EXHALATION VALVE

K132143 · Intersurgical Incorporated · CBP · Jun 4, 2014 · Anesthesiology

Device Facts

• Record ID: K132143
• Device Name: EXHALATION VALVE
• Applicant: Intersurgical Incorporated
• Product Code: CBP · Anesthesiology
• Decision Date: Jun 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. A pediatric is defined as 10 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.

Device Story

Exhalation valves (MK3, MK3b) connect to single limb breathing circuits; function as interface between patient and ventilator. Device uses balloon valve mechanism; ventilator applies pressure via control line to inflate balloon, closing exhalation port during inspiration; pressure release deflates balloon during expiration, allowing air exhaust. Prevents rebreathing; enables single limb system use. Used in hospital and home settings; operated by clinicians or patients/caregivers. Provides pressure control and enables spontaneous breath triggering. Benefits include reduced circuit clutter/waste; improved ventilator compatibility via integrated connectors; 30-day usage duration.

Clinical Evidence

Bench testing only. Evaluated resistance to flow, pressure ratio, leakage, and connector tapers. Biocompatibility testing per ISO 10993-1 (genotoxicity, implantation, cytotoxicity, sensitization, irritation). Validated for 30-day use.

Technological Characteristics

Materials: HDPE (body), Polypropylene (cap), Polycarbonate (chamber), Silicone (valve). Conical connectors per ISO 5356-1:2004. Non-sterile. Single patient use. Mechanical balloon valve actuated by pneumatic pressure from ventilator. Integrated proximal pressure port (select models).

Indications for Use

Indicated for adult and pediatric patients (≥10 kg) requiring ventilation via a single limb breathing system to control inspiratory pressure and expel expired air. Not for use in neonates. Prescription use only.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Predicate Devices

• Intersurgical 1922500 exhalation valve (K984481)

Submission Summary (Full Text)

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K132143

# JUN 0 4 2014

# Section 5 510(k) Summary

### 510K Submitter Address and Establishment Registration Number:

Registration Number: 1319447 Name: INTERSURGICAL INCORPORATED 417 Electronics Parkwav Address: Liverpool, NY 13088 Date: May 2, 2014 Contact Person: Michael Zalewski - VP RAIQA/CS Phone Number: 315-451-2900 X 202 Fax Number: 315-451-3696

Classification: 21 CFR 868.5870, Classification Name: Non-rebreathing Valve, Classification Product Code: 73 CBP, Device Class: II, 510K Submission: Traditional.

### Predicate Device:

The 1923500 & 1924501 MK3 exhalation valve and the 1924504 MK3b exhalation valves are substantially equivalent to the Intersurgical 1922500 exhalation valve (K984481). The predicate device can be used on a single limb breathing systems. The valve sits on a T-piece connected at the patient end of the breathing tube. When the patient inspires, pressure applied via the exhalation line inflates the valve membrane causing it to close off the exhalation port. Then when the patient exhales the pressure on the membrane is released allowing the exhaled air to escape. The predicate valve has a 1:2 pressure ratio similar to the MKIIIb. The device is for single patient use on adults and pediatrics.

The function of all three valves is the same, however the MK3 and MK3b can seal with a low inspiratory drive in order that the ventilator can trigger a spontaneous breath. IPPB machines in the past had no requirement for PEEP control. however ventilators are generally now fitted with controllable PEEP modes

The predicate device is aesthetically different to the MK3 and MK3b, the MK3 valves are now inline, reducing the need for additional connectors.

### Description of Device:

Double limb breathing systems comprising of an inspiratory and expiratory limb is commonly used for respiratory care. To reduce waste and clutter single limb breathing systems can be used with an exhalation valve to dispel exhaled air from the patient. Some ventilator designs or specifications do not require proximal pressure monitoring; airway pressure is monitored inside the ventilator. There are three variants of the exhalation valve in this submission.

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### Description of Device:

### Exhalation valve with proximal pressure port (1924501 &1924504)

A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. A pressure monitor line and exhalation valve control line directly connects the valve to the ventilator. Via exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases yet allowing for a single limb breathing system to be used instead of a double limb system. The pressure line monitors the pressure in the valve body. The patient end of the exhalation valve has a swivel connector end.

#### Exhalation valve without proximal proximal prossure port (1923500)

A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. An exhalation valve control line directly connects the valve to the ventilator. Via the exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases vet allowing for a single limb breathing system to be used instead of a double limb system. The patient end of the exhalation valve has a swivel connector end.

Different ventilators require valves which work with different pressure ratios. The MKIII exhalation valve (1923500 and 1924501) has a 1:1.5 pressure ratio which caters for the majority of ventilators. However, there are markets which have applications for ratio of 1:1, and 1:2. The MK3b exhalation valve (1924504) has a 1:2 pressure ratio. The pressure ratio is the pressure difference between the control line pressure and the pressure that will be generated on the patient side of the valve.

#### Indications for Use:

The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.

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## Technology Characteristics Summary

The intended use of the Intersurgical Exhalation Valves 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 resistance to flow, pressure ratio and leakage when compared to the legally marketed devices.

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

| Characteristic<br>Compared | MK3 Exhalation Valve<br>-1923500 non-ported<br>and 1924501 ported | MK3b Exhalation<br>Valve - 1924504<br>ported | Predicate Exhalation<br>Valve 1922500<br>K984481 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:<br>Target population | Adult/pediatric patient<br>using a single limb<br>breathing tube. | Adult/pediatric patient<br>using a single limb<br>breathing tube. | Adult/pediatric patient<br>using a single limb<br>breathing tube. |
| Indications for use<br>Product has been designed<br>and validated for 30 days<br>whereas predicate product<br>was not. It is an<br>improvement on the<br>product, the performance<br>remains comparable to the<br>predicate. | The exhalation valves<br>are used to control<br>Inspiratory pressure and<br>expel the expired air<br>from a patient being<br>ventilated via a single<br>limb breathing system.<br>The exhalation valve and<br>single limb breathing<br>systems are used with<br>adults/pediatrics and<br>prescribed by a<br>physician. The device<br>can be used within<br>hospitals and for home<br>care use. It is a single<br>patient use device and<br>can be used for a<br>maximum of 30 days. | The exhalation valves<br>are used to control<br>Inspiratory pressure and<br>expel the expired air<br>from a patient being<br>ventilated via a single<br>limb breathing system.<br>The exhalation valve<br>and single limb<br>breathing systems are<br>used with<br>adults/pediatrics and<br>prescribed by a<br>physician. The device<br>can be used within<br>hospitals and for home<br>care use. It is a single<br>patient use device and<br>can be used for a<br>maximum of 30 days. | A one-way valve that<br>prevents the escape of<br>inspiratory gases and<br>rebreathing of of<br>expired gases while<br>providing a means of<br>egress for expired gases.<br>Fits all 22 male T-pieces<br>and allows for the use of<br>PEEP valve as the gases<br>exit the valve via a<br>22mm port.<br>Recommended change:<br>every 24 hours or more<br>frequently if visible<br>deterioration is<br>observed. Single patient<br>use. |

## Device Comparison Table

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# Device Comparison Table

| Characteristic<br>Compared | MK3 Exhalation Valve<br>3500 non-ported<br>1924531 DOI | 3b.Exhalation<br>11:48 | Predicate Exhala<br>Valve 1922500 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Where used | Hospital and home | Hospital and home | Hospital and home |
| Product Labeling | Breathing circuit<br>with<br>exhalation valve. | Breathing circuit with<br>exhalation valve. | Breathing<br>circuit<br>with<br>exhalation valve. |
| Single Use or Reusable? | Single Patient Use | Single Patient Use | Single Patient Use |
| Design<br>and<br>Performance: | | | |
| Flow<br>Resistance<br>to<br>at<br>10L/min in mbar | 0.6 | 0.6 same body as MK3 | 0.6 |
| Resistance<br>to<br>Flow<br>at<br>30L/min in mbar | 0.9 | 0.9 same body as MK3 | 1.0 |
| Pressure Ratio | 1:1.5 | 1:2 | 1:2 |
| Leakage<br>balloon<br>in<br>ml/min | <0.5 | 0.0 | <0.5 |
| Leakage<br>in main<br>body<br>ml/min | <0.5 | 1.3 | 3.5 |
| Conditioned/storage<br>testing (-20 degrees + 50<br>degrees) | Same as mk3b | Complete and pass | Complete and pass |
| Tapers | Pass | Pass | Pass |
| Aging 5 year | Pass | Pass | No test work conducted |
| 30 day testing | Pass | Same as MK3 | Pass |
| Trigger | Trigger by 30ms | Same as MK3 | N/a different design |
| Internal Diameter of seat<br>mm | 17.17 +/- 0.05 | 15.5 +/- 0.04 | N/a different design |
| Materials: | | | |
| Body | HDPE | HDPE | Styrene Butadiene |
| Cap | Polypropylene | Polypropylene | Polypropylene |
| Chamber | Polycarbonate | Polycarbonate | N/A |
| Valve | Silicone | Silicone | Silicone |
| Swivel Color | Trans (Clear) Styrene<br>Butadiene | Green Styrene<br>Butadiene | N/A |
| Energy Used/Delivered: | Air flow through device<br>used to deliver<br>inspiratory air and<br>exhale expiratory air<br>to/from patient | Air flow through device<br>used to deliver<br>inspiratory air and<br>exhale expiratory air<br>to/from patient | Air flow through device<br>used to deliver inspiratory<br>air and exhale expiratory<br>air to/from patient |
| Compatibility: | Designed for use with<br>single limb breathing<br>tube | Designed for use with<br>single limb breathing<br>tube | Designed for use with<br>single limb breathing tube |
| Biocompatibility: | ISO 10993 | ISO 10993 | |
| Sterility: | Non Sterile | Non Sterile | Non Sterile |
| Applicable Standards: | | | |
| Standards Met: | ISO 5356 (Connectors) | ISO 5356 (Connectors) | ISO 5356 (Connectors) |

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### Summary of Testing:

Both subject and predicate devices are for use in the hospital and home and are single patient use.

The target population is adult and pediatric patients using a single limb breathing tube. A pediatric population is defined as 10 kg in weight. The product is not for use in neonates.

The resistance to flow through the valve is the same for both predicate and the subiect valve.

The pressure ratio for the MK3b and predicate device are exactly the same, meaning it will provide the same performance on the ventilators.

The subject and predicate valve have the same principal of operation.

Although there are a few performance differences between the subject and the predicate devices the intended use is the same. They are used in the same configuration i.e. on a breathing system, connected to a ventilator, except the subject devices incorporate the connector into the design making it more economical, and saves on deadspace.

The leakage in the balloon and the main body is slightly higher in the predicate device than the subject devices, however this leakage is minimal. Intersurgical's internal requirement is for devices to leak less than 5ml/min, however most standard requirements are much larger than this. There is no standard requirement for exhalation valves. The less leakage the more efficient the device will be.

The trigger feature is an additional function which the predicate device is unable to perform, this is a benefit with the new valves and does not alter the intended use, it just means the subject valves can be used on more ventilators. The new valves are validated for patient trigged spontaneous breaths.

The predicate device was previously validated for 24 hours whereas the subject device have been shown to work without any impairment to the performance for 30 days. The predicate device has not been tested for this duration.

Nonclinical tests submitted to demonstrate substantial equivalence for the Exhalation Valve include Resistance to Flow, Pressure Ratio, Leakage and Tapers when compared to the legally marketed device. All materials used in the Exhalation Valve 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 genetotoxicity, implantation, cytotoxicity, sensitization, and irritation. The Exhalation Valve connectors meet the requirements of Anesthetic and respiratory equipment - conical connectors: Part 1: Cones and Sockets ISO 5356-1:2004.

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## Substantial Equivalence:

Intersurgical Incorporated has demonstrated that the proposed device is as safe and as 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.

## K132143

Premarket Notification [510(k)] Number

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled 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-G60 Silver Spring, MD 20993-0002

June 4, 2014

Intersurgical. Inc. Michael Zalewski Vice President, RA/QA/CS 417 Electronics Parkway Liverpool, NY 13088-6098

Re: K132143

Trade/Device Name: Exhalation valve Regulation Number: 21 CFR 868.5870 Regulation Name: Non-rebreathing Valve Regulatory Class: II Product Code: CBP Dated: May 05, 2014 Received: May 06, 2014

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 10 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: CDRFI 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. Michael 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/ResourcesforYou/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,

MarySBunner-S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Slatement on last page.

#### 510(k) Number (if known) K132143

#### Device Name

Indications for Use (Describe)

Product # 1923500 - MK3 Exhalation Valve without a proximal pressure port Product # 1924501 - MK3 Exhalation Valve with a proximal pressure port Product # 1924504 - MK3b Exhalation Valve with a proximal pressure port

Product # 1924904 - RRS-30 Exhalation Valve with a proximal pressure port.

indications For Use: The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatios and prescribed by a physician. A pediation is defined as 10 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and ean be used for a maximum of 30 days.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY |
|------------------------------------------------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Anya C. Harry -S |
| 2014.06.04 |
| 05:38:03 -04'00' |