(349 days)
None
Not Found
No
The summary describes a manual resuscitator and contains no mention of AI, ML, or related concepts.
Yes
The device is a manual resuscitator, which is used for assisted ventilation, a therapeutic intervention for patients.
No
Explanation: The device, a manual resuscitator, is intended for ventilation (treatment), not for identifying or diagnosing a condition.
No
The description clearly states "Manual Resuscitator," which is a hardware device used for ventilation. There is no mention of software as the primary or sole component.
Based on the provided information, the STURDY Manual Resuscitator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The STURDY Manual Resuscitator is a device used for manually assisting or controlling a patient's breathing. It directly interacts with the patient's respiratory system, not with samples taken from the body.
- Intended Use: The intended use clearly describes a mechanical function related to ventilation, not a diagnostic test performed on a sample.
Therefore, the STURDY Manual Resuscitator falls under the category of a medical device used for patient care, specifically respiratory support, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without added oxygen. The child model is intended for patients weighing more than 10kg. The adult model is intended for patients weighing more than 30kg.
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
Child model: patients weighing more than 10kg. Adult model: patients weighing more than 30kg.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
AUG - 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sturdy Industrial Company Limited C/O Dr. Eric Luo Lodestar Products, Incorporated 6833 Saint Lawrence Street Plano, Texas 75024
Re: K032596
Trade/Device Name: STURDY Manual Resuscitator Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: June 29, 2004 Received: June 30, 2004
Dear Dr. Luo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devises 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 approvisions of the Act. The general controls provisions of the Act include condiols provisions of the vistration, 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 (1 MA), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.
1
Page 2 - Dr. Luo
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 mean that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal states and equirements, including, but not limited to: registration 1 ou must comply with and 07); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF rear on 7), and 1007), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality aion 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) This letter whilanon yourse of substantial equivalence of your device to a premarket notification. - The PDF mails 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 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 ovean outer generational 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,
Chiu Liu, Ph.D.
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 Statement
510(k) Number (if known): __K032596
Device Name: STURDY Manual Resuscitator
Indications for Use:
The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted The STORD T Manual Resusetator 15 Intendout 16 The child model is intended for patients wore than ventillation with ambient an with of without addit only only in the edult model the more than 30kg.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032596
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