(47 days)
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No
The summary describes a manual resuscitator and contains no mention of AI, ML, or any related technologies.
Yes
The device is described as a "Resuscitator," intended for "pulmonary resuscitation and emergency respiratory support," which are therapeutic actions.
No
The device description indicates its use for "pulmonary resuscitation and emergency respiratory support," which are therapeutic actions, not diagnostic ones.
No
The device description is not available, but the intended use clearly describes a physical resuscitator (Ambu SPUR II Adult Single Patient Use Resuscitator), which is a hardware device.
Based on the provided information, the Ambu SPUR II Adult Single Patient Use Resuscitator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pulmonary resuscitation and emergency respiratory support." This describes a device used to directly assist a patient's breathing, which is an in-vivo (within the living body) function.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The Ambu SPUR II does not perform any such tests.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the Ambu SPUR II is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).
Product codes
BTM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pulmonary
Indicated Patient Age Range
adult patients with a body weight of more than 66lbs (30kg)
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2004
Ms. Sanjay Parikh Technical and Regulatory Affairs Ambu. Incorporated 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356
Re: K042682
Trade/Device Name: Ambu® SPUR® II Adult Single Patient Use Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: September 28, 2004 Received: September 29, 2004
Dear Ms. Parikh:
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.
1
Page 2 - Ms. Parikh
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 (240) 276-0120. 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,
Chaves
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):
Device Name: Ambu® SPUR® II. Adult Single Patient Use Resuscitator.
Indications For Use:
.
The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).
AND/OR Over-The-Counter Use ... . . . . . . . . . . . . . . . . X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ceeer Suliom
1 of
(Division Sign-Okt) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number K042682