(331 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ventilator functionality and control by software, not adaptive or learning algorithms.
Yes
The device is a ventilator used to provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, which directly aims to treat and manage their medical condition.
No
This device is a ventilator, which provides ventilatory support, not diagnostic information. Its intended use is to deliver oxygen-enriched air and administer nebulized medications, which are therapeutic functions.
No
The device description explicitly states it is a "portable, computer controlled, electrically powered ventilator" and mentions an "internal battery," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the SmartVent™ 201 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The SmartVent™ 201 is a ventilator, which is a device that provides mechanical breathing support directly to a patient. It does not analyze biological samples.
- The intended use and device description clearly state its function is to provide ventilatory support to patients. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
Therefore, the SmartVent™ 201 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- Assist/Control (Pressure Controlled or Volume Controlled) .
- SIMV (Pressure Controlled or Volume Controlled) .
- CPAP/PSV ●
The SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
The SmartVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The SmartVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the SmartVent™ 201 Software.
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
adult and pediatric patients
Intended User / Care Setting
qualified, trained personnel under the direction of a physician; intra-hospital use, home and alternate-site use, transport and energy use.
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)
a series of safety and performance testing including a comparative study and analysis of similarities and differences
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or other winged creature, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2004 APR 1
Jerome Korten President and CEO Versamed Corporation 2 Blue Hill Plaza Pearl River, NY 10965
Re: K981668
Trade/Device Name: SmartVent™ 201 Portable Ventilator Regulatory Class: II (Two) Product Code: 73 CBK Dated: January 10, 1999 Received: January 14, 1999
Dear Jerome Korten:
This letter corrects our substantially equivalent letter of April 7, 1999. 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 (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 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.
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
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Page 2- Mr. Korten
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toU free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
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
2
INDICATIONS FOR USE
510(k) Number (if known): K981668
Device Name: SmartVent™ 201 Portable Ventilator
Indications for Use:
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- Assist/Control (Pressure Controlled or Volume Controlled) .
- SIMV (Pressure Controlled or Volume Controlled) .
- CPAP/PSV ●
The SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
The SmartVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K981668
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
Signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Numbe
3
4/7/99
510(k) Summary Ultramind International Ltd. SmartVent™ 201 Portable Ventilator 510(k) Number K 981668
Submitter's Name:
A.M.E. Ltd. 14 Raul Wallenberg St. Ramat Hachayal, Tel-Aviv 69719, Israel
Contact Person:
Shoshana Friedman 117 Ahuzah St. Ra'ananna 43373, Israel Tel: 972-9-771-8130 Fax: 972-9-771-8131
Trade Name:
SmartVent™ 201 Portable Ventilator (Temporary name)
Classification Name:
Continuous Ventilator
Classification:
The FDA has classified these devices as a class II device (product code 73 CBK) and are reviewed by the Anesthesiology, Respiratory, and Defibrillator Devices Group.
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Predicate Devices:
The SmartVent™ 201 Portable Ventilator is substantially equivalent to:
- · TBIRD VS & AVS Ventilators (Bird Product Co.), cleared under K950484
- · Oxylog 2000 (Dräger, Inc.), cleared under K943531.
Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the SmartVent™ 201 Portable Ventilator complies with the following voluntary standards: ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1, ISO 10651-2, ISO 10651-3, EN 60601-1-1, EN 60601-1-2.
Indication for Use:
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- · Assist/Control (Pressure Controlled or Volume Controlled)
- · SIMV (Pressure Controlled or Volume Controlled)
- · CPAP/PSV
The SmartVent™ 201 ventilator is suitable for inter-hospital use, home and alternate-site use, transport and emergency use.
The SmartVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
Device Description:
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The
5
SmartVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the SmartVent™ 201 Software.
Substantial Equivalence:
Based on a series of safety and performance testing including a comparative study and analysis of similarities and differences we believe that the SmartVent™ 201 is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.