(283 days)
Not Found
No
The summary describes a manual resuscitator with no mention of AI or ML features, image processing, or data sets for training/testing.
Yes
The device is intended for manual pulmonary resuscitation and emergency respiratory support, which are therapeutic interventions.
No
Explanation: The device is described as a manual resuscitator for pulmonary resuscitation and respiratory support, not for diagnosing medical conditions.
No
The device description explicitly states it is a "hand operated resuscitator" and provides "control of the volume of delivered ventilation gas," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "manual pulmonary resuscitation and emergency respiratory support." This describes a device used on a patient to provide respiratory assistance, not a device used to test samples from a patient to diagnose a condition.
- Device Description: The description confirms it's a "hand operated resuscitator" that delivers ventilation gas. This aligns with a therapeutic or life-support device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The SAVe Resuscitator does not fit this description.
N/A
Intended Use / Indications for Use
The SAVe™ Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support.
SAVe™ Resuscitator is intended for patients with a body mass of more than 15kg (~33 lbs), approx. 3 years of age.
Product codes
BTM
Device Description
The SAVe™ Manual Resuscitator is a hand operated resuscitator that provides control of the volume of delivered ventilation gas (air or oxygenenriched gas).
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
approx. 3 years of age
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
5. 510(k) Summary
Image /page/0/Picture/2 description: The image shows a handwritten sequence of numbers. The numbers are '073410'. The numbers are written in a simple, slightly slanted style, with varying stroke thicknesses.
Image /page/0/Picture/3 description: The image shows a black and white drawing of a pair of lungs. The lungs are depicted with a stippled effect, creating a textured appearance. The overall impression is that of a medical illustration or diagram.
SEP 1 2 2008
Submitting Information:
| 510(k) Owner's Name | ArtiVent Corporation |
|---|---|
| Address | 270 Frederick Street No. 2 |
| San Francisco, CA 94117 | |
| Phone Number | 415-759-8400 |
| Fax Number | 415-759-8493 |
| Contact Person | Grace Holland |
| Company | Regulatory Specialists, Inc. |
| Contact Address | 3722 Ave. Sausalito |
| Irvine, CA 92606 | |
| Contact Phone | 949-262-0411 |
| Date | November 30, 2007 |
Device Information:
| Trade Name | SAVE™ Resuscitator |
|---|---|
| Common Name | Manual resuscitator |
| Classification Name | Ventilator, Emergency, Manual |
| (Resuscitator) | |
| CFR Reference | 868.5915 |
| Product Code | BTM |
Predicate Information:
| K # | Predicate Name | Submitter |
|---|---|---|
| K023793 | 1st Response Intermediate | |
| Manual Resuscitator | Portex Inc. | |
| K053140 | Ambu Mark IV Resuscitator | Ambu Corp. |
Device Description:
The SAVe™ Manual Resuscitator is a hand operated resuscitator that provides control of the volume of delivered ventilation gas (air or oxygenenriched gas).
1
Indications for Use:
The SAVe™ Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. SAVe Resuscitator is intended for patients with a body mass of more than 15kg (~33 lbs), approx. 3 years of age.
Summary of the technological characteristics of our device compared to the predicate devices:
The SAVe™ Resuscitator differs from the predicates, K053140, Ambu Mark IV Resuscitator and K023793, 1ª Response Intermediate Manual Resuscitator in that it has an adjustable volume control.
The SAVe™ Resuscitator is substantially equivalent to the predicates, K053140, Ambu Mark IV Resuscitator and K023793, 1st Response Intermediate Manual Resuscitator in the following respects:
-
- indications for use
-
- target population
-
- anatomical sites
-
- where used (hospital, home, ambulance, etc)
-
- energy used and/or delivered
-
- design
-
- performance
-
- standards met
-
- materials
-
- biocompatibility
-
- compatibility with the environment and other devices
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
ArtiVent Corporation C/O Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K073410
Trade/Device Name: SAVe Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: September 8, 2008 Received: September 9, 2008
Dear Ms. Holland:
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. Holland
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Th. Samuels-Lund, m.D. forel.
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
Enclosures
4
4. Indications for Use Statement Indications for Use
510(k) Number (if known): _/