33.3	30	30
Resistance to flow @ 30L/min (mbar)	3.3	2.1	2.2
Weight (g)	21.3	20.0	18.4
Minimum tidal volume (ml)	75	75	75
Maximum tidal volume (ml)	300	250	250
Type of filtration	Electrostatic	Electrostatic	Electrostatic
Filtration efficiency (%)	>99.99	99.98 BFE, 99.95 VFE	99.91 BFE, 99.98 VFE
Tapers	ISO standard 15mm and 22mm	PASS	PASS
Ageing: 5 months	N/A (not explicitly listed for predicate)	PASS	PASS
Ageing: 5 years	N/A (not explicitly listed for predicate)	PASS	PASS
Materials	- (not specified in detail for predicate)	Acrylonitrile Butadiene Styrene (HMEF housing), Polypropylene-based fiber blend (Electrostatic filter), Cellulose-based paper (HME paper), Thermoplastic Elastomer with green color (Retainable luer port cap)	Acrylonitrile Butadiene Styrene (HMEF housing), Polypropylene-based fiber blend (Electrostatic filter), Cellulose-based paper (HME paper), Thermoplastic Elastomer with green color (Retainable luer port cap)
Energy Used/Delivered	Warm humidified air is extracted from expiratory air and delivered to the patient's inspiratory air.	Warm humidified air is extracted from expiratory air and delivered to the patient's inspiratory air.	Warm humidified air is extracted from expiratory air and delivered to the patient's inspiratory air.
Compatibility	Designed for use with breathing systems, elbows, catheter mounts and CO2 monitoring lines.	Designed for use with breathing systems, elbows, catheter mounts and CO2 monitoring lines.	Designed for use with breathing systems, elbows, catheter mounts and CO2 monitoring lines.
Biocompatibility	- (presumably meets standards)	Meets requirements of Bluebook Memo, General Program Memorandum G95-1 (cytotoxicity, sensitization, irritation)	Meets requirements of Bluebook Memo, General Program Memorandum G95-1 (cytotoxicity, sensitization, irritation)
Sterility	Clean	Sterile	Sterile
Standards Met (HME)	ISO 9360-1:1992	ISO 9360-1:1992	ISO 9360-1:1992
Standards Met (Conical Connector ends)	ISO 5356-1:2004	ISO 5356-1:2004	ISO 5356-1:2004
Standards Met (Luer lock connectors)	- (not specified for predicate)	ISO 594-2:1998	ISO 594-2:1998

2. Sample size used for the test set and the data provenance:

The document explicitly states: "Non-clinical test results are submitted to confirm product safety and substantial equivalence to predicate device." and "Nonclinical tests submitted to demonstrate substantial equivalence for moisture return, resistance to flow, weight, tapers and filtration efficiency."

Sample Size for Test Set: Not explicitly stated as a number of devices tested. The data presented in the comparison table are performance metrics, implying that testing was conducted on a sufficient number of units to obtain these typical or representative values.
Data Provenance: The tests are "non-clinical," meaning they were likely conducted in a laboratory or engineering environment. The country of origin for the data is not specified. It is a prospective evaluation as these tests were conducted on the new devices to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable in this context. The document describes a 510(k) submission for substantial equivalence based on non-clinical, performance testing of a medical device, not an AI or diagnostic tool where expert ground truth interpretation would be required. The "ground truth" here is objective physical and performance measurements (e.g., moisture return, resistance to flow, weight) as per established international standards.

4. Adjudication method for the test set:

This information is not applicable. As stated above, this is non-clinical performance testing against objective standards and comparison with a predicate device, not a study involving human interpretation of medical data that would require an adjudication method.

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:

This information is not applicable. This is a 510(k) submission for a physical medical device (HMEF) and not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI improvement metrics are provided or relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. This submission is for a physical medical device (HMEF) and does not involve an algorithm or AI.

7. The type of ground truth used:

The "ground truth" for this submission are the performance specifications and measurements obtained through standardized non-clinical testing. These include:

Objective physical measurements (e.g., compressible volume, weight).
Functional performance measurements according to international standards (e.g., moisture return per ISO 9360-1:1992, resistance to flow, filtration efficiency).
Compliance with connector standards (ISO 5356-1:2004, ISO 594-2:1998).
Biocompatibility testing against a regulatory memo (Bluebook Memo, G95-1).

The ground truth is established by these objective, reproducible tests and comparison to a legally marketed predicate device.

8. The sample size for the training set:

This information is not applicable. This medical device submission does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

This information is not applicable. As explained above, there is no "training set" for this device submission.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 12, 2015

Intersurgical® Inc. Mr. Michael Zalewski Vice President, RA/QA/CS 417 Electronics Parkway Liverpool NY, 13088

Re: K141087

Trade/Device Name: Product # 1331030S-Inter-Therm Mini Pediatric HMEF sterile Product # 1332030S-Inter-Therm Mini Pediatric angled HMEF sterile Regulation Number: 21 CFR 868.5260 Regulation Name: Filter, Bacterial, Breathing Circuit Regulatory Class: II Product Code: CAH Dated: January 12, 2015 Received: January 13, 2015

Dear Mr. Zalewski:

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 may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Zalewski

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section 4 Indications for Use Statement

510(k) Number (if known): K141087

Device Name:

Product # 1331030S - Inter-Therm Mini Pediatric HMEF sterile Product # 1332030S - Inter-Therm Mini Pediatric angled HMEF sterile

Indications For Use: The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to < 30 days. The recommended pediatric weight range is 11 kg to 35 kg. The recommended tidal volume is 75 to 250 ml.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5 510(k) Summary of Safety and Effectiveness

510K Submitter Address and Establishment Registration Number:

Registration Number: 1319447 Name: INTERSURGICAL INCORPORATED Address: 417 Electronics Parkway Liverpool, NY 13088 Date: February 2, 2015 Contact Person: Michael Zalewski - VP RA/QA/CS Phone Number: 315-451-2900 X 202 Fax Number: 315-451-3696

Classification: 21 CFR 868.5260, Classification Name: Filter, Bacterial, Breathing Circuit, Classification Product Code: 73 CAH, Device Class: II, 510K Submission: Traditional.

Subject Device Trade Name:

Product # 1331030S - Inter-Therm Mini Pediatric HMEF sterile Product # 1332030S - Inter-Therm Mini Pediatric angled HMEF sterile

Predicate Device:

The Inter-Therm Mini Pediatric HMEF sterile (Product # 1331030S) and the Inter-Therm Mini Pediatric angled HMEF sterile (Product #1332030S) are substantially equivalent to the Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small - K941381- Hygroboy).

The 355U5430 DAR HMEF is a heat and moisture exchanger that allows for heated humidified air to be supplied to the patient when ventilated or under anaesthesia. The electrostatic filter prevents cross contamination between the patient and the breathing system. The HMEF is provided clean and is used in breathing systems in anesthesia and intensive care. The filter has an end tidal CO2 sampling port for CO2 monitoring. This port has a cap to block the port when it is not in use.

Description of Device:

Inter-Therm Mini Pediatric HMEF sterile ( Product # 1331030S)

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Section 5 510(k) Summary of Safety and Effectiveness

The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has a 22F/15M connector at the machine end and a 22M/15F connector at the patient end.

Inter-Therm Mini Pediatric angled HMEF sterile (Product # 1332030S)

Indications for Use:

Technology Characteristics Summary

The intended use of the Intersurgical Inter-Therm Mini Breathing Filter and Heat and Moisture Exchanger is comparable to the referenced predicate device. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for moisture return, resistance to flow, weight, tapers and filtration efficiency when compared to the legally marketed devices.

Non-clinical test results are submitted to confirm product safety and substantial equivalence to predicate device.

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Section 5 510(k) Summary of Safety and Effectiveness Device Comparison Table

CharacteristicCompared	Inter-Therm MiniPediatric HMEF sterile1331030S	Inter-Therm MiniPediatric angled HMEFsterile 1332030S	DAR™ Infant -PediatricElectrostatic FilterHME (Small)355U5430K941381
Intended Use:
Target population	Pediatric patientsmechanically ventilatedrequiring heatedhumidified air	Pediatric patientsmechanically ventilatedrequiring heatedhumidified air	Pediatric patientsmechanicallyventilated requiringheated humidified air
Indications for use	The Inter-Therm MiniPediatric HMEF Sterile isfor use at the patientconnections. The device isto be attached betweenthe breathing circuit andpatient connection. It isdesigned to reducebacterial/viral transmissionbetween the patient andequipment and to reducethe loss of patient heatand humidity. The filter isfor single patient use onlyand therefore must bedisposed of after a singlepatient usage and/or afterits maximum duration ofuse at 24 hours. Thedevice is a single usedevice that is required tobe changed daily whenused with devices (i.e.long-term ventilators) thatare design to have patientbody contact between 24hours to < 30 days. Therecommended pediatricweight range is 11 kg to35 kg. The recommendedtidal volume is 75 to 250ml.	The Inter-Therm MiniPediatric HMEF Sterile isfor use at the patientconnections. The device isto be attached between thebreathing circuit and patientconnection. It is designedto reduce bacterial/viraltransmission between thepatient and equipment andto reduce the loss of patientheat and humidity. Thefilter is for single patientuse only and thereforemust be disposed of after asingle patient usage and/orafter its maximum durationof use at 24 hours. Thedevice is a single usedevice that is required to bechanged daily when usedwith devices (i.e. long-termventilators) that are designto have patient bodycontact between 24 hoursto < 30 days. Therecommended pediatricweight range is 11 kg to 35kg. The recommended tidalvolume is 75 to 250 ml.	The HMEFs are usedto provide heatedhumidified air andprevent crosscontaminationbetween the patientand breathing system.CO2 monitoring alsopossible.Only for use onpediatric patients andprescribed by aphysician. It is a singlepatient use device andcan be used for amaximum of 24 hours.
Where used	Hospital	Hospital	Hospital
Product Labeling	Inter-Therm HMEF MiniPediatric	Inter-Therm HMEF MiniAngled Pediatric	DAR Infant - PediatricElectrostatic FilterHME (Small)
Single Use orReusable?	Single patient use for24 hours	Single patient use for 24hours	Single patient use for24 hours
CharacteristicCompared	Inter-Therm MiniPediatric HMEF sterile1331030S	Inter-Therm MiniPediatric angled HMEFsterile 1332030S	DAR™ Infant -PediatricElectrostatic FilterHME (Small)355U5430K941381
Design andPerformance:
CompressibleVolume (ml)	28	29	29.5
Moisture Return(mg/L)	30 @ 250ml tidalvolume	30 @ 250ml tidal volume	33.3 @ 250ml tidalvolume
Resistance to flow@ 30L/min (mbar)	2.1	2.2	3.3
Weight (g)	20.0	18.4	21.3
Minimum tidalvolume (ml)	75	75	75 (4)
Maximum tidalvolume (ml)	250	250	300 (4)
Type of filtration	Electrostatic	Electrostatic	Electrostatic
Filtration efficiency(%)	99.98 BFE99.95 VFE	99.91 BFE99.98 VFE	>99.99
Tapers	PASS	PASS	ISO standard 15mmand 22mm
Ageing: 5 months	PASS	PASS	N/A
Ageing: 5 years	PASS	PASS	N/A
Materials:
HMEF housing	Acrylonitrile ButadieneStyrene	Acrylonitrile ButadieneStyrene	-
Electrostatic filter	Polypropylene-basedfiber blend	Polypropylene-basedfiber blend	-
HME paper	Cellulose-based paper	Cellulose-based paper	-
Retainable luer portcap	ThermoplasticElastomer with greencolor	Thermoplastic Elastomerwith green color	-
EnergyUsed/Delivered:	Warm humidified air isextracted fromexpiratory air anddelivered to thepatient's inspiratory air.	Warm humidified air isextracted from expiratoryair and delivered to thepatient's inspiratory air.	Warm humidified air isextracted fromexpiratory air anddelivered to thepatient's inspiratoryair.
Compatibility:	Designed for use withbreathing systems,elbows, cathetermounts and CO2monitoring lines	Designed for use withbreathing systems,elbows, catheter mountsand CO2 monitoringlines	Designed for use withbreathing systems,elbows, cathetermounts and CO2monitoring lines
Biocompatibility:
Sterility:	Sterile	Sterile	Clean
Standards Met:
HME	ISO 9360-1:1992	ISO 9360-1:1992	ISO 9360-1:1992

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Section 5 510(k) Summary of Safety and Effectiveness Device Comparison Table

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Section 5 510(k) Summary of Safety and Effectiveness Device Comparison Table

CharacteristicCompared	Inter-Therm MiniPediatric HMEF sterile1331030S	Inter-Therm MiniPediatric angled HMEFsterile 1332030S	DARTM Infant -PediatricElectrostatic FilterHME (Small)355U5430K941381
Conical Connectorends	ISO 5356-1:2004	ISO 5356-1:2004	ISO 5356-1:2004
Luer lock connectors	ISO 594-2:1998	ISO 594-2:1998	-

Summary of Testing:

Nonclinical tests submitted to demonstrate substantial equivalence for moisture return, resistance to flow, weight, tapers and filtration efficiency. All materials used in the breathing filters have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The connectors meet the requirements of Anesthetic and respiratory equipment - conical connectors: Part 1: Cones and Sockets ISO 5356-1:2004. ISO 594-2:1998 Conical Fittings with a Luer Taper and Heat and Moisture Exchangers ISO 9360-1:1992.

Substantial Equivalence:

Intersurgical Incorporated has demonstrated that the proposed device is as safe and effective as the predicate device. It is considered to be substantially equivalent to the currently marketed predicate device which has been previously reviewed for market clearance by the FDA.

K141087 Premarket Notification [510(k)] Number

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).