(29 days)
Not Found
None
No
The summary describes a manual resuscitator and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as a "Resuscitator," intended for "pulmonary resuscitation and emergency respiratory support," which are therapeutic actions.
No
Explanation: The device is a resuscitator intended for pulmonary resuscitation and emergency respiratory support, which are treatment functions, not diagnostic ones.
No
The device is described as a "Single Patient Use Resuscitator," which is a physical medical device used for pulmonary resuscitation. The description does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pulmonary resuscitation and emergency respiratory support." This is a direct medical intervention on a patient's respiratory system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The Ambu SPUR II does not perform any such tests.
- Device Description: While the description is "Not Found," the intended use clearly indicates a device used for breathing support, not laboratory testing.
- Other Sections: The absence of information related to image processing, AI/ML, imaging modalities, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These sections are typically relevant for devices that analyze data or images, which is characteristic of some IVDs.
Therefore, the Ambu SPUR II is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).
The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.
Product codes
BTM
Device Description
Not Found
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
The Ambu® SPUR® II. Infant Single Patient Use Resuscitator is for neonates and infants.
The Ambu® SPUR® II. Pediatric Single Patient Use Resuscitator is for infants and children with a body weight up to 66lbs (30kg), approx. 9 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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 12 2004
Ms. Sanjay Parikh Technical and Regulatory Affairs Ambu, Incorporated 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356
Re: K042843
Trade/Device Name: Ambu® SPUR® II. Pediatric Single Patient Use Resuscitator and Ambu® SPUR® II. Infant Single Patient Use Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: October 13, 2004 Received: October 14, 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 Please be advised that I Dr 3 issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal sales and regisments, including, but not limited to: registration You must comply with an the Hecker of to CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), lasting (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 18, Cal requirents as set form in the quality by oversions (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) I his letter will anow you to other of substantial equivalence of your device to a premarket notification. The PDF 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), If you desire specific at 120 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dristor (800) 638-2041 or (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):
Device Name: Ambu® SPUR® II. Infant Single Patient Use Resuscitator.
Indications For Use:
The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).
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)
Quyetluon
20f 2
(Division Sigh Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: K042843
3
Indications for Use
510(k) Number (if known):
Device Name: Ambu® SPUR® II. Pediatric Single Patient Use Resuscitator.
Indications For Use:
The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.
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)
Auee Jucom
1 of $\frac{1}{4}$
(Division Sigh-Off Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number