PLV CONTINUUM VENTILATOR, MODEL P1000

K022750 · Respironics California, Inc. · NOU · Nov 20, 2003 · Anesthesiology

Device Facts

• Record ID: K022750
• Device Name: PLV CONTINUUM VENTILATOR, MODEL P1000
• Applicant: Respironics California, Inc.
• Product Code: NOU · Anesthesiology
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation. PLVC is not intended for use as an emergency transport ventilator. It is not intended for use in the presence of flammable anæsthetics. PLVC is a prescription use device that is intended for sale by or on the order of a physician.

Device Story

PLV Continuum is a microprocessor-controlled, compressor-based mechanical ventilator. It delivers room air to patients via invasive or non-invasive interfaces. Device utilizes an internal compressor to generate compressed air; breath delivery is managed by software algorithms. User interface features a membrane keypad and LED indicators for setting selection and alarm monitoring. Supports A/C, SIMV, CPAP, Volume-Controlled (VC), Pressure-Controlled (PC), and Pressure Support (PS) modes. Used in home, institutional, and portable settings by clinicians or trained caregivers. Output allows healthcare providers to monitor ventilatory status and adjust therapy parameters. Benefits include providing necessary respiratory support for patients requiring mechanical ventilation.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F 1100-90 and F 1246-91. EMC testing performed per IEC 60601-1-2. Electrical, mechanical, and environmental testing performed per FDA Draft Reviewer Guidance (1993). Software validation performed per FDA Guidance (1998).

Technological Characteristics

Microprocessor-controlled, compressor-based ventilator. Internal compressor generates compressed air. Membrane keypad and LED user interface. Supports invasive and non-invasive ventilation. Software-controlled breath delivery. Tested to ASTM F 1100-90, ASTM F 1246-91, and IEC 60601-1-2.

Indications for Use

Indicated for pediatric and adult patients weighing at least 5 kg (11 lbs) requiring continuous or intermittent mechanical ventilatory support. May be used invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). Contraindicated for emergency transport and use in the presence of flammable anesthetics.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Respironics PLV-102 Ventilator (K842876)
• Respironics Esprit Ventilator (K981072)
• Pulmonetic Systems LTV 1000 (K984056)

Submission Summary (Full Text)

{0}------------------------------------------------

KOZZ750

NOV 2 0 2003

### SUMMARY OF SAFETY AND EFFECTIVENESS 16

| Company<br>Information: | Respironics, California Inc.<br>2271 Cosmos Court<br>Carlsbad, CA. 92009 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Information: | Mary Funk<br>Regulatory Affairs Project Manager |
| | Phone Number: [phone]<br>Fax Number: [phone] |
| Date Prepared: | June 25, 2002 |
| Product Name: | PLVC Ventilator |
| Common Name: | Ventilator |
| Classification: | Class II<br>Continuous Ventilator (per 21 CFR 868.5895) |
| Predicate<br>Devices: | • Respironics PLV-102 Ventilator K842876<br>• Respironics Esprit Ventilator K981072<br>• Pulmonetic Systems LTV 1000 K984056 |

#### Device Description: 16.1

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PLV Continuum is capable of providing the following types of ventilatory support:

- Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece).
- Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
- Volume-Controlled (VC). Available in A/C and SIMV. .
- Pressure-Controlled (PC). Available in A/C and SIMV. .
- Pressure Support (PS). Available in SIMV and SPONT. ●

{1}------------------------------------------------

#### 16.2 Intended Use:

The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

PLVC is not intended for use as an emergency transport ventilator. It is not intended for use in the presence of flammable anæsthetics. PLVC is a prescription use device that is intended for sale by or on the order of a physician.

#### 16.3 Technological Characteristics:

Like other continuous ventilators, PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator (reference K981072). PLVC does not incorporate any new technological characteristics.

#### 16.4 Determination of Substantial Equivalence:

The modes of ventilation on PLVC are similar to those on other currently marketed continuous ventilators. PLVC has similar performance characteristics to the predicate devices, the same intended use, same environment of use and patient populations. PLVC does not raise new questions of safety or effectiveness. The PLVC labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices.

#### 16.5 Summary of Performance Testing:

Performance testing was conducted per the applicable sections of ASTM F 1100-90 and F 1246-91. EMC testing was performed per IEC 60601-1-2. Electrical, mechanical and environmental testing was performed in accordance with the FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993). Software validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all testing demonstrate that all design and system requirements for the PLV Continuum have been met.

#### 16.6 Conclusion:

The technological characteristics of the PLV Continuum ventilator and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Respironics, California Incorporated Ms. Mary Funk Regulatory Affairs Project Manager Hospital Division 2271Cosmos Court Carlsbad, California 92009-1517

Re: K022750

Trade/Device Name: PLV Continuum Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: NOU, CBK Dated: August 25, 2003 Received: August 26, 2003

Dear Ms. Funk:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 - Ms. Funk

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Ole

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Respironics PLV Continuum Ventilator 510(k) Premarket Notification

## Indications For Use Statement

Applicant:

Respironics (California) Inc. 2271 Cosmos Court Carlsbad, CA 92009 USA

K022750 510(k) Number:

PLV Continuum Ventilator Device Name:

Indications for use:

The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

Prescription Use:

Yes (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

---

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022750

Prescription Use V

or

OTC Use