(78 days)
No
The document describes a microprocessor-controlled ventilator with software for breath delivery, but there is no mention of AI or ML in the intended use, device description, or performance studies. The software validation is based on 1998 guidance, which predates widespread AI/ML in medical devices.
Yes
The device is a ventilator used to provide ventilatory support for individuals requiring mechanical ventilation, which directly impacts and improves a patient's health condition.
No
This device is a ventilator, designed to provide ventilatory support by delivering air to a patient. Its function is to assist breathing, not to diagnose a medical condition.
No
The device description explicitly states it is a "microprocessor controlled, compressor-based, ventilator" and utilizes an "internal compressor to generate compressed air," indicating it is a hardware device with integrated software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device provides "continuous or intermittent ventilatory support" for patients requiring mechanical ventilation. This is a direct therapeutic intervention on a living patient.
- Device Description: The description details how the device delivers air to the patient and controls breathing parameters. This is a life support function, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This ventilator does not perform any of these functions.
N/A
Intended Use / Indications for Use
The intended use of the PLVC II 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 II 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.
Product codes
73 CBK, 73 NOU
Device Description
The PLV Continuum ventilator is a microprocessor controlled, compressor-based, continuous ventilator designed to provide ventilatory support 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. PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings. The 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, Synchronized 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
The PLV Continuum II ventilator is intended for use in home, institutional and portable settings.
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 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 modified PLV Continuum have been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text "K03403Z" in a bold, sans-serif font. The text is oriented diagonally, sloping upwards from left to right. The characters are large and clearly legible, with a slight distortion or blurriness that suggests the image may be a scan or photograph of a physical document.
Modification to PLV Continuum Ventilator 510(k) Premarket Notification
MAR 1 6 2004
510(k) SUMMARY 16
| Company
Information: | Respironics, California Inc.
2271 Cosmos Court
Carlsbad, CA. 92009 | |
|-------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------|
| Contact
Information: | Mary Funk
Regulatory Affairs Project Manager | |
| | Phone Number: (760) 918-7328
Fax Number: (760) 918-0169 | |
| Date Prepared: | December 3, 2003 | |
| Product Name: | PLV Continuum II Ventilator | |
| Product Code: | 73 CBK; 73 NOU | |
| Common Name: | Ventilator | |
| Classification: | Class II
Continuous Ventilator (per 21 CFR 868.5895) | |
| Predicate
Devices: | • Respironics PLVC Ventilator
• Respironics Esprit Ventilator
• Pulmonetics LTV 1000 Ventilator | K022750
K981072
K984056 |
Device Description: 16.1
The PLV Continuum ventilator is a microprocessor controlled, compressor-based, The PLV Continuum ventilator is a mioroprobocour cannothing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generalled by offware air to the patient. FLV Continuin untile Breath delivery is controlled by software compressed an for delivery to the patient. Broadm has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient Indicator Light Enlitting Diodos (EEB) for the continuum is capable of providing the following types of ventilatory support:
- Positive Pressure Ventilation, delivered either invasively (via endotracheal or . r osltive 1 roosarely (via mask or mon-invasively (via mask or mouthpiece).
- tracheolonny table/ intermittent Mandatory Ventilation (SIMV) or . Assist Control, "Opentanov 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 PLVC II is to provide continuous or intermittent ventilatory rno intention as a re of individuals who require mechanical ventilation. The intended Support for the our of increasiatric and adult patients who weigh at least 5 kg (11 pation: population ninuum ventilator is intended for use in home, institutional and 1007. He 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.
Technological Characteristics: 16.3
Like other continuous ventilators, PLVC II 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 algontinus that the entilator (K022750). PLVC II does not incorporate any new technological characteristics.
Determination of Substantial Equivalence: 16.4
The modes of ventilation on PLVC II are the same as the current PLVC, K022750 as well as other currently marketed ventilators. PLVC II has similar performance characteristics to the predicate devices with the same intended use, the same environment of use and patient populations. The PLVC II labeling and instructional information, including warning and caution statements, is standard for critical care ventilators used in institutional and home care environments.
Summary of Performance Testing: 16.5
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 modified PLV Continuum have been met.
16.6 Conclusion:
The technological characteristics of the modified 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
· Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2004
Ms. Mary Funk Regulatory Affairs Project Manager Respironics, California Incorporated 2271Cosmos Court Carlsbad, California 92009-1517
Re: K034032
Trade/Device Name: PLV Continuum II Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: NOU, CBK Dated: December 26, 2003 Received: December 29, 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 (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.
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for
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
Indications For Use Statement
| Applicant: | Respironics California, Inc.
2271 Cosmos Court
Carlsbad, CA 92009
USA |
|----------------|--------------------------------------------------------------------------------|
| 510(k) Number: | K034032 |
PLV Continuum II Device Name:
Indications for use: The intended use of the PLV Continuum II 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 II 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 Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KD 34032 510(k) Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
OTC Use ______________________________________________________________________________________________________________________________________________________________________