INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF

K141087 · Intersurgical Incorporated · CAH · Feb 12, 2015 · Anesthesiology

Device Facts

• Record ID: K141087
• Device Name: INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
• Applicant: Intersurgical Incorporated
• Product Code: CAH · Anesthesiology
• Decision Date: Feb 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Sterile heat and moisture exchanger with integrated electrostatic filter (HMEF) for pediatric patients (11-35 kg) undergoing mechanical ventilation or anesthesia. Device connects between breathing circuit and patient airway. Operation: HME paper traps heat/moisture from exhaled air for return during inspiration; electrostatic filter pad prevents cross-contamination. Includes luer lock port for CO2 monitoring. Used in hospital settings. Output: heated, humidified air; CO2 sampling capability. Benefits: maintains airway humidity/temperature; reduces infection risk. Single-use, 24-hour maximum duration.

Clinical Evidence

Bench testing only. Performance metrics evaluated include moisture return (mg/L), resistance to flow (mbar), weight (g), filtration efficiency (BFE/VFE %), and mechanical integrity of tapers/connectors. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation).

Technological Characteristics

Housing: Acrylonitrile Butadiene Styrene (ABS). Filter: Polypropylene-based fiber blend. HME: Cellulose-based paper. Port cap: Thermoplastic Elastomer. Connectors: 22F/15M (machine) and 22M/15F (patient) or angled 15M. Standards: ISO 9360-1:1992 (HME), ISO 5356-1:2004 (conical connectors), ISO 594-2:1998 (luer tapers). Sterile, single-use.

Indications for Use

Indicated for pediatric patients (11-35 kg) requiring mechanical ventilation or anesthesia. Used to provide passive humidification and reduce bacterial/viral transmission between patient and breathing circuit. For single patient use, max 24 hours.

Regulatory Classification

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.

Predicate Devices

• Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small) (K941381)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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)

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.

### 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.

## 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

| Characteristic<br>Compared | Inter-Therm Mini<br>Pediatric HMEF sterile<br>1331030S | Inter-Therm Mini<br>Pediatric angled HMEF<br>sterile 1332030S | DAR™ Infant -<br>Pediatric<br>Electrostatic Filter<br>HME (Small)<br>355U5430<br>K941381 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | | | |
| Target population | Pediatric patients<br>mechanically ventilated<br>requiring heated<br>humidified air | Pediatric patients<br>mechanically ventilated<br>requiring heated<br>humidified air | Pediatric patients<br>mechanically<br>ventilated requiring<br>heated humidified air |
| Indications for use | The Inter-Therm Mini<br>Pediatric HMEF Sterile is<br>for use at the patient<br>connections. The device is<br>to be attached between<br>the breathing circuit and<br>patient connection. It is<br>designed to reduce<br>bacterial/viral transmission<br>between the patient and<br>equipment and to reduce<br>the loss of patient heat<br>and humidity. The filter is<br>for single patient use only<br>and therefore must be<br>disposed of after a single<br>patient usage and/or after<br>its maximum duration of<br>use at 24 hours. The<br>device is a single use<br>device that is required to<br>be changed daily when<br>used with devices (i.e.<br>long-term ventilators) that<br>are design to have patient<br>body contact between 24<br>hours to < 30 days. The<br>recommended pediatric<br>weight range is 11 kg to<br>35 kg. The recommended<br>tidal volume is 75 to 250<br>ml. | The Inter-Therm Mini<br>Pediatric HMEF Sterile is<br>for use at the patient<br>connections. The device is<br>to be attached between the<br>breathing circuit and patient<br>connection. It is designed<br>to reduce bacterial/viral<br>transmission between the<br>patient and equipment and<br>to reduce the loss of patient<br>heat and humidity. The<br>filter is for single patient<br>use only and therefore<br>must be disposed of after a<br>single patient usage and/or<br>after its maximum duration<br>of use at 24 hours. The<br>device is a single use<br>device that is required to be<br>changed daily when used<br>with devices (i.e. long-term<br>ventilators) that are design<br>to have patient body<br>contact between 24 hours<br>to < 30 days. The<br>recommended pediatric<br>weight range is 11 kg to 35<br>kg. The recommended tidal<br>volume is 75 to 250 ml. | The HMEFs are used<br>to provide heated<br>humidified air and<br>prevent cross<br>contamination<br>between the patient<br>and breathing system.<br>CO2 monitoring also<br>possible.<br>Only for use on<br>pediatric patients and<br>prescribed by a<br>physician. It is a single<br>patient use device and<br>can be used for a<br>maximum of 24 hours. |
| Where used | Hospital | Hospital | Hospital |
| Product Labeling | Inter-Therm HMEF Mini<br>Pediatric | Inter-Therm HMEF Mini<br>Angled Pediatric | DAR Infant - Pediatric<br>Electrostatic Filter<br>HME (Small) |
| Single Use or<br>Reusable? | Single patient use for<br>24 hours | Single patient use for 24<br>hours | Single patient use for<br>24 hours |
| Characteristic<br>Compared | Inter-Therm Mini<br>Pediatric HMEF sterile<br>1331030S | Inter-Therm Mini<br>Pediatric angled HMEF<br>sterile 1332030S | DAR™ Infant -<br>Pediatric<br>Electrostatic Filter<br>HME (Small)<br>355U5430<br>K941381 |
| Design and<br>Performance: | | | |
| Compressible<br>Volume (ml) | 28 | 29 | 29.5 |
| Moisture Return<br>(mg/L) | 30 @ 250ml tidal<br>volume | 30 @ 250ml tidal volume | 33.3 @ 250ml tidal<br>volume |
| Resistance to flow<br>@ 30L/min (mbar) | 2.1 | 2.2 | 3.3 |
| Weight (g) | 20.0 | 18.4 | 21.3 |
| Minimum tidal<br>volume (ml) | 75 | 75 | 75 (4) |
| Maximum tidal<br>volume (ml) | 250 | 250 | 300 (4) |
| Type of filtration | Electrostatic | Electrostatic | Electrostatic |
| Filtration efficiency<br>(%) | 99.98 BFE<br>99.95 VFE | 99.91 BFE<br>99.98 VFE | >99.99 |
| Tapers | PASS | PASS | ISO standard 15mm<br>and 22mm |
| Ageing: 5 months | PASS | PASS | N/A |
| Ageing: 5 years | PASS | PASS | N/A |
| Materials: | | | |
| HMEF housing | Acrylonitrile Butadiene<br>Styrene | Acrylonitrile Butadiene<br>Styrene | - |
| Electrostatic filter | Polypropylene-based<br>fiber blend | Polypropylene-based<br>fiber blend | - |
| HME paper | Cellulose-based paper | Cellulose-based paper | - |
| Retainable luer port<br>cap | Thermoplastic<br>Elastomer with green<br>color | Thermoplastic Elastomer<br>with green color | - |
| Energy<br>Used/Delivered: | Warm humidified air is<br>extracted from<br>expiratory air and<br>delivered to the<br>patient's inspiratory air. | Warm humidified air is<br>extracted from expiratory<br>air and delivered to the<br>patient's inspiratory air. | Warm humidified air is<br>extracted from<br>expiratory air and<br>delivered to the<br>patient's inspiratory<br>air. |
| Compatibility: | Designed for use with<br>breathing systems,<br>elbows, catheter<br>mounts and CO2<br>monitoring lines | Designed for use with<br>breathing systems,<br>elbows, catheter mounts<br>and CO2 monitoring<br>lines | Designed for use with<br>breathing systems,<br>elbows, catheter<br>mounts and CO2<br>monitoring 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

| Characteristic<br>Compared | Inter-Therm Mini<br>Pediatric HMEF sterile<br>1331030S | Inter-Therm Mini<br>Pediatric angled HMEF<br>sterile 1332030S | DARTM Infant -<br>Pediatric<br>Electrostatic Filter<br>HME (Small)<br>355U5430<br>K941381 |
|----------------------------|--------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Conical Connector<br>ends | 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 req…