(331 days)
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.
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.
This document is a 510(k) summary for the SmartVent™ 201 Portable Ventilator, and it does not contain the detailed information required to describe specific acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document states:
- "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."
- It also lists several voluntary performance standards that the device complies with (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).
However, it does not provide:
- A table of acceptance criteria and reported device performance: While voluntary standards are listed, specific pass/fail metrics and the device's measured performance against them are not detailed.
- Sample size used for the test set and data provenance: The "comparative study" is mentioned but no details on sample size or data origin are provided.
- Number of experts and their qualifications for ground truth: Not applicable for a ventilator's technical performance study.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: This is not a study focused on human reader improvement with AI in image analysis, so it's not applicable.
- Standalone (algorithm only) performance: Not applicable as this is a medical device, not an AI algorithm. Its performance is intrinsic to its design and function.
- Type of ground truth used: Not explicitly stated beyond "safety and performance testing."
- Sample size for the training set: Not applicable for a physical device's performance testing.
- How ground truth for the training set was established: Not applicable.
Therefore, I cannot fulfill the request with the provided input. This document is a regulatory approval letter and a summary, not a detailed performance study report.
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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
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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
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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
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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.
§ 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).